By failing to follow informed consent protocols and regulations, a researcher engaging in CBPR may inflict permanent harm on the participating community and chill future research among disadvantaged populations.
Physicians have a professional obligation and, in many states, a legal duty to report drivers whose functional or cognitive impairments may pose a safety hazard.
Clinical trials for the blood substitute PolyHeme exposed the possibility for ambiguous interpretation of the FDA’s waiver of informed consent for emergency research.