Journal ofmedical ethics, 1989, 15, 6-11

The myth of informed consent: in dailypractice and in clinical trialsWilliam A Silverman Greenbrae, California

Author's abstractUntil about thirtyyears ago, the extent ofdisclosure aboutand consent-seeking for medical interventions wasinfluenced by a beneficence model ofprofessionalbehaviour. Informed consent shifted attention to a duty torespect the autonomy ofpatients. The new requirementarrived on theAmerican scene in two separate contexts: fordaily practice in 1957, andfor clinical study in 1966. Aconfusing double standard has been established. 'Dailyconsent' is reviewed, ifat all, only in retrospect. Doctorsare merely exhorted to obtain infonned consent; they oftenminimise uncertainties about 'best' treatment and they feelduty-bound to provide patients with an unequivocalrecommendation for action. 'Study consent' in a clinicaltrial is reviewed prospectively, and doctors are compelledby regulation topoint out that there is insufficient evidenceto make a rational choice between two comparedtreatments. It has been impossible to devise informedconsent practices that satisfy, in full, the competing moralimperatives of respect for autonomy, concern forbeneficence with emphasis on the value of health, and avigilfor justice. A way must befound to experiment withvarious discretionary approaches that would strike arealistic balance among competing interests.

Truth-telling and consent-seeking for specificinterventions (particularly surgical invasion) have longbeen a part of medical tradition (1). Moreover, thepatient's right of prior consent has long been protectedin many countries under laws of assault and battery.But the doctrine, until relatively recently, wasnarrowly defined. Doctors were obliged only todisclose the nature of a proposed procedure; the patientreserved the right of refusal. In 1767, for example, aBritish judge noted that 'a patient should be told whatis about to be done to him, that he may take courageand put himself in such a situation as to enable him toundergo the operation' (2). Following the disclosure, apatient 'voted with his/her feet': voluntary submissionwas taken as proof of consent.

Key wordsInformed consent; clinical trials; patients' autonomy;beneficence; justice; medical practice; hedging strategy (inclinical study).

Domination of beneficenceUntil about thirty years ago, the extent of disclosureand consent-seeking was very much influenced by abeneficence model of professional behaviour. Aphysician's primary obligation (surpassing respect forpatient autonomy), it was held, is to provide medicalbenefits. In 1803, Thomas Percival noted that the firstrole of the physician is to be 'the minister of hope andcomfort'. And he asked: 'How far is it justifiable toviolate truth for the supposed benefit of the patient?'He concluded that 'the balance oftruthfulness yields tobeneficence in critical situations' (3). The physiciandoes not actually lie in actions of deception andfalsehood, Percival argued, as long as the objective is togive hope to the dejected or sick patient. Since therewas no appreciable dissent from this view, thebeneficence model, roughly as outlined by Percival,served, widely and apparently well, as a guide todoctors when they interpreted their responsibility topatients (4).Informed consent in daily practiceInformed consent is a modern American invention. Thenew principle shifted attention to a physician's duty torespect the autonomy of patients. As I have notedelsewhere, it arrived on the medical scene in thecontext of daily practice (5).THE SALGO DECISIONThe pregnant phrase was first used in 1957 by JusticeBray of the California Court of Appeals in the legalcontroversy of Salgo v Stanford University (6). (MartinSalgo suffered permanent paralysis followingdiagnostic translumbar aortography. He complainedthat his physicians were negligent in carrying out theprocedure and that they failed to inform him of the riskof paralysis.) The court (using words suggested by theAmerican College of Surgeons in a friend-of-the-courtbrief (7)) concluded that Salgo's doctors had a duty todisclose 'any facts which are necessary to form the basisof an intelligent consent by the patient to the proposedtreatment'. Justice Bray went on to indicate that thisnew duty to disclose risks and alternatives of treatmentwas a logical extension of the already establishedobligation to reveal a treatment's nature and itsconsequences. 'In discussing the element of risk', Braywrote, 'a certain amount of discretion must be

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employed consistent with full disclosure of factsnecessary to an infonned consent' [emphasis added].A NEW STANDARDLegal scholars have pointed out that the Salgo decisionintroduced distinctly new elements into therelationship of trust between doctors and their patients(4). Unlike previous opinions about consent to medicaltreatment, the Salgo court focused on the problem ofwhether or not the consent had been informed whengiven. The court created an 'informed consent'standard: the nature, consequences, harm andbenefits, risks and alternatives of a treatment on offerwere now held to be the information needed by apatient in order to know what he/she is choosing.The relatively new doctrine of informed consent, in

the daily routines of the doctor-patient relationship,has achieved high social visibility and has beendiscussed widely. Nonetheless, there is surprisinglylittle evidence of meaningful implementation.

