bioethics, sport and the genetically enhanced athlete (2002)

OBSAH / CONTENTSMEDICÍNSKAETIKA&BIOETIKA

MEDICALETHICS&BIOETHICS

ČASOPIS PREMEDICÍNSKU ETIKU A BIOETIKU

JOURNAL FORMEDICAL ETHICS AND BIOETHICS

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BRATISLAVA, SLOVAK REPUBLICAutumn– Winter 2002 Vol. 9 No. 3 – 4

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PPPPôôôôvvvvooooddddnnnnéééé pppprrrráááácccceeee////OOOOrrrriiiiggggiiiinnnnaaaallll ppppaaaappppeeeerrrrssss ................................................................................................................................................................................................................................................................................................................................................2222 – Bioethics, Sport and the Genetically Enhanced Athlete.

[Bioetika, šport a geneticky zvýhodnený atlét.] A. Miyah .......................... 2– Borderline Viability Resuscitation Cases.

[Resuscitácia v prípadoch hraničnej životaschopnosti.] D. O’Brien ..... 6– K problému revitalizácie etických komisií v Slovenskej republike.

[Contribution to the Problem of Revitalisation of Ethics Committees in the Slovak Republic.] J. Glasa ............................ 10

■ DDDDooookkkkuuuummmmeeeennnnttttyyyy////DDDDooooccccuuuummmmeeeennnnttttssss ................................................................................................................................................................................................................................................................................................................................................................................................................11112222– CIOMS: International Ethical Guidelines for Biomedical Research

Involving Human Subjects (excerpts). [CIOMS: Medzinárodné etické smernice pre biomedicínsky výskum s účasťou ľudských osôb (výňatky).] ............................................................... 15

– Europan Parliament: European Strategy in the field of Biotechnologies. [Európsky parlament: Európska stratégia na poli biotechnológií.] ................................................. 19

– Záverečný dokument Medzinárodnej konferencie o bioetike v strednej a východnej Európe, [Final Statement of the International Conference on Bioethics in Central and Eastern Europe.], Vilnius, 10. - 12. 11. 2002 .................. 22

– Pontificial Academy for Life: The Nature and Dignity of the Human Person. [Pontifikálna akadémia pre život: Podstata a dôstojnosť ľudskej osoby.] ............................................................. 22

– Assisi Decalogue for Peace. [Dekalóg mieru z Assisi.] .............................. 24– Etický kódex lekára a zubného lekára (príloha zákona

NR SR č. 219/2002 o povolaní lekára a zubného lekára). [Code of Practice of Physician and Physician-Stomatologist (appendix to the Law of the NC SR No. 219/2002 on the profession of physician and physician-stomatologist).] ................................................. 24

■ KKKKoooonnnnffffeeeerrrreeeennnncccciiiieeee////CCCCoooonnnnffffeeeerrrreeeennnncccceeeessss ....................................................................................................................................................................................................................................................................................................................................................................................................22225555– International Bioethics Conference - Ethics in Science and Research.

[Medzinárodná bioetická konferencia - Etika vo vede a výskume.], Bratislava, 18. - 19. 3. 2002 J. Glasa .................................................................. 25

– Medzinárodná bioetická konferencia - Etika humánnej genetiky: Problémy (post)genómovej éry. [International Bioethics Conference - Ethics of Human Genetics: Challenges of the (Post)Genomic Era.], Bratislava, 23. - 24. 10. 2002 J. Glasa ............................................................... 26

■ IIIInnnnššššttttiiiittttúúúúcccciiiieeee////IIIInnnnssssttttiiiittttuuuuttttiiiioooonnnnssss ........................................................................................................................................................................................................................................................................................................................................................................................................................................22228888– Department of Medical Education of S.P.A.M. - 25 Years.

[Katedra medicínskej pedagogiky S.P.A.M. - 25 rokov.] Z. Takáčová, J. Glasa .............................................................................................. 28

■ OOOO kkkknnnniiiihhhháááácccchhhh////BBBBooooooookkkk RRRReeeevvvviiiieeeewwwwssss ............................................................................................................................................................................................................................................................................................................................................................................................................33330000– CIOMS: International Ethical Guidelines for Biomedical Research

Involving Human Subjects. J. Glasa ................................................................. 30■ OOOObbbbssssaaaahhhh rrrrooooččččnnnnííííkkkkaaaa 9999 ((((2222000000002222)))) //// CCCCuuuummmmmmmmuuuullllaaaattttiiiivvvveeee CCCCoooonnnntttteeeennnnttttssss ooooffff tttthhhheeee VVVVoooollll.... 9999 ((((2222000000002222))))........................33332222

An issue, mainly for those countries and perhaps less pertinent now than inthe past, has been the extent to which ethical principles are considered universalor as culturally relative – the universalist versus the pluralist view. The challengeto international research ethics is to apply universal ethical principles to biomedi-cal research in a multicultural world with a multiplicity of health-care systems andconsiderable variation in standards of health care. The Guidelines take the posi-tion that research involving human subjects must not violate any universally appli-cable ethical standards, but acknowledge that, in superficial aspects, the applica-tion of the ethical principles, e.g., in relation to individual autonomy and informedconsent, needs to take account of cultural values, while respecting absolutely theethical standards.

Related to this issue is that of the human rights of research subjects, as well asof health professionals as researchers in a variety of sociocultural contexts, andthe contribution that international human rights instruments can make in theapplication of the general principles of ethics to research involving human sub-jects. The issue concerns largely, though not exclusively, two principles: respectfor autonomy and protection of dependent or vulnerable persons and popula-tions. In the preparation of the Guidelines the potential contribution in theserespects of human rights instruments and norms was discussed, and the Guidelinedrafters have represented the views of commentators on safeguarding the corres-ponding rights of subjects.

CIOMS: International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva, 2002, p. 11.

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Andy Miah

University of Paisley, Paisley, Scotland,United Kingdom

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This paper begins by acknowledging the interest ta-ken by various international organisations in geneticenhancement and sport, including the US President’sCouncil on Bioethics (July, 2002) and the World Anti-Do-ping Agency (March, 2002). It is noticed how sportingorganisations have been particularly concerned to em-phasise the ‘threat’ of genetics to sport, whereas otherinstitutions have recognised the broader bioethical issuesarising from this prospect, which do not readily rejectthe use of genetic technology in sport. Sports are identi-fied as necessarily ‘human’ and ‘moral’ practices, theexploration of which can reveal greater insight into theintuitive fears about genetic modification. It is arguedthat anti-doping testing measures and sanctions unac-ceptably persecute the athlete. While there are substan-tial reasons to be concerned about the use of geneticmodification in sport, the desire for policy ought notdiminish the need for ethical research; nor ought suchresearch embody the similar guise of traditional ‘anti’doping strategies. Rather, the approach to genetics insport must be informed more by broader social policiesin bioethics and recognition of the greater goods arisingfrom genetic technology.

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The prospect of using genetic technology to augmentathletic performance is, for many, an abhorrent misuseof science. Prima facie, there are far more worthwhileuses to which genetics can be put. Additionally, the ge-netic science does not yet seem anywhere near beingable to enhance humans safely, or with any certainty ofthe effects. Yet, the climate of performance modificationin sport has provoked concerns about whether athleteswill now seek the use of genetic modification (GM) toevade anti-doping testing procedures. Consequently, thetopic has given rise to questioning the merits of geneti-cally modified athletes and, particularly, how we canensure that such humans do not emerge. To this extent,the emerging discourse about GM in sport has alreadybecome one of prevention, not of reflective value ques-tioning. GM sport has already been concluded by keysporting organisations such as the International OlympicCommittee (IOC) and the World Anti-Doping Agency(WADA) as unethical, nay, immoral. Their strategy is toestablish the means by which it is possible to maintain adistance between GM and sport.

While recognising that there are good reasons to beweary of GM in sport, I argue that this approach over-looks a significant philosophical opportunity, which isprovided by the prospect of genetically modifying athle-tes. Such a possibility offers a tangible human and social

context within which it is possible to question the valueof genetic technologies more deeply. Sport is a contextabout which many people have strong feelings of therebeing a valued ‘human’ and ‘moral’ component that seemsthreatened by genetically modifying people. Exploringwhat these components are, I suggest, can providegreater insights into our understanding of what is valu-able about being human and why this is challenged bygenetic manipulation. It is partly for this reason that I cri-tique the ‘anti’ position in regard to GM in sport. How-ever, my rationale for considering this topic is also basedupon the specific ethical issues, which are facing sport-ing authorities, as well as emerging scientific researchthat indicates why genetically modified athletes areimminent.

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It is only in the last 2 years that any serious attentionhas been given to the prospect of GM in sport both in theacademic literature and in the organisation of sport. Yet,a significant amount of research has taken place in sportregarding the ethics of performance enhancement insport generally. This work has emerged largely out of thesporting side of ethics, rather than biomedicine, emana-ting significantly from post-1980 volumes of the Journalof the Philosophy of Sport, journal of the InternationalAssociation for the Philosophy of Sport, established 1972.These articles range in their method of argumentation,a number of which include the following:

1. Coercion: Permitting drug use is permitting anenvironment that forces athletes into choosing drugs toremain competitive, thus risking harm to their life. (8, 11,29, 34, 36).

2. Unfair: Permitting drug use has some unfair con-sequence for either the participating athletes, othermembers of the sporting community, or over the sportitself. (8, 11, 14, 28, 31, 34, 35, 36).

3. Health Risk: Permitting drug use entails a substan-tial risk to the biological constitution of an athlete, whichis unacceptable, unnecessary, and undesirable. (3, 11, 28,31, 34-36).

4. Unnatural: drugs are unethical because sportingperformances are supposed to be natural, which drugsare not. (9-11, 28, 30, 35).

5. Rule Breaking / Cheating / Respect: Drug taking isunacceptable because it is against the rules. Thus, usingthem is cheating and demonstrates a lack of respect forother participants and the sport. (1, 10, 33, 34).

6. Unearned advantage: Because drugs are not permit-ted, using prohibited drugs provides an unfair advantageover other competitors and the sport (5).

7. Contrary to / Does not promote the internal goodsof sport: Sport is valued because of the ‘internal goods’(16) and the use of drugs does not contribute and is con-trary to such goods. As such, it is unethical. (30).

8. Contrary to the nature of sport: Sport has an inter-nal essence that is compromised by the use of drugs. Assuch, their use is unethical. (34, 36).

9. Contract Violation: Entering into sporting competi-tion entails making a tacit contract with one’s opponentto play under the same conditions, failing to do this byusing drugs which are not agreed upon means, breaksthis contract. (4, 6, 7, 13, 22, 36).

However, bioethics writers such as Thomas H. Murray(25-27), Christian Munthe (23, 24) and Michael Shapiro(32) have given some time to considering the ethics ofperformance modification in sport, even mentioning theprospects of GM. Indeed, Shapiro’s extensive considera-tion of performance modification in sport provides a ve-ry useful conceptual framework from which to depart in

PÔVODNÉ PRÁCEORIGINAL PAPERS

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understanding why GM is alarming in sport, both for athle-tes and the broader social community.

This work has focused largely on drug use, thoughthe broader category of ‘doping’ has also been included.The definition of doping seems important to clarify, thoughis a somewhat befuddling term. Of course, organisationssuch as the IOC and WADA do give it a specific definition,as have governmental organisations, such as the Councilof Europe (CoE) and UNESCO. For example, one of theearliest definitions, given by the IOC was that doping is,

The administration of or use by a competing athlete ofany substance foreign to the body or any physiologic sub-stance taken in abnormal quantity or taken by an abnor-mal route of entry into the body with the sole intentionof increasing in an artificial and unfair manner his/herperformance in competition. (IOC, 1963, cited in 10, 39).

This remains a useful definition to critique in order tounderstand why it is that anti-doping policy began on aroute that has been lacking in philosophical rigour, sinceits employment of such terms as ‘abnormal’, ‘intention’,‘artificial’ and ‘unfair’ have been challenged in all mannerof ways. The definition is useful also because these termstend often to be used as intuitive reactions to why druguse is wrong.

Importantly, the new international body WADA hasrecently revised its anti-doping code, distinguishing be-t-ween substances that are performance enhancing (ille-gal) and those that are not (legal). This comes in reactionto anti-doping critics who claim that the role of sportingorganisations in prohibiting the freedoms of athletes(qua humans) has long been overstated by the restric-tions within the anti-doping code.

However, its definition remains unclear and philo-sophically suspicious. For example, it is not often consi-dered that one solution to the argument of fairness couldbe to make all forms of doping legal. On this basis,nobody would have an advantage over others. Alterna-tively, the concept of what is artificial or natural seems tohave little strength when the training regime of non-do-ping athlete is, itself, highly unnatural. For some sportethicists, it is not evident that the anti-doping efforts areanything more than a political wrangling and media cir-cus, given the vast inconsistencies between, for example,the rejection of drugs and the acceptance of new sportsequipment, which each seem to be used for the samepurpose. This problem is exacerbated by the prospect ofgenetic modification.

Outside of sport, the Australian Law Reforms Com-mission (ALRC) published a paper in 2001 about thelegal concerns for the use of genetic information. Withinthis document, they devoted a section specifically tosuch concerns in the context of sport. Here the ALRC isworried about the potential for discrimination againstathletes on the basis of their genetic disposition. Theystate, genetic testing may lead to discrimination againstcertain athletes. For example, an athlete with a suscepti-bility to a particular injury may never in fact develop theinjury, but may be dropped from the team by manage-ment in an effort to avoid potential liability if the injurymanifests. Alternatively, a sports co-ordination body mayseek to impose certain conditions on players to minimiseits own liability for any injuries they may suffer. Forexample, the Professional Boxing and Martial Arts Board(Vic) has proposed the genetic testing of all professionalboxers in Victoria as a condition of their license to fight(2, section 12.29, HTML).

The most recent institution to take an interest ingenetic enhancement in sport has been the United StatesPresident’s Council on Bioethics (38). On 11 July 2002,the Council met and received a paper from Dr. Ted Fried-mann, who also sits on the WADA Executive Board andwho has been active in WADA to raise the genetics issue.

The meeting was titled the ‘Potential for Genetic Enhan-cements in Sports’ and the conclusions varied significant-ly from arguing that GM threatens a ‘romantic’ view ofsport, to arguing GM as integral of the ‘technological-rationality’ of contemporary elite sport.

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It is widely recognised that the present level of so-phistication in genetic research is such that the applica-tions to sport are highly unlikely. With relatively few suc-cesses in gene therapy, the prospects for genetic enhan-cement seem uncertain, though pessimistic. However,this is not any basis on which to conclude, therefore, thatthe possible applications to sport are of no serious ethi-cal concern. It is possible to identify a number of emer-ging studies in genetic science, which could lead intosporting applications. For example, two of the major con-cerns for the US President’s Council on Bioethics wereIGF-1 or insulin-like growth factor, which has the medi-cal purpose of treating muscle wasting disease, thoughmight be used by athletes for boosting muscle mass.Research in this area is being undertaken by Dr. H. LeeSweeney at University of Pennslyvania (USA) and sepa-rately, Geoffrey Goldspink at the Royal Free and Univer-sity College Medical School in London, who have madesimilar findings. Using a form of IGF-1 called mechanogrowth factor (MGF) with mice, which is used to treatmuscle-wasting diseases such as muscular dystrophy, Gold-spink’s team were able to isolate muscle tissue and insertthe MGF gene. The results showed an increase in musclemass by approximately 20 percent after two weeks.

At Harvard University, Dr. Nadia Rosenthal used IGF-1 ingene therapy in mice to halt depletion of muscle strengththat comes with old age. As Rosenthal notes, „Older miceincreased their muscle strength by as much as 27 percentin the experiment, which suggested possibilities for ath-letes as well as for preserving muscle strength in elderlypeople and increasing muscle power in those who sufferfrom muscular dystrophy“ (cited in 15).

The other concern of the US President’s Council on Bio-ethics was genetically engineered erythropoietin (EPO),which has the potential to increase endurance capabili-ties, though its medical application is to increase thehematocrit level in patients with chronic renal disease.Research identifies the effects of inserting genes into avirus to produce a specific bodily effect. For example, atthe University of Chicago, Jeffrey Leiden used an adeno-virus to deliver EPO to mice and monkeys, to observewhether it would render a difference in biological capa-bilities. By inserting the gene into a virus strand, it wastransported throughout the body and did, indeed, havethe effect of increasing the level of red blood cells thatwere being pumped around the body. In performance,this produces a similar effect to that of blooddoping,which operates on a similar principle by reintroducingblood into the body to boost the amount of oxygen beingtransported around the body, to off set fatigue. Thus, ge-netically inserting EPO into an athlete could increase thecapabilities for endurance when active, which would beuseful for any long distance event. Similar work has beenconducted by Dr. Steven Rudich, of University of Michi-gan, where inserting EPO into the leg muscles of mon-keys produced a significantly elevated red blood cell le-vel for 20 to 30 weeks (15).

Other emerging research from Lin et al. (12) includesthe gene ‘PGC-1’, which is known to tell other genes inmuscle whether they should be turned on or off. Theimplications of manipulating this gene entail the possibili-ty of being able to switch on those muscle fibres (fast orslow twitch) which are most conducive to an athlete’s

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chosen sport. Alternatively, the ACE gene (angiotension-converting enzyme) has been received by Montgomeryet al. (20, 21) and is claimed to be associated with endu-rance capabilities. Collectively, these findings are provi-ding a scientific basis for arguing why there are serious con-cerns about the ethical status of sport in the era of geneticmodification and this seems reflected by the breadth ofinstitutions, which are taking this matter seriously.

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Engaging with the suggestion that GM might actuallybe good for sport is absent from any of the opinions ininternational sport. To suggest that GM is a legitimatemeans, by which an athlete could enhance their perfor-mance, seems incomprehensible by most. However, adeeper account of the rationale behind anti-doping poli-cies in general and subsequently applied to genetics re-veals some inconsistencies and some basis for seekinggenetically modified athletes.

One of the major criticisms of organisations like WADA(it is one of many other bodies, such as the AustralianSports Drug Agency or the United States Anti-Doping Agen-cy) is that it unfairly persecutes the athlete through itspolicies. Even if one has moral concerns about the ath-lete’s using drugs, there are even more serious moralissues regarding how an athlete becomes nationally andinternationally persecuted through relatively minor actswithin sport. Such concerns for the athlete’s well beingare equally, if not more, alarming than the fact of themtaking some banned substance. For example, the inges-tion of minute amounts of banned substance or the ta-king of cold remedies are among the ‘drugs’ that can pro-duce a scandal in many newspapers. From a moral pers-pective, it seems excessive (and harmful) to demonise aperson so very much on account of using such soft sub-stances to try and beat others in sport. This concern iscomparable to that which is also highlighted by the ALRC(2) document on genetic information.

Additionally, anti-doping policies have been criticisedbecause they only target the athlete. Regarded as an inde-pendent, rational, free-choosing agent, the athlete is seenas having sole responsibility for ingesting banned sub-stances. Yet, athletes do not act alone. Rather they arepart of a larger entourage and system of significant o-thers including coaches, sponsors, family, and other sup-porting scientists - including medical doctors who havebeen known to prescribe the drugs needed to boost anathlete’s performance or to treat the individual as an athle-te rather than as a patient. Such people do have somepart to play in having created this ‘culture’ of doping, asit is widely regarded.

Certainly, public opinion is against drugs in sport, butit can be questioned how much of this opinion is basedupon sound engagement with the ethical and moralissues the matter raises rather than the broad, social am-bivalence towards drugs in general. Many societies em-body an anti-drug taking attitude, despite readily accep-ting the use of some stimulants and depressants as part oftheir daily life. It is worth noting that caffeine is regardedas unacceptable if an athlete is found with too much of it intheir body. It is also worth noting that very little scientificevidence is available to demonstrate whether performance-enhancing drugs do actually have any effect on perfor-mance. If the response by anti-doping policy makers is the‘health’ argument (as noted above), then they must also beable to justify why certain kinds of health risks are accep-table over others. As well, it must be considered why it isthat an approach of paternalism is warranted in the caseof sports, where it is not in other professions.

Thus, with GM looming, the basis for forming ethical

policy might not best be informed by the approachdescribed as ‘anti-doping’. Indeed, it might not do to be‘anti-genetics’ at all. As with any new technology, rationalpersons are rightfully concerned about potential abuses.However, the critical question facing WADA ought to bewhat constitutes an abuse of such technology and why.The controversial conclusions are whether any kinds ofGM or use of genetic technology at all are acceptable insport. The perspectives of key figures in world sport arealready relating the technology to drugs and so a similarway of approaching these performance enhancers is be-ginning to ensue. Yet, it is not clear that GM is analogousto the drug issue, especially since the ethical issues ari-sing from genetics outside of sport seem qualitatively dif-ferent from ethical issues concerning drug use. At most,there are some forms of GM that are comparable to otherforms of doping in sport. For example, somatic-cell modi-fication can confer similar benefits to the blood-boostingprocess of blood doping, where blood is removed from thebody and then introduced at a later date to boost the redblood-cell count and promote endurance capacity.

However, while I have set out some reasons for doub-ting the unethical status of GM in sport, it is not clearwhether genetics might actually be ‘good’ for sport. Inresponse, it is necessary to question the role of genes insport. Currently, sport is an activity where ‘genetic-luck’is accepted as a given circumstance of competition. Thus,even if one cannot claim that genetic variance enhancessporting value, it seems evident that it most certainlydoes not enhance such value for the genetically disadvan-taged. However, sport can be seen as being partly a testof what is humanly possible and that this involves a ge-netic component. On this view, sport performances havevalue partly for them being a reflection of what a humanbeing can achieve biologically and without artifice. Assuch, in a similar way to how drug use is unacceptable,GM is unacceptable because it prevents us appraising aperformance as being human. This approach can be criti-cised on account of having never been clear that suchclaims are at all possible. Indeed, this argument is compa-rable to the ‘romantic’ view of sport, articulated withinthe U.S. President’s Council on Bioethics meeting ongenetics and sport. Yet, an athlete’s performance has al-ways been tainted by the technology they employ, whe-ther it is new running shoes, faster swimming costumes,or drugs.

On another view, genetic difference is negative and -following the ‘level playing field’ argument where theethical ideal is to ensure all athletes begin from the samestarting point - it is desirable to try and omit such inequa-lities to ensure that only characteristics such as ‘effort’ or‘training hours’ are evaluated. Accepting this, GM mightbe useful to try and promote genetic parity betweencompetitors, though the argument must also recognisethat GM might not confer similar effects on different per-sons. As such, the argument might have only to be liber-tarian rather than egalitarian, ensuring that, at least, peop-le have the chance to lessen their disadvantages, even iftheir final circumstances might not ensure equality for all.

A further matter arises in respect to the prospect ofGM outside of sport and how this might impact uponsport. So far, the discussion has focused primarily uponpost-natal GM, though it has not yet been consideredwhat ought to be the position of sporting authorities iffaced with a human being who has been engineeredbefore birth and who has a particularly advantageousgenetic disposition for a particular kind of sport. It doesnot seem justifiable to exclude such persons from com-petition on account of them having transgressed someethical rules since they will not have done anythingwrong. Rather, if there is any wrong that has been done,then it will have been done on their behalf by those who

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decided to enhance them. The exclusion of such personsfrom sport implies a discrimination of persons basedupon their genetic disposition that does not sit well withbroader policy about genetics.

These arguments, which loosely seem to be in favourof engaging with the possibility that GM is not inconsis-tent with sport, can be contrasted with other bioethicalconcerns about such applications. The appeal to therights of the unborn not to be disadvantaged by sportingpolicy that prevents their participation in competitivesport must be balanced with the concern about what itmeans to engineer a life for a given purpose. If, as anextreme (and unlikely) case, it is possible to engineer anembryo to become a better tennis player, then we wouldrightly be concerned for the motivations of a parent orguardian for seeking to engineer their child for such aspecific future. Thus, one of the major concerns aboutengineering a child for sport, or any highly specialisedpursuit, is that it implies a sense of objectifying life -treating that life as a means to an end, rather than an endin itself. In sport, this problem is particularly acute, as itseems many parents are overly influential in their child-ren’s choices to train quite as hard as is necessary tobecome elite. At a deeper level, one can question whe-ther a parent or guardian should have the authority tomodify the genes of their future offspring in such cases.

More likely than not, this is an immediate and insur-mountable ethical issue within medicine, which wouldprohibit the freedom to make such choices. However,there are important fuzzy boundaries to this matter, ashas been indicated by the recent questioning of sexselection and its legitimacy. Potentially, the modificationof embryos for sporting reasons could be justified onsimilar ‘parental freedom’ bases as might be argued inthe case of sex selection and it need not imply that theparents are overly objectifying their future child. It mightsimply entail that they have a clear and defensible visionabout what is best for the future of their child and this ismore problematic to criticise. Additionally, it does notdismiss the possible circumstances whereby a ‘healthrelated’ GM gives rise to a potential performance advan-tage for sporting competition. In such instances, furtherargumentation would be necessary for considering whe-ther this is acceptable, since it would be very difficult toargue the modification as being ethically unacceptable.Indeed, in such circumstances, any discussion about sportwould be secondary.

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It can be quite popular to agree with WADA and feelan affinity with what it is trying to prevent. Similarly, it isunderstandable that people feel sympathy with anti-drugcampaigns in general, regardless of whether it is drugs insport. However, there is an ethical component to thesporting issue that demands an adherence to philosophi-cally rigorous arguments. While there seems to be a lot offuss made about the use of drugs in sport, it is not alwaysthe case that such anti-doping policies are well formula-ted or that they only prohibit the kinds of drugs that weare really concerned about. Thus, it is not just anabolicsteroids that are prohibited; it is also caffeine and alcoholor nasal decongestants. It is not necessarily the case thatan athlete who has been found guilty of having ingesteda banned substance is trying to cheat their fellow com-petitors or has no respect for sport. As well, it need notbe the case that the genetically modified athlete is chea-ting sport or other athletes. If such technology is madesafe, or if a person finds himself or herself to be geneti-cally modified in a manner that is conducive to beinggood at a particular sport, then this does not justify their

being disqualified from competition on account of someprescribed concept of fair play.

Equally, the use of performance modification in sportmust be re-appraised. As I indicated at the outset of thepaper, one of the more interesting reasons for conside-ring GM in sport is that it can reveal some greater insightinto the use of enhancement technologies more general-ly. In respect of sport, the case of GM calls for an entirere-evaluation of enhancement in sport, bringing into fo-cus a number of taken-for-granted assumptions about eli-te sport. It ought not be construed solely as an extensionof anti-doping policy. From such a perspective GM is asmall part of a general obsession with enhancement,which sport participants and fans seems to value. Thus,GM in sport is an opportunity to question the develop-ment of technology aimed at enhancing the performan-ce of the athlete, which might demand the conclusionthat performance-based sport as an indication of value, ishighly impoverished. It might, for example, give rise tore-questioning the moral limits of ‘parental autonomy’, aparticularly entrenched value within Western society.

By extension, the role of bioethics in this debate canbe to inform the scope of sports ethical discussions. It isnot sufficient for this discussion to remain at the spor-ting value, though its rich context of contested values canprovide a means for grounding bioethical debates aboutgenetic engineering in a social context. Until now, thediscussions in sport have focused largely upon sport as aself-contained system of logic and ethics. Sports operatethrough their own internal logic and rules, without muchrecourse to broader social values, although overlaps canbe identified. Nevertheless, questioning what it means tobe a technological-human remains largely un-touched(9). Moreover, the context of genetic technology hasbeen explored only recently in sports ethical discussions(17-19, 23, 24, 37). Genetics in sport is providing a wel-come departure from this internal logic, making explicitthe broader ethical links with, for example, medicine,which has also been under-researched in relation to thedrug issue. However, in so doing the approach must alsobe to recognise that genetically modified athletes mightactually be desirable in sports or, at least, impossible todisqualify.

