AMA Journal of Ethics^®

Clinical equipoise—the idea that the community of medical experts is uncertain about the relative therapeutic merits of the arms of a clinical trial at its outset—mitigates physicians’ responsibility for patients’ poor outcomes when patients are assigned to the control arm or are harmed by an investigational agent.

In 2014, the Department of Health and Human Services and the National Institutes of Health published proposals to expand clinical trial registration requirements and to promote sharing of clinical research data, but these and other efforts at improving data transparency and access need to be supported by changes in the academic reward structure and significant funding.

Scientists and journalists both face pressures to “publish or perish,” which may result in over- or misrepresentation of findings.

Undue influence, which occurs when prospective research participants who otherwise would not enroll are induced to enter studies that might pose significant risks, may also involve social injustices such as unequal payment and participant selection methods that unequally distribute the potential harms and benefits of research.

This month, AMA Journal of Ethics theme editor Cynthia Tsay, MPhil, a second-year medical student at the Yale School of Medicine, interviewed Robert Levine, MD, about changes in clinical research guidelines, problems with IRB documentation, and the top ethical challenges facing clinical researchers today.

The FDA’s expanded access pathway allows patients with no other therapeutic options to request access to investigational agents, but manufacturers do not often grant it.

The 2015 proposed changes to the Common Rule for human subjects research protections, which are a response to novel methods of data collection and analysis, clarify and broaden the scope of informed consent processes, identify exemptions, and make changes to Institutional Review Board requirements.

Advice for enrolling patients in clinical trials.

The AMA Code of Medical Ethics’ opinions on clinical investigation, subject selection for clinical trials, including members from vulnerable groups, and managing conflicts of interest in the conduct of clinical trials.

The National Clinician Scholars Program, which will begin training physician and nursing scholars in partnership with local community-based agencies in 2016, aims to develop health care leaders who pursue community-centered goals and treat their community partners with equality and respect.