Gottesman, Michael M. MD; Jaffe, Holli Beckerman JD
Dr. Gottesman is deputy director for intramural research, National Institutes of Health, Bethesda, Maryland.
Ms. Jaffe is senior policy officer, NIH Ethics Office, National Institutes of Health, Bethesda, Maryland.
Correspondence should be addressed to Dr. Gottesman, National Institutes of Health, 9000 Rockville Pike, Building 1, Room 160, Bethesda, MD 20852; telephone: (301) 496-1921; fax: (301) 402-4273; e-mail: firstname.lastname@example.org.
Editor's Note: This is a commentary on Zinner D, DesRoches C, Bristol S, Clarridge B, and Campbell E. Tightening Conflict-of-Interest Policies: The Impact of 2005 Ethics Rules at the NIH. Acad Med. 2010;85:1685–1691.
In 2005, in response to increasing public concerns about potential conflicts of interest in biomedical research, the Department of Health and Human Services (DHHS) tightened its ethics rules to prohibit National Institutes of Health (NIH) employees from receiving consulting fees from “significantly affected organizations.” In response, NIH took steps to implement these regulations and ensure that relationships between intramural NIH researchers and industry could proceed without threatening the integrity of federally funded research. Examples of these steps include creating an ethics advisory committee to review outside activities of NIH scientists and subjecting its researchers to special scrutiny to eliminate any perception of personal profit or conflict of interest. In the authors' experiences, interactions between NIH scientists and industry have continued relatively unaffected by these regulations. The continuing success of the technology transfer program at NIH and the number and types of cooperative research and development agreements with industry are good measures of the extent of productive interactions with industry since the implementation of the 2005 ethics rules. Although recruitment of outstanding scientists to the intramural program has continued, these regulations also have challenged NIH's ability to attract and retain some of the most qualified scientists, who fear they may miss certain opportunities because of the tighter regulations. As DHHS revises the regulations governing oversight of financial conflicts of interest in the extramural community, the authors recognize that the NIH intramural experience may provide valuable lessons about developing and implementing the next generation of financial conflict-of-interest rules.
The National Institutes of Health (NIH)—the leading funder of biomedical research in the United States—is committed to turning discovery into health. Whereas the effort to move discoveries from the microscope to the marketplace often requires partnerships between NIH-supported researchers and industry, NIH has taken a variety of steps in recent years to ensure that such relationships proceed without threatening the integrity of federally funded research. In their article, Zinner et al explore the impact of some of these changes on the morale and productivity of the thousands of researchers directly employed by NIH.
Since World War II, the vast majority of NIH funding has gone to support the research of scientists at more than 3,000 universities, institutions, and organizations, also known as the extramural research community. Slightly less than 10% of the NIH budget, however, is devoted to the distinctive research that takes place within the federal laboratories on NIH campuses, research known as the intramural program. More than 1,000 principal investigators currently work in the intramural program as federal employees.
In 2005, in response to increasing public concerns about potential conflicts of interest in biomedical research, the Department of Health and Human Services (DHHS) tightened its ethics rules to prohibit NIH employees from receiving consulting fees from “significantly affected organizations.” Such organizations, which include pharmaceutical, biotechnology, and medical device companies, develop and/or produce products that are directly influenced by NIH research. These DHHS rules that apply to intramural scientists differ from the current conflict-of-interest rules for extramural scientists, which are based on identifying any perceived or actual conflicts of interest and managing such conflicts through disclosure and other means. Those rules for extramural scientists are under revision, discussed in more detail below, and will result in greater scrutiny in the future.
The survey by Zinner et al found that NIH intramural researchers were generally unhappy about the 2005 rule changes, but few effects on the researchers' scientific productivity could be demonstrated. We concur with the latter part of the study's conclusions. In our experiences since 2005, the stricter ethics rules have not posed a major barrier to recruitment or a serious impediment to retention of a first-rate scientific workforce at NIH. As discussed more fully below, we have not found the new rules to be an obstacle to NIH-approved, or “official duty,” interactions with industry.
To increase oversight and help implement the 2005 regulations, NIH built a sophisticated reporting system for use by NIH employees and ethics staff. We also created an NIH ethics advisory committee of scientific peers to evaluate requests for the most high-risk outside activities. To encourage normal academic interactions and community service, NIH scientists are allowed under most circumstances to accept honoraria for teaching, speaking, writing, and editing activities, as well as compensation for clinical activities that they conduct outside of their government jobs. Clinical researchers, however, are subject to special scrutiny to eliminate any perception of personal profit associated with human subjects research.
