i. What will be provided by the sponsor?
ii. What additional costs might the subject incur?
COMPENSATION FOR INJURY-
i. Is the sponsor paying for everything including adverse events?
ii. Will the subject’s insurance pay for it or will the cost shift to the subject?
45 CFR 46.116(b)(3): Department of Health and Human Services (DHHS) Regulations on the Protection of Human Research Subjects; and 21 CFR 50.25(b)(3): FDA Regulation on Human Subjects, Informed Consent
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