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1111.... Arnold, P. J. (1997). Sport, Ethics and Education. London, CassellEducation. 2222.... Australia Law Reforms Commission (2001). Issues Paper 26Protection of Human Genetic Information - 12. Other services and con-texts. Sydney, Australian Law Reforms Commission. Hypertext Docu-ment: http://www.austlii.edu.au/au/other/alrc/publications/issues/26/. 3333....Brown, W. M. (1995). „Personal Best.“ Journal of the Philosophy of SportXXII: 1-10. 4444.... Butcher, R. and A. Schneider (1998). „Fair Play as Respectfor the Game.“ Journal of the Philosophy of Sport XXV: 1-22. 5555.... Carr, D.(1999). „Where’s the Merit if the Best Man Wins?“ Journal of the Philo-sophy of Sport XXVI: 1-9. 6666.... Eassom, S. B. (1998). Games, rules and con-tracts. Ethics and Sport. M. J. McNamee and S. J. Parry. London and NewYork, E&F.N. Spon: 57-78. 7777.... Feezell, R. M. (1988). „On the wrongness ofcheating and why cheaters can’t play the game.“ Journal of the Philoso-phy of Sport XV: 57-68. 8888.... Gardner, R. (1989). „On Performance-Enhan-cing Substances and the Unfair Advantage Argument.“ Journal of thePhilosophy of Sport XVI: 59-73. 9999.... Hoberman, J. M. (1992). Mortal Engi-nes: The Science of Performance and the Dehumanization of Sport. NewYork, The Free Press. 11110000.... Houlihan, B. (1999). Dying to Win: Doping inSport and the Development of Anti-Doping Policy, Council of EuropePublishing. 11111111.... Lavin, M. (1987). „Are the current bans justified?“ Journalof the Philosophy of Sport XIV: 34-43. 11112222.... Lin, J., H. Wu, et al. (2002).„Transcriptional co-activator PGC-1 dfrives the formation of slow-twichmuscle fibres.“ Nature 418: 797-801. 11113333.... Loland, S. (1998). The RecordDilemma. 20th World Congress of Philosophy. Hypertext Document:http://www.bu.edu/wcp/Papers/Spor/SporLola.htm 11114444.... Loland, S. (2002).Fair Play in Sport: A moral norm system. London & New York, Routledge.11115555.... Longman, J. (2001). Pushing the Limits: Getting the Athletic Edge MayMean Altering Genes. The New York Times. Hypertext Document:http://www.nytimes.com/2001/05/11/sports/11GENE.html 11116666.... MacIn-tyre, A. (1985). After Virtue: A Study in Moral Theory (Second Edition).London, Duckworth. 11117777.... Miah, A. (2000). „The Engineered Athlete:Human Rights in the Genetic Revolution.“ Culture, Sport, Society 3(3): 25-40. 11118888.... Miah, A. (2001). „Genetic Technologies and Sport: The NewEthical Issue.“ Journal of the Philosophy of Sport XXVIII: 32-52. 11119999.... Miah,A. (2002). Genes, Sports, and Ethics: A Response to Munthe (2000). Sport

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Technology: History, Philosophy & Policy. A. Miah and S. B. Eassom.Oxford, Elsevier Science. 21: 269-289. 22220000.... Montgomery, H., R. Marshall, etal. (1998). „Human Gene for Physical Performance.“ Nature 393(21 May):221-222. 22221111.... Montgomery, H., P. Clarkson, et al. (1999). „Angiotension-converting-enzyme gene insertion/deletion polymorphism and responseto physical training.“ The Lancet 353(February 13): 541-545. 22222222.... Morgan,W. J. (1994). Lefitst Theories of Sport: A Critique and Reconstruction.Urbana, University of Illinois Press. 22223333.... Munthe, C. (2000). SelectedChampions: Making Winners in an Age of Genetic Technology. Values inSport: Elitism, Nationalism, Gender Equality, and the Scientific Manufac-ture of Winners. T. Tannsjo and C. Tamburrini. London and New York, E& F.N. Spon: 217-231. 22224444.... Munthe, C. (2002). „Prospects and Tensions inthe Meeting of Bioethics and the Philosophy of Sports: A Response toMiah (2002).“ Research in Philo-sophy and Technology 21, 291-299 22225555....Murray, T. H. (1983). „The Coercive Power of Drugs in Sports.“ TheHastings Center Report August: 24-30. 22226666.... Murray, T. H. (1984). Drugs,Sports, and Ethics. Feeling Good and Doing Better. T. H. Murray, W.Gaylin and R. Macklin. Clifton, New Jersey, Humana Press: 107-126. 22227777....Murray, T. H. (1987). The Ethics of Drugs in Sport. Drugs and Perfor-mance in Sports. R. H. Strauss. London, W.B. Saunders Company: 11-21.22228888.... Parry, S. J. (1987). „The Devil’s Advocate.“ Sport & Leisure NovDec: 34-35. 22229999.... Perry, C. (1988). Blood Doping and Athletic Competition.Philosophic Inquiry in Sport. W. J. Morgan and K. V. Meier. Illinois,Human Kinetics pp.307-311. 33330000.... Schneider, A. J. and R. B. Butcher (1994).„Why Olympic athletes should avoid the use and seek the elimination ofperformance enhancing substances and practices from the OlympicGames.“ Journal of the Philo-sophy of Sport XXI: 64-81. 33331111.... Schneider, A. J.and R. B. Butcher (2000). A philosophical overview of the arguments onbanning doping in sport. Values in Sport: Elitism, Nationalism, GenderEquality, and the Scientific Manufacture of Winners. T. Tännsjö and C.Tamburrini. London, E & FN Spon: 185-199. 33332222.... Shapiro, M. H. (1991).„The Technology of Perfection: Performance Enhancement and the Cont-rol of Attributes.“ Southern California Law Review 65: 11-113. 33333333.... Simon,R. L. (1985). Sports and Social Values. Englewood Cliffs, NJ, Prentice-Hall.33334444.... Simon, R. L. (1991). Fair Play: Sport, values, and society. Boulder, CO,Westview Press. 33335555.... Tamburrini, C. M. (2000). The ‘Hand of God’? Essaysin the Philosophy of Sports. Goteborg, Acta Universitatis Gotoburgensis.33336666.... Tamburrini, C. M. (2000). What’s wrong with doping? Values in Sport:Elitism, Nationalism, Gender Equality, and the Scientific Manufacture ofWinners. T. Tannsjo and C. Tamburrini. London, E & FN Spon: 200-216.33337777.... Tamburrini, C. M. (2002). „After Doping What? The Morality of theGenetic Engineering of Athletes.“ Research in Philosophy and Techno-logy 21, 253-268. 33338888.... The President’s Council on Bioethics (2002). Session4: Enhancement 2: Potential for Genetic Enhancements in Sports. Wa-shington, D.C., The President’s Council on Bioethics. Hypertext Docu-ment: http://www.bioethics.gov/200207/session4.html 33339999.... Wadler, G. I.(1998). Doping in Sport: From Strychnine to Genetic Enhancement, It’s aMoving Target. The Duke Conference on Doping in Sport, R. David Tho-mas Executive Conference Center. Hypertext Document: http://www.law.du-ke.edu/sportscenter/wadler.pdf

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MMMMiiiiaaaahhhh,,,, AAAA....:::: BBBBiiiiooooeeeetttthhhhiiiiccccssss,,,, SSSSppppoooorrrrtttt aaaannnndddd tttthhhheeee GGGGeeeennnneeeettttiiiiccccaaaallllllllyyyy EEEEnnnnhhhhaaaannnncccceeeeddddAAAAtttthhhhlllleeeetttteeee.... [[[[BBBBiiiiooooeeeettttiiiikkkkaaaa,,,, ššššppppoooorrrrtttt aaaa ggggeeeennnneeeettttiiiicccckkkkyyyy zzzzvvvvýýýýhhhhooooddddnnnneeeennnnýýýý aaaattttlllléééétttt....]]]] MMMMeeeedddd....EEEEtttthhhh.... BBBBiiiiooooeeeetttt....,,,, 9999,,,, 2222000000002222,,,, NNNNoooo.... 3333 - 4444,,,, pppp.... 2222 ---- 6666.... Práca začína konštato-vaním záujmu, ktorý o problematiku „genetického zlepšova-nia“ (angl. genetic enhancement) vo vzťahu k športu pre-javujú viaceré medzinárodné inštitúcie, vrátane Rady prezi-denta Spojených štátov amerických pre bioetiku (júl 2002) aSvetovej protidopingovej agentúry (marec 2002). Všíma si,ako športové organizácie v tejto súvislosti predovšetkým zdô-razňujú „hrozbu“ zo strany genetiky pre šport, kým iné orga-nizácie si viac všímajú širšie bioetické skutočnosti, ktoré sú-visia s touto problematikou, pričom ich odsúdenie použitiagenetickej technológie v oblasti športu nie je také jedno-značné. Športové odvetvia treba považovať za nutne „ľudské“a „morálne“ činnosti, pričom analýza týchto ich aspektovmôže lepšie osvetliť intuitívne obavy z genetickej modifiká-cie v oblasti športu. Autor tvrdí, že protidopingové testova-cie opatrenia a sankcie neakceptovateľne prenasledujú špor-tovcov. Hoci existujú podstatné dôvody pre obavy zo zneu-žitia genetickej modifikácie v oblasti športu, snaha o rýchlezavedenie určitých smerníc by nemala znamenať zníženiepotreby ďalšieho bioetického skúmania tohto problému; pri-čom takéto skúmanie by sa nemalo obmedziť iba na prístupytradičného „antidopingového“ pohľadu. Naopak, skúmanievzťahu genetiky a športu by malo byť informované širšímbioetickým hľadiskom a poznaním väčších dobier, ktoré pri-náša genetická technológia. KKKKľľľľúúúúččččoooovvvvéééé sssslllloooovvvváááá: bioetika, šport,génový (genetický) doping, športovec, fair play, „genetickézlepšovanie“ (genetic enhancement).

Address for the correspondence: Ass. Prof. Andy Miah, BA, PhD., Universityof Paisley, Paisley, Scotland, UK.

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Dan O’Brien

Ascension Health, St. Louis, Missouri, USA


Decisions on whether to resuscitate severely prema-ture infants are especially difficult in „borderline viabili-ty“ cases - those cases where the probability of survival isslim, and where, if survival is possible, multiple co-mor-bidities and severe disabilities are likely. The 2000 Inter-national Guidelines on Cardiopulmonary Resuscitationare comprehensive, yet leave open some of the more dif-ficult ethical questions that must be addressed by deci-sion-makers. This paper recommends evidence-based,clinical ethical guidelines for neonatal resuscitation, dra-wing on one large Catholic health system’s approach,arguing from the perspective of the Catholic moral tradi-tion and the Ethical and Religious Directives for CatholicHealth Care Services (the ERD are policy for all of Catho-lic health care in the U.S). The paper presumes that thereis an inherent dignity of the human person to be respec-ted and protected regardless of the nature of the person’shealth problem or social status. But it also presumes and ar-gues that treatments can be justified only by a proportio-nate benefit to the patient. In maintaining a holistic viewof the human person, two extremes are avoided: a „vita-listic“ approach where life is preserved at all costs; andthe „easy“ alternative of euthanasia. Several principles ofmedicine, theology, ethics and Anglo-American commonlaw are applied to three categories of preterm infants,each of which calls for a different basic response: Catego-ry I - infants with a confirmed gestational age of < 23-0/7weeks; Category II - infants with a confirmed gestationalage between 23-0/7 and 25-0/7 weeks; and Category III -infants with a gestational age > 25-0/7 weeks. Studiesshow that survival rates and outcomes vary dramaticallyfor these three groups, even with the availability of thelatest technologies.

KKKKeeeeyyyy WWWWoooorrrrddddssss:::: neonatal resuscitation; guidelines; severe-ly premature infants; borderline viability; evidence-ba-sed; treatment decisions; Catholic moral tradition; inhe-rent dignity; human person; holistic view; proportionateand disproportionate means; medical futility; euthanasia

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Sometimes a decision about whether to resuscitate apremature infant is relatively simple to make. In onecase, the newborn is relatively far along in gestationalage (>26 weeks), is of good weight, and will be deliveredat a fully equipped level II or III NICU (Neonatal Inten-sive Care Unit) with a skilled team of professionals stan-ding by who have anticipated the delivery, and have madeadequate preparations and accurate evaluations. In ano-ther case, the baby is below 20 weeks gestation - no spe-cial facility or amount of technical skills will save thebaby. Then there are those cases of borderline viability -e.g., babies born at 23-0/7 weeks gestation. The outco-mes are far less predictable in such cases, and the appro-priateness of a resuscitation decision more ambiguous.

The International Guidelines Conference on Cardio-pulmonary Resuscitation, gathering in February of 2000,assembled experts from many fields from all over theworld, including neonatal resuscitation, producing strong

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evidence-based International Guidelines for Neonatal Re-suscitation.[1] The ethics segment of those guidelinesargue that changes in resuscitation and intensive carepractices and neonatal outcomes make it imperative thatall protocols be reviewed regularly and modified as ne-cessary. This paper considers what the ethics portion ofsuch protocols might contain to facilitate decision-ma-kers. Should a live-born infant always be resuscitated?Should professionals always acquiesce to parental de-mands for resuscitation or non-resuscitation? When wouldit be ethically appropriate not to resuscitate? Althoughthe law will vary from state to state, a dialogue with theCatholic moral tradition can shed some meaningful lighton these questions.

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Neonatal resuscitation decisions should take intoaccount the intrinsic value of the individual infant, thereasonable wishes of the parents (if known), normativeprinciples, and concrete circumstances including thelikelihood of the infant’s survival, known or expected co-morbidities and anomalies, expected burdens and bene-fits and risks of treatment or non-treatment, and expec-ted outcomes-all within the realistic limits of medicalpractice.

Consistent with Catholic moral teaching, as summa-rized by the Ethical and Religious Directives for CatholicHealth Care Services (ERD)[2], Catholic health care facili-ties are committed to the claim that „the inherent dignityof the human person must be respected and protectedregardless of the nature of the person’s health problemor social status“ (ERD, 23). Rooted in this inherent digni-ty and fundamental value is the right to life to whichevery person, no matter how vulnerable, has an inalien-able claim.[3] However, although this right to life is invio-lable, our obligation to preserve life by the application ofa particular treatment is limited and „can be justifiedonly by a proportionate benefit to the patient“ (ERD, 33). If physical life were the highest value of the human per-son, what would constitute a „proportionate benefit“could be measured simply by the likelihood of survival.Some might assume that any chance of survival woulddemand a decision to resuscitate. But the Catholic moraltradition suggests otherwise. Physical life is not, webelieve, the highest value of the human person, to beprotected or preserved at all costs. As Pope Pius XII re-minds us, „life, health, all temporal activities are in factsubordinated to spiritual ends.“[4] Maintaining a holisticview of the human person, therefore, must inform alldecisions concerning the preservation of physical life. Afailure to appreciate this holistic view of the human per-son can too easily lead to a „vitalistic“ understanding ofour moral duty to preserve life, giving euthanasia orinfanticide the appearance of being the only „reason-able“ alternatives.

A decision to use a particular treatment for the pre-servation of physical life must also not be driven by a„technological imperative.“ Simply because we can employa certain therapy does not necessarily mean that weought to do so in every case. Rather, decisions to resusci-tate or to use any life-sustaining treatment must take intoaccount the physical, emotional, intellectual and spiritualcondition of the particular individual, including theprospects for survival and any co-morbidities that arelikely to occur with or without medical intervention.Still, no matter what course of treatment or non-treat-ment is chosen, continuous care should persist evenwhen resuscitation is no longer a realistic option. A deci-sion not to resuscitate requires a continuous commit-ment to compassionate care no less than a decision to

resuscitate. Other principles and judgments to considerinclude but are not necessarily limited to the following.

„FFFFiiiirrrrsssstttt,,,, ddddoooo nnnnoooo hhhhaaaarrrrmmmm....““““ Every treatment carries with itexpected benefits, burdens, risks and harms. The ques-tion for us is whether the expected benefits of a treatmentwill justify its concomitant burdens or harms. This firstprinciple in the practice of medicine is difficult to applywith „borderline“ neonates, where the outcome is souncertain and unpredictable. „First, do no harm“ neces-sarily requires the virtue of Prudence. According to St.Thomas Aquinas, Prudence, or the capacity for discern-ment, is the moral virtue by which the individual trans-lates general principles and demands of morality intoconcrete action. It is not simply a matter of knowingwhat is generally good, but of knowing what is the bestthing to do in the particular case. The virtue of Prudencenormally can only be acquired through reflection andexperience. In the context of our borderline cases andthe Catholic moral tradition, prudential judgments mustat least preclude actions intended to harm or to devaluethe life of a newborn (ERD, 23). Concern for justice, orgiving to each what is due on account of his or herhumanity, will take into account what it means to flou-rish in a truly human way. There can come a point whentreatments to preserve life become more harmful thanbeneficial. When that point is thought to be reached willdepend on the particular circumstances and condition ofthe patient involved, as well as a realistic appreciation forthe current limits and capabilities of medical practice.Such a judgment certainly involves scientific knowledgeand technical skill, but also moves into the realm of art.This is where the knowledge, experience and virtue ofthe physician become so critical for helping to guide theparents when a decision has to be made.

PPPPrrrrooooppppoooorrrrttttiiiioooonnnnaaaatttteeee aaaannnndddd ddddiiiisssspppprrrrooooppppoooorrrrttttiiiioooonnnnaaaatttteeee mmmmeeeeaaaannnnssss.... „Propor-tionate means“ are those treatments that in the judgmentof the infant’s parents offer a reasonable hope of benefitand are not too burdensome for the infant or for others(ERD, 56). „Disproportionate means“ are those treat-ments that in the judgment of the infant’s parents do notoffer a reasonable hope of benefit or entail an excessiveburden, either for the infant or for others (ERD, 57).Reasonable people will not always agree on what countsas a „sufficient benefit.“ This is where the prudence ofthe physician and a well-informed ethics consultationservice may be vital for assisting the parents to form theirmoral judgment. A decision not to initiate or to discon-tinue resuscitation based on these principles must not beconfused with euthanasia. In order to distinguish eutha-nasia from the morally licit foregoing of treatment, weare reminded by Pope John Paul II to consider not onlythe intention of the agent but also the proportionate bene-fits of a treatment in the particular case:

Euthanasia must be distinguished from the decisionto forego so-called „aggressive medical treatment,“ inother words, medical procedures which no longer corres-pond to the real situation of the patient either becausethey are by now disproportionate to any expected resultsor because they impose an excessive burden on the pa-tient and his family.Certainly there is a moral obligationto care for oneself [or others].but this duty must takeaccount of concrete circumstances. It needs to be deter-mined whether the means of treatment available are ob-jectively proportionate to the prospects of improvement.To forego extraordinary or disproportionate means is notthe equivalent of suicide or euthanasia; it rather expres-ses acceptance of the human condition in the face ofdeath. [5]

In considering how to weigh the proportionate bene-fits and burdens of treatment, it may be helpful to defineexactly what we mean by „benefits and burdens.“ Bene-fits are the goals that a specific medical intervention in

8 ME&B 9 (3–4) 2002

all probability will be successful in attaining. As in con-cerns for justice, considering what is of sufficient benefitmust also take into account an adequate view of the hu-man person, and what it means to flourish in a humanway (ERD 33). Burdens are the physical and emotionalpain, discomfort, suffering and/or losses that a medicalintervention will impose or fail to prevent. What the pa-rents will consider to be a worthy risk and a tolerableburden will be influenced both by their understandingof the practice and limits of neonatal medicine as well asby their personal value system. Adequate information isvital, therefore, as many parents will first come into thedecision-making process with a wholly inaccurate andinadequate set of ideas about the medical possibilities.

TTTThhhheeee „bbbbeeeesssstttt iiiinnnntttteeeerrrreeeessssttttssss““““ ssssttttaaaannnnddddaaaarrrrdddd.... A resuscitation decisionmust always be guided by a commitment to seek the bestinterests of the infant. This is the only appropriate surro-gacy standard for newborns, as infants have yet to deve-lop any particular values, intentions or beliefs of theirown (see ERD, 25). Respect for the autonomy of the pa-rents to make such decisions is generally appropriate,but we must also consider that the child is not merely anextension of its parent’s values and beliefs. Rather, thechild has an inherent dignity and an inherent value of itsown (ERD, 23). The best interests standard is widely recog-nized by the courts as applicable to care decisions madefor infants. It provides a positive framework for under-standing the proper limits of parental autonomy. „Bestinterests“ is a good faith determination of what treat-ment would promote the patient’s overall greatest wel-fare, in accord with all relevant ethical and medical stan-dards. Relevant factors include: present and future levelof physical, sensory, emotional and cognitive functio-ning; the degree of pain and suffering resulting from theinfant’s condition with or without treatment and fromthe treatment itself; life expectancy, recovery and degreeand/or complexity of disability; and other relative risks,benefits, burdens and alternatives of treatment.[6] ManyU.S. courts and juries have accepted parental judgmentsto forego burdensome or futile treatment from a prema-ture infant or catastrophically injured child as a legiti-mate application of the right of informed consent, madein the child’s best interests. [7]

IIIInnnnffffoooorrrrmmmmeeeedddd ccccoooonnnnsssseeeennnntttt aaaannnndddd rrrreeeessssppppeeeecccctttt ffffoooorrrr aaaauuuuttttoooonnnnoooommmmyyyy.... Fromthe perspective of the Catholic moral tradition, a personhas a moral right to advance his or her own physical andspiritual welfare, and the physical and spiritual welfareof his or her own child. On this account, respect forparental autonomy involves not only refraining frominterfering with the reasonable wishes of the parents,but entails providing them with the necessary conditionsand opportunities for making decisions within appropria-te limits. The principle of respect for autonomy impliesthat one should be free from coercion in deciding to act,and that others are obligated to protect confidentiality,respect privacy, and tell the truth. In the practice of healthcare, a person’s autonomy is exercised through the pro-cess of obtaining informed consent. The principle ofrespect for autonomy, however, does not imply that onemust necessarily cooperate with another’s actions inorder to respect that individual’s autonomy. Guidelineswould be helpful for defining the limits of parentalautonomy that will be respected by the institution throughthe process of informed consent. Quality informed con-sent requires four conditions: adequate disclosure ofinformation; the freedom of the parent to decide withoutcoercion (within appropriate limits); comprehension onthe part of the parent; and the capacity of the parent tomake a decision. [8] Written materials may be useful forhelping the parents to examine and understand the medi-cal and moral issues.

MMMMeeeeddddiiiiccccaaaallll ffffuuuuttttiiiilllliiiittttyyyy.... A treatment can be considered futile

when there is virtual certainty that the treatment in ques-tion will not be successful in attaining the mutuallyagreed-upon goals of treatment or the treatment’s desi-red physiological effect. [9] Whether a given treatmentcan be considered futile in the case of „borderline“ neo-nate will not always be clear. Therefore, conversationsabout the futility of treatment should be the startingpoint of a conversation, not the blunt instrument forending conversation. Resuscitating a 20 week infant maybe medically futile, but there may also be more humaneways of informing parents of this reality.

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In applying these principles to borderline viabilitycases, and to all neonatal resuscitation decisions for thatmatter, it will be helpful to consider relevant clinicaldata. Take Ascension Health facilities, for example. From1998 through 1999, in 23 Ascension Health facilities, out-comes for extremely low birth weight babies (< 499grams) were very poor. Of 7 babies born in our Level Inurseries, 6 died. Of 21 babies born in Level II nurseries,14 died. Of 136 babies born in Level III nurseries, 103died. During the same period, 206 babies were bornweighing between 500 and 749 grams. Both babies bornin a Level I nursery died. Of 32 babies born in a Level IInursery, 9 died. Of 172 babies born in a Level III nursery,68 died. During the same period, 246 babies were bornweighing between 750 and 999 grams. Both babies bornin a Level I nursery survived. Of 26 babies born in a LevelII nursery, only 1 died. Of 218 babies born in a Level IIInursery, 16 died.

A 1999 study in Early Human Development discussessurvival outcomes over the course of the 1990s, exami-ning both low birthweight (< 800 g) and gestational age(< 26 weeks) together. [10] In a review of the world litera-ture, Hack and Fanaroff found that the survival rates forlive births at 23 weeks gestation ranged from 2% to 35%.At 24 weeks, the range varies from 17% to 58%, and at 25weeks from 35% to 85%. They speculated that differencesin population descriptors, in the initiation and withdra-wal of treatment and the duration of survival consideredmay have accounted for the wide variation. They alsocorrelated morbidity increases with decreasing gesta-tional age and birthweight. The rates of severe cerebralabnormalities detected by ultrasound ranged from 10%to 83% at 23 weeks; 17% to 64% at 24 weeks; and 10% to22% at 25 weeks. At 23 weeks gestation, chronic lungdisease occurred in 57% to 70% of survivors; 33% to 89%at 24 weeks; and 16% to 71% at 25 weeks. They foundthat the rates for neurodevelopmental disabilities (inclu-ding subnormal cognitive function, cerebral palsy, blind-ness and deafness) did not vary significantly from babiesborn prior to 1990. Of 30 survivors reported at 23 weeksgestation, 9 (30%) were severely disabled. At 24 weeks,the rates range from 17% to 45%, and at 25 weeks therates range from 12% to 35%. From these and other litera-ture reviewed, Hack’s and Fanaroff’s study strongly sug-gests that we have reached the medical limits of viability.Those who survive birth at a lower gestational age willbe very rare, and not without several developmental disa-bilities.

A 2000 study on developmental disabilities in survi-ving preterm infants in the New England Journal of Me-dicine also reveals catastrophic outcomes for babiesborn at 25 weeks gestation or less. [11] Wood, Marlow,et al evaluated all children born in this category in theUnited Kingdom and Ireland from March through De-cember 1995 at the time when they reached a medianage of 30 months. 283 children were formally assessedby an independent examiner, using the Bayley Scales of

9ME&B 9 (3–4) 2002

will include a comprehensive transportation plan. 4444.... LLLLeeeeggggaaaallll ccccoooonnnnssssiiiiddddeeeerrrraaaattttiiiioooonnnnssss.... Ascension Health ministries

equipped to delivery babies will have policies and proce-dures for neonatal resuscitation that are consistent withFederal, State and local laws and regulations.

5555.... WWWWeeeeiiiigggghhhhtttt aaaannnndddd ggggeeeessssttttaaaattttiiiioooonnnnaaaallll aaaaggggeeee ccccoooonnnnssssiiiiddddeeeerrrraaaattttiiiioooonnnnssss.... Ges-tational weight alone will normally not be used to decidewhether to resuscitate a preterm infant. In cases of un-certain gestational age, resuscitation options include atrial of therapy and noninitiation or discontinuation ofresuscitation after further assessment. Guidelines for theresuscitation of preterm infants include the categories asgiven in the ttttaaaabbbblllleeee 1111.

TTTTaaaabbbblllleeee 1111.... Guidelines for the Resuscitation of Preterm In-fants - Categories According to the Gestational Age


These guidelines will not provide pat answers for eve-ry moral dilemma. Rather, they provide a general frame-work for how to think morally about the issue of resusci-tation for preterm newborns, consistent with the Catho-lic tradition and the ERD, and suggest general parametersfor protocols developed at the local level. Category Iclearly supports forgoing resuscitation as ethically appro-priate, but does not mandate it. Parents who would wanta child under this category to be resuscitated need tounderstand the likely consequences of such a decision.Category II could support a parental decision to forgoresuscitation, assuming that the parent is reasonable andis attempting to act in the best interests of the child.Category III would normally not support a parental deci-sion to forgo resuscitation, unless there are other seriousmedical factors that would warrant such a decision. Allthree categories do not preclude a decision to initiateand later to forgo resuscitation after further evaluation,or after it has become more apparent that such effortsare no longer „proportionate to the prospects of impro-vement.“ A person who makes any judgment withoutconsidering the clinical facts of the particular is not ac-ting in good conscience. A bad conscience is reflected bythe tendency to make judgments without regard formoral norms or relevant information that may affect themoral character of an action. Nevertheless, people actingin good conscience will invariably disagree with eachother. These guidelines allow for such disagreement.Achieving moral consensus requires hard work that noguidelines can substitute.

Infant Development. Neurologic function was assessedby a standardized examination. The 283 children repre-sent 92 percent of 308 surviving children in this catego-ry. Overall, 138 children had disability (49%; 95% confi-dence interval, 43 to 55 percent), including 64 (23%) whowere severely disabled. When data from 17 assessmentsby local pediatricians were included, 155 of 314 infantsdischarged (49%) had no disability.

Motivated by the 2000 International Guidelines, bythese studies above as well as others, including variousmodel guidelines, and by the knowledge that our indivi-dual Health Ministries utilize several or even no proto-cols with considerable variation, Ascension’s MaternalChild Clinical Excellence team convened a work groupin 2001-2002, consisting of individuals with broad exper-tise from across the System, with the hopes of develo-ping model clinical and ethical guidelines that would fa-cilitate the development of consistent protocols and ethi-cal decision-making across the System. The reader willnote that gestational age is the principal indicator in thethree general categories. However, this does not meanthat clinicians should not consider birthweight as a fac-tor among all the assessments. The purpose of thesemodel guidelines is to supplement, not to replace the2000 International Guidelines, in order to ensure consis-tency with Catholic values and principles. Included inthe draft guidelines are discussions of the relevant ethi-cal principles, briefer than in this article, followed by theactual treatment guidelines below:

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In cases of emergency delivery of a preterm infant, inthe absence of a complete assessment, consent for resus-citation may be presumed until the infant can be stabi-lized and/or further assessment is made, consistent withthe ethical principles above and guidelines below, and, ifapplicable, until appropriate transfer can be made.

1111.... DDDDeeeecccciiiissssiiiioooonnnnssss iiiinnnn tttthhhheeee pppprrrreeeesssseeeennnncccceeee ooooffff sssseeeevvvveeeerrrreeee ccccoooonnnnggggeeeennnniiiittttaaaallllaaaannnnoooommmmaaaalllliiiieeeessss.... Following on the above ethical considera-tions, a decision for noninitiation or discontinuation ofresuscitation for live born infants with a confirmed diag-nosis of Anencephaly, Trisomy 13 or 18, or for other in-fants with severe congenital anomalies generally consi-dered incompatible with life is both medically and ethi-cally appropriate. In cases of uncertain diagnosis and/orprognosis, resuscitation options include a trial of therapyand noninitiation or discontinuation of resuscitation af-ter further assessment. In such cases, initiation of resusci-tation at delivery does not mandate continued support.

2222.... DDDDeeeecccciiiissssiiiioooonnnnssss ffffoooorrrr nnnnoooonnnniiiinnnniiiittttiiiiaaaattttiiiioooonnnn oooorrrr ddddiiiissssccccoooonnnnttttiiiinnnnuuuuaaaattttiiiioooonnnn ooooffffttttrrrreeeeaaaattttmmmmeeeennnntttt.... Following on the above ethical considera-tions, there will be other circumstances in which nonini-tiation or discontinuation of resuscitation of newborns isboth clinically and ethically appropriate. Noninitiation ofsupport and later withdrawal of support may generallybe considered ethically equivalent, assuming that otherappropriate clinical and ethical considerations have beenmade. A decision to resuscitate and then to withdrawlater may allow time to gather more complete clinicalinformation and to provide counseling to the family. On-going evaluation and discussion with the parents and thehealth care team should guide decisions for continuationor withdrawal of support. In general, there is no advan-tage to delayed, graded, or partial support; if the infantsurvives, outcome may be worsened as a result of thisapproach.

3333.... DDDDeeeelllliiiivvvveeeerrrryyyy aaaannnndddd ttttrrrraaaannnnssssppppoooorrrrttttaaaattttiiiioooonnnn ccccoooonnnnssssiiiiddddeeeerrrraaaattttiiiioooonnnnssss.... Ascen-sion Health ministries equipped to delivery babies willhave protocols and mechanisms in place for ensuringthat delivery occurs at the most appropriate site, and

CCCCaaaatttteeeeggggoooorrrryyyy IIIIIt is ethically appropriate not to resuscitate infantswith a confirmed gestational age of less than 23-0/7weeks.

CCCCaaaatttteeeeggggoooorrrryyyy IIIIIIIIInfants with a confirmed gestational age between 23-0/7 and 25-0/7 weeks:

● When there has been no pre-delivery consultation, resuscitation may be initiated when determined to be medically appropriate;

● When there has been a pre-delivery consultation, parental wishes will be respected and followed, unless contrary to these guidelines.

CCCCaaaatttteeeeggggoooorrrryyyy IIIIIIIIIIIIInfants with a gestational age greater than 25-0/7 weekswill be routinely resuscitated.

