AAMC Releases Report on Conflict of Interest Guidelines

Malpractice Update: States Say Federal Help Needed To Deal With Spiraling Costs

Image Guided Surgery: Making "X-Ray Vision" A New Reality

Medical Schools Branch Out: Regional Medical Campuses on the Rise

Computer-Based MCAT Gets a Test in London

"A Day in the Life of a Medical Student"

Caring for Community

Leadership Q & A

Viewpoint

A Word From the President

Reporter Archive

AAMC Newsroom

Managing Editor Scott Harris sharris@aamc.org Staff Writer Elissa Fuchs efuchs@aamc.org

Preserving Research Integrity: AAMC Releases Report On Conflict of Interest Guidelines

After two years of groundwork, the AAMC has issued a new report that seeks to establish a framework for assessing and addressing financial conflicts of interest in human subjects research at the institutional level.

In October 2000, the AAMC responded to the increasing concern of legislators, the media, and the public at large regarding the safety of individuals enrolled in human subjects research by forming the Task Force on Financial Conflicts of Interest in Clinical Research.

Chaired by William Danforth, M.D., chancellor emeritus of Washington University in St. Louis, the task force released the report, Protecting Subjects, Preserving Trust, Promoting Progress: Guidelines for Developing and Implementing a Policy Concerning Individual Financial Interests in Human Subjects Research, in December 2001. The document offers guidance to academic medical centers seeking to develop policy in cases in which individual researchers hold financial interests in human subjects research they are conducting.

“We’ve heard from a number of institutions that have taken those guidelines and gone through the process of reassessing their own policies and are considering where they might want to make changes,” says Jennifer Kulynych, J.D., Ph.D., former director and regulatory counsel in the AAMC Division of Biomedical and Health Sciences Research (DBHSR). “I think this is the first report addressing this subject with this level of detail and with this degree of specificity,” Dr. Kulynych says.

“There have been a few other reports and journal articles that have raised this topic, but as far as I know this is the most specific and detailed set of recommendations to date.”

Coordinated effort

Dr. Kulynych was instrumental in coordinating the efforts of the task force, a body of 28 members representing the panoply of human subjects research stakeholders, including clinical investigators; patient representatives; medical school, teaching hospital, and university leaders; and representatives from industry, law, and the media.

Along with David Korn, M.D., senior vice president in the DBHSR, Dr. Kulynych has recently worked to coordinate the efforts of the same group to address institutional financial conflicts of interest, an area of human research protections that has been rarely add-ressed, much less clearly defined, by the academic medicine community.

Acknowledging that institutional conflicts of interest constitute “a problem of remarkable complexity,” the task force does not attempt to provide an “exhaustive list” of potentially troublesome financial interests, but instead purports to offer “a conceptual framework” for assessing such conflicts and “a set of specific recommendations for the oversight of certain financial interests in human subjects research.”

The report establishes a general framework for dealing with institutional conflicts by explicitly defining when one may exist and laying out the “fundamental principle” that institutions should separate their financial and research functions to avoid the presence or appearance of conflicts of interest. The report details the circumstances under which an individual official’s conflict of interest may rise to the level of the institution itself.

“The guidelines separately address the financial interests of institutional officials with research oversight responsibilities, such as the dean of research or the chair of a department, who might have a financial interest in research being conducted by someone over whom they have responsibility,” explains Dr. Kulynych. “Their interests would not necessarily fall under the scope of our first report, because that report dealt with a person’s financial interest in his or her own research. The task force members therefore identify the circumstances under which an institutional official’s financial interests might actually rise to the level of an institutional conflict of interest because of the scope of their authority.”

The report also details specific circumstances that may create institutional conflicts of interest and there- fore should receive close scrutiny. These include financial relationships between institutions and commercial sponsors of human subjects research, such as those involving royalties, equity interests and entitlements, gifts, and advisory appointments for institutional officials at companies funding research. “The report doesn’t give specific recommendations as to how those situations should be addressed,” says Dr. Kulynych. “But it does flag them as potential areas of concern.”

The task force also outlines how institutions can fulfill its recommendation that standing “institutional conflict of interest committees” be established at schools and hospitals to review circumstances that merit their attention when they arise. Recommendations for the review processes of such committees are also detailed. Task force members go on to offer additional guidelines involving the handling of recusals in cases where officials hold significant stakes in products or commercial entities sponsoring human subjects research at their institutions.

The report’s final sections address the responsibility of IRB members to disclose any financial interests that could appear to be affected in the course of their duties and enjoins institutions to publicly disclose all potential financial conflicts of interest that have not been eliminated through recusal or other means.

“These guidelines are a much-needed contribution to the ongoing conversation regarding financial conflicts of interest in human subjects research,” says AAMC President Jordan J. Cohen, M.D.

— Barbara A. Gabriel, bgabriel@aamc.org

Contact Us    © 1995-2008 AAMC    Terms and Conditions    Privacy Statement