An ethical case explores a lawsuit against Fred Hutchinson Cancer Center of Seattle by patients who claimed they were not told of the full risks associated with a clinical trial they participated in.
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.