NIH Conflict of Interest:
Recusal Policies for Senior Employees Need Clarification
GAO-07-319: Published: Apr 30, 2007. Publicly Released: May 31, 2007.
To safeguard the integrity of National Institutes of Health (NIH) research, government employees who have significant decision-making responsibilities and peer reviewers who evaluate the scientific and technical merit of research funding requests should be free from conflicts of interest. One method to resolve a conflict of interest is recusal, which is accomplished by not participating in work that will affect a personal interest or involves a personal relationship. GAO reported on (1) how NIH informs senior employees about recusal and what the requirements are for them to notify supervisors, and (2) how NIH informs peer reviewers about recusal and how NIH monitors their compliance with recusals. GAO reviewed relevant NIH policy manual chapters and NIH guidance and interviewed NIH officials. GAO selected NIH's National Cancer Institute and National Institute of Allergy and Infectious Diseases for the review because they have the largest budgets at NIH.
NIH has provided several methods to inform senior employees about recusal as a remedy to conflicts of interest, such as annual ethics training. However, NIH has not established clear recusal policies for senior employees, as the NIH policy manual is contradictory on whether senior employees must recuse in writing and notify their supervisors of their recusals. For example, the policy manual contains contradictory directions on how employees seeking nongovernment employment are to recuse. One section states that the employee "must" put the recusal in writing and that his or her supervisor "should" be notified, while another section states that the recusal "may" be done in writing and that the supervisor "must" be notified if the recusal is not written. Moreover, the two definitions of recusal in the policy manual imply that the employee must put a recusal into writing but do not explicitly require such action, and neither definition requires that the employee's supervisor be notified of the recusal. Senior employees who consult the policy manual may or may not put their recusals in writing and may or may not notify their supervisors, depending on what section of the policy manual they consult. NIH provides written and oral methods for informing peer reviewers about recusal and for monitoring compliance with recusals. In the NIH policy manual and guidance, NIH states that peer reviewers must be informed about NIH conflict of interest regulations and policies, which include information pertaining to recusal. The policy manual refers to a form that describes situations that may constitute conflicts of interest and the need to recuse in those situations. The Scientific Review Administrators (SRAs)-- NIH employees who manage the scientific review group (SRG), or peer review meeting--are also instructed to give oral guidance on the NIH conflict of interest policy to peer reviewers, according to NIH guidance. The NIH policy manual states that the SRA is responsible for overseeing the SRG meeting to ensure fair and unbiased evaluations of research funding requests, and that peer reviewers must certify in writing after the meeting that they have executed their recusals. GAO concludes that, although the NIH policy manual and guidance describe how peer reviewers are to be informed about and comply with recusals, the lack of clear recusal policies for senior employees results in a vulnerability in the management of one part of NIH's conflict of interest policies.
Recommendation for Executive Action
Comments: NIH's August 2, 2007 60-day follow-up letter addressed to the House Committee on Oversight and Government Reform and the Senate Committee on Homeland Security and Governmental Affairs reiterates the agency's response to the report recommendation, stating that NIH expects to update and reissue relevant portions of its policy manual chapter by October 15, 2007. On June 18, 2008, NIH issued new chapters of its policy manual related to our recommendation including 2400-01, "Introduction to Government Ethics at the NIH," and 2400-04, "Managing Conflicts of Interests and the Introduction of Bias." It has not yet released other chapters relevant to our recommendation, including 2400-07, "Outside Activities." In our report, we specifically found contradictions between the chapters "Avoiding Conflicts of Interest" and "Outside Work and Related Activities" with respect to whether senior employees must recuse in writing and notify their supervisors of recusals. Therefore, it will be necessary to evaluate manual chapters that have not yet been released in order to close this recommendation. According to an NIH official, the remaining relevant chapters of the manual are scheduled to be released by fall 2008. As of 8/26/09, the chapter "Outside Work and Related Activities" (now called simply "Outside Activities")had not been released. An NIH official provided a status report for this chapter with current status noted as "Under review by the NIH Ethics Office" with a completion date of spring 2010.
Recommendation: To address the inconsistencies in the policy manual related to senior employees' notification of recusals and ensure that NIH helps its senior employees fulfill their responsibilities related to recusal, the Director of NIH should expeditiously clarify NIH policies with regard to written recusals and supervisor notification related to senior employees' use of recusal to resolve conflicrs of interest.
Agency Affected: Department of Health and Human Services: Public Health Service: National Institutes of Health