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ETHICAL PRINCIPLES IN HEALTH RESEARCHThe Belmont Report

• Ethical Principles and Guidelines for the Protection of Human Subjects• Published in 1978 by the National Commission for the Protection of Human Subjects of iomedical and

eha!ioral "esearch• #ell $no%n today for its frame%or& of basic moral principles' referred to as the (elmont Principles)• Pro!ided a basic frame%or& for analy*in+ ethical issues that arise durin+ medical research in the ,S an

many other countries• -denti.ed / +eneral principles0- "espect for persons- Nonmale.cence and ene.cence

- 2ustice

- "espect for Persons -nformed Consent- Nonmale.cence and ene.cence 3 "is&s4ene.ts assessment-  2ustice selection of "esearch participants

P"-NC-P5E 6 "ESPEC 6" PE"S6NS• utonomy•  Persons can ma&e +ood decisions for themsel!es•  Persons not ade:uately autonomous be protected by consent of an authori*ed /rd party %ho %ill loo&

after their best interests;•  here must be informed consent•  Purpose of informed consent is to sho% respect for the autonomy of the indi!iduals•  o pro!ide su

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•  ene.ts to society throu+h the +eneration of &no%led+e•  Secondary bene.ts li&e recei!in+ hepatitis !accine not considered;

/; he ris&s and potential bene.ts of the clinical research inter!entions to indi!idual participants should becompared;

•  -n +eneral' the more li&ely or more se!ere the potential ris&s' the +reater in li&elihood or ma+nitude thprospecti!e bene.ts must be

•  Con!ersely' research entailin+ potentialris&s that are less li&ely or of lo%erse!erity can ha!e more uncertainpotential bene.ts;

PES 6 "-S$S• Physical•  Psycholo+ical•  Social•  Economical• ?inor•  Potentially serious or disablin+•  ransient or permanent

PSCH656G-C5 "-S$S• Could be minimal or serious= transient•  Could be due to0

-n!asion of Pri!acy reach of con.dentiality

•  ?ay lead to feelin+s of embarassment' +uilt' depression' stress' confusion

6HE" "-S$S• Social ris&s0 embarrassment= ris& of bein+ sta+mati*ed•  Economic ris&s0 additional eBpenses= time oF from %or&

H6# CN "-S$ E ?-N-?-IE@J• y usin+ procedures consistent %ith sound research desi+nKri+ht sample si*eL and %hich do not

unnecessarily eBpose subjects to ris&•  y usin+ procedures already bein+ performed on the subjects•  Ha!in+ only trained and competent indi!iduals in the research team•  Ha!in+ an appropriate data safety monitorin+ plan

"E?E?E";;( #hen research ris&s eBceed the combination of potential medical bene.ts to indi!iduals and the bene.ts ofuseful &no%led+e to society' clinical research is not justi.able)P"-NC-P5E 6 2,S-CE

• "e:uires fairness in the distribution of both the burden and the bene.ts of research•  Persons %ho are already burdened by some form of disability or institutionali*ation should not be as&e

to accept the burden of research•  "e:uires special le!els of protection for !ulnerable and disad!anta+ed parties;• Historically' populations that %ere poor' uneducated or po%erless to defend their o%n interests %ere

tar+eted for hi+h ris& research•  Promisin+ research %as oFered to more pri!ile+ed indi!iduals•  air selection of participants re:uires that the research objecti!es be the primary basis for determinin+

eli+ibility;P"-NC-P5E 6 2,S-CE0 ENCH?"$S

1; he study population should be selected to ensure !alid science;•  Hi+h pre!alence or incidence of disease•  ma+nitude of harm caused by the disease

• Hi+h transmission rates of an infection•  Special dru+ resistance patterns•  @epri!ed social circumstances that increase disease susceptibilty  Social status should not inMuence selection

A; Selectin+ participants in a %ay that minimi*es ris& is essential•  -n an H-> !accine study' choose populations from a community that pro!ides protection to H->infecte

patients•  -ndi!iduals %ith hi+h creatinine clearance be eBcluded from a trial of a potentially renal toBic dru+

/; -ndi!iduals should be selected to enhance both the social !alue of research and the possibility of bene.ts toparticipants;

•  if a disease lar+ely aFects %omen' an ade:uate number of %omen in the study needs to be selected• -ndi!iduals %ho are able to comply %ith re:uirements %ill enhance tha chances that they %ill bene.t an

that the study %ill ha!e a !alid data;

• "espect for participants

?6N-6"-NG @,"-NG "ESE"C

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• ; actors such as co+niti!e ability' a+e' clinical status' familial relationships' social mar+inali*ation'political po%erlessness and economic depri!ation should be considered in order to determine!ulnerability of indi!iduals or +roups;

Speci.c safe+uards0 consent monitorin+' clinical monitorin+' ensurin+ con.dentiality' freedom to %ithdra% frothe study;General Guidance for "esarch

•  he ethical justi.cation of biomedical research in!ol!in+ human subjects is the prospect of disco!erin+ne% %ays of bene.ttin+ peoples health; Such research can be ethically justi.able only if it is carried oin %ays that respect and protect and are fair to the sujects of that research and are morally acceptable%ithin the communities in %hich the rsearch is carried out;