Informed Consent Elements: Proposed Rule
Federal Register 2009 December 29; 74(248): 68750-68756
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Unknown author (Food and Drug Administration, HHS, 2011-01-04)The Food and Drug Administration (FDA) is amending the current informed consent regulations to require that informed consent documents and processes for applicable drug (including biological products) and device clinical ...
Protection of Human Subjects; Informed Consent; Standards for Institutional Review Boards for Clinical Investigations. Proposed Rule Unknown author (United States. Food and Drug Administration, 1988-11-10)