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Witness Testimony
Dr. Norman R. Augustine Ph.D.
NIH Ethics Concerns: Consulting Arrangements and Outside Awards
Mr. Chairman and Members of the Committee, thank you for this opportunity to share with you the findings of our Panel which evaluated Conflict of Interest Policies affecting the National Institutes of Health (NIH). We are, of course, well aware of the support given by this committee to the NIH over the years and of the high expectations you, and indeed the American people, hold for NIH. We appear today on behalf of the members of the Panel, a complete list of whom is attached to this testimony. Our Panel was established at the request of Dr. Elias Zerhouni, Director of NIH, and was requested to complete its work within 90 days because of the urgency of the matter at hand. Administratively, we were formed as a Working Group of the Advisory Committee to the Director of the National Institutes of Health. We should note that our assignment was forward-looking; that is, we were concerned with policy rather than with specific cases that occurred in the past. As you are aware, there are a number of on-going investigations of prior matters being conducted by entities within the government. Other than providing our basic charter, which was to review existing conflict of interest policies and to propose new policies where appropriate, no constraints were placed by NIH on the content of our work. In carrying out the Panel's responsibilities we met a total of five days and held one telephone conference. We heard testimony from over 30 individuals, including members of the public, and established an internal web site which received over 300 responses from NIH employees. In addition, we interviewed the Directors of all 27 NIH Centers and Institutes. Notices of meetings were placed in the Federal Register. The National Institutes of Health represents a national and global treasure. Its principal asset is the truly remarkable scientists and practitioners who choose to serve as its employees. In many ways the future health of our nation depends on a robust and productive NIH. But if care is not taken, the ability of NIH to continue to serve the public's health could be severely damaged in either of two ways by issues affecting conflict of interests. On the one hand, if the science NIH conducts or its funding decisions are, or even appear to be, biased or corrupted, the public, the broader scientific community, and the government's funding officials could lose faith in the institution's credibility. On the other hand, if a unique set of rules were to be enacted that is so inconsistent with the established practices of the scientific community, it could drive talented individuals away from NIH as an employer and at the same time discourage the dissemination of knowledge. Developing sound policies for managing and preventing conflicts of interest requires the balancing of several sometimes competing values and considerations. First, government employees, like all citizens, are entitled to a life of their own with reasonable privacy-but at the same time, the public has a right to complete assurance that outside activities will not inappropriately influence an employee's judgment or commitment to public service. Second, although sound arguments can be made for the enactment of consistent and uniform conflict of interest rules across the federal government, each agency, including NIH, has unique circumstances and needs. Third, it is clear that a government employee should not receive personal financial gain for outside activities by exploiting knowledge gained through his or her government position, yet much of the accumulated knowledge and value of a scientist might well have resulted from efforts made and accomplishments achieved outside of government service. The Panel has sought diligently to balance these sometimes conflicting considerations as it developed its recommendations. In its deliberations the Panel found an extremely complex set of rules governing conflicts of interest at NIH and, in fact, across the federal government. In the context of NIH, with its unique mission to conduct and support biomedical and health-related research on its own campus, across the country, and internationally, these rules are widely misunderstood by some of the very people to whom they are intended to apply. This has created uncertainty about allowable behavior and has engendered fear that inadvertent transgressions could occur-significantly damaging morale. The Panel found that most of NIH's policies and procedures for managing conflicts of interest are reasonable and appropriate and it believes that the agency has been responsive to direction provided to it in this area by the Department of Health and Human Services (HHS), the Office of Government Ethics (OGE), and Congress. However, significant improvements can be made, including imposing greater restrictions on some types of activities, relaxing some restrictions that are inappropriate and counterproductive, enhancing disclosure and transparency, and improving the overall management of these issues at NIH through better training, education, and resource management. We believe the existing conflict of interest policies affecting NIH do not sufficiently discriminate among groups of employees who have widely differing responsibilities and therefore widely differing susceptibility to conflicts of interest. In particular, we conclude that the policies affecting senior officials of NIH should, as a matter of policy, be tightened-that is, made more restrictive. It is our view that greater internal and, in some circumstances, public, disclosure can be beneficial in assuring the continued quality of the NIH's work and the confidence the public can place in that work. In particular, some senior NIH staff members, absent case-by-case approval authority, are, under present interpretation of the relevant laws, not expected to file public disclosure forms. On the other hand, we found that many well-intentioned constraints that have been placed on researchers at NIH who perform purely scientific work have been counterproductive. As but one example, NIH scientists are generally prohibited from indicating their affiliation with NIH when giving lectures, even when those lectures are accompanied by appropriate disclaimers. At present, only a relatively small number of NIH employees are engaged in consulting arrangements with industry. In contrast, a substantial number of NIH employees are