PRACTICAL CONSEQUENCESThe Salgo court's words, and subsequent legaldecisions, have not changed the time-honoured 'silentworld' of doctor and patient in a realistic way (7). Forexample, surveys in the United States give theimpression that informed consent is routinely soughtin daily medical practice. In 1982, among 805physicians surveyed almost all indicated that theyobtained written consent (80 per cent) or both writtenand oral consent (15 per cent) before inpatient surgeryor the administration of anaesthesia (8). However,responses obtained in this survey suggest that most ofthe doctors recognised only the information-givingaspect of informed consent. Few of the respondents(9 per cent) seemed to be aware that the consent-seeking routine was intended to allow patients to makea choice or to state a preference about the treatment onoffer. There is, in fact, no credible evidence about theextent to which the rituals of consent-seeking carriedout in daily practice satisfy three reasonable criteriaproposed by Faden and Beauchamp (4).

1. A patient must agree to an intervention based on anunderstanding of (usually disclosed) relevantinformation,2. Consent must not be controlled by influences thatwould engineer the outcome,3. The consent must involve the intentional giving ofpermission for an intervention.

ROLE OF LEGISLATION AND THE COURTSFollowing the Salgo decision, the dimensions of therequirement for informed consent for everydayprocedures were slowly shaped in the United States bycase law (that is to say, in judicial opinions concerningspecific law suits, and, later, as defined in statutes).However, the legal 'life' of the doctrine, has not beenvery robust. Everyday consent, it should be noted, isreviewed, if at all, only in retrospect (for example, atthe time of a law suit for malpractice). Katz has

observed that judges in the United States have toyedbriefly with the idea of patients' right to self-determination (7). For the most part, however, juristshave not been supportive. 'The law of informedconsent,' Katz opines, 'is fairy-tale like'. In the'implementation of dicta it conveys a mythicpessimism of human capacities to be choice makers'.Informed consent in clinical trialsNine years after Salgo, informed consent was spelledout as a requirement in American guidelines for clinicalresearch. In February 1966, a memorandum entitledClinical Investigations Using Human Subjects wascirculated by the Surgeon General (9). For the firsttime, clinical studies using federal funds were requiredto institute prior review which was to include 'theappropriateness of methods to secure informedconsent'.A PARADOXICAL DUALITYThe new ruling made it clear that study-consent was tobe considered quite separately from daily-consent. Themajor difference turned on the issue of candour aboutcurrent evidence. When obtaining study-consent in atreatment trial, for example, a doctor was now requiredto disclose the justification for the trial by pointing outthat there was insufficient existing information forboth doctor and patient to make a rational, informedchoice about the most effective treatment. In daily-consent, doctors have always been inclined (even afterSalgo) to minimise the uncertainties about 'best'treatment. Moreover, they have also felt duty-bound toprovide patients with an unequivocal recommendationfor action.The new rules of the game defined in the Surgeon-

General's memorandum gave rise to a paradoxicalduality with respect to the issue ofinformed consent. Acurious difference was now established between theclinical practice context (involving the overwhelmingmajority of patients) and the research context (for arelatively small number ofpatients) (1): in daily patientencounters, doctors were merely exhorted to solicitconsent by an appeal to medical ethics or to legal self-interest; in clinical research, investigators were nowcompelled by regulation to obtain informed consent.IMMEDIATE IMPACTOne practical effect was immediate and dramatic:study-consent suddenly became a highly visible step inthe planning of all clinical studies - most particularly,in the design of controlled clinical trials. Unlike thelaissez faire policy which characterised daily medicalexperience, study-consent was now reviewedprospectively and it quickly moved to centre stage inrespect of concerns about the conduct of studies.RESPECT FOR PATIENT AUTONOMYThe arrival of study-consent in 1966 struck downdoctors' arguments based on a beneficence model tojustify the broad limits of their authority in clinicalresearch. The underlying, and indeed the controlling,idea of the new dictum in formal clinical studies wasone of respect for patients' autonomy. Now that the

