Perspective
Disclosing Industry Relationships — Toward an Improved Federal Research Policy
N Engl J Med 2010; 363:604-606August 12, 2010
- Article
Some types of academic–industry relationships are an essential component of the research enterprise in the life sciences. Empirical data show that more than half of academic scientists have such relationships, which most often involve consulting, receiving research funding, and providing scientific advice.1 These and other forms of industry relationships are significantly more common among the most productive academic scientists than among their less productive colleagues. Moreover, every academic institution that is involved in research most likely has some form of institutional relationship with industry.2
Academic–industry relationships have both benefits and risks. Whether through direct sponsorship of research or through advising, such relationships facilitate the discovery of new drugs, devices, and other medical innovations that often result in the improved diagnosis, treatment, and prevention of human disease. At the same time, published studies whose conduct involved financial relationships between academia and industry have been shown to disproportionately support the use, safety, and desirability of the companies' products and services, leading to the perception that industry sponsorship results in a systematic bias in favor of industry.2
Disclosure has been the usual response to concerns about academic–industry relationships. Current federal regulations require that academic researchers receiving funding from the National Institutes of Health (NIH) or selected other agencies of the Department of Health and Human Services (DHHS) report to their institution any industry relationships valued at $10,000 or more that would reasonably appear to affect the research for which a grant is being sought. Once such a conflict has been reported, institutions are required to reduce, manage, or eliminate it and report their actions to the government.
The effective functioning of this system relies on two key steps, both of which have major potential limitations. First, it requires faculty members to fully disclose any payments from companies that are made directly to them as individuals — money that is often invisible to their institutions. When such industry relationships are not disclosed, institutions cannot evaluate and manage them. Although instances of the failure of scientists to disclose such ties have come to light, there are no systematic, empirical data regarding the frequency with which this occurs.
The second step is for institutions to evaluate scientists' disclosures and decide what action should be taken. The processes and outcomes of such decisions are unique to each academic institution, have been poorly studied, are largely free of governmental oversight, and are almost always shrouded in secrecy. Also, these decisions are frequently made by institutions that themselves have undisclosed financial relationships with industry, the existence of which most likely affects their decisions regarding investigators' industry relationships. In fiscal year 2006, only 41 grantee institutions reported conflicts to the NIH (a total of 225 conflicts), and the Office of Inspector General complained that the oversight process consisted of mere “reliance on the assurances that the grantee institutions have followed Federal regulations.”3
To address these problems, the DHHS has proposed revising federal regulations (with a public comment period through July 20, 2010; http://edocket.access.gpo.gov/2010/pdf/2010-11885.pdf). The proposals include lowering the disclosure threshold to $5,000; requiring disclosure to the investigator's institution of all relationships, not just those that the investigator decides are related to a given grant; and requiring institutions to determine the relevance of relationships, to develop a management plan for all conflicts, and to share the results of these management plans with the NIH and the public through a public Web site.4
The efficiency and effectiveness of the federal regulations could be enhanced in a few additional ways (see Recommendations for Improved Federal Regulation of Academic–Industry Relationships) — several of which are very similar to those proposed recently by the Institute of Medicine.2 First, we believe that the disclosure threshold of $5,000 is excessively high. The Affordable Care Act (ACA) requires drug and device manufacturers to publicly report all gifts and compensation of $10 or more (or at least $100 per year) that they pay to individual physicians or teaching hospitals. The new threshold should be consistent with that set by the ACA, allowing for built-in cross-checking of reporting for physician investigators.
Second, we believe that a standardized federal reporting form should be developed by the DHHS and that its use should be required by all grantee institutions. This form should be electronic in nature and easy to update by scientists; whenever possible, it should replace the duplicative, poorly defined, and sometimes conflicting practices for reporting outside activities that are often used at academic institutions. Furthermore, the standardized form should easily format information about academic–industry relationships to satisfy reporting requirements associated with common scientific activities, including publications, presentations, and grant applications. Adoption of such a form would standardize the reporting process and greatly reduce the burden for investigators who often have to complete many disclosures a year. This may be especially important for the most productive investigators, since we would not want the burden of completing multiple disclosures to cause scientists to cut back on beneficial and appropriate relationships with industry.
