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.
The federal government has changed the regulations that require informed consent for medical experiments. If a review board decides that informing people of risks will interfere with medical research,.
The Food and Drug Administration ("FDA") expands informed consent exceptions with a final rule permitting institutional review board ("IRB") waiver or alteration of elements for certain.