Clinical Research Ethics

Twentieth-century human subject research protections developed as pointed responses to well-documented human rights abuses, such as those revealed in the Nuremburg Trials and those that occurred in the US Public Health Service Syphilis Study at Tuskegee. Today, clinical research ethics has expanded beyond the need to secure informed consent from potential human subjects to incorporating the input of subjects and their communities into planning, implementing, and sharing results of research. The December 2015 issue of the AMA Journal of Ethics interprets lessons from important historical moments in our past and also suggests how key ideas, such as open data sharing, command our current consideration and help broaden the nature and scope of future research ethics questions and dilemmas.

Volume 17, Number 12: 1103-1196 Full Issue PDF
  • From the Editor
    Dec 2015

    Revisiting the Ethics of Research on Human Subjects

    Cynthia Tsay, MPhil
    Ethical questions in clinical research have evolved with cultural and technological innovations.
    AMA J Ethics. 2015;17(12):1105-1107. doi: 10.1001/journalofethics.2015.17.12.fred1-1512.
  • Case and Commentary
    Dec 2015

    The Question of Clinical Equipoise and Patients’ Best Interests

    Spencer Phillips Hey, PhD and Robert D. Truog, MD
    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.
    AMA J Ethics. 2015;17(12):1108-1115. doi: 10.1001/journalofethics.2015.17.12.ecas1-1512.
  • Case and Commentary
    Dec 2015

    When Does the Amount We Pay Research Participants Become “Undue Influence”?

    Erin P. Williams, MBE and Jennifer K. Walter, MD, PhD, MS
    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.
    AMA J Ethics. 2015;17(12):1116-1121. doi: 10.1001/journalofethics.2015.17.12.ecas2-1512.
  • Medical Education
    Dec 2015

    The National Clinician Scholars Program: Teaching Transformational Leadership and Promoting Health Justice through Community-Engaged Research Ethics

    Elizabeth Bromley, MD, PhD, Loretta Jones, MA, ThD, Marjorie S. Rosenthal, MD, MPH, Michele Heisler, MD, MPA, Julie A. Sochalski, PhD, RN, Deborah Koniak-Griffin, RNC, EdD, Cristina Punzalan, MPH, and Kenneth B. Wells, MD, MPH
    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.
    AMA J Ethics. 2015;17(12):1127-1135. doi: 10.1001/journalofethics.2015.17.12.medu1-1512.
  • Health Law
    Dec 2015

    New Developments in Human Subjects Protections: Proposed Updates to the Common Rule

    Richard Weinmeyer, JD, MA, MPhil
    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.
    AMA J Ethics. 2015;17(12):1147-1151. doi: 10.1001/journalofethics.2015.17.12.hlaw1-1512.
  • AMA Code Says
    Dec 2015

    AMA Code of Medical Ethics’ Opinions on Clinical Research

    AMA Council on Ethical and Judicial Affairs
    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.
    AMA J Ethics. 2015;17(12):1136-1141. doi: 10.1001/journalofethics.2015.17.12.coet1-1512.
  • Policy Forum
    Dec 2015

    US Federal Government Efforts to Improve Clinical Trial Transparency with Expanded Trial Registries and Open Data Sharing

    Daniel L. Shaw and Joseph S. Ross, MD, MHS
    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.
    AMA J Ethics. 2015;17(12):1152-1159. doi: 10.1001/journalofethics.2015.17.12.pfor1-1512.
  • History of Medicine
    Dec 2015

    Dying for Science: Historical Perspectives on Research Participants’ Deaths

    Susan E. Lederer, PhD
    The continuance of public and institutional support for medical research after the publicized deaths of human research participants in the 1950s contrasts sharply with the disciplining of institutions responsible for two such deaths in recent decades, which suggests that medical research participants are no longer receiving public recognition for their contributions to science.
    AMA J Ethics. 2015;17(12):1166-1171. doi: 10.1001/journalofethics.2015.17.12.mhst1-1512.