A history of device oversight by the US Food and Drug Administration traces regulatory changes in response to injuries caused by Dalkon Shield intrauterine devices.
AMA J Ethics. 2021;23(9):E712-720. doi:
10.1001/amajethics.2021.712.
Douglas E. Paull, MD, MS and Paul N. Uhlig, MD, MPA
Risk managers can help patient-subjects and clinician-researchers make informed novel device implantation decisions in the absence of preclinical trial data.
AMA J Ethics. 2020;22(11):E911-918. doi:
10.1001/amajethics.2020.911.
Large precision health initiatives like the National Institutes of Health’s All of Us campaign raise important ethical questions about consent, privacy, and inclusivity. This month on Ethics Talk, we explore with Dr Katie Johansen Taber and Ysabel Duron strategies for protecting participants and ensuring that diverse communities are represented.