21 CFR 50.23(d) Waiver Of Prior Consent Requirement: Armed Forces Flashcards
Under what circumstances may the President waive the prior consent requirement for administration of an investigational new drug to a member of the armed forces?
*In connection with the member’s participation in a particular military operation
*Only the President may do it
*Must be determined in writing
*Consent is not feasible or;
*Consent is contrary to the best interests of the military member or;
*Consent is not in the interests of national security.
What standards and criteria must the President apply to make the determination to waive consent?
FDA regulations for waiver of informed consent in section 505(i)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355 (i)(4)
Who must request a determination from the President that informed consent is not feasible or is contrary to the best interests of the military members involved?
The Secretary of Defense