Third, to address the problems of nondisclosure by individual scientists, we believe that the NIH should fund research to accurately determine the nature, extent, and consequences of the failure of faculty members to fully inform their institutions about their industry ties. Findings from such research could be used to guide additional government actions. If severe underreporting is discovered, the government could require companies to provide institutions that receive federal funding with copies of all 1099 tax forms of scientists and institutional leaders who are paid for outside activities related to their area of scientific expertise. A second option would be to require that all payments for outside activities be made to the institution and then passed on to the faculty member. Whatever the mechanism, such requirements would create an institutional record of academic–industry relationships that is not reliant on self-disclosures by faculty scientists and would facilitate accurate public reporting.
Fourth, since many institutions probably lack the skills, experience, or motivation to manage financial conflicts of interest properly, there may well be wide variations in the degree of institutional leniency regarding the same types of relationships. We believe that, at least at first, grantee institutions should be given some guidance from the DHHS regarding the types of industry relationships that are the most problematic and that therefore require the greatest institutional scrutiny. In cases in which an empirical basis for such guidance is lacking, we propose that the NIH fund additional research that empirically addresses this and other relevant issues. The results of this research should form the foundation for future guidance.
Fifth, we believe that information about all academic–industry relationships at the investigator and institutional levels should be made available on institutional Web sites with appropriate protections for intellectual property and other relevant concerns. These data should be provided in a common format and should be usable by various scientific constituencies, including journal editors, peer reviewers, potential collaborators, institutional review boards, conference organizers, and other interested parties involved in research. Also, these data should be easy to locate and be searchable by individual name, company, and other pertinent characteristics.
Finally, we suspect that the costs of following such new requirements would be substantial, especially in the most research-intensive institutions. If current funds that are provided as part of the facilities and administrative costs of grants are not sufficient, then additional funding should be provided to offset the additional costs associated with increased monitoring and reporting of industry relationships.
These proposed changes in federal policy would represent a step toward creating a more organized, efficient, and effective system related to academic–industry relationships. Like all policy changes, however, they would be neither perfect nor easily implemented. Research relationships with industry should be allowed and even encouraged, but we must ensure that they are consistently disclosed and properly managed by institutions according to empirically based guidance.
Recommendations for Improved Federal Regulation of Academic–Industry Relationships.
1. The disclosure threshold should be lowered to the level set by the ACA: $10 per gift or payment, or $100 per year, from a company.
2. A standardized federal reporting form should be developed, and all DHHS grantee institutions should be required to use it.
3. The NIH should fund research on the nature, extent, and consequences of the failure of faculty members to fully inform their institutions about industry ties; research findings should guide further government actions.
4. The DHHS should offer guidance to grantee institutions regarding the most problematic types of industry relationships, and the NIH should fund additional research into such questions.
5. Data on academic–industry relationships at the investigator and institutional levels should be made available, in a common format, on institutional Web sites.
6. If existing monies are not sufficient, additional funding should be provided to offset the additional costs associated with increased monitoring and reporting of industry relationships by academic institutions.
Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.
This article (10.1056/NEJMp1006973) was published on July 14, 2010, at NEJM.org.
Source Information
From the Mongan Institute for Health Policy, Massachusetts General Hospital, Boston (E.G.C.); and the Heller School for Social Policy and Management, Brandeis University, Waltham, MA (D.E.Z.).
- References
References
1
Zinner DE ,Bolcic-Jankovic D ,Clarridge B ,Blumenthal D ,Campbell EG . Participation of academic scientists in relationships with industry. Health Aff (Millwood) 2009;28:1814-1825
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Institute of Medicine. Conflict of interest in medical research, education, and practice. Washington, DC: National Academies Press, 2009.
3
Department of Health and Human Services, Office of the Inspector General. How grantees manage financial conflicts of interest in research funded by the National Institutes of Health. Washington, DC: DHHS/OIG, November 2009. (Publication no. OEI-03-07-00700.)
4
Rockey SJ ,Collins FS . Managing financial conflict of interest in biomedical research. JAMA 2010;303:2400-2402
CrossRef | Web of Science | Medline
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Stephan Sahm. (2011) Of mugs, meals and more: the intricate relations between physicians and the medical industry. Medicine, Health Care and Philosophy
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Danielle Laraque, Ruth Etzel. (2011) Statement of Principles: APA-Industry Relationship. Academic Pediatrics 11:5, 355-356
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C. Stein. (2011) Wissenstransfer zwischen Forschung und Praxis. Der Anaesthesist 60:5, 405-405
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