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Conflict of Interest Guidance Issued

March 20, 2008

Additional guidance on financial conflicts of interest in human subjects research, issued recently by the Association of American Medical Colleges and the Association of American Universities, provides useful advice for others as well as the research community. Building on recommendations made in 2001 and 2002 on individual and institutional conflicts of interest in research, the associations convened an advisory committee in 2006 to:

• Define key issues confronting the biomedical research community;
• Develop a more nuanced stratification of the risks and benefits;
• Provide detailed guidance about the analysis and management of conflicts of interest; and,
• Provide practical tools to ensure that academic research continues to be conducted in conformity with the institutions’ core values.

The result of that effort is Protecting Patients, Preserving Integrity, Advancing Health: Accelerating the Implementation of COI Policies in Human Subjects Research. The three chapters of the 87-page report cover individual conflict of interest policies, institutional conflict of interest policies, and implementation of conflict management programs. The discussion of implementation provides detailed steps leading to a systematic approach to analyzing and managing conflicts of interest, including a template that can be used for analysis, and ten detailed case studies based on real situations.