FIMA Year Book 2009 - Federation of Islamic Medical Associations

Ethics of Clinical ResearchGuideline 12. Equitable Distributionof Burdens and Benefits in theSelection of Groups of Subjects inResearchThis guideline is again in harmony withIslamic law which calls for justice inall affairs of life. (23) So, it is unfair thatparticipants in a study share in theburdens i.e. the potential side effectsor other hardships but they do notshare in the benefits when a successfulintervention is achieved but is notmade available to them.Guideline 13. Research InvolvingVulnerable PersonsThese include persons with limitedcapacities or freedom to consentor decline to consent. They may bementally incapacitated, elderly peoplewho developed varying degrees ofdementia, residents of nursing homes,people receiving welfare benefits, theunemployed, patients in emergencyrooms, some ethnic or racial minoritiesgroups, homeless persons, nomads,refugees, prisoners and patientswith incurable diseases. Junior orsubordinate members of hierarchicalgroups, for example medical andnursing students, employees ofpharmaceutical companies andmembers of the armed forces or police,are all considered vulnerable groups.Their agreement to volunteer maybe influenced by the expectation ofpreferential treatment if they agree andretaliation if they refuse.Ethical justifications for theinvolvement of these vulnerable groupsare:1. The research could not be carried outequally well with less vulnerablepersons.2. The research will lead to improvedtreatment of health problemsunique to the vulnerable class.3. They are assured that they will havereasonable access to any productthat comes out of the research4. The risk is minimal.5. The agreement to participate issupplanted by the permission of alegal guardian or other appropriaterepresentative.This CIOMS guideline is in conformitywith Islamic law. These individuals needtheir rights and interests protected.They should not be forced, pressured,deceived, or subjected to exploitationof their psychological condition orfinancial difficulties in order to makethem consent to be research subjects.Such coercion or exploitation involvesinjustice that is disapproved by Islamiclaw. In a divine tradition, ProphetMuhammad (PBUH) quotes his Lord(SWT), as saying,“My worshippers, I have forbiddeninjustice on my part and made itforbidden among you, so do not beunjust to one another”. (31)Thus, a special justification of recruitingvulnerable individuals to serve asresearch subjects is required in IslamicLaw, and, as stipulated in the CIOMSFIMA YearBook 2009146