Page 2 - Common Rule News Today

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.

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...

On October 11, the National Institutes of Health ("NIH") issued a request for information ("RFI"), which proposes sample language regarding the use of digital health...

The Food and Drug Administration (FDA) has issued a final rule, Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations, which...

FDA issued a final rule to help advance medical product development without compromising the rights, safety and welfare of people participating in clinical research.