Uniform conflict rules needed

US government agencies funding research should work toward a uniform conflict of interest policy, according to a US Government Accounting Office (GAO) report released on Friday (November 14). The GAO studied but did not offer any recommendations on making government-funded research data freely available to the public.GAO study author Richard Cheston, assistant director of the GAO's Natural Resources and Environment branch, told The Scientist that the GAO felt it “premature” to make recommendations on data release, given that it would involve “carefully walking through a minefield of concerns.” However, the GAO did call for more immediate release of research results from the Department of Education.The recommendations were part of a report titled “University research: Most federal agencies need to better protect against financial conflicts of interest,” which was compiled at the request of Senator Richard Shelby (R-Ala). The GAO last reported on conflict of interest 10 years ago, but has never taken on the issue of data access, according to Cheston.Currently, only the National Institutes of Health (NIH) and National Science Foundation (NSF) conflict of interest policies are in place, formed as a result of a collaboration that culminated in the issuing of standards in 1995. However, it's generally up to the universities that receive NIH and NSF grants to police their own faculty. According to the report, universities generally comply with NIH and NSF guidelines. Of the 171 research universities surveyed as part of the GAO report, 82% reported that they require scientists to indicate whether a conflict may exist when a grant proposal is submitted; 63% require scientists to annually submit financial disclosure forms to institution officials; and 81% require scientists to update financial disclosure forms during the year if new possible financial conflicts of interest arise.Although other agencies don't have official standards, conflict of interest policies do extend outside of NIH- and NSF-funded research, the report found. Eighty-seven percent of the universities surveyed reported that they apply financial conflict of interest policies to all of their federally funded research that are consistent with either NIH's or NSF's standards. But 17 universities reported that they do not extend either agency's requirements to research grants from other federal agencies. The report concludes, “Unless federal agencies uniformly require that universities implement conflict of interest policies, the government cannot properly safeguard against financial conflicts of interest that might bias federally funded research.”Although the Office of Science and Technology Policy (OSTP) likes the idea of a uniform standard, OSTP officials said in the GAO report that “recent experience in developing a common rule for research misconduct has demonstrated that the process of reaching consensus among federal agencies can be difficult and prolonged.” The report states that 124 universities strongly supported and 25 universities somewhat supported creating a single financial conflict of interest policy for all federally funded research.Even the NIH and the NSF, despite having conflict of interest policies in place, are not doing enough to police their grantees, said Michael Jacobson, executive director of Center for Science in the Public Interest. “The NIH doesn't get any information about conflicts of interest of potential grantees, and neither does the public,” said Jacobson. “All the NIH gets is some bland assurance from the university that everything is in order.”Jacobson would like to see the NIH—and not just universities—require that researchers list potential conflicts of interest when they apply for grants so that affiliations would be taken into consideration when the grant was awarded. The NIH should also have a publicly accessible Web site listing all grant recipients, their proposal topics, and investigators' outside affiliations, he said. Jacobson also suggested that universities, and not only individuals, be required to reveal their industry investments. Robin Fritsch, a legal analyst and deputy ethics official at the NSF, said that such a policy has been discussed at the NSF and the NIH in the past year, but that no draft yet exists.Fritsch said that the NIH and NSF initially had proposed a more invasive policy when the two agencies began discussions in the 1990s. The original policy would have required that researchers submit financial disclosures when applying for grants. But since only a third of the applicants are actually funded, many such disclosures were thought to be superfluous and possibly intrusive, she said. Complaints from researchers and universities convinced the agencies to settle for a more hands-off approach.Noting that it took the NIH and NSF several years to formulate their own regulations, Fritsch said that a uniform policy would be quite difficult to achieve. “You have to have some flexibility in there because of the type of research you fund or resources you have,” she said. For example, the NSF has a waiver process in place to allow for conflicts of interest deemed insignificant or inconsequential. The NIH does not have such a stipulation because conflicts in biomedical or clinical research could have much more serious consequences than in basic research.On the issue of open access to government-funded data, report authors had a very negative reaction from biomedical researchers at Emory University when they proposed posting all results on the World Wide Web, Cheston said. Among the major concerns were protecting patentable information, avoiding rejections from prestigious journals as a result of premature data release, and ensuring that findings have been properly vetted by peer review so that neither researchers nor the public are misled. The GAO did recommend, however, that the Department of Education post the final technical reports of the research it funds on its Web site.Although the GAO study did not mention a recently introduced bill from Rep. Martin Sabo (D-Minn.) calling for access to data generated by federally funded research, Cheston did say that the findings of the GAO report argued against the sort of wholesale data release across all government agencies that Sabo's bill requested. Sabo's office said they could not comment by press time because they had not yet examined the GAO report.

Uniform conflict rules needed

US GAO wants single policy across funding agencies, but defers call for open access

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