The legal definition of a patient and the corresponding duties of the physician have been debated in state courts for over a century, and many aspects of the question are still unresolved.
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.
Clinical trials for the blood substitute PolyHeme exposed the possibility for ambiguous interpretation of the FDA’s waiver of informed consent for emergency research.