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.
Good ethics and good business don’t have to be in conflict. Ophthalmologists shouldn’t resort to requiring their patients to buy contact lenses in-house; instead, they should focus on expanding their skill set and providing personalized service.
Clinical trials for the blood substitute PolyHeme exposed the possibility for ambiguous interpretation of the FDA’s waiver of informed consent for emergency research.