<< Previous Section | < Previous Page | Next Page > | Next Section >> Bibliography (page 1 of 13) Cohen, J. J. (2001). "Trust Us to Make a Difference: Ensuring Public Confidence in the Integrity of Clinical Research." Acad Med 76(2): 209-214.       Investigators' and institutions' financial conflicts of interest in clinical research raise serious questions about the objectivity of such research, the safety of human subjects, and the threat to public trust in the integrity of clinical research. Yet the author makes clear that a conflict of interest is a state of affairs, not a behavior, and therefore not automatically a manifestation of improper actions. But it is clear that both non-financial conflicts of interest and financial ones are double-edged: they can motivate individuals to do their best work but also can compromise judgment and undermine objectivity. The author offers eight suggestions for what academic medicine's leaders might do in this regard (comply with existing full-disclosure requirements; establish principles governing institutional conflicts of interest; etc.). He closes by reiterating that the pursuit of clinical research depends entirely on the ability and willingness of the research community to merit public trust. (2003). "Protecting Subjects, Preserving Trust, Promoting Progress I: Policy and Guidelines for the Oversight of Individual Financial Interests in Human Subjects Research." Acad Med 78(2): 225-236.       (From the Executive Summary) In December 2001, the AAMC Task Force on Financial Conflicts of Interest in Clinical Research released this report, the first of two (both published in this issue of Academic Medicine). This report focuses on gaps in existing federal financial disclosure regulations of individual conflicts of interests, finding that additional scrutiny is recommended in two areas: human subjects research and privately sponsored research. The task force suggests that when potential conflicts exist, a conflicts of interest committee should apply a rebuttable presumption against engaging in human subjects research. The task force recommends that the circumstances giving rise to the presumption against the proposed activity be balanced against compelling circumstances in favor of the conduct of the research. The AAMC task force delineates core principles to guide institutional policy development. First, an institution should regard all significant financial interests in human subjects research as requiring close scrutiny. Second, in the event of compelling circumstances, an individual holding a significant financial interest may be permitted to conduct the research. Whether circumstances are deemed compelling will depend in each case upon the nature of the science, the nature of the interest, how closely the interest is related to the research, and the degree to which the interest may be affected by the research. Four other core principles for development of institutional policies are identified in the report, pertaining to reporting, monitoring, management of conflicts, and accountability. (2003). "Protecting Subjects, Preserving Trust, Promoting Progress II: Principles and Recommendations for Oversight of an Institution's Financial Interests in Human Subjects Research." Acad Med 78(2): 237-245.      (From the Executive Summary) The AAMC Task Force on Financial Conflicts of Interest in Clinical Research issued this report, the second of two, in October 2002. (The first report is also published in this issue of Academic Medicine.) This report offers a unique perspective on the new phenomenon of "institutional" conflicts of interest. The task force acknowledges the diverse obligations of academic institutions that conduct research and also invest in--and accept the philanthropy of--commercial research sponsors. The task force emphasizes the importance of disclosing institutional financial interests as an integral part of the research process, critical to allaying public concerns, and to strengthening the trust relationship between research subjects, the public and the scientific community. The task force found that the safety and welfare of research subjects and the objectivity of the research could be--or could appear to be--compromised whenever an institution holds a significant financial interest that may be affected by the outcome of the research. Thus, the task force recommends separating the functional and administrative responsibilities related to human subjects research from those related to investment managing and technology licensing, and encourages the establishment of institutional conflicts-of-interest committees. As in the first report, the task force recommends that institutions should develop policies establishing a rebuttable presumption against the conduct of research at or under the auspices of an institution where potential conflicts in human subjects research are identified. This presumption against engaging in the research is to be balanced against compelling circumstances in favor of the conduct of the proposed research activity. << Previous Section | < Previous Page | Next Page > | Next Section >> Chapter 4 Quick Links Conflicts of Interest (COI) Definitions Consequences of a COI Government Intervention Industry Sponsorship Professional Societies Clinical Practice Guidelines Other Initiatives COI in Financial Consulting Cases Bibliography Chapter 4 Download (PDF)