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Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards
The Belmont Report’s guidelines could help avoid repeating past mistakes in AI-related human subjects research.
The HIPAA Privacy Rule sets forth provisions related to the waiver or alteration of authorization in relation to clinical research studies for circumstances in which it would be...
The Food and Drug Administration (FDA) is seeking strategies from Jeffrey W. Taub, M.D., to prevent future violations of human subject regulations the agency said were documented during...
The Food and Drug Administration expands informed consent exceptions with a final rule permitting institutional review board waiver or alteration of elements for certain FDA-regulated minimal-risk clinical investigations.