Does an IRB or institution have to compensate subjects if injury occurs as a result of participation in a research study?
Institutional policy, not FDA regulation, determines whether compensation and medical treatment(s) will be offered and the conditions that might be placed on subject eligibility for compensation or treatment(s). The FDA informed consent regulation on compensation [21 CFR 50.25(a)(6)] requires that, for research involving more than minimal risk, the subject must be told whether any compensation and any medical treatment(s) are available if injury occurs and, if so, what they are, or where further information may be obtained. Any statement that compensation is not offered must avoid waiving or appearing to waive any of the subject’s rights or releasing or appearing to release the investigator, sponsor, or institution from liability for negligence [21 CFR 50.20].
Related Questions
- When should an Institutional Review Board (IRB) or institution request a "407" review for research involving children as subjects?
- Is there any requirement for compensation of injury or illness arising from participation of subjects in the research study?
- Does an IRB or institution have to compensate subjects if injury occurs as a result of participation in a research study?