10 ME&B 9 (3–4) 2002


1111.... See S Niermeyer, J Kattwinkel, P Van Reempts, et al, „InternationalGuidelines for Neonatal Resuscitation: An Excerpt From the Guidelines2000 for Cardiopulmonary Resuscitation and Emergency CardiovascularCare: International Consensus on Science,“ Pediatrics 106:3 (September2000): e29, on Website at: . For the complete guidelines ratified by theAmerican Academy of Pediatrics and the American Heart Association see„International Guidelines 2000 for CPR and ECC,“ Circulation (2000;102(suppl I): I-343-I-357. 2222.... On Website at: . 3333.... 1974 Vatican Declarationon Procured Abortion, n. 8, on Website at: . 4444.... Pius XII, „The Prolongationof Life,“ in Critical Choices and Critical Care, ed. K.W. Wildes (Nether-lands: Kluwer Academic Press, 1995), pp. 189-96, at 192. 5555.... John Paul II,1995 Encyclical, The Gospel of Life, n. 65, on Website at: . 6666.... This under-standing of „Best Interests“ is based on the definition used in theMichigan Supreme Court Ruling, In re Martin, a Legally IncapacitatedPerson, North West Rep Second Ser. 538:399-420, 1995 Aug 22 (date ofdecision). Other states may employ a different variation of this legal-ethi-cal concept. 7777.... See, for example, In re Joelle Rosebush, 195 Mich. App.675 (1992), on Website at: ; see also the trial of Dr. Gregory Messenger,who was acquitted of murder by a jury after removing life-supports fromhis infant against the wishes of the attending physician and the hospital,in „The Messenger Case: Summary and Analysis“ (adopted from a chronol-ogy in the Detroit Free Press, February 4, 1995), by Howard Brody, at . 8888....See PS Applebaum and T Grisso, „Assessing Patients’ Capacities toConsent to Treatment,“ New E Journal Med 319:25 (Dec 22, 1988): 1635-38. 9999.... See G. Trotter, „Response to ‘Bringing clarity to the futility debate:done use the wrong cases’ by Howard Brody and ‘Commentary: bringingclarity to the futility debate: are the cases wrong?’ by L.J. Schneiderman,„Cambridge Quarterly of Healthcare Ethics 1999: 8; 527-37; also JP Slosar,„.“ Health Care Ethics USA 10, 1 (Spring 2002): 26-31. 11110000.... M Hack and AAFanaroff, „Outcomes of Children of Extremely Low Birthweight andGestational Age in the 1990s,“ Early Hum Dev 53, 3 (January 1999): 193-218. 11111111.... NS Wood, N Marlow, et al, „Neurologic and DevelopmentalDisability After Extremely Preterm Birth,“ N Engl J Med 343, 6 (August 10,2000): 378-84.


DDDDaaaannnn OOOO’’’’BBBBrrrriiiieeeennnn,,,, DDDD.... :::: BBBBoooorrrrddddeeeerrrrlllliiiinnnneeee VVVViiiiaaaabbbbiiiilllliiiittttyyyy RRRReeeessssuuuusssscccciiiittttaaaattttiiiioooonnnn CCCCaaaasssseeeessss....[[[[RRRReeeessssuuuusssscccciiiittttáááácccciiiiaaaa vvvv pppprrrrííííppppaaaaddddoooocccchhhh hhhhrrrraaaannnniiiiččččnnnneeeejjjj žžžžiiiivvvvoooottttaaaasssscccchhhhooooppppnnnnoooossssttttiiii....]]]] MMMMeeeedddd.... EEEEtttthhhh.... BBBBiiiiooooeeeetttt....,,,, 9999,,,,2222000000002222,,,, NNNNoooo.... 3333 ---- 4444,,,, pppp.... 6666 ---- 11110000.... Rozhodnutia o resuscitácií extrémne nezrelýchnovorodencov sú zvlášť ťažké v prípadoch tzv. „hraničnej životaschopnos-ti“, kde je malá pravdepodobnosť prežitia, a ak je prežitie možné, bývaspojené s mnohopočetnou komorbiditou a ťažkými poškodeniami unovorodenca. Medziná-rodné smernice o kardiopulmonálnej resuscitáciiz roku 2000 sú podrobné, avšak ponechávajú otvorené niektoré náročnéetické otázky, ktoré musia riešiť priamo tí, ktorí v danom prípade rozho-dujú o ďalšom postupe starostlivosti u konkrétneho dieťaťa. Táto prácaodporúča klinické etické smernice (guidelines) pre resuscitáciu takýchtonovorodencov založené na vedeckých dôkazoch (evidence-based),pričom sa opiera o prístup používaný v rámci jedného veľkého katolícke-ho zdravotníckeho systému v USA. V etickej argumentácii sa opiera okatolícku morálnu tradíciu a o dokument Etické a náboženské direktívypre katolícke zdravotnícke služby (END; ide o dokument, ktorý platí prevšetky zdravotnícke zariadenia na území USA, ktoré patria Katolíckejcirkvi). Predpokladá prítomnosť inherentnej dôstojnosti ľudskej osoby,ktorú je potrebné rešpektovať a chrániť bez ohľadu na podstatu konkrét-neho zdravotného problému alebo sociálneho statusu danej osoby.Súčasne však predpokladá a zdôrazňuje, že určitý liečebný postup možnoodôvodnene použiť len vtedy, ak znamená pre daného pacienta propor-cionálny prospech. Pri zachovaní holistického pohľadu na ľudskú osobusa vyhne dvom extrémom: „vitalistickému“ prístupu, kedy sa životzachraňuje za každú cenu; ako aj „ľahkej“ alternatíve eutanázie. Viaceréprincípy medicíny, teológie, etiky a anglo-amerického práva sa aplikujúv prípade troch kategórií nezrelých novorodencov, pričom každá z nich sivyžaduje odlišný základný prístup vo vzťahu k neonatálnej resuscitácií:kategória I - novorodenci s potvrdeným gestačným vekom < 23-0/7týždňov; kategória II - novorodenci s potvrdeným gestačným vekommedzi 23-0/7 a 25-0/7 týždňov; a kategória III - novorodenci s potvr-deným gestačným vekom > 25-0/7 týždňov. Doterajšie klinické štúdieukázali, že prežitie a výsledky sú výrazne rozdielne u novorodencovpatriacich do odlišných kategórií, a to aj pri dostupnosti najmodernejšíchtechnických prostriedkov. KKKKľľľľúúúúččččoooovvvvéééé sssslllloooovvvváááá: neonatálna resuscitácia; smer-nice (guidelines); ťažko nezrelí novorodenci; hraničná životaschopnosť;založený/á na dôkazoch; rozhodnutia o liečbe; katolícka morálna tradícia;inherentná dôstojnosť; ľudská osoba; holistický pohľad; proporcionálne adisproporcionálne prostriedky; eutanázia.

Address for the correspondence: Dan O’Brien, PhD., Vice Presi-dent, Ethics, Ascension Health, St. Louis, Missouri, USA.

KKKK PPPPRRRROOOOBBBBLLLLÉÉÉÉMMMMUUUU RRRREEEEVVVVIIIITTTTAAAALLLLIIIIZZZZÁÁÁÁCCCCIIIIEEEE EEEETTTTIIIICCCCKKKKÝÝÝÝCCCCHHHHKKKKOOOOMMMMIIIISSSSIIIIÍÍÍÍ VVVV SSSSLLLLOOOOVVVVEEEENNNNSSSSKKKKEEEEJJJJ RRRREEEEPPPPUUUUBBBBLLLLIIIIKKKKEEEE

Jozef Glasa

Subkatedra klinickej farmakológie Sloven-skej zdravotníckej univerzity; Nadácia Ústav medicínskej etiky a bioetiky; Bratislava


Problematika etických komisií (EK) sa v Slovenskejrepublike (SR) začala rozvíjať až po politických zmenáchv novembri 1989. Prvé EK v modernom zmysle slovavznikali ako neformálne skupiny nadšencov z radovzdravotníckych pracovníkov, teológov, psychológov apredstaviteľov ďalších humanitných disciplín a zvyčajneboli viazané na väčšie nemocnice (fakultné, krajské)alebo na tie zdravotnícke zariadenia, kde sa v minulosti,napriek určitému riziku alebo aj prenasledovaniu,udržovali isté etické tradície, nezriedka viazané na čin-nosť intelektuálneho alebo náboženského disentu.V roku 1990 bola na Ministerstve zdravotníctva (MZ) SRzaložená Centrálna etická komisia (CEK), ktorá sa ujalainiciatívy, ktorej výsledkom bolo vybudovanie základ-ných inštitucionálnych podmienok tak pre činnosť EKv SR, ako aj pre vznik a rozvoj odboru medicínskej etiky abioetiky. V období 1993 - 2001 prišlo k určitej stagnácií,ktorá bola zapríčinená nedostatočnou legislatívnou, poli-tickou, odbornou a organizačnou podporou tejto prob-lematiky. Napriek tomu činnosť EK, predovšetkým voveľkých nemocniciach a výskumných ústavoch rezortuzdravotníctva, pokračovala, a to najmä vzhľadom napotrebu etického posudzovania protokolov klinickéhoskúšania liečiv a projektov biomedicínskeho výskumu,ktoré striktne vyžadovali sponzorujúce farmaceutickéfirmy a zahraničné i domáce grantové agentúry. Po obno-vení riadnej činnosti CEK v júni 2002 je v SR potrebnénadviazať na dosiaľ vybudované inštitucionálne, odbornéa personálne predpoklady a revitalizovať činnosť EK akosystému, a to tak pre ich nezastupiteľnú činnosť v oblastietického dohľadu nad klinickým skúšaním liečiv (vzmysle plnenia požiadaviek Správnej klinickej praxe) avykonávaním biomedicínskeho výskumu (oblasť etikybiomedicínskeho výskumu), ako aj pre perspektívu ichaktívnejšej činnosti v zdravotníckych zariadeniach aliečebných ústavoch SR (oblasť klinickej etiky).

KKKKľľľľúúúúččččoooovvvvéééé sssslllloooovvvváááá: etické komisie, história, vývoj, revitali-zácia, Slovenská republika, klinické skúšanie liečiv, bio-medicínsky výskum, klinická etika

1111.... ÚÚÚÚvvvvoooodddd [[[[1111]]]]

Problematika etických komisií (EK) v modernomzmysle slova sa v Slovenskej republike (SR) začala rozvíjaťaž po zmenách, ktoré začali v rokoch 1989/1990. Niek-toré funkcie EK v predchádzajúcom období suplovali inéštátne štruktúry (Komisia pre nové liečivá Ministerstvazdravotníctva (MZ), Štátny plán vedecko-technickéhorozvoja, ai.). Náplňou práce „etických komisií“ v zdravot-níckych zariadeniach, ak v nich vôbec EK existovali, bolonajmä riešenie občasných úplatkárskych afér. Preto tietoEK mali skôr zlú ako dobrú povesť. Iným druhom boli„interrupčné komisie“ zriadené podľa zákona o umelomprerušení tehotenstva (zrušené novelizáciou zákona v ro-ku 1986).

Po roku 1990 sa začali v SR objavovať EK v modernomzmysle slova, a to spočiatku ako neformálne skupiny

11ME&B 9 (3–4) 2002

nadšencov z radov zdravotníckych pracovníkov, prípad-ne teológov, psychológov a predstaviteľov ďalších huma-nitných disciplín. Boli zvyčajne viazané na väčšie nemoc-nice (fakultné, krajské) alebo na zdravotnícke zariadenia,kde sa v minulosti, napriek určitému riziku alebo aj pre-nasledovaniu, udržovali isté etické tradície, nezriedka vy-chádzajúce z náboženských koreňov, prípadne viazanéna činnosť intelektuálneho alebo náboženského „under-groundu“ alebo „disentu“. V tomto čase vznikli aj EK naLekárskej fakulte UK v Bratislave (najmä vďaka aktivitámDoc. M. Babála, CSc. a spolupracovníkov a pochopeniu azáujmu vtedajšieho vedenia LF UK) a na Ústave preven-tívnej a klinickej medicíny (ÚPKM) v Bratislave (najmäzásluhou Prof. T. R. Niederlanda a jeho spolupracovní-kov, ktorí vydali aj prvú modernú príručku o klinickomskúšaní liekov a úlohách i zodpovednosti EK [2]).

V roku 1990 bola založená prvá Centrálna etickákomisia (CEK) na MZ SR (spoločne s obdobnou CEK MZČR). Ujala sa aktivity, ktorej výsledkom bolo vybudovaniezákladných inštitucionálnych podmienok pre činnosť EKv SR, ako aj pre vznik a rozvoj odboru medicínskej etiky abioetiky. Najvýznamnejšie kroky ukazuje ttttaaaabbbbuuuuľľľľkkkkaaaa 1111.

TTTTaaaabbbbuuuuľľľľkkkkaaaa 1111.... Vznik inštitúcií odboru medicínskej etiky a bioetiky v Slovenskej republike

Dôležité boli aj početné vzdelávacie aktivity organizo-vané najmä pod hlavičkou Ústavu medicínskej etiky abioetiky (ÚMEB) IVZ a LFUK v Bratislave, zavedenie výu-ky medicínskej etiky na LF (Bratislava, v obmedzenomrozsahu aj Martin a Košice; vydanie prvých skrípt [3]) aetiky ošetrovateľstva na stredných zdravotných školách(SZŠ) na celom území SR (ako povinného predmetu;vydanie prvej učebnice [4]), ako aj viaceré medzinárodnékonferencie organizované v spolupráci s Radou Európy,Medzinárodnou spoločnosťou pre etiku, právo a vedu(Milazzo group) a viacerými významnými medzinárod-nými organizáciami alebo zahraničnými ústavmi medi-cínskej etiky a/alebo bioetiky z Európy i zo zámoria.Umožnili prepojenie odborných a vzdelávacích aktivítv SR s vývojom v Európe a vo svete a priniesli významnéuznanie SR ako krajine s mimoriadne aktívnym a úspeš-ným prístupom k rozvoju bioetiky [5].

2222.... SSSSúúúúččččaaaassssnnnnýýýý ssssttttaaaavvvv

V roku 1993, pri neoficiálnom orientačnom priesku-me organizovanom v rámci ÚMEB sa počet EK v zdravot-níckych zariadeniach a výskumných ústavoch v SR odha-doval na cca 70. Odvtedy problematika EK značne stag-novala - i z dôvodu jej nedostatočnej prioritizácie zo stra-ny MZ SR a útlmu aktivít samotnej CEK (po personálnychzmenách v r. 1993). Činnosť EK v zdravotníckych zariade-

niach prakticky ustala, s výnimkou práce tých EK, ktoréposudzovali protokoly klinického skúšania liečiv a pro-jekty biomedicínskeho výskumu. V tomto smere význam-nú úlohu zohrali požiadavky a tlak zahraničných farma-ceutických firiem (vyžadujúcich plnenie kritérií Správnejklinickej praxe (SKP)) a snaha výskumných pracovníkovz pracovísk SR o aktívne zapojenie do medzinárodnýchvýskumných projektov (napr. 5FP Európskej komisie,bilaterálne projekty s krajinami Európskej únie (EÚ),USA, ai.). Niektoré aktivity EK (vrátane činnosti CEK)čiastočne suplovala činnosť ÚMEB-u a tiež iniciatíva viace-rých jednotlivcov - expertov nominovaných za SR dorôznych medzinárodných komisií. Smerom k zahraničiuto bola aj činnosť Zahraničného odboru MZ SR, najmäreferátu európskej integrácie, prípadne aj niektoré zahra-ničné aktivity SLS (najmä smerom k Svetovej asociáciilekárov (WMA), ale aj k Európskej únii medicínskychšpecialistov (EUMS), ai.).

Absencia metodického vedenia EK v uplynulom ob-dobí, útlm celoštátnych postgraduálnych edukačnýchaktivít pre členov EK, ako aj viac alebo menej deklaro-vané „pochybnosti“ o samotnej potrebe a koncepcii EKv SR, spôsobili, že v súčasnosti chýbajú presnejšie údaje opočte, zložení (profesijnej štruktúre) a spôsobe práce EKv SR. Získanie relevantných údajov v tomto smere jenutné nielen pre plánovanie potrebných opatrení, ale ajvzhľadom na vykazovanie príslušných parametrov vočizahraničiu (s väzbou na kompetitívnosť vedeckovýskum-ných pracovísk v SR voči obdobným pracoviskám v za-hraničí, vrátane vykonávania klinických skúšaní novýchliekov a plnenia požiadaviek SKP).

Vzhľadom na rastúce nároky na odborné zabezpeče-nie záväzkov a aktivít SR voči medzinárodným organizá-ciám a inštitúciám (Rada Európy, Európska komisia,UNESCO, WHO, ai.) bolo potrebné už dávnejšie situáciunečinnosti CEK a nedostatočnej akcieschopnosti a efek-tívnosti systému EK riešiť. Nedávna revitalizácia CEK MZSR (apríl - jún 2002) bola prvým nevyhnutným krokomtohto procesu.

3333.... PPPPrrrriiiinnnnccccííííppppyyyy ssssyyyyssssttttéééémmmmoooovvvvééééhhhhoooo rrrriiiieeeeššššeeeennnniiiiaaaa

V ďalšom v stručnosti načrtneme najpotrebnejšiekroky, ktoré sú nevyhnutné na zabezpečenie revitalizáciesystému EK v SR.

LLLLeeeeggggiiiissssllllaaaattttíííívvvvnnnneeee pppprrrreeeeddddppppooookkkkllllaaaaddddyyyy

Základným predpokladom je zakotvenie existencie a rám-cových podmienok činnosti EK v zákonnej norme. Prešpeciálnu oblasť klinického skúšania liečiv sa tak už stalov rámci zákona o lieku (zákon č. 144/1998 Z. z. v znení nes-korších predpisov). Vyhláška o klinickom skúšaní liečiv ao správnej klinickej praxi však dosiaľ nebola vydaná.

Zákonná norma upravujúca vznik, činnosť a zodpo-vednosť EK v ostatných oblastiach výskumu, ako aj v rám-ci zdravotníckych zariadení (tzv. „nemocničných EK“)nateraz chýba. V návrhu zákona o zdravotníckych zaria-deniach, pripravovanom v predchádzajúcom volebnomobdobí (avšak až k jeho koncu 2001/2002), bola čias-točne riešená aj problematika EK (vrátane CEK). Zákonmal splnomocniť MZ SR na vydanie vyhlášky o etickýchkomisiách, ktorá by mala túto problematiku riešiť komp-lexne (vrátane zjednotenia príslušnej terminológie).

Prijatím potrebných zákonných noriem a vydanímpríslušných vykonávacích vyhlášok by sa vytvorili nevyh-nutné legislatívne predpoklady pre činnosť systému EKv SR. V ďalšom období by bolo potrebné postupne dopl-niť tieto právne záväzné dokumenty súborom odbornýchusmernení, reagujúcich na riešenie aktuálnych etických

RRRRooookkkk AAAAkkkkttttiiiivvvviiiittttaaaa

1990 založenie Centrálnej etickej komisie MZ SR1991 založenie Katedry medicínskej etiky IVZ

v Bratislave1992 vydanie prvých smerníc MZ SR pre zriadenie

a činnosť etických komisií1991 vznik etických komisií v zdravotníckych -1992 zariadeniach a výskumných ústavoch rezortu

zdravotníctva 1992 založenie Ústavu medicínskej etiky a bioetiky

IVZ a LFUK1994 založenie časopisu Medicínska etika

& Bioetika1997, revitalizácia Centrálnej etickej komisie MZ SR2002

tov biomedicínskeho výskumu informovať EK o prípad-nom predchádzajúcom etickom posúdení protokolu ale-bo projektu inou EK.

MMMMoooottttiiiivvvváááácccciiiiaaaa aaaa vvvvzzzzddddeeeelllláááávvvvaaaannnniiiieeee ččččlllleeeennnnoooovvvv EEEEKKKK

Úroveň práce EK priamo závisí od motivácie a infor-movanosti (vzdelania) členov EK. Obe stránky je nnnneeeevvvvyyyyhhhh----nnnnuuuuttttnnnnéééé ssssyyyysssstttteeeemmmmaaaattttiiiicccckkkkyyyy zzzzaaaabbbbeeeezzzzppppeeeeččččiiiiťťťť, vrátane vytvorenia prime-raných ppppeeeerrrrssssoooonnnnáááállllnnnnyyyycccchhhh a mmmmaaaatttteeeerrrriiiiáááállllnnnnyyyycccchhhh ppppooooddddmmmmiiiieeeennnnooookkkk (a to ivzhľadom na narastajúce nároky na objem a kvalitu práceEK a jej jednotlivých členov, najmä v oblasti posudzova-nia protokolov klinického skúšania liečiv a projektov bio-medicínskeho výskumu).

V mmmmoooottttiiiivvvváááácccciiiiiiii ččččlllleeeennnnoooovvvv EEEEKKKK bude potrebné vhodne uplat-ňovať:

a) nepeňažné prostriedky (napr. vytvárať vhodné pod-mienky pre prácu EK a priebeh zasadnutí (vhodná miest-nosť, občerstvenie, technické a administratívne zabezpe-čenie, ai.), zvýšiť spoločenské uznanie za prácu v EK aprestíž členov EK (informovanosť, médiá, ai.), účasť čle-nov na atraktívnych vzdelávacích aktivitách, ai.),

b) finančné prostriedky (napr. honorovanie práce prispracovaní posudku na prejednávaný projekt, vyžiada-ných písomných materiálov pre potreby EK, ai.).

Vo vvvvzzzzddddeeeelllláááávvvvaaaannnníííí ččččlllleeeennnnoooovvvv EEEEKKKK sa ukazuje vhodným rozlíšiťdve etapy:

a) vstupné školenie pre nových členov EK (napr. in-štruktáž na úrovni danej EK, vstupný seminár pre novýchčlenov EK na miestnej alebo regionálnej úrovni, kurzÚMEB, ai.),

b) kontinuálne vzdelávanie členov EK (napr. kurzy/se-mináre na miestnej alebo regionálnej úrovni, kurzy ÚMEB,účasť na konferenciách, ai.).

Je nevyhnutné vypracovať ucelený a otvorený ssssyyyyssssttttéééémmmmvvvvzzzzddddeeeelllláááávvvvaaaannnniiiiaaaa ččččlllleeeennnnoooovvvv EEEEKKKK - i vzhľadom na požiadavky SKP(viaceré zahraničné inštitúcie a firmy napr. vyžadujú in-formáciu o vzdelávaní členov EK pri prieskume zabez-pečenia plnenia podmienok SKP na danom pracovis-ku/pracoviskách).

Podporiť vypracovanie ssssúúúúbbbboooorrrruuuu iiiinnnnffffoooorrrrmmmmaaaaččččnnnnýýýýcccchhhh mmmmaaaatttteeeerrrriiiiáááá----lllloooovvvv pppprrrreeee ččččlllleeeennnnoooovvvv EEEEKKKK, medzi ktoré by mali patriť:

– príručka člena EK (v pravidelných intervaloch ino-vovaná, vydaná knižne ako brožúra, prípadne aj na dis-kete alebo CD),

– portfólio materiálov pre člena EK (pripravené apravidelne doplňované na úrovni jednotlivých EK alebocentrálne (CEK, ÚMEB) - ako jednoduchá doplňovaciapríručka, prípadne (alebo len) na diskete/CD),

– časopis „Medicínska etika & Bioetika“ (členom EKzasielať zdarma v elektronickej forme (PDF), zabezpečiťzasielanie 1 výtlačku pre jednotlivé EK v SR).

ÚÚÚÚlllloooohhhhyyyy CCCCeeeennnnttttrrrráááállllnnnneeeejjjj eeeettttiiiicccckkkkeeeejjjj kkkkoooommmmiiiissssiiiieeee

Úlohy, ktoré pri revitalizácií systému EK v SR má plniťCEK vyplývajú priamo z jej štatútu. Sú predovšetkýmv oblasti legislatívnej, metodickej (koncepčné, konzul-tačné a edukačné) a motivačnej. V menšej miere, vzhľa-dom na aktuálne možnosti a obmedzenia, by sa CEKmohla podieľať na audite činnosti EK (v oblasti klinick-ého skúšania liekov túto činnosť vykonáva zo stranysponzora monitor (vnútorný audit); inšpekcie SKP zostrany štátnej správy vykonáva ŠÚKL, možné sú aj kon-troly/inšpekcie poverenými zástupcami medzinárodnýchorganizácií a inštitúcií - a to aj viac rokov po ukončení kli-nickej štúdie, napr. FDA, EMEA, ai.).

Podľa štatútu CEK ide najmä o tieto ddddllllhhhhooooddddoooobbbbééééúúúúlllloooohhhhyyyy::::

◆ vykonáva odbornú konzultačnú činnosť v oblasti

12 ME&B 9 (3–4) 2002

problémov medicíny, zdravotníctva a biomedicínskehovýskumu (napr. pripravených CEK v spolupráci s ďalšímizainteresovanými inštitúciami).

OOOOddddbbbboooorrrrnnnnéééé rrrriiiiaaaaddddeeeennnniiiieeee ssssyyyyssssttttéééémmmmuuuu EEEEKKKK

SSSSyyyyssssttttéééémmmm EEEEKKKK (tabuľka 2) nepredpokladá vzájomnú„podriadenosť“ miestnych EK komisiám vyššieho typu -krajské EK (KEK), CEK. Odlišnosť je v rozsahu úloh, zod-povednosti a kompetencií.

OOOOddddbbbboooorrrrnnnnéééé rrrriiiiaaaaddddeeeennnniiiieeee systému EK v SR musí byť úúúúlllloooohhhhoooouuuuMMMMZZZZ SSSSRRRR. Realizáciu by mala zabezpečiť metodická a kon-zultačná činnosť CCCCEEEEKKKK.... Dôležitú pomocnú úlohu by maliplniť výskumné a edukačné aktivity ÚÚÚÚMMMMEEEEBBBB (SZU) a ďal-ších zainteresovaných organizácií a inštitúcií (ŠÚKL, od-borné spoločnosti SLS, ai.).

TTTTaaaabbbbuuuuľľľľkkkkaaaa 2222.... Typy etických komisií, ich činnosť a hlavné úlohy

VVVVzzzzáááájjjjoooommmmnnnnýýýý kkkkoooonnnnttttaaaakkkktttt aaaa ssssppppoooolllluuuupppprrrrááááccccaaaa EEEEKKKK

Pre dobré fungovanie systému EK sa v zahraničí, av minulosti i u nás, osvedčili pravidelné kontakty členovEK, vzájomná výmena informácií a spolupráca medzi EK,a to tak v horizontálnom (MEK-MEK, KEK-KEK; CEKv rámci Medzinárodnej konferencie národných etickýchkomisií (COMETH) + bilaterálne vzťahy, v našich pod-mienkach najmä spolupráca s CEK MZ ČR) ako aj vo ver-tikálnom smere (MEK - KEK, KEK - CEK).

Pre tieto účely bude v budúcnosti potrebné najmä:– vybudovať iiiinnnnffffoooorrrrmmmmaaaaččččnnnnúúúú ssssiiiieeeeťťťť EEEEKKKK (internet, webová

stránka CEK, projekt EURETHNET, ai.),– organizovať pravidelné „ddddiiiisssskkkkuuuussssnnnnéééé ssssúúúússssttttrrrreeeeddddeeeennnniiiiaaaa““““ čle-

nov EK (aspoň raz ročne, prípadne spojené s kurzomÚMEB alebo SZU, alebo vedecko-odbornou konferencioubioetiky),

– v budúcich ssssmmmmeeeerrrrnnnniiiicccciiiiaaaacccchhhh pre činnosť EK zakotviťpovinnosť vzájomnej informácie EK, ako aj povinnosťpredkladateľov protokolov klinického skúšania a projek-

TTTTyyyypppp eeeettttiiiicccckkkkeeeejjjj kkkkoooommmmiiiissssiiiieeee –––– HHHHllllaaaavvvvnnnnáááá oooobbbbllllaaaassssťťťť ččččiiiinnnnnnnnoooossssttttiiii –––– úúúúlllloooohhhhyyyy

CCCCeeeennnnttttrrrráááállllnnnnaaaa (CCCCEEEEKKKK) – legislatíva; koncepčná činnosť; konzultačná čin-

nosť pre EK v SR; medzinárodné vzťahy a spolupráca;medzinárodné inštitúcie, organizácie a odborné komi-sie; stanoviská k aktuálnym problémom bioetiky, atď.

KKKKrrrraaaajjjjsssskkkkáááá (regionálna) (KKKKEEEEKKKK)– posudzovanie protokolov multicentrických štúdií

klinického skúšania liečiv a projektov multicentrické-ho biomedicínskeho výskumu, konzultačná činnosťpre MEK v rámci kraja/regiónu; regionálne predpisy ausmernenia; prípadne špecializácia na posudzovanieetických problémov v konkrétnej, vysokošpecializo-vanej oblasti; atď.;

MMMMiiiieeeessssttttnnnnaaaa (lokálna) (MMMMEEEEKKKK)aaaa)))) MMMMEEEEKKKK pppprrrreeee bbbbiiiioooommmmeeeeddddiiiiccccíííínnnnsssskkkkyyyy vvvvýýýýsssskkkkuuuummmm////kkkklllliiiinnnniiiicccckkkkéééé

sssskkkkúúúúššššaaaannnniiiieeee lllliiiieeeeččččiiiivvvv: posudzovanie protokolov klinickéhoskúšania liečiv a ďalšie činnosti podľa požiadaviek SKP;konzultácie pre výskumných pracovníkov a účastníkovvýskumu; štandardné pracovné postupy na miestnejúrovni; atď.;

bbbb)))) MMMMEEEEKKKK pppprrrreeee kkkklllliiiinnnniiiicccckkkkúúúú eeeettttiiiikkkkuuuu ((((„„„„nnnneeeemmmmooooccccnnnniiiiččččnnnnáááá““““)))): vzdelá-vanie zdravotníckych pracovníkov v medicínskej eti-ke/bioetike; konzultácie pre zdravotníckych pracov-níkov, pacientov a ich príbuzných; riešenie etickyproblémových klinických prípadov; atď.

13ME&B 9 (3–4) 2002

medicínskej etiky, zdravotníckej etiky a bioetiky pre EKzdravotníckych zariadení a EK pre biomedicínsky výskum,

◆ spracováva stanoviská k predloženým materiálom avyjadrenia k etickej stránke aktuálnych problémov medicí-ny a zdravotníctva, spracováva koncepčné materiály preoblasť medicínskej etiky, zdravotníckej etiky a bioetiky,

◆ pripravuje vecné návrhy právnych predpisov týka-júcich sa etických aspektov problémov medicíny, zdra-votníctva a biomedicínskych vied,

◆ podieľa sa na tvorbe a inovácii koncepcie vzdeláva-nia zdravotníckych pracovníkov a členov EK v biomedi-cínskej etike v spolupráci s ďalšími zainteresovanýmiinštitúciami a organizáciami (napr. Slovenská zdravotníc-ka univerzita v Bratislave, lekárske fakulty, Ústav medicín-skej etiky a bioetiky v Bratislave, Štátny ústav pre kontro-lu liečiv, ai.),

◆ udržuje kontakty s orgánmi profesijných organizá-cií zdravotníckych pracovníkov, odborných lekárskychspoločností a s inými inštitúciami a organizáciami zaobe-rajúcimi sa etikou medicíny, zdravotníctva a bioetikouv Slovenskej republike (a v cudzine),

◆ iniciuje a podieľa sa na verejnej diskusii na aktuálnetémy biomedicínskej etiky a etiky zdravotníctva, ako aj nainformačných kampaniach a vzdelávacích aktivitách ur-čených pre širokú verejnosť.

