This week the Association of American Medical Colleges (AAMC) released the first report of its Task Force on Conflicts of Interest in Clinical Research, "Protecting Subjects, Preserving Trust, Promoting Progress." The report discusses guidelines for oversight of individual scientists financial interests in human subjects research. Next year, the task force will develop guidelines to monitor institutional financial interest in human subjects research.
The task force includes patient advocates, clinical investigators, leaders in industry, law, and the media, and selected heads of medical schools, teaching hospitals, and universities. I am serving as academic medical center representative.
The report recommends that institutions appoint a standing conflict of interest committee to review requests from researchers, document subsequent findings, exchange findings with the institutional review board and other responsible officials, and monitor procedures whereby a financially interested individual may conduct human subjects research. The report encourages institutions to share best practices in managing conflict of interest.
The UW Academic Medical Center has had a conflict of financial interest advisory group for many years. It includes representative faculty from across the institution, as well as public affairs representatives who examine real or apparent conflicts with public perception in mind.
Researchers and their institutions must continually make certain that the trust the public places in the way clinical research is conducted is well founded. The safety of human research subjects should not be jeopardized by financial conflicts of interest.
The United States General Accounting Office has asked the Secretary of Health and Human Services to develop specific guidance or regulations regarding institutional financial conflict of interest. At present there are no such regulations.
The AAMC guidelines respect institutional autonomy and flexibility. They are not meant to stifle productive relationships between academic institutions and the private sector. They are an attempt to create principled relationships that will withstand public scrutiny and benefit the public through medical innovation.
Paul Ramsey, M.D.
Vice President for Medical Affairs
And Dean of the School of Medicine