Conflict of Interest in Medical Research, Education, and Practice (2009) / Chapter Skim
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8 Institutional Conflicts of Interest
8 Institutional Conflicts of Interest
Pages 216-229
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From page 216... ...
For example, gifts to endow named professorships or fund the construction of research facilities support the core teaching and research missions of academic medical centers. The committee heard testimony that new kinds of institutional relationships between academia and industry -- beyond relationships involving individual faculty members -- could promote the translation of basic discoveries into new therapies and thereby benefit society (Benz, 2008; Moses, 2008)
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From page 217... ...
. This project issued practice guidelines recommending an increase in the target hemoglobin level for patients with chronic kidney disease, which would entail the use of higher doses of epoetin and increased sales of the sponsor's product.
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From page 218... ...
In addition, institutional conflicts of interest exist when senior officials who act on behalf of the institution have personal financial interests that may be affected by their administrative decisions. For instance, a department chair or dean who has a major equity holding in a medical device company could make decisions about faculty appointments and promotions or assignment of office or laboratory space in ways that favor the interests of the company but compromise the overall research, educational, or clinical mission of the institution.
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From page 219... ...
Chapter 4 reviewed the results of a survey of department chairs in medical schools and large independent teaching hospitals that found that 27 percent of preclinical departments and 16 percent of clinical departments received income from intellectual property licensing (Campbell et al., 2007b)
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From page 220... ...
Groups that report sources of funding for activities such as clinical practice guideline development usually do not report the amount of company funding for an activity or what percentage of an activity's cost was accounted for by company funds. These data would assist with assessments of the risk of undue influence.
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From page 221... ...
Medical school continuing medical education programs received about 62 percent of their income from these sources; for publishing and education companies, the figure was 73 percent. RESPONSES TO INSTITUTIONAL CONFLICTS OF INTEREST Federal regulations and laws have not consistently targeted institutional conflicts of interest.
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From page 222... ...
In addition to reiterating the importance of such policies, the 2008 AAMC-AAU report set forth several guiding principles for institutional conflict of interest policies. They were • "research and financial decision-making processes and agents must be separated"; • "decisions about whether or not to pursue a particular human subjects research project in the presence of an institutional conflict of interest should be governed by a ‘rebuttable presumption' against doing the research at or under the auspices of the conflicted institution" unless a compelling case can be made to justify an exception; and • institutional conflict of interests "will be addressed consistently throughout the institution, such that those subject to institutional financial conflict of interest policies, specifically officials of the institution and the institutions themselves, are subject to substantive reporting, disclosure, and management of their financial interests." (pp.
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From page 223... ...
One university's policy lists several issues to be considered in evaluations of the circumstances that might justify institutional involvement in a human subjects research project despite a conflict of interest (University of Rochester, 2006)
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From page 224... ...
Chapter 6 discussed the actions that the Accreditation Council for Continuing Medical Education initiated to limit industry influence associated with providers' solicitation and acceptance of industry funding. Chapter 7 described the steps taken by some professional societies to insulate activities such as clinical practice guideline development from influence associated with industry funding.
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From page 225... ...
The leaders of professional societies and patient advocacy groups that depend significantly on member dues or individual contributions may be reluctant to reject grants from industry, even though they create a risk of undue influence over activities such as the development of clinical practice guidelines or educational programs. The potential for conflicts of interest among senior institutional officials is one reason for the committee's recommendation below that the key responsibility for oversight of institutional conflicts of interest be lodged with an institution's governing body.
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From page 226... ...
RECOMMENDATION 8.1 The boards of trustees or the equivalent governing bodies of institutions engaged in medical research, medical education, patient care, or practice guideline development should estab lish their own standing committees on institutional conflicts of interest. These standing committees should
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This board committee would be different from the committee established to address individual conflicts of interests, as suggested in Recommendation 3.1. Although the board should be accountable for institutional conflicts of interest, the committee recognizes that board members may not be well suited to carry out day-to-day oversight or conduct special investigations, especially in academic medical centers and other large institutions.
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From page 228... ...
Such rules would also call attention to the issue and encourage institutions that do not receive research funds but that are engaged in medical education, clinical care, or the development of practice guidelines to voluntarily take action to avoid and oversee potential conflicts of interest. Ideally, the development of new PHS rules would be harmonized with corresponding revisions in the regulations of the National Science Foundation.
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From page 229... ...
The intent of the recommendations in this report is to promote a culture in which conflicts of interest are taken seriously by institutions and individuals engaged in medical research, education, and practice and practice guideline development. For this to happen, institutions must effectively manage their own conflicts and be seen to be doing so.
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