Medzi kkkkrrrrááááttttkkkkooooddddoooobbbbéééé úúúúlllloooohhhhyyyy CEK by v najbližšom obdobímali patriť:

◆ usporiadanie (1-2 razy ročne) diskusných sústre-dení pre členov EK (prvé sa uskutočnilo 24. októbra2002 v priebehu medzinárodnej konferencie bioetiky„Ethics of Human Genetics“ v rámci Programu DEBRARady Európy v Bratislave),

◆ podporiť dotvorenie legislatívnej bázy pre činnosťEK v SR (najmä vydanie vyhlášky o klinickom skúšaníliečiv a o správnej klinickej praxi, ako aj vyhlášky o etic-kých komisiách),

◆ podporiť, spoluiniciovať tvorbu informačnej sieteEK (napr. v nadväznosti na plánované zriadenie Infor-mačného a dokumentačného centra bioetiky v Bratislavea program EURETHNET),

◆ podporiť vznik informačných materiálov pre čle-nov EK.

4444.... EEEEttttiiiicccckkkkéééé kkkkoooommmmiiiissssiiiieeee vvvv zzzzddddrrrraaaavvvvoooottttnnnníííícccckkkkyyyycccchhhh zzzzaaaarrrriiiiaaaaddddeeee----nnnniiiiaaaacccchhhh ((((kkkkoooommmmiiiissssiiiieeee pppprrrreeee „„„„kkkklllliiiinnnniiiicccckkkkúúúú eeeettttiiiikkkkuuuu““““))))

EEEEttttiiiicccckkkkéééé kkkkoooommmmiiiissssiiiieeee pppprrrreeee kkkklllliiiinnnniiiicccckkkkúúúú eeeettttiiiikkkkuuuu sú v zdravotníckychzariadeniach v našich podmienkach pomerne novým adosiaľ zriedkavým fenoménom. Vzhľadom k nedosta-točnému záujmu a podpore zo strany zdravotníckehomanažmentu, samotných zdravotníckych pracovníkov,ako i pacientov a širšej verejnosti sa (s výnimkou spon-tánne vzniklých diskusných skupín lekárov v niektorýchväčších nemocniciach v období po novembri 1989) také-to EK v našich nemocniciach alebo iných zdravotníckychzariadeniach zatiaľ širšie nerozvinuli. EK posudzujúceprojekty biomedicínskeho výskumu alebo protokoly kli-nického skúšania liekov sa len výnimočne vo svojej prácizaoberajú etickými problémami medicínskej aleboošetrovateľskej praxe. Vzhľadom na vývoj v okolitýchkrajinách s rozvinutým zdravotníctvom, ako aj na aktuál-ne trendy v globálnom meradle, však možno predpokla-dať, že etická problematika spojená s poskytovanímzdravotnej starostlivosti a výkonom zdravotníckych po-volaní bude už v relatívne blízkej budúcnosti aj u násvýznamne narastať. Najčastejšie ddddôôôôvvvvooooddddyyyy, ktoré sa na zria-denie EK pre klinickú etiku uvádzajú, sú súhrnne uve-dené v tabuľke 3. Poslanie, účel zriadenia a náplň činnos-ti týchto EK sú v mnohých aspektoch odlišné od komisií

pracujúcich v oblasti biomedicínskeho výskumu aleboklinického skúšania. Niektoré ooooddddlllliiiiššššnnnnoooossssttttiiii sú uvedenév tabuľke 4.

TTTTaaaabbbbuuuuľľľľkkkkaaaa 3333.... Dôvody pre zriadenie etických komisií v zdravotníckych zariadeniach

TTTTaaaabbbbuuuuľľľľkkkkaaaa 4444.... Porovnanie etických komisií pre klinickú etiku v zdravotníckych zariadeniach (AAAA) a etických komisií pre biomedicínsky výskum (BBBB)

ÚÚÚÚlllloooohhhhyyyy aaaa ččččiiiinnnnnnnnoooossssťťťť eeeettttiiiicccckkkkeeeejjjj kkkkoooommmmiiiissssiiiieeee vvvv zzzzddddrrrraaaavvvvoooottttnnnníííícccckkkkoooommmm zzzzaaaarrrriiiiaaaaddddeeeennnníííí

Úlohy, ktoré má EK plniť v zariadeniach poskytujúcichzdravotnú starostlivosť, možno rozdeliť do piatich hlav-

● pokrok v oblasti medicíny a zdravotníctva;● ekonomické hranice v oblasti zdravotníctva;● tímový prístup pri poskytovaní zdravotnej

starostlivosti;● rastúca autonómia pacienta;● komplikovanosť medicínskych rozhodnutí v praxi

(pre samotných odborníkov);● komplikovanosť medicínskej problematiky a nároč-

nosť v rozhodovaní pre pacientov a ich rodinných príslušníkov, resp. zákonných zástupcov (pre medi-cínskych „laikov“);

● nové medicínske technológie s ďalekosiahlym vply-vom na osobný a rodinný život (napr. aplikácie hu-mánnej genetiky, metódy asistovanej reprodukcie človeka, ai.);

● možný vplyv novej medicínskej technológie na okolie pacienta alebo na blízke či vzdialené budúce generácie (napr. génová terapia, xenotransplantácie);

● zvýšený výskyt eticky podmienených konfliktov v oblasti zdravotnej starostlivosti;

● pluralizmus v morálnej (etickej) oblasti;● rastúci multikulturalizmus spoločnosti, vrátane

náboženskej plurality;● narastajúca multietnicita spoločnosti;● potreba brať do úvahy hodnotové postoje pacienta

a jeho príbuzných;● záujmy spoločnosti, záujmy menších spoločenstiev;● potreba „neutrálnej pôdy“ pre mediáciu, objasňova-

nie, rozhodovanie;● potreba ochrany dôstojnosti, práv, integrity, identity

a ďalších oprávnených záujmov pacienta;

VVVVllllaaaassssttttnnnnoooossssťťťť////ČČČČiiiinnnnnnnnoooossssťťťť////PPPPoooossssllllaaaannnniiiieeee////PPPPrrrriiiioooorrrriiiittttaaaa AAAA BBBB

Vzdelávacie aktivity + +Posudzovanie projektov biomedicínskeho výskumu –/+* +Konzultácie pre vedenie zariadenia + +Konzultácie pre pracovníkov zariadenia + +Konzultácie pre pacientov + –/+Konzultácie pre účastníkov výskumu –/+**** –/+Konzultácie pre rodinných príslušníkov + –/+Problematika klinickej etiky + –/+Správna klinická prax –/+**** +Problematika etiky biomedicínskeho výskumu -/+**** +Vypracovanie odporúčaného postupu, smerníc pre dané zariadenie, oddelenie + –Riešenie konkrétnych klinických prípadov + –

**** Pokiaľ sa plánuje alebo vykonáva klinický výskum.

14 ME&B 9 (3–4) 2002

ných skupín. V rôznych obdobiach svojej činnosti EK,v súlade s aktuálnymi potrebami daného zdravotníckehozariadenia, plní tieto úlohy v rôznom rozsahu a intenzite.

Ide predovšetkým o tieto oblasti činnosti:1111.... VVVVzzzzddddeeeelllláááávvvvaaaannnniiiieeee vvvv medicínskej a ooooššššeeeettttrrrroooovvvvaaaatttteeeeľľľľsssskkkkeeeejjjj eeeettttiiiikkkkeeee

(prípadne bbbbiiiiooooeeeettttiiiikkkkeeee). Orientuje sa na aktuálne potrebyzzzzddddrrrraaaavvvvoooottttnnnníííícccckkkkyyyycccchhhh pppprrrraaaaccccoooovvvvnnnnííííkkkkoooovvvv zdravotníckeho zariadenia,dané typom poskytovanej zdravotnej starostlivosti a spek-trom i náročnosťou riešených prípadov. Cieľom je nieleninformovať zdravotníckych pracovníkov o relevantnýchetických problémoch a plauzibilných riešeniach, o rôz-nych etických smerniciach, profesijných etických kóde-xoch, atď., ale predovšetkým zvyšovanie ich eeeettttiiiicccckkkkeeeejjjj kkkkoooommmm----ppppeeeetttteeeennnncccciiiieeee - t.j. schopnosti samostatne rozpoznávať, analy-zovať a riešiť etické problémy, s ktorými sa vo svojejmedicínskej alebo ošetrovateľskej praxi stretávajú. EKmá takto prispievať k eeeettttiiiicccckkkkeeeejjjj kkkkuuuullllttttúúúúrrrreeee daného zdravotníc-keho zariadenia, čo má nezriedka priamy dopad na kvali-tu poskytovanej zdravotnej starostlivosti.

Zvlášť na začiatku svojej činnosti má EK zamerať vzde-lávacie aktivity na ssssvvvvoooojjjjiiiicccchhhh vvvvllllaaaassssttttnnnnýýýýcccchhhh ččččlllleeeennnnoooovvvv - na nadobud-nutie špeciálnych individuálnych aj „kolektívnych“ schop-ností potrebných pre plnenie úloh v danom zariadení. Naabsolvovanie určitého „vstupného minima“ pre všetkýchčlenov novej EK, i pre komisiu ako celok (najmä školeniaz problematiky skupinovej dynamiky a metodológie efek-tívnej skupinovej práce), musí nadväzovať primeranýprogram kontinuálneho vzdelávania, zameraný na zvyšo-vanie odbornej úrovne a kompetencie jednotlivých čle-nov i celej komisie.

2222.... VVVVyyyypppprrrraaaaccccoooovvvvaaaannnniiiieeee a ppppoooossssuuuuddddzzzzoooovvvvaaaannnniiiieeee ssssmmmmeeeerrrrnnnníííícccc a ššššttttaaaannnn----ddddaaaarrrrddddnnnnýýýýcccchhhh pppprrrraaaaccccoooovvvvnnnnýýýýcccchhhh ppppoooossssttttuuuuppppoooovvvv v rámci daného zdravot-níckeho zariadenia. Ide o účasť EK pri tvorbe rozhodova-cích algoritmov pre klinicky náročné alebo hraničné situ-ácie, kde buď dosiaľ neexistujú všeobecne prijaté diag-nostické a liečebné postupy, alebo ich aplikácia v kon-krétnej situácii je problematická pre zložitosť situáciealebo závislosť od konkrétnych podmienok daného zdra-votníckeho zariadenia (napr. prístrojové vybavenie, dos-tupnosť príslušných odborníkov, ai.). Príkladom môžebyť: postup pri starostlivosti o novorodencov s extrémnenízkou pôrodnou hmotnosťou, indikácie a kontraindiká-cie konkrétnych nedostatkových alebo finančne veľmináročných diagnostických alebo terapeutických pos-tupov, postup pri odmietaní život zachraňujúcej alebopredlžujúcej liečby zo strany pacienta alebo jeho rodin-ných príslušníkov, atď.

Významnou súčasťou činnosti EK by malo byť ppppoooossssúúúúddddeeee----nnnniiiieeee eeeettttiiiicccckkkkýýýýcccchhhh aaaassssppppeeeekkkkttttoooovvvv novo zavádzaných ddddiiiiaaaaggggnnnnoooossssttttiiiicccckkkkýýýýcccchhhh,,,,lllliiiieeeeččččeeeebbbbnnnnýýýýcccchhhh,,,, pppprrrreeeevvvveeeennnnttttíííívvvvnnnnyyyycccchhhh alebo ooooššššeeeettttrrrroooovvvvaaaatttteeeeľľľľsssskkkkýýýýcccchhhh mmmmeeeettttóóóóddddaaaa ppppoooossssttttuuuuppppoooovvvv,,,, prípadne významných zmien alebo rušeniadosiaľ zavedených metód a postupov. Cieľom tohto posú-denia – okrem posúdenia všeobecných etických a medi-cínskych aspektov novej metódy – je posúdenie týchtoaspektov vo vzťahu ku konkrétnym podmienkam danéhozdravotníckeho zariadenia (prístrojové a personálne vy-bavenie, nároky na služby a financie, atď.), a to aj z hľa-diska prípadných morálnych záväzkov a postojov správcualebo vlastníka tohto zdravotníckeho zariadenia (napr.zdravotnícke zariadenia spravované/vlastnené cirkvoualebo náboženskou spoločnosťou), ako aj obyvateľstvaregiónu, v ktorom dané zdravotnícke zariadenie pracuje.Vyjadrenie EK by sa malo stať súčasťou procedúry zave-denia každej novej metódy alebo postupu v rámci da-ného zdravotníckeho zariadenia. Môže predísť závažnýmdiskusiám a problémom v neskorších fázach implementá-cie novej metódy alebo postupu, a byť určitou bázou preinformovanú diskusiu aj v prípade nepredvídaných alebonežiaducich reakcií alebo udalostí.

3333.... PPPPoooossssuuuuddddzzzzoooovvvvaaaannnniiiieeee a rrrriiiieeeeššššeeeennnniiiieeee eeeettttiiiicccckkkkyyyy pppprrrroooobbbblllleeeemmmmaaaattttiiiicccckkkkýýýýcccchhhhkkkklllliiiinnnniiiicccckkkkýýýýcccchhhh pppprrrrííííppppaaaaddddoooovvvv. Ide o veľmi zodpovednú a náročnúčinnosť EK. V našich podmienkach v najbližšom období

bude pomerne zriedkavá. So vzrastajúcim povedomímlekárskej i širšej verejnosti o existencii a možnostiach EKv zdravotníckych zariadeniach (prípadne v nadväznostina niektoré nové všeobecne záväzné predpisy alebo ajniektoré odborné smernice) bude pravdepodobne početklinických prípadov, ku ktorým bude požadované stano-visko EK, narastať.

4444.... KKKKoooonnnnzzzzuuuullllttttaaaaččččnnnnáááá ččččiiiinnnnnnnnoooossssťťťť.... EK prostredníctvom svojichpoverených členov, alebo aj ako celok v rámci svojich riad-nych zasadnutí, má poskytovať vo vhodnom čase a pries-tore odborné konzultácie z oblasti zdravotníckej, ošetro-vateľskej etiky a bioetiky pre všetkých potenciálnych záu-jemcov. Spočiatku bude pravdepodobne táto zložka jej čin-nosti pomerne málo rozvinutá, resp. obmedzená na konzultá-cie pre vedenie a pracovníkov jednotlivých oddelení danéhozdravotníckeho zaradenia. Neskôr, podobne ako v prípaderiešenia konkrétnych klinických prípadov, sa okruh konzultu-júcich subjektov pravdepodobne rozšíri aj na pacientov a ichrodinných príslušníkov, prípadne na zástupcov organizáciípacientov alebo aj širšej verejnosti (napr. predstavitelia komu-nity - regiónu, v ktorom dané zdravotnícke zariadenie pra-cuje, apod.).

5555.... RRRRiiiieeeeššššeeeennnniiiieeee kkkkoooonnnncccceeeeppppččččnnnnýýýýcccchhhh oooottttáááázzzzooookkkk.... Znamená podieľaniesa EK na riešení otázok súvisiacich so samotným posla-ním, ďalšou existenciou a smerovaním zdravotníckehozariadenia (napr. plán ďalšieho rozvoja, priority investič-nej činnosti, priority modernizácie, rozvoja určitých od-delení, reštrukturalizácia, ai.). Môže ísť aj o reflexiu špe-ciálnych etických otázok, súvisiacich s aplikáciou špecific-kých morálnych noriem správcu alebo vlastníka danéhozdravotníckeho zariadenia (napr. určitej cirkvi alebo ná-boženskej spoločnosti) v situácii neustáleho pokrokusamotnej medicíny a ošetrovateľstva – a potreby zavádzanianových diagnostických, liečebných a preventívnych metód,ktoré môžu predstavovať v rámci daného morálneho systé-mu väčší alebo menší morálny problém alebo konflikt.

ZZZZáááávvvveeeerrrroooommmm je potrebné zdôrazniť, že revitalizáciu a roz-voj činnosti EK v SR je potrebné vidieť v kontexte vytvá-rania predpokladov pre úspešný priebeh pripravovanýchtransformačných krokov zdravotníckeho systému, a totak v oblasti samotnej zdravotnej starostlivosti (EK pre„klinickú etiku“), ako aj na poli klinického skúšania liečiva biomedicínskeho výskumu. Tieto kroky majú prispieť ajk úspešnému začleneniu domácich pracovísk a inštitúciído príslušných európskych a medzinárodných štruktúr,zvlášť na pôde Európskej únie a Rady Európy.

DDDDoooocccc.... MMMMUUUUDDDDrrrr.... JJJJoooozzzzeeeeffff GGGGllllaaaassssaaaa,,,, CCCCSSSScccc....

LLLLiiiitttteeeerrrraaaattttúúúúrrrraaaa

1111.... Predchádzajúca, stručnejšia verzia článku bola zaslaná na uverejne-nie v časopise Medicínsky monitor pod názvom Revitalizácia systémuetických komisií v Slovenskej republike - Náčrt problematiky a jej systé-mové riešenie (Glasa, J., Medicínsky monitor SLS, 2003, v tlači). Podstat-nou súčasťou článku je materiál pripravený autorom ako podklad prerokovanie Centrálnej etickej komisie (CEK) MZ SR (prerokovaný naschôdzi CEK 24. 6. 2002). 2222.... Dzúrik, R., Niederland, T. R. (Eds.): Klinickéaspekty skúšania nových liečiv. Osveta, Martin, 1993. 3333.... Šoltés, L., et al.:Vybrané kapitoly z medicínskej etiky. (skriptá), Lekárska fakulta UK vBratislave, 1994. 4444.... Glasa, J., Šoltés, L. (Eds.): Ošetrovateľská etika 1.Osveta, Martin, 1998. 5555.... Glasa, J. (Ed.): Ethics Committees in Central andEastern Europe. Council of Europe - Charis - IMEB Fdn., Bratislava, 2000.


GGGGllllaaaassssaaaa,,,, JJJJ....:::: KKKK pppprrrroooobbbblllléééémmmmuuuu rrrreeeevvvviiiittttaaaalllliiiizzzzáááácccciiiieeee eeeettttiiiicccckkkkýýýýcccchhhh kkkkoooommmmiiiissssiiiiíííí vvvv SSSSlllloooovvvveeeennnnsssskkkkeeeejjjjrrrreeeeppppuuuubbbblllliiiikkkkeeee.... [[[[CCCCoooonnnnttttrrrriiiibbbbuuuuttttiiiioooonnnn ttttoooo tttthhhheeee PPPPrrrroooobbbblllleeeemmmm ooooffff RRRReeeevvvviiiittttaaaalllliiiissssaaaattttiiiioooonnnn ooooffff EEEEtttthhhhiiiiccccssssCCCCoooommmmmmmmiiiitttttttteeeeeeeessss iiiinnnn tttthhhheeee SSSSlllloooovvvvaaaakkkk RRRReeeeppppuuuubbbblllliiiicccc....]]]] MMMMeeeedddd.... EEEEtttthhhh.... BBBBiiiiooooeeeetttt....,,,, 9999,,,, 2222000000002222,,,, NNNNoooo.... 3333 - 4444,,,, pppp....11110000 ---- 11115555.... Ethics committees (ECs) begun to develop in the Slovak Republic(SR) after the political changes started in November 1989. First ECs of amodern type were established in SR as informal groups of enthusiastscomposed of health professionals (physicians and nurses), theologians,psychologists, and workers in other humanities, being usually bound to

15ME&B 9 (3–4) 2002

The collection, analysis and interpretation of informa-tion obtained from research involving human beings con-tribute significantly to the improvement of human health.

Research involving human subjects includes:– studies of a physiological, biochemical or pathologi-

cal process, or of the response to a specific intervention -whether physical, chemical or psychological - in healthysubjects or patients;

– controlled trials of diagnostic, preventive or thera-peutic measures in larger groups of persons, designed todemonstrate a specific generalizable response to thesemeasures against a background of individual biologicalvariation;

– studies designed to determine the consequencesfor individuals and communities of specific preventiveor therapeutic measures; and

– studies concerning human health-related behaviourin a variety of circumstances and environments.

Research involving human subjects may employ eitherobservation or physical, chemical or psychological inter-vention; it may also either generate records or make useof existing records containing biomedical or other infor-mation about individuals who may or may not be identi-fiable from the records or information. The use of suchrecords and the protection of the confidentiality of dataobtained from those records are discussed in Internatio-nal Guidelines for Ethical Review of Epidemiological Stu-dies (CIOMS, 1991).

The research may be concerned with the social envi-ronment, manipulating environmental factors in a waythat could affect incidentally-exposed individuals. It isdefined in broad terms in order to embrace field studiesof pathogenic organisms and toxic chemicals under in-vestigation for health-related purposes.

Biomedical research with human subjects is to be dis-tinguished from the practice of medicine, public healthand other forms of health care, which is designed to con-tribute directly to the health of individuals or communi-ties. Prospective subjects may find it confusing whenresearch and practice are to be conducted simultaneous-ly, as when research is designed to obtain new informa-tion about the efficacy of a drug or other therapeutic,diagnostic or preventive modality.

As stated in Paragraph 32 of the Declaration of Helsin-ki, „In the treatment of a patient, where proven prophy-lactic, diagnostic and therapeutic methods do not existor have been ineffective, the physician, with informedconsent from the patient, must be free to use unprovenor new prophylactic, diagnostic and therapeutic mea-sures, if in the physician’s judgement it offers hope ofsaving life, re-establishing health or alleviating suffering.Where possible, these measures should be made theobject of research, designed to evaluate their safety andefficacy. In all cases, new information should be recor-ded and, where appropriate, published. The other rele-vant guidelines of this Declaration should be followed.“

Professionals whose roles combine investigation andtreatment have a special obligation to protect the rightsand welfare of the patient-subjects. An investigator whoagrees to act as physician-investigator undertakes someor all of the legal and ethical responsibilities of the sub-ject’s primary-care physician. In such a case, if the subjectwithdraws from the research owing to complications rela-ted to the research or in the exercise of the right to with-draw without loss of benefit, the physician has an obliga-tion to continue to provide medical care, or to see that thesubject receives the necessary care in the healthcare sys-tem, or to offer assistance in finding another physician.

Research with human subjects should be carried outonly by, or strictly supervised by, suitably qualified andexperienced investigators and in accordance with a pro-tocol that clearly states: the aim of the research; the rea-

bigger hospitals (teaching, faculty, regional) or to other health care facili-ties, where, in the recent past, despite some risks or even persecution,some ethical traditions were kept alive, frequently in connection to theintellectual or religious dissent. In 1990, the Central Ethics Committee(CEC) was established at the Ministry of Health (MH) SR, which under-took various conceptual activities that contribute considerably to estab-lishing of the basic institutional pre-requisites for the establishment andwork of ECs in SR, as well as for founding and successful development ofthe disciplines of medical ethics and bioethics in the country. In 1993 -2001, some stagnation occurred, which was cau-sed by insufficient le-gislative, political, professional and organisational support. Despite theseshortcomings, the work of ECs, especially those established in the bighospitals and health and biomedical research institutes, continued toexist and develop, mainly due to the necessity of ethics review of the pro-tocols of clinical trials of drugs, and the projects of biomedical research,which were strictly required by sponsoring pharmaceutical companies,as well as domestic and international grant research agencies. Afterrestoration of the regular work of CEC in June 2002, it is necessary in SR tobuild on the previously established and developed institutional, professio-nal and personnel foundations, and to make all necessary steps for the revi-talisation of the ECs’ work, as a system, both concerning their indispensablerole in ethical review of clinical trials of drugs (according to the require-ments of Good Clinical Practice) and the projects of biomedical research,but also for the perspective of their more active work in the health carefacilities and health care institutes in SR (ECs for clinical ethics). KKKKeeeeyyyywwwwoooorrrrddddssss: ethics committees, history, development, revitalisation, SlovakRepublic, clinical trials of drugs, biomedical research, clinical ethics.

Adresa autora: Doc. MUDr. Jozef Glasa, CSc., SZU, Limbová 12, 83303Bratislava, Slovenská republika.

IIIINNNNTTTTEEEERRRRNNNNAAAATTTTIIIIOOOONNNNAAAALLLL EEEETTTTHHHHIIIICCCCAAAALLLL GGGGUUUUIIIIDDDDEEEELLLLIIIINNNNEEEESSSSFFFFOOOORRRR BBBBIIIIOOOOMMMMEEEEDDDDIIIICCCCAAAALLLL RRRREEEESSSSEEEEAAAARRRRCCCCHHHH IIIINNNNVVVVOOOOLLLLVVVVIIIINNNNGGGGHHHHUUUUMMMMAAAANNNN SSSSUUUUBBBBJJJJEEEECCCCTTTTSSSS [[[[1111]]]]

PPPPrrrreeeeppppaaaarrrreeeedddd bbbbyyyy tttthhhheeee CCCCoooouuuunnnncccciiiillll ffffoooorrrr IIIInnnntttteeeerrrrnnnnaaaattttiiiioooonnnnaaaallll OOOOrrrrggggaaaannnniiiizzzzaaaattttiiiioooonnnnssssooooffff MMMMeeeeddddiiiiccccaaaallll SSSScccciiiieeeennnncccceeeessss ((((CCCCIIIIOOOOMMMMSSSS)))) iiiinnnn ccccoooollllllllaaaabbbboooorrrraaaattttiiiioooonnnn wwwwiiiitttthhhh tttthhhheeeeWWWWoooorrrrlllldddd HHHHeeeeaaaalllltttthhhh OOOOrrrrggggaaaannnniiiizzzzaaaattttiiiioooonnnn ((((WWWWHHHHOOOO))))

CIOMS, Geneva, 2002

PPPPrrrreeeeaaaammmmbbbblllleeee

The term „research“ refers to a class of activity desig-ned to develop or contribute to generalizable know-ledge. Generalizable knowledge consists of theories,principles or relationships, or the accumulation of infor-mation on which they are based, that can be corrobora-ted by accepted scientific methods of observation andinference. In the present context „research“ includesboth medical and behavioural studies pertaining tohuman health. Usually „research“ is modified by theadjective „biomedical“ to indicate its relation to health.

Progress in medical care and disease prevention de-pends upon an understanding of physiological and pa-thological processes or epidemiological findings, and re-quires at some time research involving human subjects.

[[[[1111]]]] EEEEddddiiiittttoooorrrriiiiaaaallll NNNNooootttteeee:::: We reprint here, with the kind permission of CIOMS,the excerpts of the 2002 CIOMS Guidelines, namely the Preamble, andthe Guidelines 1 - 21. Ommitted here, because of the space constraints,were the chapters: Background, Introduction, International Instrumentsand Guidelines, General Ethical Principles, the Commentaries to theGuidelines 1 - 21, and the Appendices 1 – 3 (the 2000 version of theWMA Helsinki Declaration was already published in our journal: Med.Eth. Bioet., 7, 2000, No. 3 - 4, p. 13 - 14). The deleted portions of the origi-nal text were replaced by the following sign: (...). Assss tttthhhheeee CCCCoooommmmmmmmeeeennnnttttaaaarrrriiiieeeessssaaaarrrreeee eeeesssssssseeeennnnttttiiiiaaaallll ffffoooorrrr tttthhhheeee pppprrrrooooppppeeeerrrr uuuunnnnddddeeeerrrrssssttttaaaannnnddddiiiinnnngggg aaaannnndddd aaaapppppppplllliiiiccccaaaattttiiiioooonnnn ooooffff tttthhhheeeeGGGGuuuuiiiiddddeeeelllliiiinnnneeeessss,,,, wwwweeee ssssttttrrrroooonnnnggggllllyyyy rrrreeeeccccoooommmmmmmmeeeennnndddd tttthhhheeee rrrreeeeaaaaddddeeeerrrr ttttoooo rrrreeeeaaaadddd tttthhhheeee ffffuuuullllllll tttteeeexxxxtttt ooooffff tttthhhheeeeGGGGuuuuiiiiddddeeeelllliiiinnnneeeessss.... It may be found at the CIOMS website, or purchased as a sepa-rate publication directly from CIOMS, c/o WHO, Avenue Appia, 1211Geneva 27, Switzerland, or from the booksellers through the network ofWHO sales agents.

DOKUMENTY / DOCUMENTS

16 ME&B 9 (3–4) 2002

GGGGuuuuiiiiddddeeeelllliiiinnnneeee 5555:::: OOOObbbbttttaaaaiiiinnnniiiinnnngggg iiiinnnnffffoooorrrrmmmmeeeedddd ccccoooonnnnsssseeeennnntttt:::: EEEEsssssssseeeennnnttttiiiiaaaallll iiiinnnnffffoooorrrr----mmmmaaaattttiiiioooonnnn ffffoooorrrr pppprrrroooossssppppeeeeccccttttiiiivvvveeee rrrreeeesssseeeeaaaarrrrcccchhhh ssssuuuubbbbjjjjeeeeccccttttssssBefore requesting an individual’s consent to participatein research, the investigator must provide the followinginformation, in language or another form of communica-tion that the individual can understand:

1. that the individual is invited to participate in re-search, the reasons for considering the individual suit-able for the research, and that participation is voluntary;

2. that the individual is free to refuse to participateand will be free to withdraw from the research at any ti-me without penalty or loss of benefits to which he or shewould otherwise be entitled;

3. the purpose of the research, the procedures to becarried out by the investigator and the subject, and anexplanation of how the research differs from routinemedical care;

4. for controlled trials, an explanation of features ofthe research design (e.g., randomization, double-blinding),and that the subject will not be told of the assigned treat-ment until the study has been completed and the blindhas been broken;

5. the expected duration of the individual’s participa-tion (including number and duration of visits to the re-search centre and the total time involved) and the possi-bility of early termination of the trial or of the indivi-dual’s participation in it;

6. whether money or other forms of material goodswill be provided in return for the individual’s participa-tion and, if so, the kind and amount;

7. that, after the completion of the study, subjects willbe informed of the findings of the research in general,and individual subjects will be informed of any findingthat relates to their particular health status;

8. that subjects have the right of access to their dataon demand, even if these data lack immediate clinicalutility (unless the ethical review committee has appro-ved temporary or permanent non-disclosure of data, inwhich case the subject should be informed of, and given,the reasons for such non-disclosure);

9. any foreseeable risks, pain or discomfort, or incon-venience to the individual (or others) associated with par-ticipation in the research, including risks to the health orwell-being of a subject’s spouse or partner;

10. the direct benefits, if any, expected to result tosubjects from participating in the research

11. the expected benefits of the research to the com-munity or to society at large, or contributions to scientificknowledge;

12. whether, when and how any products or interven-tions proven by the research to be safe and effective willbe made available to subjects after they have completedtheir participation in the research, and whether they willbe expected to pay for them;

13. any currently available alternative interventionsor courses of treatment;

14. the provisions that will be made to ensure respectfor the privacy of subjects and for the confidentiality ofrecords in which subjects are identified;

15. the limits, legal or other, to the investigators’ abili-ty to safeguard confidentiality, and the possible conse-quences of breaches of confidentiality;

16. policy with regard to the use of results of genetictests and familial genetic information, and the precau-tions in place to prevent disclosure of the results of asubject’s genetic tests

17. to immediate family relatives or to others (e.g.,insurance companies or employers) without the consentof the subject;

18. the sponsors of the research, the institutional affilia-tion of the investigators, and the nature and sources offunding for the research;

sons for proposing that it involve human subjects; thenature and degree of any known risks to the subjects; thesources from which it is proposed to recruit subjects;and the means proposed for ensuring that subjects’ con-sent will be adequately informed and voluntary. The pro-tocol should be scientifically and ethically appraised byone or more suitably constituted review bodies, indepen-dent of the investigators.

