FINANCIAL CONFLICTS OF INTEREST AND RESEARCH OBJECTIVITY: ISSUES FOR INVESTIGATORS AND INSTITUTIONAL REVIEW BOARDS Release Date: June 5, 2000 NOTICE: OD-00-040 National Institutes of Health Introduction Objectivity of researchers is an essential value in scientific research and the basis for public trust. Researchers should be led by their data, not by other interests that might undermine the scientific integrity of their work. Of course, success in research is likely to bring valued publications, grant renewals, career advancement, and the satisfaction of accomplishment. And that accomplishment is often linked to rewards such as the development of new modalities for saving lives and alleviating suffering. These incentives are widely known and broadly shared. Any research links with industry raise the prospect that scientific advances will bring financial gain as well. The opportunity for investigators= personal financial gain or reward is not intrinsically unacceptable. However, recent highly publicized instances of apparent financial conflicts of interest have generated concern within the research and lay communities. Because of the complexity of the issues and the potential threats to the integrity of research posed by such conflicts of interest, the NIH is issuing these points to consider and announcing a public consultation to be held on this issue in the Summer of 2000. Why are there concerns? Concerns are raised when financial considerations may compromise or have the appearance of compromising an investigator"s professional judgment and independence in the design, conduct, or publication of research. Public Health Service regulations, promulgated in July 1995, Responsibility of Applicants for Promoting Objectivity in Research ( require institutions to: o maintain a written, enforced policy on financial conflict of interest, o inform research investigators of that policy, the associated reporting responsibilities, and related federal regulations, o report to awarding offices the existence of any conflicting interest(s) and assure that the interest(s) have been managed, reduced, or eliminated in accordance with the regulations. Institutions are required, therefore, to know what conflicts might exist, to manage, reduce, or eliminate those conflicts, and to report that information to the NIH. (Institutions are not required to provide the details of the conflict.) When Institutional Review Boards (IRBs) review specific protocols for the procedures to protect human subjects, the IRB must determine that: o risks to subjects are minimized, o risks to subjects are reasonable in relation to the anticipated benefits, o selection of subjects is equitable, o informed consent will be sought from each prospective subject and appropriately documented. When appropriate, the IRB should also determine that the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects, to protect the privacy of subjects, and to maintain the confidentiality of data. While there is no regulatory requirement for IRBs to consider investigators= financial conflict of interest, the protection of human subjects requires objectivity in communicating risks, selecting subjects, promoting informed consent, and gathering, analyzing and reporting data. IRBs should refer to their institution’s policies and procedures for identifying and managing conflicts of interest. In some cases, IRBs are incorporating conflict of interest issues in their deliberations. Some strategies used by IRBs to consider investigators Conflict of Interest How do individual IRBs deal with the potential that financial holdings might interfere with objectivity in research? Some estimates indicate that 25% of IRBs routinely deal with investigators= and IRB members= conflicts of interest during IRB deliberations. Some of their approaches include: o Make IRBs aware of the conflict of interest policies and procedures in their institution and elect to include a statement in the informed consent form that all clinical investigators comply with the institutional guidelines. o Ask investigators to complete a short questionnaire in which they are asked whether they or any other person responsible for the design, conduct, or reporting of this research has an economic interest in, or acts as an officer or a director of any outside entity whose financial interests would reasonably appear to be affected by, the research. o Provide instruction to IRB members during their orientation on how to identify and respond to a perceived financial, academic, or other conflict of interest. Public Consultation In the summer of 2000, the Department of Health and Human Services (DHHS) will host a forum on financial conflicts of interest. This forum will afford an opportunity to discuss sharing of information on the conduct of clinical trials between IRBs and compliance offices that deal with institutional policies and procedures on investigators conflict of interest. Other topics for discussion will include conflicts of interest pertaining to institutions, individual investigators, and IRB members. The forum will take place at the NIH Natcher Building on August 15 and 16, 2000. Further details will appear in the weekly NIH Guide for Grants and Contracts.

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