Clinical trials for the blood substitute PolyHeme exposed the possibility for ambiguous interpretation of the FDA’s waiver of informed consent for emergency research.
Regulations prohibit discrimination against women and caregivers who are being considered for hiring and promotion. Hospital residency programs also must adapt to comply with those regulations.
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.