FIMA Year Book 2009 - Federation of Islamic Medical Associations

Ethics of Clinical Researchmethods, sources of funding, andpotential risks of the study. Theyshould be informed about their rightto abstain from participation or towithdraw from the study without anyreprisal. For a research subject whois a minor or legally incompetent, theinvestigator must obtain informedconsent from the legal guardian. Theseand other vulnerable groups shouldnot be included in research unless it isnecessary to promote the health of theparticular group from which they arerecruited.In the United States, the US NationalCommission for the Protection ofHuman Subjects of Biomedical Researchwas created in 1974 and produced theBelmont Report in 1979 which distilledprinciples of ethics related to research. (18)It addresses boundaries between medicalpractice and research; basic ethicalprinciples such as respect for persons,beneficence, and justice; and informedconsent, assessment of risks and benefits,and selection of subjects.Another international organization,The Council for InternationalOrganizations of Medical Sciences(CIOMS), was founded in 1949 underthe auspices of the World HealthOrganization (WHO) and the UnitedNations Educational Scientific CulturalOrganization (UNESCO). CIOMS,in association with WHO undertookits work on the ethics of biomedicalresearch in the 1970s . It producedguidelines to enable the effectiveapplication of the ethical principles setforth in the Declaration of Helsinki,particularly in developing countries.Their first report was published in1982. Following that, there were majordevelopments such as the outbreak ofthe HIV/AIDS pandemic and proposalsto undergo large scale experiments withvaccines and medications. There werealso rapid advances in biotechnologyand an increase in multinational fieldtrials involving vulnerable populationsin developing countries. Thesedevelopments raised new ethical issuesand in 1996 CIOMS updated its reportand published International EthicalGuidelines for Biomedical Researchinvolving Human Subjects and updatedit in 2002. This consisted of a statementof general ethics, a preamble and 21guidelines. (19)The Islamic Viewpoint on CIOMSGuidelinesThe Islamic Organization of MedicalSciences (IOMS), based in Kuwait,translated this document into Arabic.It was then reviewed by a scholarof Islamic Jurisprudence principles.The document along with the latter’scomments were discussed by a group ofMuslim scholars, physicians, includingmyself, and other individuals withinterest in ethics and the law. TheIslamic viewpoint on each of theseguidelines was studied in depth bythis group and discussed in a threeday conference held in Cairo, Egypt,December 2004. The results of thesedeliberations were published as theInternational Ethical Guidelines forFIMA YearBook 2009140