21 CFR 50.24 Toby A. Silverman, M.D. Branch Chief, Clinical Review Branch Division of Hematology, Office of Blood December 14, 2006.

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21 CFR Toby A. Silverman, M.D. Branch Chief, Clinical Review Branch Division of Hematology, Office of Blood December 14, 2006

21 CFR 312 Regulations governing conduct of investigations with investigational new drugs –“research subjects are not exposed to unreasonable risk” (52 FR 8798 ff; March 19, 1987) –Investigations also subject to other regulations to protect the rights and safety of subjects 21 CFR Part 56- institutional review board 21 CFR Part 50- informed consent

21 CFR Set of regulations governing conduct of clinical trials in emergency situations with exception from the requirements for informed consent

21 CFR (a)(2) subjects must be in a life-threatening situation for which available treatments are unsatisfactory/unproven need to collect valid scientific evidence…to determine the safety and effectiveness of particular interventions, obtaining informed consent is not feasible –subjects will not be able to give their informed consent as a result of their medical condition – the intervention under investigation must be administered before consent from the subjects’ legally authorized representative is feasible, and there is no reasonable way to identify prospectively the individuals likely to become eligible for participation in the clinical investigation.

21 CFR (a) (3) Participation in the research must hold out the prospect of direct benefit to the subjects in the study

Potential for Direct Benefit Information from appropriate animal and other preclinical studies and related evidence support potential of the product to provide a direct benefit to the individual subject 21 CFR (a)(3)(ii) –“…despite the uncertainty, …the investigational intervention is intended to be beneficial and that there is conceptual, preclinical, and possibly clinical (e.g., other settings, preliminary results) evidence that the hoped for benefits outweigh the potential risks…” (61 FR 51505, October 2, 1996)

Harms Minimized To minimize harms, –“The risks associated with the study are reasonable in relation to all available information about The medical condition of the subjects of the study, The risks and benefits of standard therapy, if any, The risks and benefits of the proposed intervention or activity” [21 CFR (a)(3)(iii)]