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Release: April 19, 2002

UPDATE 4:45 p.m.: Due to a scheduling change, Dr. Kelch will not be providing Senate testimony on April 23

UI's Kelch to testify before Senate subcommittee April 23

Robert P. Kelch, M.D., vice president for Statewide Health Services and dean of the University of Iowa Roy J. and Lucille A. Carver College of Medicine, will testify on behalf of the Association of American Medical Colleges (AAMC) at a public hearing before a U.S. Senate committee Tuesday, April 23 in Washington, D.C.

The Senate Committee on Health, Education, Labor and Pensions hearing is scheduled to begin at 10 a.m. (EDT) and is titled "Protecting Human Subjects in Research: Are Current Safeguards Adequate?" Kelch will present the AAMC's position on financial conflict-of-interest issues involving medical researchers. He serves as chairman of the AAMC Advisory Panel on Research and also is a current member of the AAMC Executive Council and AAMC Task Force on Financial Conflicts of Interest in Clinical Research.

This task force was formed to update the AAMC's 1990 guidelines on financial conflicts of interest as they relate to clinical research. The group's membership includes academic medical leaders such as Kelch, researchers, attorneys, ethicists, industry representatives, journalists and media experts, public/patient representatives, AAMC staff, and a representative of the Association of American Universities. In December 2001, the task force issued a report called "Protecting Subjects, Preserving Trust, Promoting Progress: Policy and Guidelines for the Oversight of Individual Financial Interest in Human Subjects Research." The report is available at www.aamc.org/members/coitf/start.htm.

The guidelines were designed to address real and perceived financial conflicts of interest of clinical investigators, with the welfare of research participants as the highest priority. Other key issues involved in conflict of interest include how researchers with conflicts due to financial holdings may participate in human research and how institutions should use reporting requirements and other policies to maintain oversight of their researchers and any potential conflicts.

Currently, researchers are said to have a financial conflict of interest if they have $10,000 or more total interest in a company associated with the research project.

Kelch also published an article on "Maintaining the Public Trust in Clinical Research" in the Jan. 24 issue of the New England Journal of Medicine. In that article, Kelch wrote, "Conflicts of interest can never be eliminated completely -- not in everyday life and not in academic medicine.

Those that cannot be eliminated must therefore be recognized, disclosed fully, and managed." He stressed the value of an extensive peer-review process to effectively manage most conflicts of interest.

As vice president of Statewide Health Services, Kelch works with deans of the four other UI health science colleges -- dentistry, nursing, pharmacy and public health -- on strategic planning and issues such as conflict-of-interest. In that position, he also serves as co-chair of the UI Health Sciences Policy Council, which coordinates leadership of the health science colleges, UI Hospitals and Clinics and the UI Hygienic Laboratory.

William Danforth, M.D., chancellor emeritus and vice-chairman of the board of trustees of Washington University in St. Louis, serves as chair of the AAMC Task Force on Financial Conflicts of Interest in Clinical Research. The Web site of the Association of American Medical Colleges is www.aamc.org.

University of Iowa Health Care describes the partnership between the UI Roy J. and Lucille A. Carver College of Medicine and UI Hospitals and Clinics and the patient care, medical education and research programs and services they provide. Visit UI Health Care online at www.uihealthcare.com.