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May 13, 2002 Deans, Chairs and Directors: In August 2001, I sent each of you a copy of a report prepared by the Task Force on Financial Conflicts of Interest in Clinical Research, a campus committee convened last year after discussion with the Deans of the School of Medicine and Chairs of the Clinical Departments. That report, submitted by the Committee's Chair, Professor Allen R. Nissenson, recommended broader disclosure of financial interests by UCLA investigators and key research personnel, promulgation of a set of principles, development of an educational program, improved information sharing between various campus entities responsible for the collection and review of financial disclosures, and clear guidelines for the faculty about the way in which various types of financial interests are viewed by the institution. I am writing now to advise you about several other reports that have been issued since that time and about actions that will .be taken on the UCLA campus as a result of the Nissenson Committee recommendations. In October 2001, the Association of American Universities (AAU) Task Force on Research Accountability issued its "Report on Individual and Institutional Financial Conflicts of Interest." Its conclusions about individual conflicts of interests echo in many ways the findings of the UCLA Task Force. Like the UCLA Task Force report, the AAU Report suggests that many financial interests are not conflicts and that many, if not most, disclosed financial interests could be managed. A copy of the AAU Report can be accessed at http://www.aau.edu/reports/report1.html. In December 2001, the Association of American Medical Colleges (AAMC) Task Force on Financial Conflicts of Interest in Clinical Research issued its report on "Protecting Subjects, Preserving Trust, Promoting Progress- Policy and Guidelines for the Oversight of Individual Financial Interests in Human Subjects Research". The AAMC Report can be accessed at: http://www.aamc.org/members/coitf/firstreport.pdf. Both the AAU and the AAMC reports underscore the importance of assuring the integrity of research conducted within the academic environment. Both suggest that academic institutions re-examine their own policies, strengthening them and updating them as appropriate. In this respect, research involving human subjects is unique because of the special risks entailed and because of the special obligations that Universities have for protecting human participants. While the review of financial disclosures related to basic research may be considered somewhat differently from research in which human subjects are involved, and decisions about how those conflicts should be managed may also be somewhat different, the campus is responsible for ensuring that all research is conducted in an environment in which the appearance or reality of conflicts of interest are minimized. Thus, upon reflection, even though the Nissenson Committee made their recommendations in the context of clinical research, I realize that with only minor modification, the principles the UCLA Task Force drafted are broadly applicable to all research and not just that conducted with human research subjects. Chancellor Carnesale, Executive Vice Chancellor Hume and I are in agreement that these principles are a clear articulation of UCLA's view and should be adopted as such. Given that, a copy of those principles is attached. They are also posted on the ORA website at: http://www.research.ucla.edu/memos/memo_coi.htm. In addition to the promulgation of governing principles, the UCLA Task Force also suggested that information about personal financial interests in non-governmental research sponsors be gathered not only from the Principal Investigator (PI) and any Co-Principal Investigators (Co-PI) as is now done, but also from all other UCLA personnel who have independent responsibility for accomplishing project objectives. For this purpose, effective September 1, 2002, we will ask all Principal Investigators to identify all other UCLA key personnel who have independent responsibility for design, conduct or reporting of grant, contract or gift-supported research projects in order to gather disclosures of financial interests from each of those individuals. This change in practice will entail a revision of UCLA Procedure 921.1 "Disclosing Financial Interest in Private Sponsors of Research". As part of the procedural change, the forms used to collect information about financial interests in non-governmental sponsors of research will also be revised. In the meantime, if you have any questions about the Task Force report or the implementation of its recommendations, please contact Ann Pollack, Assistant Vice Chancellor - Research for Policy and Standards. She may be reached at campus extension 40387 or you can contact her by e-mail at apollack@resadmin.ucla.edu. Sincerely, Roberto D.
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