involved in outside activities with professional societies and with academic and research institutions-primarily in the forms of teaching, speaking, or writing (including editing). In addition, NIH scientists who are recognized for outstanding scientific achievements, leadership, or public service are sometimes the recipients of awards, which may be accompanied by a cash prize. The Panel believes these are important-even essential-activities for NIH scientists, since they are part of the tradition of science and provide evidence of the value and significance of the NIH research community to the larger scientific community. For example, speaking at academic institutions or other similar public fora is a critical part of being a productive and contributing scientist. It provides an important avenue for the exchange of scientific ideas, and both the speakers and the audiences benefit. What did the Panel not accomplish that we sought initially to do? During our initial meetings, and in the first full draft of the report that was used to frame our Panel discussions at our April 5-6 meeting, we seriously considered proposing that selective information from the Form 520 be posted on a publicly accessible portion of the NIH website. (Form 520 must be submitted to obtain permission for any outside activity). More specifically, we discussed the possibility of requiring, as part of the permission process, the public posting of both the nature of each paid outside activity, as well as the exact amount of the compensation received each year. The Panel was thinking that such compete transparency could serve as a "disinfectant" to remove suspicions that might otherwise persist concerning the internal NIH disclosure and permission system. In the course of these deliberations, we encountered the federal Privacy Act and other relevant federal statutes and regulations. We asked the lawyer on our Panel, Dorothy Robinson, to consider these matters further and to discuss them with NIH legal counsel. She reported that the federal Privacy Act presents a serious barrier to virtually any agency-mandated public disclosure of the sort we were considering, other than the public disclosure mandated for those senior level employees designated as Form 278 filers -- including those so designated through equivalency rulings by the Office of Government Ethics. (See also Letter from Marilyn L. Glynn, Acting Director of OGE, to Bruce Alberts and Norman Augustine, April 19, 2004, attached). The Panel considered the possibility that the Privacy Act might be amended to allow for this type of disclosure, but concluded that the strong governmental policy protecting personal information against disclosure would be a formidable challenge to overcome. Instead, as you will hear, the Panel constructed recommendations aimed at augmenting and making more effective internal disclosure within NIH. We want NIH to have all of the information and abilities it needs to make thorough and effective conflict of interest reviews. We have also recommended enhanced public disclosures in connection with all speaking and publications by NIH personnel, as well as an agency-wide public report that annually summarizes the amount and nature of the outside activity by NIH employees. Our recommendations are as follows: Recommendation 1: NIH senior management and NIH extramural employees who are responsible for program funding decisions and recommendations, and professional staff managing grants and contracts and application review should not engage in consulting activities with pharmaceutical or biotechnology companies or in paid consulting for academia. The Panel considers speaking for compensation at an industry site as equivalent to consulting for industry. In addition, the Panel does not include in this prohibition time spent in clinical practice by health care practitioners, if approved as an outside activity free of conflicts. Recommendation 2: The Panel reaffirms current federal law that intramural scientists conducting research with human subjects-for example, investigators and research team members involved in patient selection, the informed consent process, and clinical management of a trial-should not be allowed to have any financial interest in or relationship with any company whose interests could be affected by their research or clinical trial, except with an appropriate waiver or authorization. Recommendation 3: In addition to existing requirements for engaging in outside activities, the following additional requirements should be in place for employees directly involved in the administration or conduct of NIH research programs and who are not subject to the restrictions posed in Recommendations 1 and 2: a. The total amount earned annually from compensated consulting with industry or academia should not exceed an amount equal to 50 percent of the employee's annual salary, and no one source should account for an amount in excess of 25 percent of annual salary. b. Employees eligible to engage in compensated outside professional activities should not: i. receive compensation in the form of stock options or other forms of equities for their services ii. spend more than 400 hours per year on these activities (writing excepted). c. An exclusion to the above limits should exist for NIH employees who are health care practitioners. For these employees, there should be a more flexible time limitation and the capitation for compensated outside medical care and patient services should be 100 percent of base pay, with the one-source limitation removed. Recommendation 4: To improve NIH's ability to manage and track approved outside activities: a. all requests for outside activities (Form 520) should be updated on an annual basis (with such updates indicating only those changes that have occurred) b. supervisors should be held accountable for the evaluation and approval of outside activity requests, and this supervisory function should be a component of a supervisor's performance evaluation c. NIH should publish an annual institute-wide statistical report on the number and types of outside activities approved for its employees. Recommendation 5: NIH should seek a change to OGE regulations so as to allow NIH scientists to receive compensation for teaching, speaking, or writing about their research, only if the information is to be shared in a public forum and it has appeared in the published literature. Recommendation 6: NIH intramural scientists should continue to be allowed to engage in compensated speaking, teaching, and