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.
The Declaration of Helsinki was recently revised to require that the control arm of a trial use the current standard of care, even if that standard is not generally available in developing nations where the research is being conducted.
Those conducting Western-style clinical trial research in developing countries must consider the manner in which ethical principals are implemented within local standards of care.
Clinical case conferences are an important component to the medical school curriculum due to the critical thinking skills that are encouraged to develop.