FIMA Year Book 2009 - Federation of Islamic Medical Associations

Ethics of Clinical Researchspecial counseling team independentof the investigator.Guideline 18. Safeguarding ConfidentialityThe subjects’ research data should beheld in strict confidentiality. However,the subjects should be told the limits,legal or otherwise, to the investigator’sability to absolutely safeguardconfidentiality and the possibleconsequences of possible breeches ofconfidentiality.Safeguarding confidentiality is abasic tenet of Islamic law. This is the“trust” between an individual and thephysician/investigator. Exceptionsfrom the requirement of safeguardingconfidentiality are made in caseswhere concealing the confidentialinformation causes greater harm forthe person involved than that caused byrevealing it or when revealing it bringsa benefit that outweighs the harm ofconcealing it. This is based on the ruleof the permissibility of commissionof the lesser of two injuries to preventthe greater injury. Also, there arecases where revealing confidentialinformation is permitted because itbrings a social benefit or preventspublic harm. (20)Guideline 19. Right of InjuredSubjects to Treatment and ReparationResearch subjects are entitled to freemedical treatment when they incurany injury or any other harm as a resultof their involvement in the research.They are also entitled to equitablecompensation for any impairment,disability or handicap that result fromtheir participation. In the case ofdeath, their dependents are entitledto compensation. Their entitlement isbased on the principle of justice, thefourth principle of ethics. The sameis true from the Islamic point of view.This is based on the Islamic legalrule of reparation, which makes it anobligation for a person who causes anydamage to another to make equitablecompensation for the loss. When asubject dies as a result of his participationin research, his heirs are entitled tomonetary compensation, which is theblood money stipulated in Islamiclegislation for accidental homicide. Theimplicit agreement between researchsponsor(s) and involved subjects entailsa religious responsibility on the partof the former party to make up forthe damages suffered by a subject as aresult of participation in the research.However, it was pointed out during thedeliberations in the Cairo conferencethat it is permissible for the investigatorsor sponsors to obtain in advance thesubjects’ informed consent to waive theinvestigators’ responsibility, includingtheir research subjects’ entitlementto compensation for disability andhandicaps, when they are not deliberatelycaused based on the fact that Islamically,a competent individual is entitledto waive voluntarily any right of his,provided that he does that completelyvoluntarily without any pressure,inducement or deception (20) . While thisis true, in my opinion there is danger ofit being abused as it will be impossibleFIMA YearBook 2009149