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RBM Project Description: Improve consistency of Federal-wide policies for Research Conflict of Interest

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RBM Project Description

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Executive Committee
Dept./Agency Participation
Federal Register Notices

Improve consistency of Federal-wide policies for Research Conflict of Interest

Working Group on Stewardship and Accountability

Goal: To improve consistency of agency practice in treatment of Federal-wide policies for research conflict of interest.

Objectivity of researchers is an essential value in scientific research and the basis for public trust. Any research links with industry while not intrinsically unacceptable raise the prospect that scientific advances will bring financial gain for the research scientist and his or her institution. Concerns arise when financial considerations may compromise—or have the appearance of compromising—the professional judgment of the investigator or the institutional official, independence in the design, conduct, publication of research, and/or the welfare of human subjects. The issues associated with individual Conflicts of Interest (COI) have already received a great deal of deliberation, with current attention now focused largely on developing and improving existing systems for managing such conflicts, as well as on sharing best practices and lessons learned. Guidelines associated with managing institutional COI are less developed but of increasing concern. This concern arises from the increase in equity holdings and royalties by universities in non-public companies that have spun off from university-based research findings, particularly in the decade following the Bayh-Dole legislation. Current efforts focus on developing new policies and principles since no regulations govern this area. Institutional review boards (IRBs), institutions, and investigators engaged in human subjects research each have appropriate roles in ensuring that financial interests do not compromise the protection of research subjects.

In 1995, The National Science Foundation (NSF) and the Department of Health and Human Services (HHS) issued rules that harmonized their grant policies on investigator financial disclosure. The two agencies have continued to work together to ensure that the rules impose consistent obligations on institutions receiving PHS and NSF funding. Research administrators have repeatedly called for Federal agencies to resolve differences in conflict of interest interpretations, and in terms and conditions, building upon the work of the Federal Demonstration Project (FDP). It is apparent that the understanding of reporting requirements and individual COI policies and procedures varies widely at institutions across the country. These variations include institution management and monitoring practices, how and when the Institutional Review Board (IRB) is involved, and limits on equity holdings and company participation.

Scope and Key Results:
The long term objective is to develop specific guidance or regulations concerning institutional financial conflicts of interest, and to resolve differences in conflict of interest interpretations and terms and conditions of Federal grant awards. The subcommittee members will work initially to determine where further adjustments can be made to harmonize approaches. Because of the need for a proper balance between federal regulation and self-regulation, the subcommittee must involve input from research institutions to develop sensible guidelines and mechanisms to ensure and enhance research integrity. The research community understands that serious action on their part in demonstrating compliance can help to mitigate increasing public pressure for government regulation. As institutions strive to balance risks, public perception, and patient safety, their development of COI policies and procedures, including clear assignment of institutional responsibility, must occur in tandem with the education of researchers and the public about proper disclosure and management of potential and real conflicts of interest, both individual and institutional.

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