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.
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.
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.