For Immediate Release

            The Center for Biomedical Ethics at the University of Virginia has been awarded a grant by the National Institutes of Health to study financial conflicts of interest in clinical research.

            According to Patti Tereskerz, Associate Professor and the study's principal investigator, the goals of the study are A) to determine the national prevalence of various financial arrangements undertaken by investigators with industry that may constitute a conflict of interest in the research setting; B) determine the national prevalence of various questionable integrity practices; and C) survey investigator knowledge of policies governing financial conflicts of interest.

            The study will also assess whether there are any differences between nursing and medical schools with regard to financial conflicts and determine which particular financial arrangements are associated with specific questionable integrity practices.

            Study co-investigators include Thomas M. Guterbock, Ph.D., Director, Center for Survey Research, Ann B. Hamric, Ph.D., R.N., F.A.A., Associate Professor, University of Virginia School of Nursing, and Jonathan D. Moreno, Ph.D., Director, Center for Biomedical Ethics. The University’s Center for Survey Research will collaborate with the investigators in conducting the study surveys.

            The research is novel in that the focus of the research is on actual practices of investigators, rather than upon institutional policies and represents the first national assessment of multiple parameters of financial conflicts of interest and their relationship to various financial arrangements between investigators and industry that may impact the integrity of research. Financial conflicts of interest that research institutions and individual researchers face represent but one of several areas encompassing research integrity and human subject protection. A coi may be defined as any financial arrangement that compromises, has the capacity to compromise, or has the appearance of compromising trust in clinical research.  Financial conflicts of interest in the research setting have been described as an inevitable collision "between profit and objectivity", whereby the primary fiduciary duty of business is to produce profits for its stockholders while that of physicians and researchers is to patients, research subjects, and the public good.

            These conflicts present an enormous and complicated challenge to the advancement of science; to the improvement of public health; and to the preservation of the publics trust in research objectivity. In the past, most support for research was provided through government grants. As a result, leading research institutions such as universities were viewed as conducting research for the public benefit with no financial stake in the outcome. The landscape has changed dramatically, with industry emerging as a major financier.

            This study was only one of only 5 selected for funding by NIH with regard to research on research integrity. It follows on the heels of another grant awarded to the Center by the NIHs National Library of Medicine which was recently renewed and is now in its third year. This grant, also undertaken under the direction of Dr. Tereskerz, who is an attorney and epidemiologist, is dedicated to exploring the legal and policy aspects of financial conflicts of interest in both the clinical and research settings.

            The Center for Biomedical Ethics is also pleased to announce that it has been selected by the Office of Research Integrity at NIH to co-sponsor a national conference on financial conflicts of interest in research to be held at the University in 2004.

            While there is significant concern among national law and policy makers about the prevalence of financial conflicts of interest in research, heretofore, there has been no national data to help steer future policy development. The research at UVA emerging from these studies will provide guidance to national law and policy makers on how to manage financial conflicts in clinical research settings.