writing for professional societies and for academic and research institutions as an outside activity as long as all ethics review and approval requirements are met. Recommendation 7: NIH should seek a change to OGE regulations to permit employees to be identified by their title or position (and institutional affiliation) when engaged in teaching, speaking, or writing as an approved outside activity. Disclaimers should be provided that the activity is not being conducted in the employee's official capacity as an NIH employee and that the views expressed do not necessarily represent the views of NIH. Recommendation 8: There should be no restrictions on royalties received on works written, edited, or published or on income received from patents licensed by any NIH employee who conducted the work as an approved outside activity. Recommendation 9: The current OGE rules regarding receipt of bona fide cash awards for meritorious public service or achievement and NIH's interpretations of the rules are reasonable and should apply to all employees. There should be no limit on the amount of money received from a bona fide award. These awards are considered gifts under current law and are not considered outside activities because the employee accepts the award in his or her official capacity. Recommendation 10: To increase NIH's ability to manage conflicts of interest, it should either move immediately to increase the number of employees required to annually file a confidential disclosure form 450 or find some other means to achieve comparable levels of internal disclosure. Recommendation 11: NIH should ask OGE to make a regulatory change or seek statutory modifications to provide NIH with greater discretion in determining whether certain Title 42 employees should file public financial disclosure form 278. This would promote the public interest by increasing transparency and thereby enhance trust in government. In the meantime, NIH should seek additional equivalency rulings from OGE to increase the number of public filers to include all the senior employees as specified in Recommendation 1. Recommendation 12: NIH supervisors should be provided with enhanced training on the criteria to be used for their annual review of financial disclosures so as to become more effective in managing and avoiding employee conflicts of interest. Recommendation 13: To preserve public confidence in NIH, the agency should put in place a policy that requires employees to disclose all relevant outside relationships and financial holdings in their work products, such as publications, speeches, and invention disclosures. In addition, where relevant, such disclosures should be made to potential research subjects as part of the informed consent process. Recommendation 14: NIH employees should be required to submit recusals in writing to immediate supervisors when a potential conflict of interest emerges. The supervisor should then be required to inform those who should be aware of the employee's need to be recused from the official duties for which there is a conflict. As is currently the case, when an employee must be recused from official duties, those duties can be reassigned only to someone at an organizational level above the employee. As such, recused employees or their supervisors will need to inform both superiors and affected subordinates of the recusal. Recommendation 15: The NIH Ethics Office should prepare a user-friendly document and website that displays ethics rules in simple language and emphasizes examples of outside activities and financial interests that are permissible as well as those that are not. Employees seeking approval of outside activities should, as part of their submission of form 520 and its supplements, indicate in writing that they have reviewed these summary materials and have discussed any questions they have with their relevant ethics official and/or supervisor. Recommendation 16: The NIH Ethics Advisory Committee should issue a report of its findings, in the form of anonymous case studies and generalizable principles, on a regular basis to provide the NIH community with a clear common body of knowledge by which to understand and interpret ethics rules. Recommendation 17: NIH management should assure that sufficient resources are provided for the administrative and management functions of its ethics activities to guarantee that the expanded program proposed in this report can be implemented. Recommendation 18: While the Panel has not addressed the application of Title 42 to the hiring and compensation of senior scientific staff, it is clear that some such hiring and compensation authority needs to be applicable to this group of employees if NIH is to remain competitive in the market for talent. In addition, the NIH Director should ask HHS to review and, if appropriate, raise the current annual salary capitation of $200,000 for the most senior Title 42 employees at NIH. The Panel is concerned that the present ceiling is limiting the agency's ability to recruit and retain the nation's best scientists as the leaders of NIH. Mr. Chairman, since our report is not unduly long and contains substantiation for these recommendation, we would like, with the committee's permission, to have it considered for inclusion in the record as an attachment to this statement. Among the more significant changes these recommendations, if implemented, would impose are:
In arriving at its findings and recommendations, the panel noted that for virtually every policy it could conceive it could also identify extraordinary circumstances under which the application of that policy would be counterproductive to the accomplishment of the NIH mission. For this reason, it is important that, within the constraint of applicable laws, the NIH Director be granted the authority to make carefully considered exceptions when deemed appropriate. In conclusion, the Panel believes that the recommendations presented in our report can correct many of the concerns that have in the past been expressed about conflict of interest practices at NIH. We urge that the recommendations be adopted as quickly as possible. This is needed to assure the continued, deserved public confidence in the extraordinary work of NIH, to enhance the continued quality of the scientific staff at NIH, and to rectify what the Panel perceives to be a growing morale problem among an excellent NIH staff. Thank you, and we would be pleased to answer your questions. Related Documents |
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