AMA Journal of Ethics®

Illuminating the art of medicine

Journal of Ethics Header

AMA Journal of Ethics®

Illuminating the art of medicine

AMA Journal of Ethics. December 2015, Volume 17, Number 12: 1103-1196.

  • Print
  • |
  • View PDF

Clinical Research Ethics

Ethics Poll

A child’s parents ask you for advice on whether to enroll their 5-year-old in a phase 3 clinical trial for an agent that might reduce the size of the child’s brain tumor. You’ve heard about this trial in a medical news source recently, and you suspect that the promising results of the phase 2 trials seemed sensationalized. You consider referring the parents to your colleague specialist, but worry that this particular colleague might overemphasize potential benefits and underemphasize potential risks. What will you do?

Content Question

Which of the following vulnerable population groups is not recognized in the US Department of Health and Human Services Code of Federal Regulations (CFR) sections on human subject research protections?
Find an answer to this question in the December issue of the AMA Journal of Ethics.

From the Editor

Revisiting the Ethics of Research on Human Subjects
Cynthia Tsay
Full Text | PDF
AMA Journal of Ethics. 2015; 17:1105-1107.

Ethics Cases

The Question of Clinical Equipoise and Patients’ Best Interests
Commentary by Spencer Phillips Hey and Robert D. Truog
Full Text | PDF
AMA Journal of Ethics. 2015; 17:1108-1115.

When Does the Amount We Pay Research Participants Become “Undue Influence”?
Commentary by Erin P. Williams and Jennifer K. Walter
Full Text | PDF
AMA Journal of Ethics. 2015; 17:1116-1121.

Enrolling Research Participants in Private Practice: Conflicts of Interest, Consistency, Therapeutic Misconception, and Informed Consent
Commentary by Armand H. Matheny Antommaria and Kristin Stanley Bramlage
Full Text | PDF
AMA Journal of Ethics. 2015; 17:1122-1126.

Podcast

Evolving Clinical Research Guidelines: A Conversation with Robert Levine Listen

Medical Education

The National Clinican Scholars Program: Teaching Transformational Leadership and Promoting Health Justice through Community-Engaged Research Ethics
Elizabeth Bromley, Loretta Jones, Marjorie Rosenthal, Michele Heisler, Julie Sochalski, D. Koniak-Griffin, Cristina Punzalan, and Kenneth B. Wells
Full Text | PDF
AMA Journal of Ethics. 2015; 17:1127-1136.

The Code Says

The AMA Code of Medical Ethics’ Opinion on Clinical Research
Full Text | PDF
AMA Journal of Ethics. 2015; 17:1137-1141.

State of the Art and Science

Expanded Access to Investigational Drugs: What Physicians and the Public Need to Know about FDA and Corporate Processes
Paige E. Finkelstein
Full Text | PDF
AMA Journal of Ethics. 2015; 17:1142-1146.

Health Law

New Developments in Human Subjects Protections: Proposed Updates to the Common Rule
Richard Weinmeyer, JD, MPhil, MA
Full Text | PDF
AMA Journal of Ethics. 2015; 17:1147-1151.

Policy Forum

US Federal Efforts to Improve Clinical Trial Transparency with Expanded Trial Registries and Open Data Sharing
Daniel L. Shaw and Joseph S. Ross
Full Text | PDF
AMA Journal of Ethics. 2015; 17:1152-1159.

Research on Medical Practices and the Patient-Physician Relationship: What Can Regulators Learn from Patients?
Stephanie Alessi Kraft, Kathryn Porter, Benjamin S. Wilfond, and the Research on Medical Practices Group
Full Text | PDF
AMA Journal of Ethics. 2015; 17:1160-1165.

History of Medicine

Dying for Science: Historical Perspectives on Research Participants’ Deaths
Susan E. Lederer
Full Text | PDF
AMA Journal of Ethics. 2015; 17:1166-1171.

Second Thoughts

How Publish or Perish Promotes Inaccuracy in Science—and Journalism
Ivan Oransky
Full Text | PDF
AMA Journal of Ethics. 2015; 17:1172-1175.

Resources

Suggested Readings and Resources
PDF
AMA Journal of Ethics. 2015; 17:1176-1191.

About the Contributors
Full Text | PDF
AMA Journal of Ethics. 2015; 17:1192-1196.