Home Government Affairs Newsroom Meetings Publications	Shopping Cart Site Map

February 2002 Reporter

Healing the Psychological Wounds of Terrorism

Researchers Speed up Efforts to Combat Threat of Bioterrorism

It's a Wired World

Viewpoint

A Word from the President

Reporter Archive

AAMC Newsroom

Managing Editor
Scott Harris
sharris@aamc.org

Staff Writer
Elissa Fuchs
efuchs@aamc.org

Viewpoint

Why Must We Tighten up Our Oversight of Financial Conflicts of Interest in Research Involving Human Subjects?

William H Danforth MD

By William H. Danforth, M.D.; Chancellor Emeritus and Vice-Chairman, Board of Trustees; Washington University

Since March of 2001, I have had the privilege of chairing the AAMC's Task Force on Financial Conflicts of Interest in Clinical Research. I thank AAMC President Jordan J. Cohen, M.D., whose concerns led to the formation of the Task Force, and David Korn, M.D., senior vice president for Biomedical and Health Sciences Research, who guided and counseled us and put together a strong committee with members of diverse experiences and roles.

Part I of our report, "Protecting Subjects, Preserving Trust, Promoting Progress: Policy and Guidelines for the Oversight of Individual Interests in Research," which was issued recently, deals with financial conflicts of interest affecting those who are directly engaged in clinical research. Our recommendations ask a lot of institutions and individuals engaged in clinical research, in terms of both added effort and added costs. I'd like to justify our reasons for doing so and outline briefly the remaining work of our Task Force.

Financial conflicts of interest are not new to physicians. People have long suspected that some physicians, paid through a fee-for-service model, may have rendered too many services. More recently, people have been concerned that physicians operating under the fiscal discipline of managed care contracts may provide too little care. In either case, we depend on professional ethics, second opinions, and information from various sources to protect our patients, our families, and ourselves.

What is new is that financial incentives for scientists engaged in clinical research have become larger by many orders of magnitude. If the research results substantiate the hope on which the company is based, stock options that today are almost valueless may next year be worth tens or even hundreds of millions of dollars. Thus, there may be serious temptations to push research faster or further than is in the best interest of research subjects.

Similarly, there may be temptations to over- or under-interpret data in ways that undermine the integrity of the research. These temptations are obvious not only to us but to our patrons, to federal regulators, and to the general public.

Thus, it is important to establish procedures for avoiding or, when avoidance is not feasible, managing financial conflicts of interest so as to protect the interests of the research subject and the integrity of the research. To do so is an important moral responsibility. In addition to acting responsibly, we must do so in ways that make it obvious to others that we are, in fact, protecting our research volunteers, as well as the integrity of the science.

Those who sponsor and pay for clinical research feel an obligation to ensure that research subjects are safe and research results are trustworthy. That is their rightful responsibility. If we cannot give our sponsors and the public confidence that our institutions are doing a reliable job of oversight, we can expect ever-more intrusive regulations that will force us to do so, or the withdrawal of financial support, or both.

We have, therefore, a triple responsibility: to our human subjects, to the integrity of our research, and to the American research enterprise as a whole. In our view, fulfilling these responsibilities requires undertaking the work that the Task Force is recommending. We hope that you agree.

Part I of our report deals with individuals who are actually conducting the research. Part II will deal with institutional conflicts of interest; that is, financial conflicts faced by individuals in exercising their official duties. Institutional officials - from presidents to laboratory directors - may be subject to conflicts of interest involving potentially large amounts of money. These temptations may develop because of personal investments or holdings, or they may develop because of responsibility to the institution, which has investments important to its goals or financial well-being.

I look forward to the continuing work of the Task Force as we delve into these issues. We welcome any comments on Part I or suggestions for Part II.