FIMA Year Book 2009 - Federation of Islamic Medical Associations

Ethics of Clinical Researchor preventive benefit. This is based on arule of jurisprudence, “Public intereststake precedence over private ones.” (20)This is different from the HelsinkiDeclaration and the CIOMS guidelineswhich emphasize that individual benefitprecedes social benefits. This point needsfurther study by Islamic scholars. Theyneed to determine to what extent publicinterest supersedes individual interest asit relates to human clinical research.Guideline 10. Research in Populations andCommunities with Limited ResourcesBefore undertaking research in apopulation or a community with limitedresources, the sponsor and investigatormust make every effort to ensure thatthe research is responsive to the healthneeds and priorities of the communityin which the research will be conducted.Also, any knowledge generated or anyintervention or product developed asa result of that research must be madereasonably available for the benefit ofthat population or community.This guideline is consistent with theIslamic principle of justice and charity. (23)Guideline 11. Choice of Controls inClinical TrialsThis guideline can also be endorsedfrom an Islamic point of view as itrequires the researchers to observe,in dealing with human subjects, theobligation of trust when choosing themethod of intervention to protect theirhuman rights fully and ensure theirsafety. “God enjoins you to deliver yourtrust to their rightful owners.” (26)Whether the use of a placebo arm inclinical trials is ethically acceptable hasbeen vigorously debated. (30) Againstobjection by scientists, the 2000 versionof the Helsinki Declaration specificallyprohibits the use of placebos except inlimited situations. CIOMS recommendsthe use of equivalency trials or add-onstudies. Equivalency trials comparean investigational intervention withan established effective treatment andproduce scientifically reliable data.An add-on design may be employedwhen the investigational therapy anda standard therapy have differentmechanisms of action. The treatmentto be tested and the placebo are eachadded to the standard treatment todetermine if the investigational therapyleads to a better outcome or to fewerside effects.If the use of a placebo arm is essentialfor the clinical trial to produce usefulinformation and there is no resultingharm to the subjects in the controlarm, it will be Islamically acceptable.The rationale for that is that “althougha sort of deception is practiced, theconsequences are safe.” (20) In my view,it may cause harm if the researchsubject in the control arm is deprivedof a currently accepted treatment.I believe that the concerned ethicsreview committee has to carefullyexamine each specific case, evaluate thepossibility of harm to the subjects inthe placebo arm and try to work withthe investigator to find an alternativestudy design.FIMA YearBook 2009145