Conflicts of Interest in Research
Financial Conflicts of Interest Regulations
Final Rule on Regulations Related to Individual Conflicts of Interest in Federally-funded Research
On August 23, 2011, the Department of Health and Human Services issued a final rule revising the regulations entitled "Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors."
AAMC is working with member medical schools and teaching hospitals to measure the effects and effectiveness of the rule using annual, aggregate data about conflict of interest review systems, disclosures made by investigators to institutions, and financial conflicts of interest identified and reported to federal funding agencies. More information and registration procedures are available at www.aamc.org/metricsproject. You may direct any questions to COIMetrics@aamc.org.
This report, issued in March 2012 by the AAMC, provides institutions subject to the new rule with some insight into how their peer institutions were thinking about these issues in the first few months after announcement of the new rule, and to provide a range of contemplated approaches. The report captures the contributions of 48 AAMC member institutions that participated in a series of regional working meetings convened in late 2011.
"Sunshine" Regulations on Reporting of Payments to Physicians and Teaching Hospitals
On February 8, 2013, the Centers for Medicare and Medicaid Services (CMS) issued a final rule entitled "Transparency Reports and Reporting of Physician Ownership or Investment Interests," (78 FR 9458). This rule implements section 6002 of the Affordable Care Act.
Informational Webinar on the Sunshine Final Rule
On February 21, 2013, AAMC hosted a webinar, The Sunshine Final Rule: What Medical Schools and Teaching Hospitals Need to Know, to present the major provisions of the final rule, the changes from CMS’ proposed rule of December 19, 2011, and the impact on physicians and teaching hospitals. This information can be accessed here: PowerPoint presentation and Webinar Recording.
AAMC Reports on Individual and Institutional Financial Conflict of Interest Policies
Protecting Patients, Preserving Integrity, Advancing Health: Accelerating the Implementation of COI Policies in Human Subjects Research
This report, issued February 2008 by the AAMC and the Association of American Universities, calls on all medical schools and major research universities to develop and implement institutional COI policies within the next two years, and to refine standards for addressing individual financial COIs.
U.S. Medical School Policies on Individual Financial Conflicts of Interest: Results of an AAMC Survey
U.S. medical schools have made significant progress since 2001 in clarifying and strengthening their financial conflicts of interest standards in clinical research; 95 percent now have a policy in place that applies to all human subjects research. This is among the findings of an AAMC survey on COI trends. Other findings and four charts summarizing survey results are available:
Protecting Subjects, Preserving Trust, Promoting Progress: Policy and Guidelines for the Oversight of Individual Financial Interests in Human Subjects Research
This first report of the AAMC Task Force on Financial Conflicts of Interest in Clinical Research, issued in 2001, provides guidance related to individual financial interests in human subjects research.
Protecting Subjects, Preserving Trust, Promoting Progress II: Principles and Recommendations for Oversight of an Institution's Financial Interests in Human Subjects Research
This second report of the AAMC Task Force offers a conceptual framework for assessing institutional conflicts of interest and a set of specific recommendations for the oversight of certain financial interest in human subjects research. The guidelines highlight areas that, in the view of the AAMC's Task Force, are especially problematic and must therefore receive close scrutiny.
Conflicts of Interest in Medical Education
The 2008 final report of the AAMC Task Force on Industry Funding of Medical Education examines the benefits and pitfalls associated with industry funding of medical education, and offers principles, recommendations, and guidelines to assist members in refashioning industry relationships to better conform to high standards of medical professionalism.
Conflicts of Interest in Clinical Care
In the Interest of Patients: Recommendations for Physician Financial Relationships and Clinical Decision Making
This 2010 AAMC report urges U.S. teaching hospitals to establish policies that manage financial relationships between physicians and industry so that these relationships do not influence patient care.
Science Behind Conflicts of Interest
AAMC Symposium on the Scientific Basis of Influence and Reciprocity
The June 12, 2007 AAMC Symposium on the Scientific Basis of Influence and Reciprocity brought together experts who discussed emerging neurobiological and psychosocial evidence demonstrating the effects of gifts, favors, and reciprocal relationships on human choices and behaviors.
News and commentary from AAMC Chief Scientific Officer Ann Bonham