Feb. 29

More Aggressive Guidance on Conflicts of Interest

To people in some corners of higher education, it may seem as if conflicts of interest became a major issue only a year ago, when New York Attorney General Andrew M. Cuomo and leading Democrats in Congress began making accusations about questionable behavior in the student loan world. The loan scandal has threatened to bleed into other areas of university operations where corporate interests are also prominent, prompting college associations to reassess their own policies and offer their member institutions guidance about dealing with real or perceived conflicts.

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In other quarters of the academy, though, conflicts of interest have been a fact of life for a long time; chief among those is in the realm of biomedical research, where the federal government has regulated conflicts in federally sponsored research for well over a decade, designed to protect human subjects from potential harm, quite literally as a matter of life and death. So it’s not surprising that the associations that deal most directly with that sphere of higher education are old hands in wrestling with these issues, and are in fact in their second go-rounds of trying to advise their members about how best to avoid or “manage” potential financial and other conflicts.

More than five years after the Association of American Universities and the Association of American Medical Colleges published their initial reports and recommendations on how institutions should deal with real and perceived conflicts, the two groups on Thursday issued a new report that goes quite a bit further in prescribing (and in some cases proscribing) certain activities and behaviors.

The report, “Protecting Patients, Preserving Integrity, Advancing Health: Accelerating the Implementation of COI Policies in Human Subjects Research,” is the product of more than two years’ work by a joint committee of the AAU, which represents 62 leading research universities, and the medical college association. Even though it was begun long before the student loan controversy unfolded, it seems timely not only for that reason, but because it follows by just two weeks the release of a survey showing that medical schools have been much slower to adopt policies governing “institutional” conflicts of interest (those involving the financial interests of a college itself and of officials there who are not directly involved in research) than “individual” conflicts (those involving scientists and others who are directly involved in research).

In many ways that finding was not surprising, given that the federal regulation of conflicts of interest in federally sponsored biomedical research focuses on individual rather than institutional conflicts, and as a result, that’s where university administrators have directed their attention. And while the new document reiterates and in some ways toughens the associations’ stance on individual conflicts, it pays significantly greater attention to institutional conflicts, reflecting the intensifying public policy concerns driven in part by recent headlines.

“Institutional conflicts of interest are a source of growing concern as the number and complexity of the roles played by institutions of higher education continue to increase, and their relationships with industry continue to expand,” the report’s authors say in their executive summary. “At the same time, and notwithstanding the earlier guidance documents, the development and implementation of comprehensive institutional conflicts of interest policies continues to challenge the academic community.” (Although this report focuses relatively narrowly on conflicts in human subjects research, the committee’s members note that the panel “recommends that AAU and AAMC member institutions should commit themselves to develop and implement comprehensive institutional conflicts of interest policies that govern all operational aspects of a university or an academic medical center.")

The report is divided into three chapters. The first focuses on individual conflicts of interest, and while it largely refines the associations’ earlier guidance, it recommends somewhat tougher standards for institutions to strive for in several key areas. For instance, it urges institutions to apply their conflicts policies to the principal investigator on a study and “any other person who shares responsibility for the design, conduct or reporting” of funded research, as well as their spouses and dependent children.

The report also recommends that institutions require individuals to report any outside financial interest related to their professional responsibilities to the institution, rather than excluding “de minimis” amounts as many such policies do. Reporting of all financial interests should occur “whether or not the individual believes these financial interests might reasonably appear to be affected by the individual’s current or anticipated human subjects research,” the report states.

While the report does not specifically address this month’s survey showing the relatively slow rate of adoption of policies on institutional conflicts, it directly challenges institutions to get with the program. Universities and medical schools that engage in biomedical research should adopt “within two years of the issuance of this report” institutional conflicts policies “covering both the financial interests of the institution and of institutional officials, including deans, department chairs and division chiefs, in human subjects research,” and a system for reporting, evaluating and managing such conflicts.

The report also clearly embraces the idea that the parts of universities that are responsible for research and, alternatively, for the institutions’ financial operations “must be separated.”

“If an institution fails to separate its responsibility for the oversight and administration of human subjects research from its responsibility for the management of the institution’s financial interests, the risks of compromising the safety of human subjects and the integrity of the research performed are significantly heightened,” the report states. “Institutions and institutional officials must segregate individuals who are entrusted with making decisions about research policy from all decisions, processes, and projects involving institutional business investments or other financial interests. Most institutions of higher education have established firewalls for these purposes. However, at some high level, the two streams of finance and research oversight inevitably converge. Therefore, systems should be in place, either in the office of the university chancellor or president, or other high ranking university official, to ensure that human subjects safety and the integrity of the data generated in human subjects research remain the institution’s top priority. Even where the separation of function is secured by a strong firewall, certain financial relationships with commercial research sponsors should be examined closely to avoid institutional conflicts of interest.”

The report also lists potential circumstances that could create institutional conflicts of interest and should be examined, including:

• When the institution is entitled to receive royalties from the sale of an investigational product that is the subject of the research.
• When, through its technology licensing activities or investments related to such activities, the institution has obtained an equity interest or an entitlement to equity of any value (including options or warrants) in a non-publicly traded sponsor of human subjects research at the institution.
• When the institution has obtained an ownership interest or an entitlement to equity (including options or warrants) of greater than $100,000 in value in a publicly traded sponsor of human subjects research at the institution.
• When, with regard to a specific research project, institutional officials with direct responsibility for human subjects research hold a significant financial interest in the commercial research sponsor or the investigational product.
• When an investigator, research administrator, or institutional official with research oversight authority participates materially in a procurement or purchasing decision involving major purchases from, or non-routine supply contracts with, a commercial entity that sponsors human subjects research at the institution.
• When the institution has received substantial gifts (including gifts in kind) from a potential commercial sponsor of human subjects research.

The report also includes a “model policy” on institutional conflicts of interest as a potential guide for member universities, as well as a set of case studies that describe some of the situations institutions might encounter and the sorts of questions they should weigh.

“Compared to what was done at the beginning of the decade, this is far more prescriptive and detailed than earlier documents,” said Patrick White, director of federal relations at the Association of American Universities, who was among the staffers who advised the panel’s members. “We were working on the chapter [on institutional conflicts] long before we had these issues flare this summer. The emphasis on institutional conflicts is in part dictated by the news, but also by concern about it as an area of performance. Our constituents, the chancellors and presidents, responded to it as an issue for them, and not just in human subjects research.”

The advisory panel was co-chaired by Robert R. Rich, senior vice president for medicine and dean at the University of Alabama at Birmingham’s School of Medicine, and Mark S.Wrighton, chancellor
of Washington University in St. Louis.

— Doug Lederman

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