Wendy E. Parmet, JD and Claudia E. Haupt, PhD, JSD
Clinicians using governing authority to make public health policy are ethically obliged to draw upon scientific and clinical information that accords professional standards.
AMA J Ethics. 2023;25(3):E194-199. doi:
10.1001/amajethics.2023.194.
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.