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.
Clinical trials for the blood substitute PolyHeme exposed the possibility for ambiguous interpretation of the FDA’s waiver of informed consent for emergency research.
An ethical case explores a lawsuit against Fred Hutchinson Cancer Center of Seattle by patients who claimed they were not told of the full risks associated with a clinical trial they participated in.