“Conflict of Interest in Medical Research, Education, and Practice.”

Bernard Lo and Marilyn J. Field, Editors; Committee on Conflict of Interest in Medical Research, Education, and Practice; Institute of Medicine
“Federal regulations and laws have not consistently targeted institutional conflicts of interest. The U.S. Public Health Service (PHS) regulations on conflict of interest, which were issued in 1995 and which are included in Appendix B, cover only individual conflicts of interest and relationships with industry. Institutional conflicts of interest were deliberately not addressed (NIH, 1995). The guidance on financial relationships in research with human participants published by the U.S. Department of Health and Human Services discusses the identification and management of institutional as well as individual financial interests (HHS, 2004). The document suggests questions and procedures for institutional review boards (IRBs), investigators, and institutions to consider in evaluating institutional relationships. Federal antikickback rules apply to illegal payments to institutions as well as individuals. The recommendation by the Medicare Policy Advisory Commission (see Chapter 3) for industry reporting of consulting and other payments covers not only payments to physicians but also payments to medical schools, professional societies, and providers of continuing medical education (MedPAC, 2009). A bill introduced in the U.S. Congress in 2007 (S. 2029) and reintroduced in 2009 (Grassley, 2009) covers payments to individual physicians.

Several academic organizations have issued reports on institutional conflicts of interest, including the Association of American Medical Colleges (AAMC, 2002; AAMC-AAU, 2008), the Association of American Universities (AAMC-AAU, 2008), and the Council on Government Relations (COGR, 2003). The 2002 AAMC and 2008 AAMC-AAU reports dealt with institutional conflicts of interest in research with human participants.

The 2008 AAMC-AAU report was in part a response to evidence that academic medical centers had not implemented the recommendations set forth in the 2002 AAMC report. In an AAMC survey of its members, only 38 percent of the institutions that responded reported that they had a conflict of interest policy that applied to the institution’s financial interest, although another 37 percent reported that they were developing such a policy (Ehringhaus et al., 2008). For institutions that had policies, the documents typically covered equity in nonpublicly held companies (90 percent) or publicly held companies (77 percent), royalties (80 percent), payments for reaching designated milestones in the course of a study (73 percent), and substantial gifts from a research sponsor (73 percent). The majority of institutions that had policies applied them to senior officials (71 percent), governing board members (66 percent), and members of the IRB (81 percent). In addition, the majority of respondents reported creating organizational arrangements to separate institutional responsibility for research from responsibility for investment management (94 percent) or technology transfer (61 percent). Although the most serious problem identified in the survey was the lack of policies at a majority of institutions, another concern was the incomplete coverage by policies of significant institutional interests.”



how much is a patient “worth”?

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