New vaccines and medicinal drugs, before being ap-proved for general use, must be tested on human sub-jects in clinical trials; such trials constitute a substantialpart of all research involving human subjects.

TTTThhhheeee GGGGuuuuiiiiddddeeeelllliiiinnnneeeessss

GGGGuuuuiiiiddddeeeelllliiiinnnneeee 1111:::: EEEEtttthhhhiiiiccccaaaallll jjjjuuuussssttttiiiiffffiiiiccccaaaattttiiiioooonnnn aaaannnndddd sssscccciiiieeeennnnttttiiiiffffiiiicccc vvvvaaaalllliiiiddddiiiittttyyyy ooooffffbbbbiiiioooommmmeeeeddddiiiiccccaaaallll rrrreeeesssseeeeaaaarrrrcccchhhh iiiinnnnvvvvoooollllvvvviiiinnnngggg hhhhuuuummmmaaaannnn bbbbeeeeiiiinnnnggggssssThe ethical justification of biomedical research invol-ving human subjects is the prospect of discovering newways of benefiting people’s health. Such research can beethically justifiable only if it is carried out in ways thatrespect and protect, and are fair to, the subjects of thatresearch and are morally acceptable within the commu-nities in which the research is carried out. Moreover, be-cause scientifically invalid research is unethical in that itexposes research subjects to risks without possible bene-fit, investigators and sponsors must ensure that proposedstudies involving human subjects conform to generallyaccepted scientific principles and are based on adequateknowledge of the pertinent scientific literature.

((((............))))

GGGGuuuuiiiiddddeeeelllliiiinnnneeee 2222:::: EEEEtttthhhhiiiiccccaaaallll rrrreeeevvvviiiieeeewwww ccccoooommmmmmmmiiiitttttttteeeeeeeessssAll proposals to conduct research involving human sub-jects must be submitted for review of their scientific me-rit and ethical acceptability to one or more scientific re-view and ethical review committees. The review commit-tees must be independent of the research team, and anydirect financial or other material benefit they may derivefrom the research should not be contingent on the out-come of their review. The investigator must obtain theirapproval or clearance before undertaking the research.The ethical review committee should conduct furtherreviews as necessary in the course of the research, inclu-ding monitoring of the progress of the study.

((((............))))

GGGGuuuuiiiiddddeeeelllliiiinnnneeee 3333:::: EEEEtttthhhhiiiiccccaaaallll rrrreeeevvvviiiieeeewwww ooooffff eeeexxxxtttteeeerrrrnnnnaaaallllllllyyyy ssssppppoooonnnnssssoooorrrreeeeddddrrrreeeesssseeeeaaaarrrrcccchhhhAn external sponsoring organization and individual in-vestigators should submit the research protocol for ethi-cal and scientific review in the country of the sponsoringorganization, and the ethical standards applied should beno less stringent than they would be for research carriedout in that country. The health authorities of the hostcountry, as well as a national or local ethical review com-mittee, should ensure that the proposed research is res-ponsive to the health needs and priorities of the hostcountry and meets the requisite ethical standards.

((((............))))

GGGGuuuuiiiiddddeeeelllliiiinnnneeee 4444:::: IIIInnnnddddiiiivvvviiiidddduuuuaaaallll iiiinnnnffffoooorrrrmmmmeeeedddd ccccoooonnnnsssseeeennnnttttFor all biomedical research involving humans the investi-gator must obtain the voluntary informed consent of theprospective subject or, in the case of an individual who isnot capable of giving informed consent, the permission ofa legally authorized representative in accordance withapplicable law. Waiver of informed consent is to be re-garded as uncommon and exceptional, and must in allcases be approved by an ethical review committee.

((((............))))

17ME&B 9 (3–4) 2002

19. the possible research uses, direct or secondary, ofthe subject`s medical records and of biological speci-mens taken in the course of clinical care (See also Gui-delines 4 and 18 Commentaries);

20. whether it is planned that biological specimenscollected in the research will be destroyed at its conclu-sion, and, if not, details about their storage (where, how,for how long, and final disposition) and possible futureuse, and that subjects have the right to decide about suchfuture use, to refuse storage, and to have the materialdestroyed (See Guideline 4 Commentary);

21. whether commercial products may be developedfrom biological specimens, and whether the participantwill receive monetary or other benefits from the develop-ment of such products;

22. whether the investigator is serving only as an in-vestigator or as both investigator and the subject`s physi-cian;

23. the extent of the investigator’s responsibility toprovide medical services to the participant;

24. that treatment will be provided free of charge forspecified types of research-related injury or for complica-tions associated with the research, the nature and dura-tion of such care, the name of the organization or indi-vidual that will provide the treatment, and whether thereis any uncertainty regarding funding of such treatment;

25. in what way, and by what organization, the sub-ject or the subject`s family or dependants will be com-pensated for disability or death resulting from such in-jury (or, when indicated, that there are no plans to pro-vide such compensation);

26. whether or not, in the country in which the pros-pective subject is invited to participate in research, theright to compensation is legally guaranteed;

27. that an ethical review committee has approved orcleared the research protocol.

((((............))))

GGGGuuuuiiiiddddeeeelllliiiinnnneeee 6666:::: OOOObbbbttttaaaaiiiinnnniiiinnnngggg iiiinnnnffffoooorrrrmmmmeeeedddd ccccoooonnnnsssseeeennnntttt:::: OOOObbbblllliiiiggggaaaattttiiiioooonnnnssss ooooffffssssppppoooonnnnssssoooorrrrssss aaaannnndddd iiiinnnnvvvveeeessssttttiiiiggggaaaattttoooorrrrssssSponsors and investigators have a duty to:

● refrain from unjustified deception, undue influen-ce, or intimidation;

● seek consent only after ascertaining that the pros-pective subject has adequate understanding of the rele-vant facts and of the consequences of participation andhas had sufficient opportunity to consider whether toparticipate;

● as a general rule, obtain from each prospective subjecta signed form as evidence of informed consent - investiga-tors should justify any exceptions to this general rule andobtain the approval of the ethical review committee (SeeGuideline 4 Commentary, Documentation of consent);

● renew the informed consent of each subject if thereare significant changes in the conditions or proceduresof the research or if new information becomes availablethat could affect the willingness of subjects to continueto participate; and,

● renew the informed consent of each subject in long-term studies at predetermined intervals, even if there areno changes in the design or objectives of the research.

((((............))))

GGGGuuuuiiiiddddeeeelllliiiinnnneeee 7777:::: IIIInnnndddduuuucccceeeemmmmeeeennnntttt ttttoooo ppppaaaarrrrttttiiiicccciiiippppaaaatttteeeeSubjects may be reimbursed for lost earnings, travel costsand other expenses incurred in taking part in a study; theymay also receive free medical services. Subjects, particular-ly those who receive no direct benefit from research, mayalso be paid or otherwise compensated for inconvenienceand time spent. The payments should not be so large, how-ever, or the medical services so extensive as to induce

prospective subjects to consent to participate in the re-search against their better judgment („undue induce-ment“). All payments, reimbursements and medical ser-vices provided to research subjects must have been appro-ved by an ethical review committee.

((((............))))

GGGGuuuuiiiiddddeeeelllliiiinnnneeee 8888:::: BBBBeeeennnneeeeffffiiiittttssss aaaannnndddd rrrriiiisssskkkkssss ooooffff ssssttttuuuuddddyyyy ppppaaaarrrrttttiiiicccciiiippppaaaattttiiiioooonnnnFor all biomedical research involving human subjects,the investigator must ensure that potential benefits andrisks are reasonably balanced and risks are minimized.

Interventions or procedures that hold out the pros-pect of direct diagnostic, therapeutic or preventive bene-fit for the individual subject must be justified by theexpectation that they will be at least as advantageous tothe individual subject, in the light of foreseeable risksand benefits, as any available alternative. Risks of such‘beneficial’ interventions or procedures must be justifiedin relation to expected benefits to the individual subject.

Risks of interventions that do not hold out the prospectof direct diagnostic, therapeutic or preventive benefit forthe individual must be justified in relation to the expectedbenefits to society (generalizable knowledge). The risks pre-sented by such interventions must be reasonable in relationto the importance of the knowledge to be gained.

((((............))))

GGGGuuuuiiiiddddeeeelllliiiinnnneeee 9999:::: SSSSppppeeeecccciiiiaaaallll lllliiiimmmmiiiittttaaaattttiiiioooonnnnssss oooonnnn rrrriiiisssskkkk wwwwhhhheeeennnn rrrreeeesssseeeeaaaarrrrcccchhhhiiiinnnnvvvvoooollllvvvveeeessss iiiinnnnddddiiiivvvviiiidddduuuuaaaallllssss wwwwhhhhoooo aaaarrrreeee nnnnooootttt ccccaaaappppaaaabbbblllleeee ooooffff ggggiiiivvvviiiinnnngggg iiiinnnnffffoooorrrr----mmmmeeeedddd ccccoooonnnnsssseeeennnnttttWhen there is ethical and scientific justification to conductresearch with individuals incapable of giving informedconsent, the risk from research interventions that do nothold out the prospect of direct benefit for the individualsubject should be no more likely and not greater than therisk attached to routine medical or psychological examina-tion of such persons. Slight or minor increases above suchrisk may be permitted when there is an overriding scienti-fic or medical rationale for such increases and when an ethi-cal review committee has approved them.

((((............))))

GGGGuuuuiiiiddddeeeelllliiiinnnneeee 11110000:::: RRRReeeesssseeeeaaaarrrrcccchhhh iiiinnnn ppppooooppppuuuullllaaaattttiiiioooonnnnssss aaaannnndddd ccccoooommmmmmmmuuuunnnniiiittttiiiieeeesssswwwwiiiitttthhhh lllliiiimmmmiiiitttteeeedddd rrrreeeessssoooouuuurrrrcccceeeessssBefore undertaking research in a population or communi-ty with limited resources, the sponsor and the investiga-tor must make every effort to ensure that:

● the research is responsive to the health needs andthe priorities of the population or community in which itis to be carried out; and

● any intervention or product developed, or know-ledge generated, will be made reasonably available forthe benefit of that population or community.

((((............))))

GGGGuuuuiiiiddddeeeelllliiiinnnneeee 11111111:::: CCCChhhhooooiiiicccceeee ooooffff ccccoooonnnnttttrrrroooollll iiiinnnn cccclllliiiinnnniiiiccccaaaallll ttttrrrriiiiaaaallllssssAs a general rule, research subjects in the control groupof a trial of a diagnostic, therapeutic, or preventive inter-vention should receive an established effective interven-tion. In some circumstances it may be ethically accep-table to use an alternative comparator, such as placebo or„no treatment“. Placebo may be used:

● when there is no established effective intervention;● when withholding an established effective inter-

vention would expose subjects to, at most, temporarydiscomfort or delay in relief of symptoms;

● when use of an established effective intervention ascomparator would not yield scientifically reliable resultsand use of placebo would not add any risk of serious orirreversible harm to the subjects.

((((............))))

18 ME&B 9 (3–4) 2002

GGGGuuuuiiiiddddeeeelllliiiinnnneeee 11112222:::: EEEEqqqquuuuiiiittttaaaabbbblllleeee ddddiiiissssttttrrrriiiibbbbuuuuttttiiiioooonnnn ooooffff bbbbuuuurrrrddddeeeennnnssss aaaannnndddd bbbbeeeennnneeee----ffffiiiittttssss iiiinnnn tttthhhheeee sssseeeelllleeeeccccttttiiiioooonnnn ooooffff ggggrrrroooouuuuppppssss ooooffff ssssuuuubbbbjjjjeeeeccccttttssss iiiinnnn rrrreeeesssseeeeaaaarrrrcccchhhhGroups or communities to be invited to be subjects of re-search should be selected in such a way that the burdensand benefits of the research will be equitably distributed.The exclusion of groups or communities that might bene-fit from study participation must be justified.

((((............))))

GGGGuuuuiiiiddddeeeelllliiiinnnneeee 11113333:::: RRRReeeesssseeeeaaaarrrrcccchhhh iiiinnnnvvvvoooollllvvvviiiinnnngggg vvvvuuuullllnnnneeeerrrraaaabbbblllleeee ppppeeeerrrrssssoooonnnnssssSpecial justification is required for inviting vulnerable in-dividuals to serve as research subjects and, if they areselected, the means of protecting their rights and welfaremust be strictly applied.

((((............))))

GGGGuuuuiiiiddddeeeelllliiiinnnneeee 11114444:::: RRRReeeesssseeeeaaaarrrrcccchhhh iiiinnnnvvvvoooollllvvvviiiinnnngggg cccchhhhiiiillllddddrrrreeeennnnBefore undertaking research involving children, the in-vestigator must ensure that:

● the research might not equally well be carried outwith adults;

● the purpose of the research is to obtain knowledgerelevant to the health needs of children;

● a parent or legal representative of each child hasgiven permission;

● the agreement (assent) of each child has been ob-tained to the extent of the child`s capabilities; and,

● a child`s refusal to participate or continue in the re-search will be respected.

((((............))))

GGGGuuuuiiiiddddeeeelllliiiinnnneeee 11115555:::: RRRReeeesssseeeeaaaarrrrcccchhhh iiiinnnnvvvvoooollllvvvviiiinnnngggg iiiinnnnddddiiiivvvviiiidddduuuuaaaallllssss wwwwhhhhoooo bbbbyyyy rrrreeeeaaaa----ssssoooonnnn ooooffff mmmmeeeennnnttttaaaallll oooorrrr bbbbeeeehhhhaaaavvvviiiioooouuuurrrraaaallll ddddiiiissssoooorrrrddddeeeerrrrssss aaaarrrreeee nnnnooootttt ccccaaaappppaaaabbbblllleeee ooooffffggggiiiivvvviiiinnnngggg aaaaddddeeeeqqqquuuuaaaatttteeeellllyyyy iiiinnnnffffoooorrrrmmmmeeeedddd ccccoooonnnnsssseeeennnnttttBefore undertaking research involving individuals whoby reason of mental or behavioural disorders are notcapable of giving adequately informed consent, the in-vestigator must ensure that:

● such persons will not be subjects of research thatmight equally well be carried out on persons whose ca-pacity to give adequately informed consent is not im-paired;

● the purpose of the research is to obtain knowledgerelevant to the particular health needs of persons withmental or behavioural disorders;

● the consent of each subject has been obtained tothe extent of that person’s capabilities, and a prospectivesubject’s refusal to participate in research is always res-pected, unless, in exceptional circumstances, there is noreasonable medical alternative and local law permitsoverriding the objection; and,

● in cases where prospective subjects lack capacity toconsent, permission is obtained from a responsible fami-ly member or a legally authorized representative inaccordance with applicable law.

((((............))))

GGGGuuuuiiiiddddeeeelllliiiinnnneeee 11116666:::: WWWWoooommmmeeeennnn aaaassss rrrreeeesssseeeeaaaarrrrcccchhhh ssssuuuubbbbjjjjeeeeccccttttssssInvestigators, sponsors or ethical review committeesshould not exclude women of reproductive age from bio-medical research. The potential for becoming pregnantduring a study should not, in itself, be used as a reasonfor precluding or limiting participation. However, a tho-rough discussion of risks to the pregnant woman and toher fetus is a prerequisite for the woman’s ability tomake a rational decision to enrol in a clinical study. Inthis discussion, if participation in the research might behazardous to a fetus or a woman if she becomes preg-nant, the sponsors/investigators should guarantee theprospective subject a pregnancy test and access to effec-tive contraceptive methods before the research commen-ces. Where such access is not possible, for legal or reli-

gious reasons, investigators should not recruit for suchpossibly hazardous research women who might becomepregnant.

((((............))))

GGGGuuuuiiiiddddeeeelllliiiinnnneeee 11117777:::: PPPPrrrreeeeggggnnnnaaaannnntttt wwwwoooommmmeeeennnn aaaassss rrrreeeesssseeeeaaaarrrrcccchhhh ppppaaaarrrrttttiiiicccciiiippppaaaannnnttttssss....Pregnant women should be presumed to be eligible forparticipation in biomedical research. Investigators andethical review committees should ensure that prospectivesubjects who are pregnant are adequately informed aboutthe risks and benefits to themselves, their pregnancies, thefetus and their subsequent offspring, and to their fertility.

Research in this population should be performed onlyif it is relevant to the particular health needs of a pregnantwoman or her fetus, or to the health needs of pregnantwomen in general, and, when appropriate, if it is suppor-ted by reliable evidence from animal experiments, parti-cularly as to risks of teratogenicity and mutagenicity .

((((............))))

GGGGuuuuiiiiddddeeeelllliiiinnnneeee 11118888:::: SSSSaaaaffffeeeegggguuuuaaaarrrrddddiiiinnnngggg ccccoooonnnnffffiiiiddddeeeennnnttttiiiiaaaalllliiiittttyyyyThe investigator must establish secure safeguards of theconfidentiality of subjects’ research data. Subjects shouldbe told the limits, legal or other, to the investigators’ abili-ty to safeguard confidentiality and the possible conse-quences of breaches of confidentiality.

((((............))))

GGGGuuuuiiiiddddeeeelllliiiinnnneeee 11119999:::: RRRRiiiigggghhhhtttt ooooffff iiiinnnnjjjjuuuurrrreeeedddd ssssuuuubbbbjjjjeeeeccccttttssss ttttoooo ttttrrrreeeeaaaattttmmmmeeeennnntttt aaaannnnddddccccoooommmmppppeeeennnnssssaaaattttiiiioooonnnnInvestigators should ensure that research subjects whosuffer injury as a result of their participation are entitledto free medical treatment for such injury and to suchfinancial or other assistance as would compensate themequitably for any resultant impairment, disability or handi-cap. In the case of death as a result of their participation,their dependants are entitled to compensation. Subjectsmust not be asked to waive the right to compensation.

((((............))))

GGGGuuuuiiiiddddeeeelllliiiinnnneeee 22220000:::: SSSSttttrrrreeeennnnggggtttthhhheeeennnniiiinnnngggg ccccaaaappppaaaacccciiiittttyyyy ffffoooorrrr eeeetttthhhhiiiiccccaaaallll aaaannnndddd sssscccciiiieeeennnn----ttttiiiiffffiiiicccc rrrreeeevvvviiiieeeewwww aaaannnndddd bbbbiiiioooommmmeeeeddddiiiiccccaaaallll rrrreeeesssseeeeaaaarrrrcccchhhhMany countries lack the capacity to assess or ensure thescientific quality or ethical acceptability of biomedicalresearch proposed or carried out in their jurisdictions. Inexternally sponsored collaborative research, sponsorsand investigators have an ethical obligation to ensurethat biomedical research projects for which they areresponsible in such countries contribute effectively tonational or local capacity to design and conduct biome-dical research, and to provide scientific and ethical re-view and monitoring of such research.

Capacity-building may include, but is not limited to,the following activities:

● establishing and strengthening independent andcompetent ethical review processes/committees

● strengthening research capacity ● developing technologies appropriate to health-care

and biomedical research ● training of research and health-care staff ● educating the community from which research sub-

jects will be drawn.((((............))))

GGGGuuuuiiiiddddeeeelllliiiinnnneeee 22221111:::: EEEEtttthhhhiiiiccccaaaallll oooobbbblllliiiiggggaaaattttiiiioooonnnn ooooffff eeeexxxxtttteeeerrrrnnnnaaaallll ssssppppoooonnnnssssoooorrrrssss ttttoooopppprrrroooovvvviiiiddddeeee hhhheeeeaaaalllltttthhhh----ccccaaaarrrreeee sssseeeerrrrvvvviiiicccceeeessssExternal sponsors are ethically obliged to ensure theavailability of:

● health-care services that are essential to the safeconduct of the research;

● treatment for subjects who suffer injury as a conse-quence of research interventions; and,

levels of R&D expenditure, particularly from the privatesector, the geographical migration of researchers outsidethe EU (brain-drain) and of companies, mainly to the US,the difficulty of access to investment and venture capitaland cumbersome patenting legislation and bureaucracy,

FFFF.... whereas the European Union has only limited com-petencies in the field of education,

GGGG.... whereas, although genetics specialists and profes-sional organisations make efforts to promote qualityassessment, genetic testing services are provided underwidely varying conditions and regulatory frameworks inthe individual Member States,

HHHH.... whereas there exists no EU legislation to guaranteea minimum standard of genetic testing and analysis ser-vices in conformity with other provisions,

1111.... Welcomes the Commission’s Action Plan on Lifesciences and Biotechnology and its vision for a long-term, competitive and responsible European model forbiotechnology with all its benefits and opportunities forour society, while respecting the cultural diversity ofeach Member State;

2222.... Welcomes the Commission’s willingness to explo-re areas where common views on fundamental guide-lines are possible, to promote an inter-institutional dia-logue, and to ensure that ethical implications are takeninto account at the earliest possible stage of EU-suppor-ted research;

3333.... Calls for primary responsibility for coordinatingthe biotechnology strategy to be conferred on one Com-missioner in particular and on a directorate-general crea-ted to that end so as to ensure greater consistency inCommunity activities;

4444.... Considers it important to inform the public thatbiotechnology offers opportunities in various fields:from health to agriculture, from industry to alternativeenergy resources; opposes the view that, in medicine,genetic technology and biotechnology are primarily asso-ciated with opportunities, whereas in agriculture theyare primarily associated with risks; is much more incli-ned to believe that in both areas there are major opportu-nities which should be taken advantage of, but also sig-nificant risks which need to be reduced by means ofappropriate legislation;

5555.... Calls on the Commission to launch a ‘B-Europe’ poli-cy which lays down the specific political agenda for thenext few years in the field of biotechnology;

6666.... Stresses that further basic statistical information isalso required on the industry’s structure and develop-ment in Europe;

7777.... Recalls that better statistics, e.g. on epidemiologicaldata or on ongoing research projects, etc. will help tobetter focus R&D projects on the real needs of citizens;

KKKKnnnnoooowwwwlllleeeeddddggggeeee,,,, eeeedddduuuuccccaaaattttiiiioooonnnn aaaannnndddd tttthhhheeee wwwwoooorrrrkkkkffffoooorrrrcccceeee8888.... Calls on the governments of the Member States, as

the European Union has only limited competencies inthe field of education, to improve basic education inschools, higher education and education for adults in thefield of biology with a particular focus on genomics andmicrobiology, not only to improve the knowledge of theworkforce but also to improve the knowledge base onwhich consumers can take their decisions;

9999.... Calls on the Commission to hasten its review ofRegulation (EEC) No 1408/71 and to draft a proposal for aharmonised procedure to transfer pension rights also forsupplementary pensions between different Member Statesto provide an incentive for the mobility of the workforce;

11110000.... Calls on the Member States to increase the pro-portion of women in science and research and develop-ment by supporting educational programmes and bychanging working conditions and improving the availa-bility and the quality of childcare;

19ME&B 9 (3–4) 2002

● services that are a necessary part of the commitmentof a sponsor to make a beneficial intervention or productdeveloped as a result of the research reasonably availableto the population or community concerned.

((((............))))

AAAAppppppppeeeennnnddddiiiixxxx 1111:::: Items to be included in a protocol (or associated docu-ments) for biomedical research involving human subjects. ((((............))))

AAAAppppppppeeeennnnddddiiiixxxx 2222:::: World Medical Association Declaration of Helsinki ((((............))))

AAAAppppppppeeeennnnddddiiiixxxx 3333:::: The Phases of Clinical Trials of Vaccines and Drugs ((((............))))

LLLLIIIIFFFFEEEE SSSSCCCCIIIIEEEENNNNCCCCEEEESSSS AAAANNNNDDDD BBBBIIIIOOOOTTTTEEEECCCCHHHHNNNNOOOOLLLLOOOOGGGGYYYY ---- AAAA SSSSTTTTRRRRAAAATTTTEEEEGGGGYYYY FFFFOOOORRRR EEEEUUUURRRROOOOPPPPEEEE

EEEEuuuurrrrooooppppeeeeaaaannnn PPPPaaaarrrrlllliiiiaaaammmmeeeennnntttt rrrreeeessssoooolllluuuuttttiiiioooonnnn oooonnnn tttthhhheeee CCCCoooommmmmmmmiiiissssssssiiiioooonnnnccccoooommmmmmmmuuuunnnniiiiccccaaaattttiiiioooonnnn oooonnnn LLLLiiiiffffeeee sssscccciiiieeeennnncccceeeessss aaaannnndddd bbbbiiiiooootttteeeecccchhhhnnnnoooollllooooggggyyyy ----AAAA SSSSttttrrrraaaatttteeeeggggyyyy ffffoooorrrr EEEEuuuurrrrooooppppeeeeCCCCOOOOMMMM((((2222000000002222)))) 22227777 ---- CCCC5555----0000222266660000////2222000000002222 ---- 2222000000002222 ////2222111122223333 ((((CCCCOOOOSSSS))))

TTTThhhheeee EEEEuuuurrrrooooppppeeeeaaaannnn PPPPaaaarrrrlllliiiiaaaammmmeeeennnntttt,,,,

– having regard to the Commission communication(COM(2002) 27 - C5-0260/2002 [1]),

– having regard to Directive 98/44/EC of the Euro-pean Parliament and of the Council of 6 July 1998 on thelegal protection of biotechnological inventions [2],

– having regard to the Commission’s report to theEuropean Parliament and the Council on the develop-ment and implications of patent law in the field ofbiotechnology and genetic engineering (COM(2002)545),

– having regard to its resolution of 15 March 2001 onthe Future of the Biotechnology Industry [3],

– having regard to the European Charter of Funda-mental Rights proclaimed at the European Council of 7December 2000,

– having regard to the European Convention on Hu-man Rights and Biomedicine of the Council of Europe,signed on 4 April 1997,

– having regard to its first reading positions on theproposal for a European Parliament and Council regula-tion on genetically modified food and feed [4] and onthe proposal for a European Parliament and Council regu-lation on traceability and labelling of genetically modi-fied organisms and traceability of food and feed derivedfrom genetically modified organisms [5],

– having regard to Rule 47(1) of the Rules of Proce-dure,

– having regard to the report of the Committee onIndustry, External Trade, Research and Energy and theopinion of the Committee on Agriculture and Rural De-velopment (A5-0359/2002),

AAAA.... whereas the Lisbon European Council set the Euro-pean Union the new strategic goal of becoming the mostcompetitive and dynamic knowledge-based economy inthe world,

BBBB.... whereas biotechnology contributes to healthcare,helps to protect the environment and can be used in in-dustrial production processes, while respecting the pre-ventive and precautionary principles,

CCCC.... whereas the European Union is not merely an eco-nomic area, but is also an area of shared fundamental va-lues based on respect for human dignity,

DDDD.... whereas awareness of biotechnology and the prin-ciples of genetics is not widely known,

EEEE.... whereas in spite of increasing efforts in the biotechsector in recent years, the EU is lagging behind its globalcompetitors, which can be demonstrated by insufficient

20 ME&B 9 (3–4) 2002

PPPPuuuubbbblllliiiicccc iiiinnnnffffoooorrrrmmmmaaaattttiiiioooonnnn aaaannnndddd ddddeeeebbbbaaaatttteeee11111111.... Observes the need to enhance and broaden public

debate, the access to objective information and the levelof scientific knowledge; emphasises the need for con-sumers to have the opportunity to address questions toscientists and to receive answers from them;

11112222.... Calls for the public authorities and industry topursue a transparent information policy based on scien-tific data; reminds the media of the major role whichthey play in this field and calls on them to cover the issueimpartially and fairly;

11113333.... Calls for an increased influence in the nominationof members of the European Group on Ethics in supportof the Commission’s proposal to strengthen Parliament’srole in exploring and providing information on Euro-pean ethical guidelines and stresses that the work of thisgroup must be transparent and that consumers should beinvolved at an early stage;

11114444.... Calls on the Commission to submit before the endof 2003 a legislative proposal specifying the mandate,working methods and the procedure of nomination ofmembers of the European Group on Ethics;

11115555.... Recommends forming a group of parlamentariansfrom the relevant committees to begin the cooperationwith the Commission proposed in Action 16; stressesthat the actions in the field of ethics proposed by theCommission should not undermine the European Parlia-ment ‘s codecision rights in the relevant fields; insiststhat the proposed ethical guidelines should not under-mine the competence of the Member States; proposes,therefore, that only minimum ethical standards whichmust be applied by all Member States should be adoptedand that Member States should have the possibility ofgoing further under national law;

IIIInnnntttteeeerrrrnnnnaaaattttiiiioooonnnnaaaallll ccccooooooooppppeeeerrrraaaattttiiiioooonnnn11116666.... States that biotechnology alone will not help to

overcome hunger in the world and that other methods,for example a better distribution of available food, arecurrently more important, but underlines that given theever increasing world population it might also be neces-sary to use genetically modified crops to produce enoughfood;

11117777.... Recalls that the European Union is the largest de-velopment aid partner world-wide, and calls on the Com-mission and Member States to promote internationalguidelines on the role of biotechnology in cooperationin respect of the improvement of health, nutrition andenvironment, respecting human dignity in developingcountries;

11118888.... Considers that Community rules concerning thewelfare and protection of consumers in the field of thelife sciences and biotechnology should also be promotedat international level but without creating barriers tocommerce and trade since many aspects are related tothe world’s trading system, which is governed by WTOagreements;

11119999.... Emphasises that developing countries themselvesmust decide if and to what extent they want to use GMOs;considers that, should a developing country want to usebiotechnology, the EU and Member States should pro-vide support so that it can strengthen its own capacities;

22220000.... Considers that biotechnology can contribute to-wards finding genuine solutions to environmental prob-lems, sustainable development and food sufficiency,which would help to combat chronic hunger and to imp-rove human health; considers, therefore, that this tech-nology should be promoted with caution and its applica-tions supported, taking full account of environmentaland health safeguards;

