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.
A lack of consensus guidelines or a belief that current evidence does not support such guidelines might be justified if a clinician expresses a commitment to patient-centered care and shared decision making.
AMA J Ethics. 2018;20(11):E1007-1016. doi:
10.1001/amajethics.2018.1007.