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Commentary: Per Capita Payments in Clinical Trials: Reasonable Costs Versus Bounty Hunting

Hall, Mark A. JD; Friedman, Joëlle Y.; King, Nancy M. P. JD; Weinfurt, Kevin P. PhD; Schulman, Kevin A. MD; Sugarman, Jeremy MD

doi: 10.1097/ACM.0b013e3181ef9cc6
Commentary

Paying more for clinical research than the cost of doing the work may create a conflict of interest that could lead to overzealous recruitment, putting participants and scientific integrity at risk. Thus, although various policies prohibit “finder's fees” simply for recruiting patients, paying the actual costs for research is permissible. Whereas industry-sponsored research routinely pays for the costs of each patient enrolled, the line between reasonable and excessive costs merits more attention. In academic medical centers (AMCs), institutional review boards and conflict of interest committees usually are not involved in reviewing research budgets to determine whether per capita payments are excessive. Also, the costs for clinical services in research are not standardized. Instead, budgets are negotiated both internally, among departments within research institutions, and externally, between researchers and sponsors. Sometimes, rates paid by sponsors exceed what researchers usually receive or are actually paid for particular services, generating a surplus. Nevertheless, the authors see only limited cause for concern because, at the AMCs with which the authors are familiar, any monetary surplus generally remains within the research enterprise to cover unanticipated budget shortfalls or to support research staff in the future during lean times. In addition, the surplus from research budgets is not shared directly with individual investigators. However, further investigation is needed to determine whether practices outside AMCs pose greater concerns.

Mr. Hall is professor of law and public health and director, Center for Bioethics, Health & Society, Wake Forest University, Winston-Salem, North Carolina.

Ms. Friedman was project leader, Duke Clinical Research Institute, Durham, North Carolina.

Ms. King is professor of public health sciences and codirector, Center for Bioethics, Health & Society, Wake Forest University, Winston-Salem, North Carolina.

Dr. Weinfurt is associate professor of psychiatry and behavioral sciences and associate professor of psychology and neuroscience, Duke University, Durham, North Carolina.

Dr. Schulman is professor of medicine and Gregory Mario and Jeremy Mario Professor of Business Administration, Duke University, and associate director, Duke Clinical Research Institute, Durham, North Carolina.

Dr. Sugarman is Harvey M. Meyerhoff Professor of Bioethics and Medicine, Berman Institute of Bioethics, and Department of Medicine, Johns Hopkins University, Baltimore, Maryland.

Correspondence should be addressed to Mr. Hall, Wake Forest University, Public Health Sciences, Medical Center Blvd., Winston-Salem, NC 27157-1063; telephone: (336) 716-9807; e-mail: mhall@wfubmc.edu.

© 2010 Association of American Medical Colleges