Does a surgeon’s complication rate in a randomized controlled trial constitute a “significant new finding” that must be reported to patients during the consent process?
Taking care of patients whose cultures, belief systems, and family hierarchy structures differ from those on which many U.S. laws and regulations involves strategies—particularly regarding end-of-life care and surrogate decision making.
Taking care of patients whose cultures, belief systems, and family hierarchy structures differ from those on which many U.S. laws and regulations involves strategies—particularly regarding end-of-life care and surrogate decision making.
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.