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International Ethical Guidelines for Biomedical Research Involving Human Subjects
Guideline 7



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Inducement to Participate

Subjects may be reimbursed for lost earnings, travel costs, and other expenses incurred in taking part in a study; they may also receive free medical services. Subjects, particularly those who receive no direct benefit from research, may also be paid or otherwise compensated for inconvenience and time spent. The payments should not be so large, however, or the medical services so extensive as to induce prospective subjects to consent to participate in the research against their better judgment ("undue inducement"). All payments, reimbursements and medical services provided to research subjects must have been approved by an ethical review committee.

Commentary on Guideline 7

Acceptable Recompense. Research subjects may be reimbursed for their transport and other expenses, including lost earnings, associated with their participation in research. Those who receive no direct benefit from the research may also receive a small sum of money for inconvenience due to their participation in the research. All subjects may receive medical services unrelated to the research and have procedures and tests performed free of charge.

Unacceptable Recompense. Payments in money or in kind to research subjects should not be so large as to persuade them to take undue risks or volunteer against their better judgment. Payments or rewards that undermine a person's capacity to exercise free choice invalidate consent. It may be difficult to distinguish between suitable recompense and undue influence to participate in research. An unemployed person or a student may view promised recompense differently from an employed person. Someone without access to medical care may or may not be unduly influenced to participate in research simply to receive such care. A prospective subject may be induced to participate in order to obtain a better diagnosis or access to a drug not otherwise available; local ethical review committees may find such inducements acceptable. Monetary and in-kind recompense must, therefore, be evaluated in the light of the traditions of the particular culture and population in which they are offered, to determine whether they constitute undue influence. The ethical review committee will ordinarily be the best judge of what constitutes reasonable material recompense in particular circumstances. When research interventions or procedures that do not hold out the prospect of direct benefit present more than minimal risk, all parties involved in the research - sponsors, investigators and ethical review committees - in both funding and host countries should be careful to avoid undue material inducement.

Incompetent Persons. Incompetent persons may be vulnerable to exploitation for financial gain by guardians. A guardian asked to give permission on behalf of an incompetent person should be offered no recompense other than a refund of travel and related expenses.

Withdrawal from a Study. A subject who withdraws from research for reasons related to the study, such as unacceptable side-effects of a study drug, or who is withdrawn on health grounds, should be paid or recompensed as if full participation had taken place. A subject who withdraws for any other reason should be paid in proportion to the amount of participation. An investigator who must remove a subject from the study for willful noncompliance is entitled to withhold part or all of the payment.

The Islamic Point of View Concerning Guideline 7

Inducement to Participate

There is no objection in Islamic Law to the compensation of research subject for lost earnings and for transport and other expenses that might incur as a result of participation in the research. Actually, the rule of reparation and the principles of justice and fairness make it necessary to compensate the subjects adequately for what they have paid.

Any additional financial or in-kind payments, or any compensation that reach an extent that indicates they are being offered to influence the will of an individual (a research subject) and pressure him to give consent that is not based on conviction, are legally prohibited. Islamic Center of Southern California

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