Institutional review boards (IRBs) have the responsibility to ensure the protection of human-research subjects and are legally liable if they fail to do so.
Posthumous fatherhood and postmenopausal motherhood raise a multitude of legal, ethical, and social concerns that the law and regulatory agencies have not been able to adequately address to date.
Clinical trials for the blood substitute PolyHeme exposed the possibility for ambiguous interpretation of the FDA’s waiver of informed consent for emergency research.