There has been a flurry of recent activity regarding concerns about the National Institutes of Health’s (NIH) oversight of extramural compliance with federal conflict of interest regulations. Current federal law requires NIH to monitor financial conflicts of interest by requiring the institutions that receive grants to collect and manage information on the money that their researchers receive from drug and device makers and others in the industry. Congressional concern about NIH’s compliance with the monitoring requirements stems from recent reports revealing that the tracking is not happening in individual cases and from an Inspector General for the Department of Health and Human Services report in January that found that NIH does not adequately monitor its extramural grants for conflicts of interest.

On June 4, Senator Chuck Grassley (R-IA) sent an inquiry to NIH regarding extramural grant recipients’ compliance with federal financial conflict of interest rules, and on June 20, NIH Director Elias Zerhouni, M.D. replied by letter to Senator Grassley’s request. In his response, Dr. Zerhouni agreed that based on “recent examples, it is clear that we need to increase transparency and enhance the NIH’s system of oversight.” He further assured Senator Grassley that “NIH takes its responsibilities in this area very seriously and that [he] is committed to taking all necessary actions within [his] power to ensure that the research that the NIH supports continues to be conducted objectively and with integrity,” inasmuch as it is “essential that we preserve the public trust.”

Then, on June 24, the Senate Labor, Health and Human Services, Education, and Related Agencies (L-HHS) Appropriations Subcommittee included report language on conflicts of interest in its markup of the fiscal year 2009 (FY2009) L-HHS appropriations bill that provides funding for next year for NIH. The language provides that while on the one hand, “the Committee greatly appreciates the Director’s efforts to produce a stronger policy for its employees regarding conflicts of interest and financial disclosure,… troubling allegations that some NIH-funded investigators have flaunted their universities’ conflict-of-interest rules have recently come to light, and it seems clear that the NIH currently has no ability to monitor or prevent such abuses.” “Moreover,” the Committee added, “up to this point, the NIH leadership has not demonstrated much interest in dealing with the issue. That must change. The Committee believes that the Director has no higher priority in the coming year than to address this situation and fix it.”

The following day, on June 25, Senator Grassley issued a press release “asking members of Congress who hold leadership positions on the appropriations committee to join his effort to hold the National Institutes of Health accountable for monitoring conflicts of interest in government sponsored medical research.”

Finally, on June 26, during the Senate Appropriations Committee’s full markup of the FY2009 L-HHS appropriations bill, Senator Wayne Allard (R-CO) offered an amendment to the bill on behalf of Senator Grassley. The Committee passed the amendment, which included the following language:

Within six months of passage of this Act, the Secretary of the Department of Health and Human Services shall issue an Advanced Notice of Proposed Rulemaking to solicit public comment in advance of modifying regulations at 42 CFR Part 50 Subpart F for the purpose of strengthening federal oversight and identifying enhancements of policies, including requirements for financial disclosure to institutions, governing financial conflicts of interest among extramural investigators receiving grant support from the National Institutes of Health.

In the June 2008 edition of NIH’s Office of Extramural Research (OER) Extramural Nexus publication, Norka Ruiz Bravo, Ph.D., OER Director and NIH Deputy Director for Extramural Research, outlined the manner in which NIH plans to respond to the issue. In her Director’s Column on Managing Financial Conflicts of Interest (FCOI), Dr. Bravo provided that NIH is “instituting a variety of measures to address these issues quickly and carefully.” First, NIH is “embarking on an enhanced outreach and education campaign to raise the awareness of the importance of proper identification and management of FCOI in the extramural community… Second, to improve [NIH’s] ability to monitor FCOI reports, [NIH] has developed a Web-based reporting and tracking tool that provides a central place for collection of all FCOI reports received across the NIH… Third, [NIH is] developing detailed internal procedures and training modules to ensure that all NIH staff is able to provide appropriate oversight of FCOI issues, [and] finally, [NIH is] considering gathering public comment on whether to modify the FCOI regulations (42 CFR Part 50, Subpart F).”

Innovation 2008

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The Federation of American Societies for Experimental Biology (FASEB) has joined Scientists and Engineers for America (SEA) and seventeen other science advocacy groups and scientific societies in calling on candidates for Congress to answer seven questions about science and technology.

The SEA Innovation 2008 homepage hosts the questions and addresses issues that include health, research, innovation, climate change, education, and water and energy policy. Participating organizations are encouraging candidates in congressional races across the country to post their answers on the Innovation 2008 website to help voters make informed decisions in November. Since the launch of the project last month, responses have already begun rolling in from challengers and incumbents, Democrat and Republican, in states including Texas, Maryland, New Jersey and Ohio.

FASEB, SEA and the seventeen other partners, including AAAS, ScienceDebate2008, and FASEB member society ASBMB, are issuing a call to scientists as well, asking them to contact their candidates and request that they respond to the questionnaire. The sponsoring organizations hope that constituents will put pressure on candidates to issue comprehensive statements on science and technology policy as part of their campaign activities.

The need for candidates for public office to declare their positions on science issues is particularly striking in light of a national poll commissioned by SEA that found that voters highly value the use of science and technology to address national concerns including global warming, energy, education and health care. A large majority of voters (84%) said that they would be more likely to vote for a candidate who is committed to improving healthcare through public investments in science and technology, and 71% responded that they would be more likely to vote for a candidate who is specifically committed to national investments in scientific research. The finding that a majority of voters support candidates who are committed to S&T remains true across party lines. These findings support earlier studies by Research!America and the National Science Foundation that found a high degree of public support for an investment in science.

FASEB joins SEA and the scientific community in asking that the public act on its support for science and research by urging candidates to answer the seven questions.

To view candidates’ answers or to send them an email, simply enter your zip code on the map above. For more information, please visit ScienceCures.org.