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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.