22221111.... Calls on the Commission and the Member Statesto promote the Johannesburg process for sustainable

development and include technology transfer as one ofthe preconditions for sustainable development in thedeveloping countries, underlines that biotechnology ifapplied prudently can contribute to sustainable develop-ment because it helps to save energy and raw materialsand can lead to less pollution;

22222222.... Supports the Commission’s idea to play a leadingrole in developing international guidelines but regretsthat this action is focused mainly on the food sector;points out that the establishment of international guide-lines is also necessary regarding the protection of humandignity in the field of biotechnology;

22223333.... Repeats its insistence that there should be a uni-versal and specific ban at the level of the United Nationson the cloning of human beings at all stages of formationand development and urges the Commission and theMember States to work towards this end;

LLLLeeeeggggiiiissssllllaaaattttiiiioooonnnn aaaannnndddd eeeennnnffffoooorrrrcccceeeemmmmeeeennnntttt ooooffff eeeexxxxiiiissssttttiiiinnnngggg lllleeeeggggiiiissssllllaaaattttiiiioooonnnn22224444.... Emphasises the urgency to complete a harmoni-

sed, knowledge-based, predictable and ethical legal fra-mework for biotechnology companies and farmers,which aims to secure consumer safety and competitive-ness and to prevent both a ‘brain-drain’ in this field and afuture dependency on the import of biotech products;

22225555.... Calls on the Member States to implement existinglegislation (e.g. Directive 2001/20/EC on clinical trialsand Directive 98/44/EC on the legal protection of biolo-gi-cal inventions) in a way that promotes the necessaryresearch activities in Europe and at the same time pre-serves citizens’ interests; urges, therefore, the Commis-sion to clarify the wording of Article 5(2) of Directive98/44/EC by way of an amendment to the Directive toexclude the total or partial sequence of a gene isolatedfrom the human body from patentability;

22226666.... Calls for the introduction of a European patentwhich meets the requirements of researchers and inno-vators in both public research institutes and industry;

CCCCoooonnnnssssuuuummmmeeeerrrr pppprrrrooootttteeeeccccttttiiiioooonnnn22227777.... Considers that users of biotechnological develop-

ments should bear no risk of liability under the relevantEuropean Union legislation;

22228888.... Recalls the need for information based on reliablescientific assessments and studies to enable consumersto make their choice on a sound basis, emphasises thatnew technologies often have been met with doubt andthat some of these doubts are not really rational and thatthe precautionary principle should be applied in a ratio-nal manner so as to provide consumer and environmen-tal protection and not serve as a barrier to political deci-sion-making and technological innovation;

22229999.... Stresses that the use of genetically modified pro-ducts and genetic engineering in production must beaccompanied by research, particularly into the long-termeffects;

33330000.... Stresses the need to ensure that consumers recei-ve reliable information about GMOs and products, foodand animal feed produced from GMOs so that they canchoose a product on the basis of prior information andcan acquire confidence in GMO products and technology;

33331111.... Supports the view that, when new products andproduction methods are introduced, the potential risksto human health and the environment should be mini-mised and that, therefore, transparent, knowledge-basedrisk assessment and risk management procedures mustbe used, taking account of the precautionary principle;

33332222.... Notes that the cautious attitude of consumers to-wards GMOs and their products recorded in various Eu-ropean surveys (Eurobarometer, December 2001, ITPSReport, etc.) is in large measure attributable to insuffi-cient provision of information about GMO technology;

21ME&B 9 (3–4) 2002

considers it essential, therefore, that consumers receivereliable and full information;

33333333.... Considers that market mechanisms operate effec-tively when the European policy of compulsory labellingof GMOs and their products is based on Communityrules, the implementation of which can be monitored bymeans of scientific and analytical methods which do notallow fraud, the misleading of consumers or distortion ofcompetition;

RRRReeeesssseeeeaaaarrrrcccchhhh aaaannnndddd ddddeeeevvvveeeellllooooppppmmmmeeeennnntttt,,,, iiiinnnndddduuuussssttttrrrryyyy,,,, eeeemmmmppppllllooooyyyymmmmeeeennnnttttaaaannnndddd SSSSMMMMEEEEssss33334444.... Calls on the Commission to promote public and

private networking within the 6th Framework Program-me and elsewhere amongst European, national and regio-nal biotech research units, clusters and companies;

33335555.... Urges Member States and the Commission to re-consider public policies that encourage or even obligeacademic scientists to collaborate with industry in orderto secure adequate funding for research since such poli-cies may mean that doubt is cast on the independence ofscientists employed by academic institutions;

33336666.... Calls on the European Union to continue researchin particular with regard to the development of food-stuffs that are beneficial for consumers, whereby the de-finition of consumer benefit should always include thenutritional and toxicological consequences of a product;

33337777.... Calls on the European Union to continue researchinto the improvement of risk assessment, taking into con-sideration the latest scientific findings;

33338888.... Takes the view that policy, together with the in-dustry and research, must produce better information asto risks for consumers, the environment and animals andlaunch a carefully formulated accompanying programmefor growing genetically modified plants;

33339999.... Asks the Member States to implement the above-mentioned Directive 98/44/EC and to recognise that thedecision of the European Patents Office on the so-calledEdinburgh Patent in July 2002 shows that ethical con-cerns are respected by the European Patents Office; reg-rets on the other hand that the earlier mistake on thispatent by the Patents Office was discovered by Green-peace (and not by the Patents Office itself); asks theEuropean Patents Office to review its working methods,so that such mistakes will not be repeated and, refers toits resolution of 30 March 2000 [6] on the Decision ofthe Patents Office on the cloning of human beings;

44440000.... Encourages the initiative of the Commission to iden-tify with appropriate European experts how to overcomethe issue of insufficient funding regarding biotech start-ups; asks the European Investment Bank to favourably con-sider recommendations resulting from that initiative;

44441111.... Stresses the importance of giving SME easier accessto innovation, training and risk capital in line with thespirit of the European Charter for Small Enterprises;

44442222.... Encourages the Commission, Member States, theEuropean Investment Bank and the Committee of theRegions to actively support setting-up bio-clusters, andwhere appropriate to support them with finance skillsand other means, and encourage networking of bio-clus-ters throughout Europe to exchange experiences andestablish best practices; calls for the development of bio-clusters and other models for technological transfer tobe promoted in the European Union and in the applicantcountries in order to stimulate investment.

EEEEnnnnvvvviiiirrrroooonnnnmmmmeeeennnntttt,,,, aaaaggggrrrriiiiccccuuuullllttttuuuurrrreeee aaaannnndddd ffffoooooooodddd44443333.... Calls on the Commission and the Member States

to support research concerning uses of biotechnologyoffering clear social or environmental benefits, includingthe use of genetically modified micro-organisms in waterpurification and soil restoration, replacing dangerous

chemicals currently in use, and developing sustainableand environmentally friendly energy sources (includingbiogas, hydrogen and ethanol);

44444444.... Asks the Commission to support the potential ofbiotechnology regarding sustainable development and tosupport the development and selection of adequateassessment techniques allowing a quantitative measure-ment of sustainability, including all three pillars: environ-mental, economical and social;

44445555.... Calls on the Commission and the Member Statesto review legislation on fuels, in particular Directive98/70/EC on the quality of fuels, so as to allow biologicalenergy sources to be economically explored and pro-ducts to be placed on the market in the short term, e.g.blending ethanol with traditional engine fuels, in particu-lar because current limitations are not economically orscientifically justified as they favour polluting fossil fuelsand undermine significant environmental improvementthrough reduction of CO2;

44446666.... Strongly supports the view that the existing de-facto moratorium on GM foods in force since 1998 shouldcease in order to promote innovation; the current situa-tion has particularly harmed SMEs, which are the mainoriginators of innovation;

44447777.... Supports the establishment of legal thresholds forthe adventitious presence of GM foods and feeds whichenable consumer choice, are set at practically appropria-te levels and are based on scientific assessment, providedthese products have been established as safe by EU stan-dards;

44448888.... Calls for the adoption of practicable thresholds andthe immediate implementation of Directive 2001/18/EC onthe deliberate release of GMOs into the environmentwithin the framework of an overall strategy for greengenetic engineering in which products containing geneti-cally modified material or produced therefrom must beclearly and unambiguously labelled and traceability en-sured in order to give consumers the greatest possibletransparency and full freedom of choice;

44449999.... Strongly supports the reduction in the use of pesti-cides and herbicides through biotechnology if it is achie-ved without risk to the environment or human health;

55550000.... Expects that greater consumer confidence in theregulatory process is achievable through centralised scien-tific review procedures performed by the European FoodSafety Authority; therefore asks the Commission to makea proposal in this direction;

HHHHeeeeaaaalllltttthhhh aaaannnndddd rrrreeeepppprrrroooodddduuuuccccttttiiiivvvveeee mmmmeeeeddddiiiicccciiiinnnneeee55551111.... Calls on the Commission to draft a regulation for

the introduction of a standard for genetic tests, sincethese services lie outside the scope of Council Regu-lation (EEC) No 2309/93 laying down Community proce-dures for the authorisation and supervision of medicinalproducts for human and veterinary use and Directive98/79/EC on in-vitro diagnostic medical devices, whichapplies only to products to be marketed;

55552222.... States that genetic testing and analysis must be con-ducted under clear rules within the frame of competent,independent and personal counselling which must covermedical, ethical, social, psychological and legal aspects;

55553333.... Solemnly reaffirms that the life and dignity of allhuman beings, whatever their stage of development andstate of health, must be respected and is opposed to anyform of research or use of life sciences and biotechnolo-gy that runs counter to this fundamental principle;

55554444.... Notes that genetic testing analysis and diagnosisdata must remain confidential and should be used onlyfor the benefit of the person requiring such tests, withthe exception of tests undertaken for clearly defined scien-tific or criminal investigation purposes, therefore suchtests should be inadmissible for social or recruitment

22 ME&B 9 (3–4) 2002

purposes, and should not jeopardise personal privacyand dignity;

55555555.... Calls on the Commission to take the necessarysteps for an EU-wide regulation on DNA-testing, choo-sing, if possible, a legal basis (e.g. Article 152 (health) orArticle 153 (consumer protection)) which leaves Mem-ber States free to introduce more stringent protectionmeasures and asks its competent Committee, subject toprior authorisation by the Conference of Presidents, toconsider drafting an own-initiative report on the legalaspects of DNA testing;

55556666.... Considers it particularly important to ensure thatno woman is compelled to have prenatal diagnosis car-ried out and that any decision not to resort to such diag-nosis is respected and supported;

55557777.... Takes the view that determination of sex in con-nection with prenatal diagnosis should be permittedonly - if at all - if there is a risk of serious gender specifichereditary diseases;

55558888.... Instructs its President to forward this resolutionto the Council and the Commission and the parliamentsof the Member States.

[1] OJ C 55, 2.3.2002, p. 3.[2] OJ L 213, 30.7.1998, p. 13.[3] OJ C 343,5.12.2001, p. 292.[4] P5_TA(2002)0354.[5] P5_TA(2002)0353.[6] OJ C378, 29.12.2000, p. 95.

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At the close of International Conference on Bioethicsin Central and Eastern Europe held on 11 and 12 No-vember 2002 in Vilnius, Lithuania we, the participantscoming from Albania, Azerbaijan, Belarus, Bulgaria, Croa-tia, Czech Republic, Estonia, Former Yugoslav Republicof Macedonia, Georgia, Latvia, Lithuania, Moldova, Po-land, Romania, Russian Federation, Slovakia, Sloveniaand Ukraine, adopt this Final Statement:

Recognizing that bioethics today plays an important rolein the protection of human rights and fundamental freedoms,

Aware of the need to promote informed, pluralisticpublic bioethics debate, taking into account the variousschools of thought, value systems, historical and culturalbackgrounds, and philosophical and religious convic-tions that make up our various societies,

Also aware of the need to ensure the imperative offreedom of research, with full respect for human dignity,Recalling the Universal Declaration on the Human Ge-nome and Human Rights, adopted in 1997 by the Gene-ral Conference of UNESCO and endorsed by the UnitedNations General Assembly in 1998,

Recalling also the Convention for Human Rights andBiomedicine with regard to the Application of Biologyand Medicine: Convention on Human Rights and Biome-dicine adopted by the Committee of Ministers of theCouncil of Europe on 19 November 1996 and openedfor signature on 4 April 1997:

1. Reiterate our common position that human repro-ductive cloning shall not be permitted and invite our Go-vernments to take appropriate measures, including le-gislative or regulatory action in order to prohibit anyattempts to clone human being.

2. Reiterate further the need to ensure that the re-sults of research in biology and genetics are used exclu-sively for peaceful purposes.

3. Emphasise the necessity to follow ethical princi-ples in the research and use of the biomedicine andbiotechnology, taking into account the principle of justand equitable access to health care.

4. Underline the importance of ensuring the infor-med consent and the protection of privacy in obtainingand using genetic information, and to support the inter-national efforts aimed at developing an international decla-ration on human genetic data.

5. Express our support for the provision of article 4of the Universal Declaration on the Human Genome andHuman Rights, that „the human genome in its naturalstate shall not give rise to financial gains“.

6. Stress the urgent need for education in bioethics inCentral and Eastern European countries.

7. Stress also the need for disseminating informationon bioethics throughout the countries of Central andEastern Europe and strongly encourage the initiativesaimed at designing the national, regional and internatio-nal bioethics information networks.

8. Encourage the Member States of the Council ofEurope not yet party to the European Convention onHuman Rights and Biomedicine to sign and ratify thisConvention and sign and ratify its Additional Protocol onProhibiting Human Cloning.

9. Welcome UNESCO’s efforts to explore the possibili-ty of developing a universal legal instrument on bioethics.

IIIInnnn ccccoooonnnncccclllluuuussssiiiioooonnnn,,,, wwwweeee,,,, tttthhhheeee ppppaaaarrrrttttiiiicccciiiippppaaaannnnttttssss iiiinnnn tttthhhheeee CCCCoooonnnnffffeeeerrrreeeennnncccceeee::::(i) Call on our Governments to proceed in accordan-

ce with this Final statement;(ii) Undertake the responsibility of promoting the

human rights and ethical consideration in science, bio-medicine and biotechnology;

(iii) Invite Lithuania and UNESCO to bring this finalstatement to the attention of Member states of UNESCO,and to disseminate it as widely as possible.

Vilnius, November 12, 2002

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From February 25th to February 27th the VIII GeneralAssembly of the Pontifical Academy for Life took place inthe Old Synod Hall of Vatican City. According to theusual practice, the members of the Academy, from va-rious scientific disciplines, and from around the worldwere convoked to discuss their experience of giving wit-ness to life as a service to the Church and to all men.With regards to the purpose of the Academy, which isspecifically: the study, information and formation on theprincipal problems of biomedicine and of law, relative tothe promotion and defense of life, above all in the directrelation that they have with Christian morality and thedirectives of the Church’s Magisterium, this years assemb-ly was dedicated to The Nature and Dignity of the Hu-man Person as the basis for the Right to Life: The Challen-ge of the Contemporary Cultural Context.

1111.... No one can mistake the fact that in the contempo-rary cultural context there exist currents of thought thatmore or less explicitly negate the existence of humannature or the capacity to know it. As a consequence, theydo not admit that the dignity of the person has an uncon-ditional and immutable value, especially at the beginningand end of human life, which require more care and pro-

23ME&B 9 (3–4) 2002

tection. In fact, as the Holy Father recalled in his addressto the participants of the Assembly „For many contempo-rary thinkers, the concepts of “nature” and of “naturallaw” appear to apply only to the physical and biologicalworld, or, as an expression of order in the cosmos, in scien-tific research or in the field of ecology. Unfortunately, insuch a view, it becomes difficult to use natural law to meanhuman nature in a metaphysical sense and to use naturallaw for the moral order” (John Paul II, Address to Parti-cipants of the VIIIth General Assembly of the PAV, n.2).

Faced with these cultural paradigms, the Academy forLife understood the need to commit itself to maintainingcontinuity with the essential components of the lengthytradition of the Catholic Church, as well as classicalphilosophical thought and to expressing them in newways, and with a different vocabulary if necessary, so asto foster dialogue with the modern world, as desired bythe Second Vatican Council.

Moreover, this theme is currently of fundamental rele-vance to an examination of the link between the creationof laws and codes at various levels of government andthe human values on which they must be based.

To this end, the General Assembly followed an itine-rary organized around three lines: the anthropologicalquestion; natural moral law considered in terms of its exis-tence and our capacity to know it; and, finally, the prob-lem of rights, with particular emphasis on the right to life.

2222.... In terms of anthropology, and recalling the tea-chings of Gaudium et Spes (n. 14), the assembly wantedto reaffirm a unitary vision of man, „corpore et anima unus“,in refutation of all dualism or reductionism, whether of aspiritual or materialist kind. Authentic respect for eachhuman being has its foundations in this corporo-spiritualidentity, of which corporeality is an authentic and consti-tutive dimension of the person through which he mani-fests and expresses himself (cf. Donum Vitae, 3), as is thespiritual dimension, through which man is open to God,finding in Him the ultimate foundation of his dignity.

A problem may arise concerning the recognition ofthe existence of a universal human nature from whichwe derive the natural moral law. With regards to this, thepresentations discussed the ways in which, in contempo-rary culture, certain schools of thought relying solely onthe historico-evolutionary dimension of man, end up bynegating the existence of a universal human nature. Ne-vertheless, this nature, understood as a „rational nature“seemed to the members of the Academy - in line with theteachings of the Church - to be an undeniable paradigmfor clearly understanding the natural moral law. In fact,what else could form the basis of the dignity of thehuman person, if not that which specifically characteri-zes him, which is to say his nature?

The Holy Father himself wished to repeat to the mem-bers of the Academy that „The human person with hisreason, is capable of recognizing this profound and ob-jective dignity of his own being, and the ethical require-ments that derive from it. In other words, man can dis-cern in himself the value and the moral requirements ofhis own dignity. It is a discernment that entails a disco-very open to further refinement following the coordina-tes of the “historicity“ so much a part of human knowing“(John Paul II Address to Participants, n. 3).

3333.... Based on this anthropological vision, the reflections ofthe members were centred on the question of the naturalmoral law; which, „is nothing other than the light of under-standing infused in us by God, whereby we understandwhat must be done and what must be avoided. God gavethis light and this law to man at creation.“ (Veritatis Splen-dor, 12 and 40). Therefore, the existence of such a law is adirect consequence of the existence of human nature.

In particular, recalling the doctrine of St. ThomasAquinas concerning the natural moral law, we wanted tounderline the fact that each man has the natural capacityto know with certainty the fundamental dictates (firstprinciples) of that law, which spring up in his heart, cal-ling him always to do good and avoid evil (Gaudium etSpes, 16). To human nature also belongs the capacity toknow the derived moral norms (such as the moral normsconcerning the defence of human life) even though incertain instances teir derivation seems to be difficult,because of the inevitable personal and cultural limita-tions that constitute the history of each person.

In this respect, the moral virtues, understood asacquired habits towards a specific good, constitute a tre-mendous help, either towards the acquisition of know-ledge of that law, or, once such knowledge is acquired,towards actions in accordance with it. At the same time,there exists the contrary, which are moral vices, and whichrepresent prior obstacles either towards the acquisitionof that knowledge, or, once acquired, towards the capaci-ty to act in accordance with it.

4444.... The requirements which derive from the naturalmoral law, and which human history clearly demonstrate,call for both their recognition and protection by law,within society. In this way, we may speak of „naturalright“, and its subsequent codification in law. The founda-tion of this right is not mere human consent; rather, it isfounded on human nature, and the dignity of the person.

It is for this reason that, historically, until the end ofthe eighteenth century, we find that the fundamentalrights of man were considered as inviolable and non-negotiable, and therefore they were safe from the arbi-trary decisions of society, or from the will of the majority.

After that time, on the contrary, in our times, we arewitnesses to a progressive change, marked by exaggera-ted claims to the ‘right’ of personal freedom, which car-ries with it many forms of attack against life at its earliestand final stages, „which present new characteristics withrespect to the past and which raise questions of extraor-dinary seriousness. It is not only that in generalized opi-nion these attacks tend no longer to be considered as “cri-mes“ paradoxically they assume the nature of “rights“ (Evan-gelium Vitae, 11). A certain sector of public opinion, be-ginning from the above presupposition, maintains thatthe State must not only cease to punish such actions, butmust also guarantee their free exercise, even going so faras to sanction them.

Faced with this transformation, referring to the fun-damental rights of man, „the Catholic Church claims forevery human being the right to life as the primary right.She does it in the name of the truth about man and as aprotection of his freedom, that cannot be sustained with-out respect for the right to life. The Church affirms theright to life of every innocent human being at every mo-ment of his existence. The distinction sometimes impliedin international documents between “human being“ and“human person“ so as to limit the right to life and to phy-sical integrity to persons already born is an artificial dis-tinction without any scientific or philosophical founda-tion: every human being, from the moment of his con-ception until the moment of his natural death, possessesan inviolable right to life and merits all the respect owedto the human person (cf. Donum vitae, n. 1)“ (John Paul IIAddress to Participants n. 6).

For this reason, the assembly of Academicians callsupon the legislators of all countries, to elaborate contem-porary juridical norms based upon an authentic truthabout man, above all in regards to the primary right to life.

5555.... In conclusion, this final communiqué wishes tomake its own the desire of the Holy Father who encou-

24 ME&B 9 (3–4) 2002

raged the Assemble to continue its “reflection on the natu-ral moral law and natural rights with the hope that fromyour discussions will come a new source of zeal for es-tablishing the true good of the human being and of a justand peaceful social order. It is always by returning to thedeep roots of human dignity and of the true good ofman, and by building on the foundation of what exists aseverlasting and essential in man, that a fruitful dialoguecan take place with men of every culture in order tobuild a society inspired by the values of justice and bro-therhood” (John Paul II Address to Participants n.7).

[1] The original Italian version was published in L’OSSERVATOREROMANO, March 6th, 2002, p. 6.

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1111.... We commit ourselves to proclaiming our firm con-viction that violence and terrorism are incompatiblewith the authentic Spirit of religion, and, as we con-demn every recourse to violence and war in the name ofGod or religion, we commit ourselves to doing every-thing possible to eliminate the root causes of terrorism.

2222.... We commit ourselves to educating people tomutual respect and esteem, in order to help bring abouta peaceful and fraternal coexistence between people ofdifferent ethnic groups, cultures, and religions.

3333.... We commit ourselves to fostering the culture ofdialogue, so that there will be an increase of understan-ding and mutual trust between individuals and amongpeoples, for these are the premises of authentic peace.

4444.... We commit ourselves to defending the right ofeveryone to live a decent life in accordance with theirown cultural identity, and to form freely a family oftheir own.

5555.... We commit ourselves to frank and patient dia-logue, refusing to consider our differences as an insur-mountable barrier, but recognizing instead that toencounter the diversity of others can become an oppor-tunity for greater reciprocal understanding.

6666.... We commit ourselves to forgiving one another forpast and present errors and prejudices, and to supportingone another in a common effort both to overcome sel-fishness and arrogance, hatred and violence, and to learnfrom the past that peace without justice is no true peace.

7777.... We commit ourselves to taking the side of thepoor and the helpless, to speaking out for those whohave no voice and to working effectively to changethese situations, out of the conviction that no one canbe happy alone.

8888.... We commit ourselves to taking up the cry of thosewho refuse to be resigned to violence and evil, and wedesire to make every effort possible to offer the menand women of our time real hope for justice and peace.

9999.... We commit ourselves to encouraging all efforts topromote friendship between peoples, for we are con-vinced that, in the absence of solidarity and understan-ding between peoples, technological progress exposesthe word to a growing risk of destruction and death.

11110000.... We commit ourselves to urging the leaders ofnations to make every effort to create and consolidate,on the national and international levels, a world of soli-darity and peace based on justice.

[1] Adopted at the prayer meeting of the leaders of many religious con-fessions held in Assisi (Italy) on January 24, 2002. Present text is the offi-cial English version. It was taken from the website: www.zenit.org, textidentifier: ZE02030405.

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(1) Stavovskou povinnosťou lekára a zubného lekáraje profesionálna starostlivosť o zdravie jednotlivca a spo-ločnosti v súlade so zásadami ľudskosti, v duchu úcty kľudskému životu od jeho počiatku až do konca so všet-kými ohľadmi na dôstojnosť ľudského jedinca.

(2) Povinnosťou lekára a zubného lekára je zachová-vať život, chrániť a obnovovať zdravie, mierniť utrpeniebez ohľadu na národnosť, rasu, vierovyznanie, politickúpríslušnosť, spoločenské postavenie, morálnu či rozu-movú úroveň a povesť pacienta a bez ohľadu na osobnépocity lekára.

(3) Lekár a zubný lekár pri výkone povolania postupu-jú v súlade so všeobecne záväznými právnymi predpismi.

(4) Povinnosťou lekára a zubného lekára je byť za všet-kých okolností vo svojich profesionálnych rozhodnutiachnezávislý a zodpovedný.

(5) Lekár a zubný lekár napomáhajú pacientom uplat-ňovať právo slobodného výberu lekára.

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(1) Lekár a zubný lekár v rámci svojej odbornej spôso-bilosti a kompetencie vykonávajú preventívne výkony,diagnostické výkony a liečebné výkony spôsobom zod-povedajúcim súčasným poznatkom lekárskej vedy.

(2) Lekár a zubný lekár plnia svoje povinnosti aj vsituáciách verejného ohrozenia a pri katastrofách prírod-nej alebo inej povahy.

(3) Od lekára a zubného lekára nemožno vyžadovaťtaký lekársky výkon alebo spoluúčasť na ňom, ktorýodporuje ich svedomiu, okrem prípadov na ochranuživota, zdravia alebo práv iných.

(4) Lekár a zubný lekár nesmú predpisovať lieky, odktorých vzniká závislosť, alebo také lieky, ktoré majúúčinky dopingu, na iné ako liečebné účely.

(5) Lekár a zubný lekár u nevyliečiteľne chorých azomierajúcich miernia bolesť, rešpektujú ľudskú dôstoj-nosť a zmierňujú utrpenie. Eutanázia a asistované suicí-dium sú neprípustné.

(6) Lekár a zubný lekár, ktorí vykonávajú povolanie, súpovinní dbať o svoj odborný rast a sústavne sa vzdelávať.

(7) Lekár a zubný lekár sú povinní pri výkone povola-nia primerane chrániť zdravotnú dokumentáciu predneoprávnenou zmenou, zničením alebo zneužitím.

(8) Lekár a zubný lekár nesmú sami alebo po doho-vore s inými ordinovať neúčelné diagnostické, liečebnéani iné výkony.

(9) Pri predpisovaní a odporúčaní liekov a zdravot-níckych pomôcok sa lekár a zubný lekár nesmú riadiť ko-merčnými hľadiskami, ale výlučne poznatkami lekárskejvedy, svojím svedomím a potrebou pacienta.

(10) Lekár a zubný lekár sa môžu zúčastňovať naprezentácii medicínskych tém na verejnosti, v tlači, roz-hlase a televízii a na diskusii k nim.

(11) Lekár a zubný lekár nemôžu používať nedôstojnépraktiky smerujúce k rozšíreniu počtu pacientov. Je zaká-zané takéto aktivity iniciovať prostredníctvom druhýchosôb. Reklama a inzercia súkromnej praxe, zdravotníckychzariadení a používaných diagnostických a liečebnýchmetód sú povolené. Reklama musí byť pravdivá, striedma,výsostne informujúca a nesmie mať znaky nekalej súťaže.Text reklamy a jej zverejnenie nesmú znížiť vážnosťpovolania lekára a povolania zubného lekára.

25ME&B 9 (3–4) 2002

(12) Lekár a zubný lekár si majú byť vedomí svojejobčianskej úlohy a svojho vplyvu na okolie.

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(1) Lekár a zubný lekár si plnia voči každému pacien-tovi svoje profesionálne povinnosti.

(2) Lekár a zubný lekár sa k pacientovi správajú ko-rektne, s pochopením a trpezlivosťou a neznížia sa k hru-bému alebo nemravnému konaniu. Lekár a zubný lekárrešpektujú pacienta ako rovnocenného partnera so všet-kými občianskymi právami i povinnosťami vrátane zod-povednosti za svoje zdravie.

(3) Lekár a zubný lekár nesmú napomáhať porušova-nie cti a dôstojnosti človeka alebo sa na ňom zúčastňovať.Každý lekár a zubný lekár je povinný oznámiť príslušnýmorgánom podozrenie z hrubého alebo krutého zaobchá-dzania a týrania pacienta, a to najmä maloletej osoby aosoby zbavenej spôsobilosti na právne úkony.

(4) Lekár a zubný lekár sú povinní zrozumiteľnýmspôsobom poučiť pacienta alebo jeho zákonného zá-stupcu o charaktere ochorenia, zamýšľaných diagnostic-kých a liečebných postupoch vrátane rizík, o uvažovanejprognóze a o ďalších dôležitých okolnostiach, ktorémôžu nastať v priebehu diagnostiky a liečby.

(5) Lekár a zubný lekár nijakým spôsobom nesmúzneužiť dôveru a závislosť pacienta.

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(1) Základom vzťahov medzi lekárom a zubným leká-rom je vzájomne čestné, slušné a spoločensky korektnésprávanie spolu s kritickou náročnosťou, rešpektovanímkompetencií a priznaním práva na odlišný názor.

(2) Lekár a zubný lekár kolegiálne spolupracujú s le-kármi, ktorí súčasne alebo následne vyšetrujú alebo liečiatoho istého pacienta.

(3) Lekár a zubný lekár sú povinní požiadať ďalšieholekára o konzílium vždy, keď si to vyžadujú okolnosti apacient s tým súhlasí. Lekár a zubný lekár majú právonavrhnúť osobu konzultanta. Závery konziliárneho vyšet-renia majú byť dokumentované písomne a je povinnos-ťou informovať o nich pacienta s osobitným dôrazomv prípadoch, keď sa názory lekárov a zubných lekárovrôznia.

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(1) Lekár a zubný lekár nesmú poskytovať zdravotnústarostlivosť za prítomnosti osoby, ktorá nie je lekáromalebo zubným lekárom a nepatrí k zdravotníckemu per-sonálu. Výnimkou z uvedených zásad je osoba, ktorálekárovi a zubnému lekárovi umožňuje poskytnúť prvúpomoc, alebo taká osoba, ktorá sa u lekára vzdeláva alebopracuje, a ďalšia osoba, s ktorej prítomnosťou pacientsúhlasí.

(2) Lekár alebo zubný lekár nesmú podporovať osobyvykonávajúce činnosť, ktorú môže vykonávať len zdravot-nícky pracovník.

[[[[1111]]]] Príloha k zákonu č. 219/2002 Z. z., in: Zbierka zákonov č. 219/2002,Čiastka 93, s. 2184 - 2185.

