The 88th meeting of the Advisory Committee to the Director (ACD) of the National Institutes of Health (NIH) was held on May 6, 2004. NIH Director Elias A. Zerhouni, M.D., began by welcoming two new ACD members in attendance, introducing members of the Blue Ribbon Panel on Conflict of Interest (COI Panel), and recognizing Institute Directors in attendance, the liaison representative from the Council of Public Representatives (COPR), and the ACD liaison representative to COPR.
Dr. Zerhouni elaborated on several items in the NIH Director's Update and mentioned recent and upcoming congressional testimony on the NIH budget and activities. He and COI Panel co-chairs were to appear May 12 before the House Energy and Commerce Committee's Subcommittee on Oversight and Investigations, and in April Dr. Zerhouni testified on NIH appropriations before House and Senate subcommittees about the NIH fiscal year 2005 budget. He testified March 25 on Re-Engineering Clinical Research before the House Energy and Commerce Committee's Subcommittee on Health, and on March 4 he briefed congressional staff on the Biosecurity Initiative. He also informed House committees about scientific advances.
Dr. Zerhouni described progress on specific initiatives of the NIH Roadmap for Medical Research, including the Nanomedicine Roadmap project, a Molecular Libraries Screening Centers Network, and the NIH Director's Pioneer Award Program. On March 26, the NIH and Food and Drug Administration (FDA) launched the Genetic Modification Clinical Research Information System (GeMCRIS), a new data system for human gene transfer research. The project is related to the National Electronic Clinical Trials and Research (NECTAR) project, part of the NIH Roadmap.
Dr. Zerhouni requested formation of a panel on conflict of interest to conduct an independent review, and Dr. Bruce Alberts, co-chair of the COI Panel, described how the panel undertook its task. The 10-member COI Panel met five times in 2004, heard testimony from more than 30 people, received public comments through a special e-mailbox, posed questions to NIH staff, and received responses from more than 300 people. The panel found that, among other things, government ethics rules are complex and not readily understood; most NIH policies and procedures are fundamentally sound, but improvements are needed; and current requirements for internal disclosure do not always capture the information needed to manage conflicts of interest. The panel's 18 recommendations address three main areas: outside activities, financial disclosure, and system management and reform.
Panel co-chair Mr. Norman Augustine discussed the recommendations and provided context to the panel's deliberations in six broad areas: senior leadership, employees with direct responsibility for extramural grants and contracts, and researchers conducting human subjects research (recommendations 1 and 2); compensated outside activities for other research-related NIH employees (recommendations 3 and 4); compensation for teaching, speaking, or writing, and awards (recommendations 5–8); disclosure and transparency (recommendations 10–14); ethics training and administration (recommendations 15–17); and other observations (recommendation 18).
Mr. John Burklow, Associate Director for Communications, provided a communications update, explaining how the communications office is connecting science to people. The NIH Strategic Communications Plan and NIH Communications Implementation Plan address goals and strategies for achieving clear and consistent communications that make medical research personally relevant, position the NIH as a trusted source of health information, and explain the NIH's role in medical research. Progress since the previous ACD meeting included graphics and a new search engine on the NIH home page, a CD version of the 2003 NIH Almanac, new stories in the NIH Overview of Research Activities that put a human face on research, and new ad templates for clinical trial and staff recruitment. He also described new collaborations and outreach activities.
Dr. Zerhouni asked Dr. Ellie Ehrenfeld and Dr. Steven Strauss (NCCAM) to convene a working group of visionary consultants to consider ways to increase the number of innovative applications submitted to NIH. This led to proposals for the Exceptional Projects Program, the Grand Challenges Program, and the NIH Director's Pioneer Award (NDPA) to encourage those who would break new ground with new ideas and approaches. The first to be implemented, the experimental NDPA award is for $500,000 a year for 5 years and is open to researchers at all career levels. Recipients will be able to set their own research agendas without adhering to a traditional research plan. The awards will be made through a nomination process that includes self-nomination.