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8 The myth ofinfortned consent: in daily practice and in clinical trials

study-consent policy has been in place for more than 20years, how can we judge the success ofthe innovation?RESPONSE TO PUBLIC CONCERNFirst, we need to remember that the 1966 directive ofthe American Surgeon-General was political. It was

made in response to a public uproar after news reportsrevealed that, in an exploratory study of immunity tocancer, researchers injected live malignant cells into a

number of elderly patients without obtaining theirpermission (10). Public concern was reinforced byBeecher's widely read paper published in June 1966(11). He charged that clinical researchers were

endangering the health and the lives of their researchsubjects (often prisoners, soldiers, and the mentallyretarded) without informing them of risks or obtainingtheir permission. Twenty-two examples of thepurported abuses were cited; they occurred, it was

alleged, in the years 1950-65.HEDGING STRATEGY LIMITS RISKBeecher's assessment of the extent of maltreatment inclinical studies has been debated for years (12). It isworth noting that the new requirement of formalstudy-consent was not put in place in the United Statesbecause ofany questions about unwarranted hazards topatients - potential or tangible - that were uncoveredin treatment trials using randomised control design.Prior to 1966 there were, in fact, encouraging signs thatthe hedging strategy of random allocation providedimportant safeguards: hoped-for benefits andunanticipated risks were distributed equitably.Additionally, the design had the potential for reducingthe numbers of injured in therapeutic disasters.Experiences in a number of neonatal clinical trialsprovided concrete examples to support the risk-limiting argument (13). Moreover, the lessons were

timely: by 1966, it was evident that unexpecteddisasters were occurring with alarming regularity as

powerful new weapons were added to medicine'sarmamentarium.Nature and magnitude of risksTen years after declaration of the study-consentdictum, a task force ofthe National Institutes ofHealthreported the results of the first systematic effort toobtain an estimate of the nature and magnitude of risksfor human subjects enrolled in clinical research (14). Intherapeutic trials conducted by 538 researchers whohad studied 39,216 patients, the survey analysts foundno indication that the risks were any greater than are

encountered when treatments are given in othermedical settings. (Most of the research-related deathsand injuries occurred in connection with the use ofchemotherapy in cancer patients.)'EFFICACY' OF STUDY-CONSENT?More than two decades after the arrival of formalstudy-consent, it is discouraging to see that so littleobjective evidence has been collected concerning whatmight be called the 'efficacy' of the new dogma. Fromthe very outset, and without let-up, questions havebeen raised about whether it is ever possible to

determine if trial participants, or their surrogates, havebeen fully informed, and if they have given trueconsent.The stipulation that consent for enrolment must be

in writing has presented very little difficulty.However, there is a strong suspicion that it is virtuallyimpossible to comply fully with the intent of the rule.What should, or can be done to determine with anycertainty whether or not participants understand thefull implications of what they have been told in adisclosure ritual? As compared with pre-1966, hasstudy-consent succeeded in providing more protectionfor enrolled patients? Has the new understandingresulted in increased respect for patients' autonomy,and, as a practical consequence, has there been achange in the power relations between doctors andpatients in the past two decades?A wide range of opinion concerning these questions

has been expressed in a flood of letters to editors, newsreports, editorials, articles and books. At a consensusconference on controlled clinical trials, more than four-fifths (79/92) of the respondents indicated that theobtaining of informed consent is problematic becausepatients (or surrogates) do not fully understand theimplications of a formal clinical trial (15). Oneneonatologist said, very bluntly (and not forattribution!): 'I think informed consent is a farce....The information [given to parents] is what I want it tobe'. Some of this scepticism is supported by thefindings in surveys of public opinion, but the evidenceis weak and unique to the circumstances of a givenstudy (16).DISCRETIONARY CONSENT FORMATSOne randomised trial involving cancer patients wascarried out in Australia; total disclosure was comparedwith a modified individual approach (17). Again, theresults obtained in this trial cannot be generalised withany confidence. Moreover, the authors indicated thatthe issue could not be studied further- Australian rulesrequiring total disclosure and written consent can nolonger be waived.