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On March 17 - 19, 2002, an international confe-rence under the same title took place in Bratislava, thecapital of the Slovak Republic (SR). The meeting wasco-organised by the Directorate General for Research(DGR), Directorate Science and Society (DSS) (Unit Ethicsin Research and Science) of the European Commission(EC), Brussels, and the Institute of Medical Ethics andBioethics (IMEB) Fdn., Bratislava, under the auspices ofboth the Slovak minister of health Mr. Roman Kováčand minister of education Mr. Milan Ftáčnik. The con-ference was supported also by the Central and EastEuropean Association of Bioethics (CEEAB), the secre-tariat thereof should be opened in Bratislava, togetherwith the new „Bioethics Information and Documenta-tion Centre“, soon after the meeting.

The ppppaaaarrrrttttiiiicccciiiippppaaaannnnttttssss of the conference were delegates of13 candidate countries to EU (representing national co-ordinators for research, national ethics committees andother national structures of relevant expertise and sco-pe of activity), as well as international speakers and ex-perts, invited to the meeting by EC (altogether morethan 70 people, 22 European countries were represen-ted). The meeting was attended also by the high rankingrepresentatives of the local scientific community (uni-versities, Slovak Academy of Sciences, leading researchinstitutions, etc.) and had a strong working character,dealing with sets of new, original facts, and assessingperspectives the candidate countries face in their integ-ration and harmonisation efforts to EU in the field ofresearch and science.

The pppprrrrooooggggrrrraaaammmm of the conference comprised severalmonothematic sessions and panel discussions, as wellas a special event open to the public, which was devo-ted to the problem of responsibility, transparency, andmedia role(s) in relation to the unprecedented scientificprogress underway in the contemporary developedcountries, and importance of public information anddebate in promotion of better understanding, and per-haps also better societal control of science and applica-tion of its breaking results in practice and societies’ lifeand future(s).

The mmmmaaaajjjjoooorrrr ttttooooppppiiiiccccssss of the meeting were as follows:the problem of the conflict of interest in science andresearch; data protection and data-banking with gene-tic content (incl. concrete country-specific case analysesof the Estonian, Latvian, Icelandic and UK projects ex-periences); elements of institutional infrastructure buil-ding in Europe for ethics in research (incl. nationalethics committees, roles of the ministries of education,science and research, ministries of health, local andregional research ethics committees, and also the rele-vant international activities, such as the Council ofEurope’s (CE’s) CDBI (Steering Committee on Bio-ethics), COMETH (Conference of the Representativesof the National Ethics Committees) and DEBRA Prog-ramme; the EC’s „Action Plan Science and Society“, andmany others); requirements of the EC’s 6th Framework

KONFERENCIE / CONFERENCES

26 ME&B 9 (3–4) 2002

Programme (6FP) and the national legal situations;exploring new strategies for ethics in science and re-search in Europe and beyond (including EURETHNETProject of EC, international networking, collaborationof ethics committees on the national and internationalbasis, etc.); the specific possibilities and concrete pro-jects for collaboration between the Central and EastEuropean (CEE) countries.

Among the many hhhhiiiigggghhhhlllliiiigggghhhhttttssss of the meeting, themost important probably were (1) the presentation ofthe results of the EC-sponsored enquiry on the ethicaland legal situation in science and research in the candi-date countries to EU; (2) the debate of the country-spe-cific case studies on the problem of gene-banking; theoutline of (3) the EC’s „Action Plan Science and So-ciety“; and of (4) the future activities of CEEAB andIMEB Fdn. co-sponsored „Bioethics Information andDocumentation Centre“, to be devoted specifically tothe bioethics collaboration and networking in CEEcountries.

A more comprehensive iiiinnnnffffoooorrrrmmmmaaaattttiiiioooonnnn on the confe-rence proceedings (to be published in a special volumeby EC) and follow-up could be found at the conferenceweb-site, which should be maintained alive by DGR -DSS of EC to foster, document and promote furtherdevelopments and collaboration in this most importantfield.

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V dňoch 23. - 24. októbra sa v Bratislave konala uždruhá významná medzinárodná bioetická konferenciav roku 2002 pod názvom - (angl.) International Bio-ethics Conference - Ethics of Human Genetics: Challen-ges of the (Post)Genomic Era.

Usporiadateľmi konferencie boli: Riaditeľstvo preprávne záležitosti Rady Európy (RE, Štrasburg; konfe-rencia sa konala v rámci Programu DEBRA) a Minister-stvo zdravotníctva Slovenskej republiky (MZ SR) (v spo-lupráci Centrálnej etickej komisie a Odboru zahranič-ných vzťahov). Spoluusporiadateľmi boli Generálne ria-diteľstvo - Veda a spoločnosť Európskej komisie (GR -VS EK; Brusel), Detská fakultná nemocnica s poli-klinikou Lekárskej fakulty UK v Bratislave, Slovenskázdravotnícka univerzita v Bratislave, Kancelária Sveto-vej zdravotníckej organizácie (SZO) v SR a NadáciaÚstav medicínskej etiky a bioetiky v Bratislave. Slávnost-ného otvorenia konferencie, ktorá sa konala pod záš-titou ministra zdravotníctva SR MUDr. Rudolfa Zajaca, sazúčastnili poprední zástupcovia usporiadajúcich orga-nizácii, ako aj predsedníčka zdravotníckeho výboru Ná-rodnej rady SR poslankyňa MUDr. Anna Záborská. Sú-časťou podujatia bolo aj prvé diskusné sústredenie predse-dov a členov etických komisií v SR, ktoré zorganizovalaobnovená Centrálna etická komisia MZ SR.

PPPPrrrrooooggggrrrraaaammmm konferencie mal predovšetkým pracovnýcharakter. Dôraz sa kládol na etickú analýzu najnovšíchpoznatkov a trendov v rýchlo sa rozvíjajúcej oblasti hu-mánnej genetiky a jej súčasných i perspektívnych ap-likácií v medicíne a zdravotníctve. Z celej šírky danejproblematiky bolo pochopiteľne na konferencii možnéprebrať len malú časť. Pri zostavovaní odborného pro-gramu preto prednosť dostali problémy s bezprostred-

ným dopadom na medicínsku prax a tiež problémy,ktoré by sa mali v dohľadnej dobe stať predmetom no-vých legislatívnych úprav v SR. Pre celý priebeh konfe-rencie, vrátane plenárnych diskusií, bolo zabezpečenékvalitné simultánne tlmočenie. Súčasťou spoločen-ského programu konferencie bola návšteva predstave-nia baletu P. I. Čajkovského „Labutie jazero“ v historickejbudove Slovenského národného divadla.

OOOOddddbbbboooorrrrnnnnýýýý pppprrrrooooggggrrrraaaammmm sa sústredil do niekoľkých mono-tematických blokov. V úvodnej časti pozvaní prednáša-telia predstavili viaceré mmmmeeeeddddzzzziiiinnnnáááárrrrooooddddnnnnéééé aaaakkkkttttiiiivvvviiiittttyyyy vvvv oooobbbbllllaaaassssttttiiiibbbbiiiiooooeeeettttiiiikkkkyyyy, ktoré sa úspešne rozvíjajú v európskom merad-le. P. Zilgalvis (RE, Štrasburg) referoval o aktivitách REv oblasti humánnej genetiky, ktorá sa v súčasnosti sú-streďuje v práci Pracovnej skupiny pre humánnu gene-tiku (angl. Working Party on Human Genetics) Riadia-ceho výboru pre bioetiku (angl. Steering Committee onBioethics - CDBI), pripravujúcej Dodatkový protokol ohumánnej genetike k Dohovoru o ľudských právach abiomedicíne (tzv. Dohovor z Ovieda, 1997). Práce naprotokole v súčasnosti smerujú k ukončeniu jeho prvejčasti - aplikácie genetiky v medicíne a zdravotníctve,menej rozpracovaná je nateraz druhá časť protokolu -aplikácie genetiky v oblasti zdravotného poisťovníctvaa zamestnávania (skríning pracovníkov s genetickypodmieneným zdravotným rizikom). Cieľom protokoluje zabezpečiť ochranu ľudských práv, integrity a identi-ty každého človeka pri aplikácií genetiky v uvedenýchsituáciách. A. Bitušíková (GR - VS EK, Brusel) hovorila oaktuálnych etických problémoch dotýkajúcich sa ob-lasti humánnej genetiky, ktoré EK riešila v súvislostis prípravou 6 rámcového programu (angl. 6th Frame-work Program) pre oblasť biomedicínskeho výskumu.S ohľadom na kandidátske krajiny Európskej únie (EÚ)priniesla v referáte zaujímavé výsledky dotazníkovéhoprieskumu uskutočneného GR - VS EK v týchto kra-jinách v rokoch 2001 - 2002, ktoré sa týkali etiky a legis-latívy pre oblasť humánnej genetiky v týchto krajinách.J. Glasa referoval o aktivitách a perspektívach činnostiStredo- a východoeurópskej asociácie bioetiky (angl.Central and Eastern European Association of Bioethics -CEEAB), najmä v súvislosti s plánovaným otvorenímkancelárie CEEAB a dokumentačno-informačného cen-tra v rámci programu EURETHNET (EK) v Bratislave.Informácie doplnili R. Komel (Ljubljana) - hovoril o legis-latívnych aspektoch vývoja v oblasti humánnej genetiky averejnej diskusii o týchto problémoch v Slovinsku, B.Belicza (Zágreb) - venovala pozornosť výuke študentov azdravotníckych pracovníkov so zameraním na eticképroblémy humánnej genetiky z hľadiska skúsenostív Chorvátsku (prednáška v písomnej forme). M. Lukáčová(Bratislava) podala prehľad o doterajšom vývoji a súčas-nom stave lekárskej genetiky v SR.

Výnimočné svojou informačnou hodnotou, kvalitouprednesu i prezentovanej dokumentácie boli dve vyžia-dané ssssttttaaaatttteeee----ooooffff----tttthhhheeee----aaaarrrrtttt pppprrrreeeeddddnnnnáááášššškkkkyyyy, ktoré priniesli prehľadaktuálneho vývoja i najnovšie poznatky v danej oblasti.Išlo o prednášku J. Rogers (The Welcome Trust SangerInstitute, Cambridge, Veľká Británia (VB); predstaviteľ-ka významného centra medzinárodného projektu výs-kumu ľudského genómu) na tému „Projekt výskumuľudského genómu - výsledky, aplikácie a budúce pers-pektívy“ a prednášku M. - L. Labat (Maisons - Alfort,Francúzsko; objaviteľka tzv. adultnej kmeňovej bunky)na tému „Ľudské kmeňové bunky - biológia a etika“.

V sekcii venovanej lllleeeeggggiiiissssllllaaaattttíííívvvvnnnnyyyymmmm aaaa eeeettttiiiicccckkkkýýýýmmmm pppprrrroooobbbblllléééé----mmmmoooommmm hhhhuuuummmmáááánnnnnnnneeeejjjj ggggeeeennnneeeettttiiiikkkkyyyy vystúpili ako pozvaní pred-nášatelia významné osobnosti na poli medzinárodnéhopráva: A. McCall-Smith (Edinburg, VB) hovoril o prob-léme ochrany „genetického súkromia“ a zamedzení

27ME&B 9 (3–4) 2002

diskriminácie z dôvodu genetickej výbavy daného člo-veka; J. Sandor (Budapešť) referovala o problematikeochrany genetických údajov a o doterajších a perspek-tívnych problémoch v tejto oblasti z právneho hľadiska;A. Nomper (Tallin, Estónsko) hovoril o legislatívnychaspektoch projektu výskumu ľudského genómu v Es-tónsku (ide o jeden z troch v súčasnosti rozvíjanýchprojektov výskumu ľudského genómu na populačnejúrovni: podstatou je zbieranie a uchovávanie vzoriekbiologického materiálu, najmä krvných vzoriek, na ge-netickú analýzu, pričom snahou je zachytiť čo najväčšiučasť danej populácie; podobný projekt už prebieha naIslande, kde však legislatívne i praktické riešenia vyvo-lali vlnu domácej i medzinárodnej kritiky; ďalší projektsa pripravuje v niektorých vybraných oblastiach VB - avenuje mimoriadnu pozornosť zvládnutiu etickej a le-gislatívnej problematiky, ako aj primeranému infor-movaniu verejnosti).

PPPPaaaannnneeeelllloooovvvváááá ddddiiiisssskkkkuuuussssiiiiaaaa na tému EEEEttttiiiicccckkkkéééé kkkkoooommmmiiiissssiiiieeee - iiiicccchhhh úúúúlllloooo----hhhhyyyy aaaa zzzzooooddddppppoooovvvveeeeddddnnnnoooossssťťťť vvvv SR bola súčasne prvým diskusnýmsústredením členov etických komisií v SR po obnovenípráce Centrálnej etickej komisie (CEK) MZ SR. V úvodediskusie J. Glasa (predseda CEK) informoval o súčas-ných legislatívnych iniciatívach v tejto oblasti. Ide naj-mä o podporu urýchleného vydania dvoch vykoná-vacích vyhlášok MZ SR - Vyhlášky o klinickom skúšaníliečiv a o správnej klinickej praxi a Vyhlášky o etickýchkomisiách. Prvá vyhláška je už po opakovanom medzi-rezortnom pripomienkovom konaní, druhá je pripra-vená v paragrafovom znení. Obe vyhlášky bude možnévydať až po plánovanej novelizácií príslušných zákon-ných noriem (zákona o lieku; zákona o zdravotníckychzariadeniach alebo zákona o zdravotníckej starostli-vosti). V. Fedelešová (predsedníčka Etickej komisie voFDNsP v Bratislave na Kramároch) a V. Spustová (pred-sedníčka Etickej komisie ÚPKM v Bratislave) hovorili opraktických aspektoch práce etických komisií v pod-mienkach fakultnej nemocnice a veľkého výskumnéhoústavu. Prítomní v bohatej diskusii poukázali na viacerékonkrétne problémy práce etických komisií v SR, ktorési vyžadujú urýchlené a systémové riešenie. Medzinajdôležitejšie otázky zaradili: doriešenie legislatívnejbázy činnosti etických komisií; ujasnenie kompetenciía zodpovednosti, a to aj vo vzťahu k orgánom profesij-ných organizácií; riešenie otázky hmotnej a nehmotnejmotivácie práce členov komisií, najmä otázky prípadnejhonorácie vyžiadaných expertíz, vrátane odbornéhoposúdenia predkladaných projektov z etického hľa-diska; vzájomnú komunikáciu a informovanosť etic-kých komisií (privítali možnosť celoštátnych diskus-ných sústredení organizovaných najmenej raz ročne,najlepšie v nadväznosti na odbornú konferenciu alebopostgraduálny kurz bioetiky); nutnosť „vstupného“ akontinuálneho vzdelávania členov etických komisií,informovanosti o aktuálnych trendoch a nových prob-lémoch v oblasti bioetiky; aktívnejšiu úlohu CEK, ktoráby mala mať koordinačnú, konzultačnú a informačnúfunkciu vo vzťahu k lokálnym a regionálnym (kraj-ským) etickým komisiám na celom území SR; dostup-nosť vzdelávacích a informačných materiálov pre prácuetických komisií v slovenskom jazyku (plánované vy-danie príručky pre etické komisie, zostavenej J. Gla-som; lepšia dostupnosť časopisu Medicínska etika &Bioetika (zasielanie jednotlivým zdravotníckym zaria-deniam, dostupnosť v PDF formáte na internete).

V úvode bloku venovaného problematike ggggeeeennnneeeettttiiiicccckkkkeeeejjjjpppprrrreeeennnnaaaattttáááállllnnnneeeejjjj ddddiiiiaaaaggggnnnnoooossssttttiiiikkkkyyyy vystúpila A. Dorries (Hannover,Nemecko; členka CDBI; pediater - genetik a bioetik)s prednáškou na tému Genetická prenatálna diagnosti-

ka - Dilema lekára a rodičov, v ktorej citlivým a fundo-vaným spôsobom poukázala na zložité metodické, etic-ké a psychologické problémy, ktoré lekár - genetik riešipri genetickom poradenstve v spolupráci s konkrétny-mi rodičmi. K. Šipr (Brno) poukázal na problém pre-natálnej genetickej diagnostiky vo vzťahu k autonómii arozhodovaniu konkrétneho rodičovského páru (pred-náška v písomnej forme). M. Šustrová (Bratislava) hovo-rila o situácií a živote rodičov, rodiny a detí narodenýchs fyzickým alebo mentálnym handikapom, pričompoukázala na existujúce aktivity v SR, i na potrebu no-vých iniciatív v tejto oblasti, vrátane lepšej systémovejspolupráce zdravotníckeho, sociálneho a mimovládne-ho sektoru. V bohatej diskusii prítomní poukázali narôznorodosť etických postojov v súčasnej pluralitnejspoločnosti i na potrebu otvorenejšieho, komplexnéhoa pravdivého informovania rodičov i širšej verejnosti.Rozvoj vedeckých poznatkov - i v oblasti špeciálnejedukácie a rehabilitácie, umožňuje čoraz väčšiemupočtu detí narodených so závažným handikapom prežiťľudsky hodnotný a šťastný život. Nevyhnutnosťou jevšak vytvorenie primeraného sociálneho, zdravotného ilegislatívneho a kultúrneho zázemia.

V záverečnej sekcii konferencie poukázali prednáša-telia na niektoré nnnnoooovvvvéééé vvvvýýýývvvvoooojjjjoooovvvvéééé ttttrrrreeeennnnddddyyyy a aplikačnéoblasti humánnej genetiky. D. Sacchini (Centro di Bio-etica, Rím) analyzoval etickú problematiku genetic-kého skríningu. Poukázal na možné prínosy a niektorénebezpečenstvá, spojené s nekontrolovanou apliká-ciou genetických skríningových metód (napr. ich na-rastajúcej komerčnej dostupnosti, avšak bez zabezpe-čenia náležitého odborného poradenstva). J. Glasa (Bra-tislava) referoval o vývoji a etických problémoch v oblas-ti farmakogenetiky a farmakogenomiky. A. Miyah (Glas-gow, VB) sa venoval etickej problematike genetickýchmanipulácií na zvýšenie úspešnosti v oblasti športu(angl. Genetic Enhancement in Sport?; prednáška v pí-somnej forme). P. H. Kieniewicz (Lublin, Poľsko) po-núkol zamyslenie nad skúmaním a prekonávaním do-terajších metodologických, „technologických“ a etic-kých hraníc v oblasti humánnej genetiky a niektorýminebezpečenstvami, ktoré by tento vývoj mohol priniesťpre vývoj ľudskej spoločnosti. Prednášky G. Magilla (St.Louis, USA) a R. W. Evansa (Castro Valley, CA, USA) oproblematike výskumu ľudských kmeňových buniek aprednáška A. Carvalho (Porto, Portugalsko) o vývojietických postojov k problematike humánnej genetiky,klonovania a ľudských kmeňových buniek v obrazemienkotvornej dennej tlače v Portugalsku, boli poskyt-nuté v písomnej podobe.

ZZZZáááávvvveeeerrrroooommmm možno konštatovať, že konferencia pri-niesla cenný prehľad aktuálnych poznatkov o kľúčo-vých odborných a etických problémoch v oblasti hu-mánnej genetiky, zvlášť v súvislosti s ich perspektívnouaplikáciou v klinickej medicíne a programoch verej-ného zdravotníctva. Pozitívom je plánované urýchlenévydanie knižnej publikácie - zborníka, ktoré sa uskutoč-ňuje pod záštitou Rady Európy (v tlači už začiatkomroka 2003). Najnovšie poznatky prezentované na kon-ferencii budú teda už v krátkom čase k dispozícii aj preširšiu odbornú verejnosť.


28 ME&B 9 (3–4) 2002


The establishment of the Department of Medical Edu-cation (DME; in 1977) of then the Institute for Postgra-duate Education of Physicians and Pharmacists (IPP) inBratislava, Slovakia; was aimed to help the new pedagogi-cal staff of various IPP departments to manage the adap-tion phase of becoming the postgraduate education andtraining professionals in their respective disciplines, aswell as to obtain or develop the necessary pedagogicalknowledge and skills, which would help them to attainthe level of required educational mastership. It alsoshould help to promote and deliver continuous trainingand methodology development in medical education tothe more senior pedagogical staff of IPP. 25 years of va-rious DME activities is documented by a survey of its na-tional and international publications and topical lectures.These deal with various methodological issues in thefield of medical education, as well as conceptually sup-port, or evaluate different DME’s activities, which alto-gether serve as a basis for postgraduate education andtraining of doctors and teachers engaged in the healthcare service. A close cooperation and coordinatedapproach of biomedical ethics and pedagogy in the fieldof medicine was considered a necessary aspect of DME’swork. It obtained a new impetus after the Institute ofMedical Ethics and Bioethics was founded at IPP (in 1992)and mutual collaboration between the two departmentswas started.

KKKKeeeeyyyy wwwwoooorrrrddddssss:::: Department of Medical Education - Bratisla-va, 25 years of activity, literature survey.

On 1-st November 1977, at the meeting of the Scienti-fic Board of the Institute for Postgraduate Education ofPhysicians and Pharmacists (IPP) in Bratislava (presentSlovak Postgraduate Academy of Medicine - SPAM), theconcept of the Cabinet of Methodology and Medical Edu-cation, which later on (by 1-st January 1985) became theDepartment of Medical Education (DME), was discussed.Under this name, DME has been operating till nowadays,and it has been incorporated, among other departments,into the School of Public Health (SPH) in Bratislava. Theinitiative of establishing such institutions came directlyfrom the World Health Organisation (WHO). The firstsuch training centre, working under the auspices of WHO,was established at the College of Medicine, University ofIllinois, Chicago (USA). DME was the first department ofits type in Slovakia, although at the same time, there weretwo similar departments in Prague. One of them washeaded by doc. MUDr. Jozef Vyšohlíd, DrSc., the secondby prof. MUDr. Aleš Šatánek, DrSc.

The staff of DME has developed, and implemented inits practical educational and training activities, an origi-nal system of preparation of young assistant professorsof IPP for their teaching work in their respective medicaldisciplines. The information on various aspects of thiseducational methodology was published nation - wide,and also abroad ((((1111----11114444)))).... The graduates of this system of

educational preparation for teachers in medicine includepresent-day professors, associate professors, faculty deansand deputy deans, ministers, department heads, and alsoseveral full or associate university professors being activeabroad.

A particular emphasis was put on continuous imple-mentation of the newest developments in educationalstrategy and up-to-date didactical methods in updatingand developing the system, while being at practical useand scrutiny in everyday’s work of DME. This long-termperspective enables to follow the changes concerningparticular educational methods and assimilate them intothe teaching programmes, so the requirements of mo-dern medical education methodology are continuouslymet ((((11115555----22223333)))).... A proper orientation in the work of variousinternational organisations in the field of medicine andhealth care, their history, activities, structure and tasks, isvitally important for new postgraduate teachers in thefield of medicine. The problem has been dealt with in anumber of publications by DME staff ((((22224444----33335555)))).

The DME staff has been training also the employeesof the so-called training districts (at present certified dist-ricts), who work as trainers. Having been requested theyarranged short-term courses and seminars for otherdepartments or educational institutions. The qualifica-tion structure of the department is formed by one profes-sor and two doctors (one of them is a clinician-geriatrist,the other is an epidemiologist). There are two assistantprofessors (one of them is a doctor of pharmaceutics, theother is a master of andragogy-culturology).

The department participates in continual education.The head of the department prof. MUDr. L. Badalík, DrSc.is a president of the Society for Health Service WorkersEducation which organizes regular seminars on educa-tion in medicine. The department is involved also in thepostgraduate education activities.

Its staff are officers and members of the state boardsfor conferring PhD. (philosophiae doctor) degrees, andthey serve as tutors/mentors, and reviewers of PhD. dis-sertations as well.


During 25 years of its activity, the Department of Me-dical Education of IPP (later on SPAM) has developedand implemented in practice the original system of assis-tant professors’ preparation for the educational work invarious medical disciplines. The system has been testedand successfully presented in Slovakia and also abroad.For example, 90 new assistant professors have passedtraining preparation for medical education at SPAM alo-ne. The department has been operating as an advisorypoint for the staff of other educational institutions, espe-cially, when something new has been introduced or de-veloped. An already long-term and fruitful relationshipand cooperation exists between DME and those workingin the field of medical ethics and bioethics as teachers,scientific workers, managers or volunteers.

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KKKKaaaatttteeeeddddrrrraaaa mmmmeeeeddddiiiiccccíííínnnnsssskkkkeeeejjjj ppppeeeeddddaaaaggggooooggggiiiikkkkyyyy SSSSlllloooovvvveeeennnnsssskkkkeeeejjjj ppppoooossssttttggggrrrraaaadddduuuuáááállllnnnneeeejjjj aaaakkkkaaaaddddéééémmmmiiiieeee mmmmeeeeddddiiiiccccíííínnnnyyyy::::22225555 rrrrooookkkkoooovvvv ččččiiiinnnnnnnnoooossssttttiiii vvvv mmmmeeeettttooooddddoooollllóóóóggggiiiiiiii mmmmeeeeddddiiiiccccíííínnnnsssskkkkeeeehhhhoooo vvvvzzzzddddeeeelllláááávvvvaaaannnniiiiaaaa

Zuzana Takáčová, Jozef Glasa

Slovak Postgraduate Academy of Medicine, Bratislava, Slovak Republic

29ME&B 9 (3–4) 2002

● ● ●

Dňa 1. 11. 1977 bol na zasadnutí Vedeckej rady Inšti-tútupre ďalšie vzdelávanie lekárov a farmaceutov (ILF; dnešnáSlovenská postgraduálna akadémia medicíny - SPAM) pre-rokovaný návrh koncepcie Kabinetu metodiky a medicín-skej pedagogiky, ktorý sa neskoršie (od 1.1. 1985) stalKatedrou medicínskej pedagogiky (KMP). Pod týmto náz-vom KMP existuje dodnes, pričom je organizačne začlenenáako samostatná katedra Školy verejného zdravotníctva.

Iniciatíva na zakladanie útvarov tohoto typu vyšla zoSZO, pričom prvé školiace stredisko SZO bolo vytvorenéna College for Medicine, University of Illinois, Chicago,USA. KMP bola na Slovensku svojho druhu prvá, i keďv Čechách v tom čase už pôsobili dve obdobné katedryv Prahe. Jednu z nich viedol doc.MUDr. Jozef Vyšohlíd,DrSc., druhú prof. MUDr. Aleš Šatánek, DrSc..

Pracovníci KMP vypracovali a odskúšali systém príp-ravy asistentov ILF na pedagogickú činnosť v medicíne,ktorý bol mnohonásobne odprednášaný doma i v zahra-ničí ((((1111----11114444)))). Medzi absolventmi tohoto systému pedago-gickej prípravy učiteľov medicíny sú dnešní profesori,docenti, dekani, ministri, prodekani, vedúci katedier, prí-padne úspešní vysokoškolskí učitelia pôsobiaci v za-hraničí.

Okrem vypracovania systému prípravy kládli pracov-níci katedry veľký dôraz na výchovu edukačnej stratégiea jednotlivých didaktických metód. Dlhodobý pohľadumožňuje porovnávať, ako sa mení paleta jednotlivýchmetód a prispôsobovať výučbu aktuálnym požiadavkám((((11115555----22223333)))). Pre nového pedagóga v oblasti zdravotníctva jeveľmi dôležitá aj dobrá orientácia v práci medzinárod-ných organizácií pôsobiacich v oblasti medicíny a zdra-votníctva, ich histórii, činnosti, štruktúre a cieľoch. Tútoproblematiku pracovníci katedry spracovali vo viacerýchpublikáciách ((((22224444----33335555)))).

Pracovníci katedry školili v medicínskej pedagogike ajpracovníkov tzv. školiacich obvodov (v súčasnosti akredi-tovaných obvodov), ktorí pôsobia ako školitelia. Na po-žiadanie usporiadali krátkodobé kurzy a semináre aj nainých fakultách prípadne iných vzdelávacích inštitúciách.Kvalifikačná štruktúra katedry pozostáva z jedného pro-fesora a dvoch doktorov lekárskych vied (jeden z nich jeklinik-geriater, druhý je epidemiológ). Na katedre pracu-jú dve odborné asistentky (jedna doktorka farmácie, dru-há magistra andragogiky-kulturológie).

Katedra sa aktívne zúčastňuje na kontinuálnom vzde-lávaní. Vedúci katedry prof. MUDr. L. Badalík. DrSc. jeprezidentom Spoločnosti pre výchovu pracovníkovv zdravotníctve, ktorá poriada pravidelné semináre zame-rané na oblasť pedagogiky v zdravotníctve.

Katedra sa podieľa aj na doktorandskom štúdiu, kdejej pracovníci pôsobia ako funkcionári a členovia komisiípre udeľovanie hodností PhD. (philosophiae doctor),z čoho vyplývajú aj ich funkcie školiteľské, prípadneoponentské.

ZZZZáááávvvveeeerrrr

Katedra medicínskej pedagogiky ILF (dnes SPAM) za25 rokov svojej existencie vypracovala systém prípravyasistentov na pedagogickú činnosť, ktorý preverila v pra-xi a opakovane prezentovala na domácich fórach i v za-hraničí. Len napríklad v rámci SPAM-u absolvovalo vstup-né školiace miesta z medicínskej pedagogiky 90 novýchasistentov. Katedra pôsobí poradensky tiež pre pracov-níkov iných vzdelávacích inštitúcií predovšetkým tam,kde sa rodí niečo nové. Dlhoročný a dobrý je tiež vzťaha príkladná spolupráca KMP s tými, ktorí pracujú na polimedicínskej etiky a bioetiky, či už ako učitelia, vedeckípracovníci, riadiaci pracovníci alebo nadšenci.


