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Speaker: David Korn, Vice Provost for Research, Harvard University; Professor of Pathology, Harvard Medical School
Dr. Korn's lecture can be viewed online.
Drawing on his experience as both scientist and academic administrator responsible for regulating faculty-industry relations at Stanford and Harvard, Dr. Korn talked about "Financial Conflicts of Interest in Academic Medicine: Whence They Came, Where They Went, Why They Vex Us So."
Borrowing from Dennis Thompson, Korn defined a conflict of interest (COI) as "a set of circumstances that creates a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest." This definition crucially takes COIs to be a matter of the situation in which the agent finds herself, rather than as a matter of her character or actions.
Korn traced the beginning of contemporary concerns about COIs in scientific research to the late 1970s, when several cases of scientific misconduct became public in which COIs played a role. Through widespread media coverage this connection entered the public mind, and became a focus of Congressional investigations that concluded in 1991 in a Congressional Report entitled "Are Scientific Misconduct and Conflicts of Interest Hazardous to Your Health?" Policies were put into place to regulate COIs in institutions receiving federal funding for research; but, Korn highlighted, the regulations were relatively lighthanded, reflecting pushback by academics who feared political interference with academic and scientific matters.
While the public initially concentrated on COIs of individual researchers, in the 1990s institutional financial COIs came increasingly into focus. Thus questions arose over the independence of Institutional Review Boards when institutions themselves have a financial stake in research outcomes.
After the death of several research subjects in the late 1990s, regulation of scientific research gained renewed political momentum, leading to the formation of several task forces seeking to develop parameters for dealing with COIs at both the individual and the institutional level. Among the most influential was the Task Force on Financial Conflicts of Interest in Clinical Research convened by the Association of American Medical Colleges (AAMC), of which Dr. Korn was a member. With regard to individual COIs, the Task Force laid down a Core Principle requiring disclosure of "related significant financial interests." Crucially, however, the Task Force did not embrace an absolute prohibition on pursuing research in which one has a financial stake: While there is a presumption against such research, this presumption is rebuttable, and the research may be pursued if the researcher can establish "compelling circumstances." Among the relevant considerations that make circumstances "compelling" are the nature, magnitude, and "relatedness" of the interest, and the risk to human subjects and to the scientific integrity of the research that these interests pose. Dr. Korn emphasized that, in his own practice, he has often been guided by a judgment whether the research could not be conducted as safely or effectively by any researcher other than the one who has COIs.
With regard to institutional COIs, the central policy prescription is to insist on a separation of administrative functions: Those related to the oversight of human subjects research should be cleanly separated from those related to the institution's investment management and technology licensing. Institutional conflicts of interests are, Korn suggested, particularly troubling because they threaten the long-standing partnership between universities and the government, whereby the government provides financial support for research yet delegates to the universities major oversight responsibilities, thus ensuring the compatibility of governmental support and academic autonomy.
In recent years government as well as the media and the general public have become increasingly conscious, and critical, of financial COIs of individuals and bodies taken to have fiduciary responsibilities. Congress has raised questions about the money that orthopedists and others have received from medical device manufacturers, and about the responsibility of doctors to disclose such payments. In response to public pressure and law suits, many companies have agreed to publicly disclose such payments. But, Korn pointed out, the effectiveness of such disclosure is debated. (More on that below.) An additional problem, revealed by a number of reports, is that existing COI policies are significantly under-enforced. Research institutions receiving federal funds for medical research are required to report investigators' COIs to the NIH. Yet many institutions rely on exceedingly narrow definitions of "investigator" in determining whose conflicts of interests must be declared; they provide only erratic reports to the NIH about COIs; and they insufficiently monitor the subrecipients of grants. As a result, the Office of the Inspector General (OIG) has pressured the NIH to more stringently enforce existing standards.
Another area in which concerns over conflicts of interest have been growing is medical education, which is currently largely financed by the medical industry. This raises questions about both the objectivity of the education provided, and about the integrity of professional decision-making that results from it. Worries about the latter are fueled by recent scientific research that shows a basic psychological tendency in humans to reciprocate and advance the interests of those who have treated them well, casting doubt on the adequacy of disclosure as a safeguard against the risk of problematic influences. Korn highlighted several findings of a symposium on "The Scientific Basis of Influence and Reciprocity" organized by the AAMC, including the observation that persons grant themselves moral "wiggle room" within which they can behave deviantly without letting this impair their self-image; and the significance for decision-making of "bounded awareness" of relevant ethical considerations. All of these suggest that disclosure alone does not solve the problems posed by COIs.
In light of these developments and findings, Korn raised a number of questions about the proper institutional response to COIs: Should management of COIs be based on a weighing of risks, or should it be formulaic, drawing "bright lines" that may not be crossed? Are arguments for formulaic policies merely logistical, or are there additional grounds for supporting them? In developing such policies, should we take into account all the kinds of risks that could be associated with COIs – risks to research subjects, to scientific integrity, to trainees and students, to the public, to the reputation of the institution – or should we focus on only some? How do we rank or weigh these risks? Would people agree on such rankings or weighings?
Korn concluded the presentation with a summary of some current developments. The Office of the Inspector General (OIG) recently requested detailed information about financial COIs from over forty institutions to whom federal grants were awarded. Among its findings were that (a) 90 percent of institutions rely on researcher's discretion to determine which financial relationships are worth reporting; (b) over half of these institutions do not require researchers to specify the value of the financial interests at stake; (c) institutions do not routinely verify the information provided, or establish documentation; and (d) institutions are not currently required to report their own financial interests in outside research-related entities. In light of these findings the OIG has recommended more stringent reporting rules for awardees. These include (a) that institutions must report to the NIH, not only the existence of, but also details regarding COIs; (b) that institutions must collect information on all revelant interests held by researchers; (c) that they must verify the reported interests, and properly document their findings; (d) that they must properly enforce the rules governing COIs. The OIG also proposes that the NIH revise its current policies so as to (a) increase oversight and (b) develop new regulations that address institutional financial COIs.
In his closing words Dr. Korn emphasized that we should think of the discussion of COIs as part of a larger discussion about the fiduciary duties that universities and research institutions have to society – duties it has become more difficult to live up to as demands for tangible results in research (made by both universities and public funding bodies) have put pressure on our commitments to institutional and individual integrity.
Daniel Viehoff, Faculty Fellow in Ethics 2009-10