PSOs are not required to share their data, which limits the ability to achieve a much-needed national perspective. Regardless, the are a step in the right direction.
U.S. courts have ruled that device manufacturer representatives’ presence in the operating room does not make them responsible for the supervision of physicians or liable for the practice of unauthorized medicine.
Research ethics should be included in the medical school curriculum so students and residents can fully understand the ethical implications of medical research.
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.