Special symposium focuses on ethical, legal, and social issues in translational research

Sep 30 2011

An important focus of medical research today is on translating new scientific discoveries into advances in clinical care that will lead to meaningful improvements in health outcomes. Ongoing ethical, legal, and social issues in this era of "translational" research are the subject of a special symposium in the October issue of The American Journal of the Medical Sciences (AJMS), official journal of the Southern Society for Clinical Investigation. The journal is published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health.

Although there are well-established systems for research ethics, "many of the issues that motivated their development remain problematic," according to an introductory editorial by Guest Editor Robert M. Sade, MD, of Medical University of South Carolina, Charleston. The symposium presents expert discussions highlighting "a few of the more controversial" ethical issues affecting "lab-to-bedside" research.

Contrasting Viewpoints on Informed Consent, Clinical Equipoise, and Animal Research
The papers reflect presentations made at last year's 17th Annual Thomas A. Pitts Memorial Lectureship, contributed by nationally recognized leaders in medical ethics and related disciplines. The eight symposium papers present contrasting viewpoints on four critical topics facing research ethics:

Incentives for research subjects.—Should patients be offered cash or other incentives to participate in research? It's an important issue in the ongoing debate over the ethical principle of informed consent. Dr. Mark Bernstein of University of Toronto believes such payments are unethical for studies involving "more than minimal risk." In an opposing view, Dr. Scott D. Halpern of University of Pennsylvania School of Medicine believes that, in the absence of "genuine concerns," restrictions on incentives are unnecessary.

Therapeutic misconception.—Another important issue related to informed consent is therapeutic misconception, referring to "the potential subject's mistaken belief that participating in research will be for his own benefit rather than for the benefit of others." Gail E. Henderson, PhD, of University of North Carolina at Chapel Hill raises the idea that informed consent is "broken"—especially with the unprecedented information being gained by genomic research. Charles W. Lidz, PhD, of University of Massachusetts, Worcester, takes the view that informed consent is still "a critical part of modern medical research."

Clinical Equipoise.—This refers to the idea that, to perform any study comparing two treatments (or active treatment versus no treatment), the researchers must be truly uncertain as to which treatment is more effective. Franklin G. Miller, PhD, of the National Institutes of Health believes that the concept of clinical equipoise can be "dispensed with," as current principles of research ethics provide sufficient guidance. Benjamin Djulbegovic, MD, PhD, of University of South Florida, Tampa, believes that equipoise "remains one of the most important ethical ideas proposed in the history of clinical research."

Research Involving Animals.—The ethics of research involving animals continues to be a high-profile, often emotional issue. Dario L. Ringach, PhD, of the University of California, Los Angeles supports responsible use of animals in research, calling for "civil discourse" over the issue. Nathan Nobis, PhD, of Morehouse College, Atlanta, outlines the logic behind his argument that in animals as in humans, any research leading to harm is "morally wrong."

Amid these and other ongoing ethical controversies, clinical and translational research continue on a "firm, though not rock solid foundation," writes Dr. Sade. He concludes, "Continual ethical debate in support of the integrity of medical science helps to ensure future achievement of the scientific knowledge needed for progressive improvement of the human condition."

The Thomas A. Pitts Memorial Lectureship, held annually since 1993, is funded by the Medical University of South Carolina Foundation. The lectureship is endowed through a bequest from Dr. Pitts, who served on MUSC's Board of Trustees for 36 years and as its chair for 25 of those years.