Dr. Daniel Sullivan, Associate Director of NCI's Cancer Imaging Program, presented results from the 2003 NIH Bioengineering Consortium (BECON) symposium on Catalyzing Team Science. BECON focused its annual symposium on credit for team members on the premise that inadequate reward for research team members is a systems problem. The symposium concluded that change is needed in funding, academia, and publications. Because universities are responsive to funding agency policies, the NIH can effect desired change in academia by modifying some rules and regulations. Recommendations included that NIH allow more than one PI on individual grants, allow multiple performance sites to get appropriate recovery of indirect costs, develop improved funding mechanisms for team science, and give more attention to the special review needs of team science.
Dr. Norka Ruiz Bravo, Deputy Director for Extramural Research, said that the Office of Extramural Research (OER) is dealing with the end of the doubling of the NIH budget; evolving public health challenges such as aging and obesity; evolving research approaches such as the NIH Roadmap that move away from single–focus, single–PI studies; an evolving research workforce; and evolving policy and operations challenges. She said the extramural program is working toward a paperless grant process and hopes that modular R01 grants for the February 2005 review cycle can be submitted electronically. OER also would like to determine how best to obtain formal, considered customer input on the kinds of research supported by OER.
Mr. Lawrence Sadwin highlighted recent COPR activities, including the creation of work groups to address current issues without neglecting continuing activities. With the NIH Public Trust Initiative staff, COPR will host a public trust dialogue meeting in October 2004 to stimulate an exchange among key stakeholders in the research enterprise about enhancing trust and participation in the research process. COPR hopes this dialogue meeting will culminate in recommendations from which it can produce a report to Dr. Zerhouni. He also noted the recent release of a COPR report, Enhancing Public Input and Transparency in the National Institutes of Health Research Priority-Setting Process, which was distributed at the ACD meeting.
Mr. Richard Turman, Associate Director for Budget, provided context for his presentation of fiscal year (FY) 2004 and 2005 budget figures. For FY 2004, the NIH discretionary budget appropriation was $27.9 billion — an increase of $805 million (3 percent) over FY 2003. In FY 2003, the success rate for grant applications was about 30 percent; it is estimated to be about 27 percent for FY 2004. The FY 2005 budget shows an increase of $729 million, for a total of $28.6 billion in discretionary budget appropriations. The total program-level budget is $28.8 billion, an increase of $764 million (2.7 percent). The FY 2005 budget is based on an estimated 10,393 new and competing research project grants, 39,984 total research project grants, and a success rate that stays at 27 percent.
Dr. Thomas Insel, Director of the National Institute of Mental Health (NIMH), introduced himself and discussed the NIMH mission and efforts to reduce the burden of mental disorders through research on mind, brain, and behavior. According to 2002 data from the World Health Organization, across all disorders, mental illnesses cause the greatest disability (26.1 percent of all years lost to disability). In the 15–44 age group, mental illnesses are responsible for almost 40 percent of all disability. About $71 billion is spent on mental illness treatment in the United States, and the nation pays $150 billion in annual costs for mental illness and invests $1.4 billion in mental health research through NIMH. Over the new few months, NIMH will reorganize to develop a different process for its extramural efforts. The focus will be on translation — from bench to bedside and from bedside to practice.
Dr. Ruth Kirschstein gave a work group update on postdoctoral training. She referred to a handout, "Who Will Do Science in the Twenty–first Century and Where and How Will They Do It?" Science asked that this paper, which she co-authored with Drs. Joan Schwartz and Walter Schaffer of the NIH and Dr. Maryrose Franko of the Howard Hughes Medical Institute (HHMI), be submitted to Science's Next Wave online publication for postdocs and other students. A second handout listed people chosen by the National Academy of Sciences as a committee for a June 16th meeting. HHMI President and Nobel Laureate Dr. Thomas Cech will chair the meeting and the National Postdoctoral Association will be represented. From that meeting, her group hopes to bring a final proposal to the ACD about increasing career options for young people, many of whom choose to go to industry early in their careers.
