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Part IV: General Principles for Management of Conflicts of Interest (COI) and Financial Conflicts of Interest (FCOI) (22–31)
- University of Illinois Press
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DETAILED DISCUSSION OF THE 56 RECOMMENDED PRINCIPLES 163 Part IV. General Principles for Management of Conflicts of Interest (COI) and Financial Conflicts of Interest (FCOI) (22–31) We have already discussed conflicts of interest at many points in this book, most thoroughly in“A Brief History of Efforts to Address Financial Conflicts of Interest at US Universities and Academic Medical Centers” under Risk 5 in the Introduction.This section will necessarily repeat some points in order to emphasize the reasons why COI and FCOI remain among the most serious threats to the freedom, autonomy, and integrity of academic work, and to the public’s support for and confidence in that work. They also remain among the most challenging problems on university campuses: and never more so than in the context of expanding academy-industry collaborations. It is also important to keep in mind that research misconduct—such as intentionally falsifying or distorting data—is a separate issue, and universities and the federal government have established separate regulations and procedures to investigate misconduct charges and to punish proven misconduct. As we point out, a growing body of empirical research shows that COI are associated with decision-making and research bias. COI tend to introduce unreliability into the research process, undermine public trust, and erode respect for universities. COI also undercut a university’s ability to perform research and teaching free of the influence of special interest groups. Disclosure of a COI, even full disclosure with informed consent, does not resolve these problems. Disclosure is an important mechanism for addressing FCOI related to academic research, but simply disclosing such conflicts is not sufficient to instill public confidence or protect the integrity of academic scholarship.Experience has clearly shown that,just as COI disclosure is inadequate , so too are policies that rely heavily, or even exclusively, on case-bycase management of individual faculty and institutional COI. As early as 1965,in“On Preventing Conflicts of Interest in GovernmentSponsored Research at Universities,” the AAUP and ACE pressed for “the formulation of standards to guide the individual university staff members in governing their conduct in relation to outside interests that might raise questions of conflicts of interest.”446 Now the AAUP is returning to this issue in the context of heightened academy-industry engagement in order to provide a set of COI principles that can be adopted campuswide.The goal of these COI principles should be to encourage research integrity and the practice of objective science; preserve an institutional environment committed to 164 DETAILED DISCUSSION OF THE 56 RECOMMENDED PRINCIPLES openness and trust; guard against unintentional bias and error; and punish misbehavior when it is uncovered. Starting in 2000, many professional and academic groups took note of rising commercial engagement and issued a series of consensus statements calling for stronger, more comprehensive university and academic medical center FCOI policies. The AAUP agrees with the consensus reached by numerous professional groups—including the AAU, IOM, AAMC, and, most recently, DHHS/NIH, which issued a new set of COI rules in August 2011—that the purpose of these COI regulations is to be preventative.447 As the DHHS/NIH explains, COI rules are “intended to be proactive rather than reactive to specific evidence of bias.”448 Rather than trying to remedy possible bias or respond to damage after it has occurred or has been unearthed by the media, COI rules are needed to reduce the risk of bias and the loss of credibility that may be associated with the mere existence of these financial conflicts. In 2009, an IOM panel on COI in biomedicine observed that “a range of supporting organizations—public and private—can promote the adoption and implementation of conflict of interest policies and help create a culture of accountability that sustains professional norms and public confidence in professional judgments.”449 The AAUP thus adds its own voice to the chorus of those calling for universities to strengthen and harmonize their COI policies .If universities do not voluntarily implement more rigorous,comprehensive , and uniform COI policies and procedures, then pressure for external regulation is likely to grow more strenuous. The AAUP wholeheartedly agrees with the AAU’s assessment that university COI policies need to be comprehensive, and must cover research “across all academic fields, not just biomedical ones.”450 This recommendation for comprehensive, campuswide COI policies has been endorsed by the AAU-AAMC (2008)451 and by an IOM panel (2009).452 The AAUP further agrees with the emerging consensus that these policies must encompass...