Alternative approaches have been proposed (forexample inform only patients allotted to theexperimental arm of a trial (18), a process model ofinformed consent based on the assumption thatmedical decision-making is a continuous process (19))but institutional review boards have been reluctant toallow any departures from inflexible regulations. It ishard to understand how it will be possible to determinethe reasonable limits of the rigid informed consentritual when it is declared by fiat to be irreproachable.In the United States, the status quo seems to have beeneffectively immunised against all criticism.AN AUTHENTICITY TESTA strange situation arises when patients who refuse tobe enrolled in a controlled clinical trial ask for the newtreatment outside of the context of the trial. Responseto this request is a powerful test ofwhat might be calledthe 'authenticity' of the trial.

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The sincerity of the statements made in the study-consent ritual explaining the justification for thecontrolled trial is placed under a dark cloud if therequest from a refuser is granted. A similar kind ofconfusion results from the therapeutic privilegeclaimed by doctors who refuse to participate in the trialand treat all eligible patients with the new treatmentcurrently under test.

THE PRE-CONDITION OF BALANCED DOUBTThese difficulties remind us that there is always anethical dilemma whenever a new treatment is proposedto replace the previous standard. It is a necessarycondition when asking for participation in a plannedtrial of parallel treatments that the doctors be in a stateof genuine uncertainty (the balanced doubt has beenlabelled 'equipoise' (20)). When doctors believe thatpatients in one arm of a planned trial are to be providedwith better treatment, they usually disqualifythemselves from participation. They argue that theycannot, in good faith, represent to patients that thetreatment choices in the trial are equal. How can weresolve the apparently irresolvable conflict between theethical requirement that a patient must always beoffered the best treatment known, and the equivocalchoice in a comparative trial? The formal exercise iscarried out in the sincere hope that the newly-proposedtreatment will surpass the accepted regimen.Deflation ofindividual preferenceThe paralysing dilemma can be resolved ifwe can agreethat the time has come to question the high moralstatus accorded an individual doctor's treatmentpreference. Particularly when that choice is backed byweak evidence. Personal and idiosyncratic decisionsabout 'best treatment known' cannot be defended,Freedman has recently pointed out, when there is anhonest disagreement among the experts about therelative merits of treatment alternatives (21).Doubt by consensusThe ethics of medical practice should grant no moralstanding to treatment preference, no matter howstrongly asserted, when that opinion is based onanything less than evidence presented publicly andconvincingly to the clinical community. Goodmedicine, Freedman reminds us, is defined, not byindividual doctors, but rather by professionalconsensus.Disclosure ofuncertaintyIt follows from these arguments that a doctor with adecided treatment preference may, in good conscience,participate in a controlled trial when he/sheacknowledges that there is insufficient evidence tojudge 'best treatment', and when that state of doubt isdisclosed to patients.PROTECTION OF REFUSERSIt also follows that, for their own protection, only thestandard treatment should be available to eligiblepatients who refuse to enrol in a formal trial. It isirresponsible, I argue, to release the untestedtreatment without the protection available in the

hedging strategy of a controlled trial. Trial participantsare provided with the fairest kind ofprotection that canbe devised against unknown hazards. Since the natureand the size of such risks are unknowable in advance,the fate of each individual is placed in the hands of thegoddess of chance (as it is in everyday life whenever westep into the unknown).Ample support for a policy banning use of new

