This highly visible report makes several recommendations designed to accelerate implementation of effective policies that address both individual and institutional financial conflicts of interest.
A Joint Advisory Committee of the Association of American Medical Colleges (AAMC) and the Association of American Universities (AAU) issued its comprehensive report today on identifying, assessing and managing individual and institutional financial conflicts of interest in research involving human subjects. The report, “Protecting Patients, Preserving Integrity, Advancing Health: Accelerating the Implementation of COI Policies in Human Subject Research,” is the culmination of two years of study and deliberations, and it refines, reinforces and builds upon the basic principles and corresponding guidelines articulated in the internationally known conflict of interest reports AAMC and AAU issued in 2001 and 2002. The report and related materials can be found here.
It is no secret that conflicts of interest in research and clinical care arising from financial relationships between providers and industry entities such as pharmaceutical and medical device manufacturers have prominently appeared on the radar screens of the government, the plaintiff’s bar, the media, trade associations and the public since the early 2000s. The predominant concern underlying the interest of, and call for reform by, these various constituencies is preventing bias in decision making that can adversely affect the safety of human subjects who participate in clinical trials and the integrity of the study and study data. Various developments and publications, including the 2001 and 2002 reports published by AAMC and AAU, the codes of ethics published by various industry trade associations such as the Pharmaceutical Research and Manufacturers of America (PhRMA) and AdvaMed, and guidance published by the Office of the Inspector General of the Department of Health and Human Services, have produced industry conflicts of interest standards that are more rigorous in many respects than the conflict of interest requirements under applicable law and regulations. (See discussion in http://www.mwe.com/info/pubs/MedicalResearchLawPolicyReport101806.pdf.)
These industry conflict of interest standards extend beyond the research context to address potential bias that relationships of medical schools and providers with industry can create for other key areas of decision making by universities, medical schools, academic medical centers, research institutions and clinical research support organizations, such as establishment of preferred vendor relationships, development of approved lists of pharmaceuticals and medical devices, investments, formation of strategic partnerships and fundraising. Further, the relationships that generate conflicts of interest compliance concern can generate federal health care fraud compliance and enforcement concerns.
The AAMC/AAU Report and Related Survey
Like the 2001 and 2002 AAMC and AAU reports, this report focuses on both individual and institutional financial conflicts of interest. However, this report is designed to make several recommendations to accelerate implementation of effective policies that address both types of conflicts. Moreover, the report emphasizes the need for consistency of policies, and ongoing collaboration, both within and among medical schools, research universities, teaching hospitals and industry entities.
Specifically, the report recommends that all medical schools, teaching hospitals and AAU institutions take the following action:
- Accelerate the development of COI policies that cover the financial interests of faculty, institutions and their officials, including deans, department chairs and division chiefs
- Implement a reporting, evaluation and management process for both individual and institutional financial COI, that includes a review system that involves a standing internal committee or an external review entity
- Complete the development and implementation of institutional COI policies in the next two years
To facilitate this effort, the report provides a model template for analyzing and managing conflicts of interest situations, and provides 10 detailed case studies based on real situations.
The work of the Joint Advisory Committee was supplemented and supported in part by a study of national medical school policies and practices for dealing with institutional conflicts of interest, undertaken jointly by AAMC and Massachusetts General Hospital. The study and its findings are discussed in detail in Susan H. Ehringhaus, et al., “Reponses of Medical Schools to Institutional Conflicts of Interest,” JAMA, February 13, 2008, Vol. 299, No. 6, p. 665-671. A February 12, 2008, news release issued by AAMC emphasized the study’s finding that significantly more study participants had focused on potential conflicts of interest arising from financial interests of senior institutional officials than on financial interests held by the institutions themselves.
Also noteworthy is that this same press release expressly recognizes that putting comprehensive conflicts of interest programs in place means that “highly integrated trans-institutional databases and management systems are required to track the multitude of frequently changing institutional financial holdings.”
The Report’s Implications
This report will undoubtedly keep conflicts of interest in the national and international spotlight, and revive a sense of urgency about implementing compliance programs that are consistent with its recommendations and with other industry standards and practices that were spawned by predecessor AAMC and AAU reports. Significant challenges in responding to this renewed call for reform will include (1) determining the extent to which these standards are “scalable” to an institution’s particular needs, complexity and resources (e.g., can all institutions effectively implement an electronic conflicts management database); and (2) developing a course of action that achieves the right balance between the need to manage the conflicts and health care fraud compliance risks on the one hand, and the need to maintain traditional relationships and promote innovation that advances medical science and improvements in health care delivery on the other. For these and many other reasons, the report is required reading by all health industry sectors.