Contrary to what many may think, restrictions on outside activities imposed by the 2005 regulations are not a blanket prohibition against collaborations between NIH scientists and industry. In fact, many such interactions have continued relatively unaffected by the implementation of the 2005 regulations. Examples of NIH's work with industry can be found before and after the issuance of the 2005 regulations through NIH's robust technology transfer program. The Federal Technology Transfer Act of 1986 established in law a requirement that NIH inventions be licensed to appropriate private-sector companies for development as new diagnostics and therapeutics. As a result, since the creation of the NIH Office of Technology Transfer (OTT) in 1989, the NIH intramural research program has generated more FDA-approved drugs and biologics than any other nonprofit U.S. institution. Royalties accrue for each individual NIH institute, and, by law, NIH inventors receive a share of any licensing fees. OTT administers approximately $90 million annually in royalty payments, and licensees reported product sales of approximately $6 billion in 2009.
In addition, NIH scientists are encouraged to develop cooperative research and development agreements (CRADAs) with significantly affected organizations. The number and types of these CRADAs are a good measure of the extent of productive interactions with industry. Although new CRADAs fell following the announcement of the 2005 ethics regulations, they have since rebounded (see Figure 1). The drop may have reflected a misperception by industry that, through the new regulations, DHHS intended to restrict all government–industry interactions. It should be noted that the recent recovery in CRADAs has occurred despite the economic slowdown and an overall budget reduction in the NIH intramural program, which has resulted in a nearly 10% decline in the number of principal investigators since 2005.
The rigorous conflict-of-interest regulations imposed in 2005 have strengthened the public's trust in the integrity of NIH science, but they also have had some negative consequences. Indeed, the provisions that place limits on certain stock holdings or prohibit outside consulting arrangements have contributed, at least in part, to a few instances in which NIH failed to recruit or retain outstanding scientists. Other NIH scientists have found bothersome the sometimes lengthy process for evaluating awards for scientific excellence and the heightened review requirements for holding office in professional organizations. In addition, some NIH scientists worry that they will miss out on the exchange of ideas and collaborative opportunities that come from paid service on pharmaceutical and biotech scientific advisory boards. However, many similar opportunities can be found through NIH's active technology transfer program, numerous official liaisons with outside institutions, healthy attendance at scientific meetings, and continued collegial interactions and collaborations.
Fortunately, even with the new rules, recruitment of early-career scientists and many senior scientists has continued within the intramural program. For many applicants, the attraction of stable and long-term research support, the satisfaction of public service, and the competitive pay at a world-class research organization outweigh the concerns about being denied the possibility of outside compensation.
As DHHS is in the process of revising the regulations governing oversight of financial conflicts of interest in the extramural community (as described in the Notice of Proposed Rulemaking [NPRM], which can be found at http://grants.nih.gov/grants/policy/coi/), we recognize that the NIH intramural experience may provide valuable lessons about how to develop and implement the next generation of financial conflict-of-interest rules. As noted in Zinner and colleagues' survey, many NIH intramural scientists expressed significant concern that payments by industry would have the potential to undermine the independence, credibility, and collegiality of the scientific staff. Federal employees who serve the public must be especially vigilant about their behavior, and most understand and accept this responsibility. However, academic scientists who are supported by the public through NIH funding must also exercise prudence in their interactions with industry. As one example, DHHS proposes in the NPRM that investigators disclose to their institutions all significant financial interests related to their institutional responsibilities, thus providing additional information with which the grantee institution is able to evaluate potential conflicts.
Institutional leaders, whether in government or in academia, face a constant struggle to balance the twin goals of scientific integrity and technology transfer. With one hand, we must create and protect a free intellectual environment that encourages high-risk, high-reward research, and, with the other, we must uphold the public's confidence that its investment in biomedical research will be translated into new treatments in a swift and trustworthy manner. If done wisely, it is a balancing act that will benefit us all.
We are grateful to Ms. Robecca Kolberg and Mr. Christopher Wanjek for their editorial comments.
The authors are full-time employees of the National Institutes of Health.