treatments outside of the context of a controlled trial isprovided by the experience of the recurrent disastersthat have taken place in the past few decades. The mostdramatic explication of the issues is provided by theexperience with the use of DES (diethylstilbestrol) toimprove pregnancy outcome (22). As it turned out,only the offspring of pregnant women in trials withconcurrent controls received an equal chance to reapthe hoped-for benefit or to be shielded from acompletely unexpected risk (alarming numbers of thedaughters born to DES-treated women developed arare type of vaginal cancer decades after birth).Although several controlled clinical trials were unableto demonstrate efficacy of treatment, during a ten-yearperiod between 1960 and 1970, an average of 100,000prescriptions for DES were written each year in theUS, outside the context of formal clinical trials, forwomen who were pregnant (23). It is worthremembering the fortuitous benefit of trialparticipation enjoyed by women whose mothers wereallotted to control groups (no DES given) in the earlycontrolled trials. These fortunate unexposedindividuals have been spared the increased cancer risk(and reproductive disturbances) hanging over the livesof hundreds of thousands of American women.JUSTICE IN CLINICAL TRIALSThe moral principle of justice is tested in the present-day study-consent requirement in clinical trials.Clinical studies in the past have been conducted morefrequently among impoverished minorities thanamong the privileged American classes. The poor wereenrolled as subjects in medical investigations because itwas convenient (researchers were located in theteaching hospitals used by poor patients), and becauseof gross insensitivity to the unfairness of the custom.An American commission has advised that children

who participate in research projects should be selectedso that the burdens of participation are distributedjustly - that is, among all segments of society (24). Therecommendation is painfully silent about how this juststandard is to be achieved in practice.Unequal representationIn clinical trials, we depend on those who give consentfreely (25). The approach thwarts the basic principlesof random sampling, which is the only way to assurethat there is a reasonable chance for equality ofrepresentation across all social classes. It is veryunlikely, I suspect, that conscription by lottery will beused in any country to guarantee that there will be nosocial inequities.Social filter effect?Nonetheless, we should be ready to question anything

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10 The myth ofinformed consent: in daily practice and in clinical trials

done in the recruitment of patients for study thatwould seem to exaggerate inequalities (26). Is itpossible, for example, that the study-consentprocedure itself functions as an effective social filter?Does it select out, for refusal, those on the upper rungsof the social ladder, the least 'captive' members of thecommunity, those most likely to understand what isrequested in the consent ritual? Among consenters, isthere disproportionate representation of those who donot understand, those too frightened to refuse, thosewho are socially disadvantaged?

Informed consent in the futureI have no doubt that the debates concerning informedconsent will (and should!) continue unabated. It hasbeen impossible, in the first two decades of study-consent, to devise practices that satisfy the competingmoral imperatives ofrespect for autonomy, concern forbeneficence with emphasis on the value of health, anda vigil for justice. It has been said, that the currentdoctrine and set of practices compromise all values andsatisfy none in their entirety - as a result, there isendless squabbling (19). I will be very surprised if weare able to find formats that will satisfy patients andtheir families, doctors, legal experts, bioethicists, andthe community at large. So long as the argumentsremain heavily freighted with opinion and so weaklychallenged by concrete evidence, the outlook forprogress seems dim.NEED FOR COMPARATIVE STUDIESA way must be found, I suggest, to experiment withvarious discretionary approaches that would strike arealistic balance among the competing interests. Weneed an approach that would conserve the spirit ofinformed consent without snuffing out the flame ofresponsible clinical study.The double standard vis-a-vis daily-consent and

study-consent will continue so long as we are unable tocome to some agreement about the outcomes ofimportance that will permit a measured comparison ofalternatives. At the controlled trial consensusconference convened in 1984, three-quarters of theconferees (70/93) agreed with the statement: 'Thereshould be no fundamental difference between theinformation given to a patient in order to obtaininformed consent in a controlled clinical trial and thatgiven to a patient in daily practice' (15). The opinion isnot very helpful, I repeat, unless it leads tocomparative studies designed to measure theconsequences of merging daily-consent and study-consent in the real world.

Author's notePortions of this paper, in different form, werepresented to the Southern Society for PediatricResearch, Annual Meeting, February 5, 1988, NewOrleans, Louisiana; these are published in theAmerican Journal ofMedical Sciences (5).

William A Silverman, MD is Professor of Pediatrics(Retired), College ofPhysicians and Surgeons, ColumbiaUniversity.

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