1111.... Badalík, L., Paniaková, M.: Optimalizácia systémuprípravy asistentov na pedagogickú činnosť v ILF.Záverečná správa výskumnej úlohy č. 48-01-02. Bratislava: ILF, 1983, 126 s. 2222.... Badalík, L., Paniaková, M.: Bratislavskisystem przygotowania asystentow. do zadaň pedago-gicznych w ksztalceniu podyplomoaym lekarzy i farma-ceutow. Ksztalcenie medyczne za granica. Probl. Szkoln.Nauk. Med. t. IX, 1984, č. 3, s. 65-69. 3333.... Badalík, L.,Paniaková, M.: Medical Teacher and his PedagogicalTraining. Experience with Bratislavian System of Trai-ning the Assistents for Pedagogical Activity in Postgra-duate Education of Physicians and Pharmacists. Cze-choslovak Medicine, 7, 1984, č. 3, s. 129-134. 4444.... Badalík,L., Paniaková, M., Bakošová, Z.: Medical Faculty Teacher.Systematic Improvement of Pedagogic Qualification ofTeachers of the Institute for Postgraduate Education ofPhysicians and Pharmacists in Bratislava. Sborník vědec-kých prací LF KU v Hradci Králové, 29, 1986, č. 3, s. 209-302. 5555.... Badalík, L., Paniaková, M.: Optimalizácia systémuprípravy asistentov na pedagogickú činnosť v Inštitútepre ďalšie vzdelávanie lekárov a farmaceutov v Bra-tislave. Aktuality zdravotníckeho výskumu, 1987, č. 5, s.330-332. 6666.... Badalík, L., Paniaková, M., Milovský, V.: TheRole of Medical Teacher Training and its Changes in theProcess of Decentralization. Seminar Decentralizationand Service-Integration in the Healthcare Systems Po-land, Hungary and the Netherlands. Proceedings Ho-geschool van Amsterdam, Part one, 1991, pp. 156-158. 7777....Badalík, L., Paniaková, M.: Innovative Course on MedicalPedagogy. Nová forma kontinuálneho vzdelávania uči-teľov medicíny. Lekársky Obzor, 40, 1991, č.11, s. 601-606. 8888.... Badalík, L., Paniaková, M.: The Present andPerspectives of Training Medical Teachers in Slovakia. 1-st. International Health Symposium: „Health and Qualityof Life in Changing Europe in the Year 2000“. Procee-dings., Sympos , New York - Bratislava - TatranskáPolianka, 1992, pp. 165-168. 9999.... Badalík, L., Paniaková, M.,Farkašová, D., Hrašková, A.: Pedagogická príprava učiteľamedicíny z pohľadu 15-ročných skúsenosti Katedry me-dicínskej pedagogiky Inštitútu pre ďalšie vzdelávanie pra-covníkov v zdravotníctve. Lekársky Obzor, 43, 1993, č.12, s. 21-25. 11110000.... Paniaková, M., Badalík, L., Farkašová, D.:Department of Medical Education of the PostgraduateMedical School in Bratislava and its Experiences withTraining Young Medical Teachers - Analysis of the Periodof Years 1984-1992. 3-rd High Tatras International HealthSymposium: „Preventive and Clinical Medicine in Chan-ging Europe“. Proceedings, Sympos, 1994, pp. 76-81. 11111111....Badalík, L., Farkašová, D., Minichová, J.B.: Training ofYoung Medical Teachers - The Bratislavian System.Abstracts. AMEE -Medical Education Conference, Copen-hagen, 1-4 Sept. 1996, s. 14. 11112222.... Badalík, L., Farkašová, D.,Minichová, J. B.: Training of Young Medical Teachers -the Bratislavian System. Abstracts. Medical Teacher, 19,1997, No 1, p. 72. 11113333.... Badalík, L., Hegyi, L., Minichová,J.B., Farkašová, D., Šajter, V.: Department of Medical Pe-dagogy and its Role in Organizational Structure of theSchool of Public Health.. Abstracts. XX ASPHER AnnualConference, 1998, p. 37. 11114444.... Badalík, L., Hegyi, L., Tóth,K.: Príprava učiteľov medicíny v pedagogike. In: Zborníkprednášok 12.-14. 10. 2000 Martin Slovensko III. celo-slovenská konferencia o lekárskom vzdelávaní s medzi-národnou účasťou „Štúdium medicíny v treťom tisícročí“.Martin : 2001, s. 33-35, ISBN 80-88866-14-6 11115555.... Pania-ková, M., Badalík, L.: Workshop ako jedna z foriem vý-učby v malých skupinách. Lekársky obzor, 37, 1988, č. 11,s. 689-691. 11116666.... Paniaková, M., Badalík, L.: Hranie úloh akojedna z metód výučby v malých skupinách. Lek.obzor, 39,1990, č. 11, s. 559-562. 11117777.... Paniaková, M., Badalík, L.:

30 ME&B 9 (3–4) 2002


TTTTaaaakkkkááááččččoooovvvváááá,,,, ZZZZ....,,,, GGGGllllaaaassssaaaa,,,, JJJJ....:::: DDDDeeeeppppaaaarrrrttttmmmmeeeennnntttt ooooffff MMMMeeeeddddiiiiccccaaaallll EEEEdddduuuu----ccccaaaatttt iiiioooonnnn ooooffff tttthhhheeee SSSSlllloooovvvvaaaakkkk PPPPoooossssttttggggrrrraaaadddduuuuaaaatttteeee AAAAccccaaaaddddeeeemmmmyyyy ooooffffMMMMeeeeddddiiiicccciiiinnnneeee:::: 22225555 YYYYeeeeaaaarrrrssss ooooffff LLLLeeeeaaaaddddeeeerrrrsssshhhhiiiipppp iiiinnnn MMMMeeeeddddiiiiccccaaaallll EEEEdddduuuu----cccc aaaa tttt iiii oooo nnnn MMMM eeee tttt hhhh oooo dddd oooo llll oooo gggg yyyy .... [[[[KKKKaaaatttteeeeddddrrrraaaa mmmmeeeeddddiiiiccccíííínnnnsssskkkkeeeejjjj ppppeeeeddddaaaa----ggggooooggggiiiikkkkyyyy SSSSlllloooovvvveeeennnnsssskkkkeeeejjjj ppppoooossssttttggggrrrraaaadddduuuuáááállllnnnneeeejjjj aaaakkkkaaaaddddéééémmmmiiiieeee mmmmeeeeddddiiiiccccíííínnnnyyyy:::: 22225555rrrrooookkkkoooovvvv ččččiiiinnnnnnnnoooossssttttiiii vvvv mmmmeeeettttooooddddoooollllóóóóggggiiiiiiii mmmmeeeeddddiiiiccccíííínnnnsssskkkkeeeehhhhoooo vvvvzzzzddddeeeelllláááávvvvaaaannnniiiiaaaa....]]]]MMMMeeeedddd.... EEEEtttthhhh.... BBBBiiiiooooeeeetttt....,,,, 9999,,,, 2222000000002222,,,, NNNNoooo.... 3333 ---- 4444,,,, pppp.... 22228888 ---- 33330000.... Cieľomvytvorenia Katedry medicínskej pedagogiky (KMP)Inštitútu pre ďalšie vzdelávanie lekárov a farmaceutov(ILF) v Bratislave bolo pomôcť novým pedagogickým pra-covníkom ILF zvládnuť adaptačnú fázu a získať pedago-gické vedomosti, schopnosti a návyky, ktoré vyústia dopotrebného pedagogického majstrovstva. Okrem tohopomôcť mladým pedagogickým pracovníkom prejsťplynulo do fázy kontinuálneho vzdelávania v medicínskejpedagogike, v rámci ktorej by si toto majstrovstvoudržiavali a ďalej ho rozvíjali. 25-ročnú činnosť KMPdemonštrujú autori pomocou literárneho prehľaduobsahujúceho súbory doma i v zahraničí publikovanýcha odprednášaných prác. Práce sú zamerané na jednotlivéproblémy, ktoré sú z hľadiska činnosti katedry dominant-né a predstavujú východiskový materiál pre ďalšie štú-dium lekárov a pedagógov pôsobiacich v zdravotníctve.Tesná spolupráca a koordinovaný prístup etiky a peda-gogiky sú práve v oblasti medicíny nevyhnutnosťou.KKKKľľľľúúúúččččoooovvvvéééé sssslllloooovvvváááá: Katedra medicínskej pedagogiky, 25rokov činnosti, literárny prehľad.

Correspondence to / Adresa: Prof. MUDr. L. Badalík, DrSc., Department ofMedical Education, Slovak Postgraduate Academy of Medicine, Limbová12, 833 03 Bratislava, Slovak Republic

CCCCIIIIOOOOMMMMSSSS:::: IIIINNNNTTTTEEEERRRRNNNNAAAATTTTIIIIOOOONNNNAAAALLLL EEEETTTTHHHHIIIICCCCAAAALLLL GGGGUUUUIIIIDDDDEEEE----LLLLIIIINNNNEEEESSSS FFFFOOOORRRR BBBBIIIIOOOOMMMMEEEEDDDDIIIICCCCAAAALLLL RRRREEEESSSSEEEEAAAARRRRCCCCHHHH IIIINNNNVVVVOOOOLLLL----VVVVIIIINNNNGGGG HHHHUUUUMMMMAAAANNNN SSSSUUUUBBBBJJJJEEEECCCCTTTTSSSS [[[[1111]]]]

This is to give the readers a brief information on thelatest edition ot the International Ethical Guidelines forBiomedical Research Involving Human Subjects pre-pared and published by CIOMS (The Council for Inter-national Organizations of Medical Sciences) in collabora-tion with WHO, while relying mostly on the informationprovided in the introductory chapters of the Guidelinesthemselves [[[[2222]]]].

This is the third in the series of international ethicalguidelines for biomedical research involving human sub-jects issued by CIOMS since 1982. The 2002 text, whichsupersedes that of 1993, consists of a statement of gene-ral ethical principles, a preamble and 21 guidelines, withan introduction and a brief account of earlier declara-tions and guidelines. Its scope and preparation reflectthe transformation that has occurred in the field ofresearch ethics in the almost quarter century. TheGuidelines, with their stated concern for the applicationof the Declaration of Helsinki in developing countries,necessarily reflect the conditions and the needs of bio-medical research in those countries, and the implicationsfor multinational or transnational research in which theymay be partners. They are designed to be of use, particu-larly to low-resource countries, in defining national poli-cies on the ethics of biomedical research, applying ethi-cal standards in local circumstances, and establishing orredefining adequate mechanisms for ethical review ofresearch involving human subjects.

Involvement of Changes in Utilization of Chosen Educa-tional Methods in the Postgraduate Medical Education.Poster presentation at the AMDE/AMEE Conferences,Paris, 2 - 6 Oct. 1991. 11118888.... Paniaková, M., Badalík, L.: TheDynamism of Development of the Educational Methodsin Postgraduate Education of Physicians and Pharmacistsin Slovakia. Abstracts. Health and Quality of Life in chan-ging Europe in the year 2000, Štrbské Pleso, 18.-20. 10.1991, p. 41. 11119999.... Milovský, V., Badalík, L.: Medical Edu-cation in Slovak Republic Seminar Decentralization andService-Integration in the Healthcare Systems Poland,Hungary and the Netherlands. Proceedings Hogeschoolvan Amsterdam, Part one, 1991, pp. 150-l55. 22220000.... Badalík,L., Paniaková, M.: The Most Frequent Mistakes by Usageof Brainstorming in Medicine. Eurorehab, 1992, č. 2, pp.93-95. 22221111.... Paniaková, M., Badalík, L.: The Dynamism ofDevelopment of the Educational Methods in Postgra-duate Education of Physicians and Pharmacists in Slova-kia. Proceedings. l-st International Health Conference„Health and Quality of Life in Changing Europe in theYear 2000“. Sympos, New York - Bratislava - TatranskáPolianka, 1992, pp. 169-173. 22222222.... Badalík, L.: Identificationof Strategy for Changing Medical Education in Slovakia.Proceedings. 3-rd International Symposium of Family,Medicine/General Practice in Lithuania, Vilnius, 1993, s.8-10. 22223333.... Badalík, L.: Kredit point system v hodnoteníkontinálneho vzdelávania. Manažment v zdravotníctve.Medicínsky Monitor, 1995, č. 5, s. 20-21. 22224444.... Badalík, L.,Paniaková, M.: Svetová zdravotnícka organizácia, jej štruk-túra a význam pre výchovu lekárov. Lekársky Obzor, 40,1991, č. 8, s. 417-420. 22225555.... Badalík, L.: ASPHER a jej úlohypri plnení stratégie „Zdravie pre všetkých do roku 2000“.Lekársky Obzor, 40, 1991, č. 9, s. 473-476. 22226666.... Minichová,J.B., Badalík, L., Ihnát, M.: Štúdia o informovanosti pracov-níkov v zdravotníctve na Slovensku o Svetovej zdravot-níckej organizácii a jej aktivitách. Eurorehab, 1994, č. 3, s.149-151. 22227777.... Minichová, J. B., Badalík, L., Ihnát, M.:Svetová zdravotnícka organizácia, jej vznik, vývoj anajvýznamnejšie aktivity. Farmaceutický Obzor, 1995, č.4, s. 95-97. 22228888.... Badalík, L.: Stratégia Svetovej zdravotníckejorganizácie. Zdravie pre všetkých do roku 2000. In:Dieška, D., Badalík, L., Šašinka, M.: Vademecum medici.Martin : Osveta, 1995, s. 29-32. 22229999.... Badalík, L.: StratégiaSvetovej zdravotníckej organizácie Zdravie pre všetkýchdo roku 2000. In: Vademecum medici. Martin : Osveta,1998, s. 29-32. 33330000.... Šašinka, M., Badalík, L.: AIDS v 21.storočí. Lekársky Obzor, 49, 2000, č. 2, s. 51-52. 33331111.... Ba-dalík, L., Farkašová, D., Palát, M., Honzátková, Z.: 21.storočie a stratégia SZO Zdravie pre všetkých. Eurorehab,2000, č. 1, s. 23-25. 33332222.... Badalík, L., Hegyi, L.: Zdravé star-nutie v Európe 21. storočia. Geriatria, 2000, č. l, s. 37-41.33333333.... Badalík, L., Krištúfek, P., Farkašová, D., Honzátková,Z.: Stratégia „Zdravie pre všetkých v 21. storočí„ a jejciele. Medicínsky Monitor, 2000, č. 3, s. 18-20. 33334444....Badalík, L., Hegyi, L., Farkašová, D., Honzátková, Z.:Stratégia rozvoja ľudských zdrojov pre zdravie v 21.storočí. Eurorehab, 2000, č. 2, s. 98-99. 33335555.... Badalík, L.,Honzátková, Z.: Siedmy cieľ stratégie SZO Zdravie prevšetkých v 21. storočí. Eurorehab, 2001, č. 3, s. 127-128.

O KNIHÁCH / BOOK REVIEWS

31ME&B 9 (3–4) 2002

After 1993, nnnneeeewwww eeeetttthhhhiiiiccccaaaallll iiiissssssssuuuueeeessss arose for which theCIOMS Guidelines had no specific provision. They rela-ted mainly to controlled clinical trials, with external spon-sors and investigators, carried out in low-resource coun-tries and to the use of comparators other than an estab-lished effective intervention. The issue in question wasthe perceived need in those countries for low-cost, tech-nologically appropriate, public-health solutions, and inparticular for HIV/AIDS treatment drugs or vaccines thatpoorer countries could afford. Opposing sides weretaken on this issue. One advocated, for low-resourcecountries, trials of interventions that, while they mightbe less effective than the treatment available in the bet-ter-off countries, would be less expensive. All researchefforts for public solutions appropriate to developingcountries should not be rejected as unethical, they clai-med. The research context should be considered. Localdecision-making should be the norm. Paternalism on thepart of the richer countries towards poorer countriesshould be avoided. The challenge was to encourageresearch for local solutions to the burden of disease inmuch of the world, while providing clear guidance onprotecting against exploitation of vulnerable communi-ties and individuals. The other argued that such trialsconstituted, or risked constituting, exploitation of poorcountries by rich countries and were inherently unethi-cal. Economic factors should not influence ethical con-siderations. It was within the capacity of rich countriesor the pharmaceutical industry to make established effec-tive treatment available for comparator purposes. Cer-tain low-resource countries had already made availablefrom their own resources established effective treatmentfor their HIV/AIDS patients. This conflict complicatedthe revision and updating of the 1993 Guidelines. Ulti-mately, it became clear that the conflicting views couldnot be reconciled, though the proponents of the firstview claimed that the new guidelines had built in effec-tive safeguards against exploitation. The commentary tothe Guideline 11, Choice of control in clinical trials, re-cognizes the unresolved, or unresolvable, conflict.

An issue, mainly for the low-income countries andperhaps less pertinent now than in the past, has been theextent to which ethical principles are considered univer-sal or as culturally relative - the universalist versus thepluralist view. The challenge to international researchethics is to apply universal ethical principles to biome-dical research in a multicultural world with a multiplicityof health-care systems and considerable variation in stan-dards of health care. The Guidelines take the positionthat research involving human subjects must not violateany universally applicable ethical standards, but acknow-ledge that, in superficial aspects, the application of theethical principles, e.g., in relation to individual autonomyand informed consent, needs to take account of culturalvalues, while respecting absolutely the ethical standards.

Related to this issue is that of the human rights ofresearch subjects, as well as of health professionals asresearchers in a variety of sociocultural contexts, and thecontribution that international human rights instrumentscan make in the application of the general principles ofethics to research involving human subjects. The issueconcerns largely, though not exclusively, two principles:respect for autonomy and protection of dependent orvulnerable persons and populations. In the preparationof the Guidelines the potential contribution in theserespects of human rights instruments and norms was dis-cussed, and the Guideline drafters have represented theviews of commentators on safeguarding the correspon-ding rights of subjects.

Certain aaaarrrreeeeaaaassss ooooffff rrrreeeesssseeeeaaaarrrrcccchhhh are nnnnooootttt rrrreeeepppprrrreeeesssseeeennnntttteeeedddd by spe-cific guidelines. One such is human genetics. It is, howe-

ver, considered in Guideline 18 Commentary under Issuesof confidentiality in genetics research. The ethics ofgenetics research was the subject of a commissionedpaper and commentary.

Another unrepresented area is research with embryoand fetal research, and fetal tissue research. An attemptto craft a guideline on the topic proved unfeasible. Atissue was the moral status of embryos and fetuses andthe degree to which risks to the life or well-being ofthese are ethically permissible. In relation to the use ofcomparators in controls, commentators have raised thethe question of standard of care to be provided to a cont-rol group. They emphasize that standard of care refers tomore than the comparator drug or other intervention,and that research subjects in the poorer countries do notusually enjoy the same standard of all-round care enjoyedby subjects in richer countries. This issue is not addres-sed specifically in the Guidelines.

In one respect the Guidelines ddddeeeeppppaaaarrrrtttt ffffrrrroooommmm tttthhhheeee tttteeeerrrrmmmmiiii----nnnnoooollllooooggggyyyy ooooffff tttthhhheeee DDDDeeeeccccllllaaaarrrraaaattttiiiioooonnnn ooooffff HHHHeeeellllssssiiiinnnnkkkkiiii. ‘Best current inter-vention’ is the term most commonly used to describe theactive comparator that is ethically preferred in control-led clinical trials. For many indications, however, there ismore than one established ‘current’ intervention and ex-pert clinicians do not agree on which is superior. Inother circumstances in which there are several estab-lished ‘current’ interventions, some expert clinicians re-cognize one as superior to the rest; some commonly pres-cribe another because the superior intervention may belocally unavailable, for example, or prohibitively expen-sive or unsuited to the capability of particular patients toadhere to a complex and rigorous regimen. ‘Establishedeffective intervention’ is the term used in Guideline 11to refer to all such interventions, including the best andthe various alternatives to the best. In some cases an ethi-cal review committee may determine that it is ethicallyacceptable to use an established effective intervention asa comparator, even in cases where such an interventionis not considered the best current intervention.

I agree with the concluding statement of the intro-ductory chapter of the Guidelines, which reminds thereaders that „the mere formulation of ethical guidelinesfor biomedical research involving human subjects willhardly resolve all the moral doubts that can arise in asso-ciation with much research, but the Guidelines can atleast draw the attention of sponsors, investigators andethical review committees to the need to consider care-fully the ethical implications of research protocols andthe conduct of research, and thus conduce to high scien-tific and ethical standards of biomedical research.“

I strongly believe that tttthhhheeee ccccaaaarrrreeeeffffuuuullll ssssttttuuuuddddyyyy ooooffff tttthhhheeeeGGGGuuuuiiiiddddeeeelllliiiinnnneeeessss iiiissss aaaa mmmmuuuusssstttt not only for all the professional par-ties involved in the biomedical research involving humansubjects, in particular for the sponsors, investigators andmembers of the ethics review committees; but also forthe professionals concerned with the development orupdating of their national legislation (laws and regula-tions) in this area. I hope, we shall be able to welcomesoon also translations of the Guidelines into various lan-guages of the countries of the Central and Eastern Euro-pe, including their translation into Slovak. The full text ofthe Guidelines may be found at the CIOMS website, orpurchased as a separate publication directly from CIOMS,c/o WHO, Avenue Appia, 1211 Geneva 27, Switzerland,or from the booksellers through the network of WHOsales agents.

[1] CIOMS: International Ethical Guidelines for Biomedical ResearchInvolving Human Subjects. CIOMS, Geneva, 2002, pb, 112 pgs, price 20CHF. [2] Ibid., p. 7 - 13.


32 ME&B 9 (3–4) 2002

Súhrnný obsah ročníka 9 (2002) / Cummulative Contens of the Vol. 9 (2002)

NNNNoooo.... 1111 ---- 2222■ OOOOdddd rrrreeeeddddaaaakkkkcccciiiieeee////EEEEddddiiiittttoooorrrriiiiaaaallll ................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................ 1111,,,, 9999

– Collaboration and networking in bioethics in Central and Eastern European countries. [Spolupráca a kontakty v oblasti bioetiky v krajinách strednej a východnej Európy.] J. Glasa ............................................. 1

■ PPPPôôôôvvvvooooddddnnnnéééé pppprrrráááácccceeee////OOOOrrrriiiiggggiiiinnnnaaaallll AAAArrrrttttiiiicccclllleeeessss ............................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................ 3333– Ethical and juridical foundations of conscientious objection for health care workers.

[Etické a právne základy výhrady svedomia u zdravotníckych pracovníkov.] G. Gambino, A. G. Spagnolo ..................... 3– K diskuzi o eutanazii v České republice. [To the euthanasia debate in the Czech Republic.] K. Šipr .............................. 5– Establishment and work of ethics committees in Central and Eastern European countries.

[Založenie a činnosť etických komisií v krajinách strednej a východnej Európy.] J. Glasa .................................................... 9■ DDDDooookkkkuuuummmmeeeennnnttttyyyy////DDDDooooccccuuuummmmeeeennnnttttssss ........................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................ 11112222

– Directive 2001/20/EC of the European Parliament and of the Council of April 2001 on (...) good clinical practice (...) [Smernica 2001/20/EC Európskeho parlamentu a Rady zo 4. apríla 2001 o (...) správnej klinickej praxi (...)] ........................................................................................................................................................... 12

NNNNoooo.... 3333 ---- 4444

■ PPPPôôôôvvvvooooddddnnnnéééé pppprrrráááácccceeee////OOOOrrrriiiiggggiiiinnnnaaaallll PPPPaaaappppeeeerrrrssss ................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................ 2222– Bioethics, Sport and the Genetically Enhanced Athlete. [Bioetika, šport a geneticky zvýhodnený atlét.] A. Miyah ..... 2– Borderline Viability Resuscitation Cases. [Resuscitácia v prípadoch hraničnej životaschopnosti.] D. O’Brien ............ 6– K problému revitalizácie etických komisií v Slovenskej republike. [Contribution to the Problem

of Revitalisation of Ethics Committees in the Slovak Republic.] J. Glasa ................................................................................... 10■ DDDDooookkkkuuuummmmeeeennnnttttyyyy////DDDDooooccccuuuummmmeeeennnnttttssss ........................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................ 11112222

– CIOMS: International Ethical Guidelines for Biomedical Research Involving Human Subjects (excerpts). [CIOMS: Medzinárodné etické smernice pre biomedicínsky výskum s účasťou ľudských osôb (výňatky).] ................ 15

– Europan Parliament: European Strategy in the field of Biotechnologies. [Európsky parlament: Európska stratégia na poli biotechnológií.] ............................................................................................ 19

– Záverečný dokument Medzinárodnej konferencie o bioetike v strednej a východnej Európe, Vilnius, 10. - 12. 11. 2002. [Final Statement of the International Conference on Bioethics in Central and Eastern Europe.], Vilnius, November 10 - 12, 2002 .................................................................................................................. 22

– Pontificial Academy for Life: The Nature and Dignity of the Human Person. [Pontifikálna akadémia pre život: Podstata a dôstojnosť ľudskej osoby.] .................................................................................................................................................... 22

– Assisi Decalogue for Peace. [Dekalóg mieru z Assisi.] ..................................................................................................................... 24– Etický kódex lekára a zubného lekára (príloha zákona NR SR č. 219/2002 o povolaní lekára a zubného lekára).

[Code of Practice of Physician and Physician-Stomatologist (appendix to the Law of the NC SR No. 219/2002 on the profession of physician and physician-stomatologist).] .................................................................................................... 24

■ KKKKoooonnnnffffeeeerrrreeeennnncccciiiieeee////CCCCoooonnnnffffeeeerrrreeeennnncccceeeessss ........................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................22225555– International Bioethics Conference - Ethics in Science and Research. [Medzinárodná bioetická konferencia

- Etika vo vede a výskume.], Bratislava, 18. - 19. 3. 2002 J. Glasa ................................................................................................... 25– Medzinárodná bioetická konferencia - Etika humánnej genetiky: Problémy (post)genómovej éry.

[International Bioethics Conference - Ethics of Human Genetics: Challenges of the (Post)Genomic Era.], Bratislava, 23. - 24. 10. 2002 J. Glasa .......................................................................... 26

■ IIIInnnnššššttttiiiittttúúúúcccciiiieeee////IIIInnnnssssttttiiiittttuuuuttttiiiioooonnnnssss .................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................... 22228888– Department of Medical Education of S.P.A.M. - 25 Years. [Katedra medicínskej pedagogiky S.P.A.M. - 25 rokov.]

Z. Takáčová, J. Glasa ....................................................................................................................................................................................... 28■ OOOO kkkknnnniiiihhhháááácccchhhh////BBBBooooooookkkk RRRReeeevvvviiiieeeewwwwssss ........................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................ 33330000

– CIOMS: International Ethical Guidelines for Biomedical Research Involving Human Subjects. J. Glasa ........................ 30■ OOOObbbbssssaaaahhhh rrrrooooččččnnnnííííkkkkaaaa 9999 ((((2222000000002222)))) //// CCCCuuuummmmmmmmuuuullllaaaattttiiiivvvveeee CCCCoooonnnntttteeeennnnttttssss ooooffff tttthhhheeee VVVVoooollll.... 9999 ((((2222000000002222))))............................................................................................................................................................................................................................................................................................................................................................................................................33332222

Vedúci redaktor/Editor: J.Glasa ■ Redakčná rada/Editorial Board: M. Babál, M. Košč, J. Labus, J. Matulník, M. Mikolášik, J. Palaščák, R. Pullmann, M. Troščák ■ Roz-šírená redakčná rada/National Advisory Board: A.Bajan, I.Ďuriš, A.Kapellerová, E.Kolibáš, Š.Krajčík, V.Krčméry ml., R.Korec, M.Kriška, J. Longauer, F. Makai, E.Mathéová,T.R.Niederland, P. Mráz, M.Pavlovič, J.Porubský ■ Medzinárodný poradný zbor/International Advisory Board: Ch.Byk (Paris), D.Callahan (Briarcliff Manor, N.Y.), T.Hope(Oxford), L. Gormally (London), H. Klaus (Washington), E.Morgan (London), M.Munzarová (Brno), R.H.Nicholson (London), J.Payne (Prague), A. Slabý (Prague), A.Spag-nolo (Rome), T. Šimek (Prague), K. Šipr (Brno), E.Topinková (Prague) ■ Výkonný redaktor/Executive Editor: H. Glasová ■ Adresa redakcie/Address: Nadácia Ústav medicínskejetiky a bioetiky/Institute of Medical Ethics and Bioethics Fdn., Limbová 12, 833 03 Bratislava ■ Tel: (+421-7) 59369472 ■ Registrované MK SR číslo 964/94. ■ Publishedby Charis Publishing House, Ipeľská 3, Bratislava (Slovak Republic) for the Institute of Medical Ethics and Bioethics Fdn., Bratislava. IIIISSSSSSSSNNNN 1111333333335555––––0000555566660000 hhhhttttttttpppp:::: ////////wwwwwwwwwwww....eeeelllliiiissss....sssskkkk////eeeettttiiiikkkkaaaa////eeeettttiiiikkkkaaaa....hhhhttttmmmmllll PPPPRRRRIIIINNNNTTTTEEEEDDDD IIIINNNN SSSSLLLLOOOOVVVVAAAAKKKKIIIIAAAA

MMMMeeeeddddiiiiccccíííínnnnsssskkkkaaaa eeeettttiiiikkkkaaaa &&&& bbbbiiiiooooeeeettttiiiikkkkaaaa ---- MMMMeeeeddddiiiiccccaaaallll EEEEtttthhhhiiiiccccssss &&&& BBBBiiiiooooeeeetttthhhhiiiiccccssss,,,, založený ako časopisÚstavu medicínskej etiky a bioetiky v Bratislave, spoločného pracoviska Lekár-skej fakulty Univerzity Komenského a Inštitútu pre ďalšie vzdelávanie zdravot-níckych pracovníkov v Bratislave. Je určený pracovníkom etických komisií v Slo-venskej republike, ako aj najširšej medicínskej a zdravotníckej verejnosti. Mátiež za cieľ napomáhať medzinárodnú výmenu informácií na poli medicínskejetiky a bioetiky. Prináša informácie o aktuálnych podujatiach a udalostiachv oblasti medicínskej etiky a bioetiky, pôvodné práce, prehľady, reprinty legisla-tívnych materiálov a smerníc pre oblasť bioetiky, listy redakcii a recenzie. Prís-pevky a materiály uverejňuje v slovenskom alebo anglickom jazyku. Vybrané ma-teriály vychádzajú dvojjazyčne. Vedecké práce publikované v časopise musiazodpovedať obvyklým medzinárodným kritériám (pozri Pokyny prispievateľom- ME&B 2/94, s. 10).

MMMMeeeeddddiiiiccccíííínnnnsssskkkkaaaa eeeettttiiiikkkkaaaa &&&& bbbbiiiiooooeeeettttiiiikkkkaaaa ---- MMMMeeeeddddiiiiccccaaaallll EEEEtttthhhhiiiiccccssss &&&& BBBBiiiiooooeeeetttthhhhiiiiccccssss,,,, founded as the journalof the Institute of Medical Ethics & Bioethics (Bratislava), a joint facility of theMedical Faculty of the Comenius University and the Postgraduate Medical Insti-tute in Bratislava (Slovak Republic). It aims to serve the informational and edu-cational needs of the members of ethics committees in the Slovak Republic andthe broadest medical and health audience as well. It aims also to enhance theinternational exchange of information in the field of medical ethics and bio-ethics. The information published comprises news, original papers, review artic-les, reprints of national and international regulatory materials, letters, reviews.Contributions and materials are published in Slovak or English. Choosen mate-rials are published in both languages. Scientific papers published in ME&B mustrespect the usual international standards (see Instructions for authors - ME&B2/94, p. 10)

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