Box 6.7Federal Policies and Guidance on Conflicts of Interest

In 1995, the Public Health Service (PHS) and the National Science Foundation (NSF) adopted federal regulations for financial conflicts of interest, setting $10,000 or more than 5 percent ownership in any single entity as the threshold for disclosure of financial arrangements [42 CFR 50 subpart F; 60 Fed. Reg. 132, 35809 (July 11, 1995)]. FDA released its own financial disclosure regulations in 1998 that required investigators to report, among other things, payments of $25,000 beyond the cost of research and equity interests valued at more than $50,000 in sponsor companies (21 CFR 54, 312, 314, 320, 330, 601, 807, 812, 814, 860). FDA review of such conflicts is retrospective, whereas the PHS/NSF regulations require disclosure by the time a grant application is submitted. An important point, however, is that the federal regulations were intended to encourage objectivity in research practice—not to protect human research participants per se.

DHHS has begun to address conflicts of interest in research involving human participants, releasing a draft interim guidance on financial relationships in clinical research in 2001 (2001a). Based on a public conference held in August 2000, the guidance includes considerations for institutions, investigators, and IRB members and staff. It also offers suggestions for informed consent considerations. The guidance has not been finalized as of publication of this report.

There is broad agreement among research organizations and policy makers that clear policies and procedures about financial conflicts of interest are needed and that these should apply to all research with human participants regardless of the funding source. Although organizations whose research is funded by PHS or NSF or regulated by FDA are mandated to have such policies and procedures, GAO found inconsistency among policies at five research organizations and notes that the policies are not accessible to staff (GAO, 2001).

The National Human Research Protections Advisory Committee (NHRPAC) and the National Bioethics Advisory Commission (NBAC) also have addressed the topic in their recommendations to federal entities (NBAC, 2001b; NHRPAC, 2001). NHRPAC, commenting on the draft guidance of DHHS, advises DHHS to use the PHS threshold for the disclosure of conflicts and suggests procedures for assessing and managing conflicts of interest. It also addresses the need for disclosure, education, and compliance.

NBAC notes that “IRB review alone is not sufficient to manage financial conflicts” and suggests that institutions should increase their regulation of investigators' financial conflicts (2001b, p.59). NBAC also proposes that noninstitutional IRB members can help to mitigate conflicts of interest and that conflicts should be disclosed to participants.

From: 6, Improving Human Research Participant Protection Program Performance and Clarifying Roles

Cover of Responsible Research
Responsible Research: A Systems Approach to Protecting Research Participants.
Institute of Medicine (US) Committee on Assessing the System for Protecting Human Research Participants; Federman DD, Hanna KE, Rodriguez LL, editors.
Washington (DC): National Academies Press (US); 2002.
Copyright © 2003, National Academy of Sciences.

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