The 88th meeting of the Advisory Committee to the Director (ACD) of the National Institutes of Health (NIH) was held May 6, 2004, and webcast globally. The next meeting will be held December 2 — 3, 2004. NIH Director Dr. Elias A. Zerhouni welcomed two new ACD appointees in attendance: Dr. Annelise Barron, an associate professor in the Department of Chemistry and Biological Engineering at Northwestern University, and Dr. C. Martin Harris, Chief Information Officer and Chairman of the Information Technology Division of the Cleveland Foundation. A third new appointee to the ACD, Dr. Joan Reede, Dean of Diversity and Community Partnership at Harvard Medical School, was unable to attend. Also unable to participate in the meeting were ACD members Dr. J. Michael Bishop, Senator Connie Mack, the Honorable James G. Martin, Dr. Steven Paul, Dr. Cecil Pickett, and Mr. Phillip Williams.
After introducing members of the Blue Ribbon Panel on Conflict of Interest (COI Panel), Dr. Zerhouni recognized Institute Directors in attendance. He also recognized Mr. Lawrence Sadwin, the liaison to the ACD from the Council of Public Representatives (COPR), and Dr. Thomas Ansfield, the liaison to the COPR from the ACD, and described the "glue between the two committees" as extremely important. COPR members were invited to attend the ACD meeting, and in addition to Mr. Sadwin, three other COPR members were present.
Dr. Zerhouni elaborated on several items in the NIH Director's Update, which was included in the notebooks for ACD members and as a handout for others who attended the meeting.
Dr. Zerhouni mentioned recent and upcoming congressional testimony on the NIH's budget and activities. He and the COI Panel co-chairs will appear May 12 before the House Energy and Commerce Committee's Subcommittee on Oversight and Investigations, chaired by Rep. James Greenwood. In April, he testified on NIH appropriations before House and Senate subcommittees about the NIH fiscal year 2005 budget. In House hearings, the Appropriations Committee expressed interest in programmatic aspects of the NIH and in management issues, asking questions related to how the NIH sets priorities for allocation of funds. Dr. Zerhouni testified March 25 on clinical research reinvention re–engineering before the House Energy and Commerce Committee's Subcommittee on Health, chaired by Rep. Michael Bilirakis, and on March 4 he briefed congressional staff on the Biosecurity Initiative. He also informed House committees about scientific advances, including progress on mental health and mental disorders, cited by Science magazine as the number two advances for 2003. (Dr. Insel's presentation provides more detail on that area of research.)
The ACD and COPR both worked on several issues. Drs. Ruth Kirschstein and David Burgess co–chair the ACD Working Group on Postdocs: Training and Career Opportunities in the 21st Century, which addresses the structure of training and career pathways of today's postdocs and what the research enterprise will need in the next few years. (See Dr. Kirschstein's presentation for more information about this working group.) Dr. Linda Waite chairs the ACD Basic Behavioral and Social Sciences Research Working Group.
Dr. Zerhouni described progress on specific initiatives of the NIH Roadmap for Medical Research. The Nanomedicine Roadmap project was launched May 4. On April 21, the NIH released a Request for Applications (RFA) for a Molecular Libraries Screening Centers Network, an NIH-wide initiative to be administered by the National Institute of Mental Health.
Another component of the NIH Roadmap is the NIH Director's Pioneer Award Program. In a test of the theory that the traditional grants system misses great ideas by great people, this program seeks to stimulate high-risk research that has the potential for high impact. The NIH received more than 1,300 nominations for fewer than 10 grants that will be awarded during the pilot phase of the program. The NIH plans to study the cohort of applicants and the categories of research that they consider underfunded by the agency. This pilot program will allow the NIH to assess a new approach to funding high risk research.
On March 26, the NIH and Food and Drug Administration (FDA) launched the Genetic Modification Clinical Research Information System (GeMCRIS), a new data system for human gene transfer research. In clinical and translational research, obstacles include the fragmented nature of essential information pathways, including reports on adverse drug events. Dr. Amy Patterson, Director of the NIH Office of Biotechnology Activities, has been working through these issues with the FDA. Together, the agencies have developed a common set of standards and a Web-based system to report adverse drug events at any site and to all parties. This system has been implemented and is targeted for expansion across the full spectrum of clinical research activities, to reach what Dr. Zerhouni described as a "vision of a fully electronic environment for medical research," which is the essence of the National Electronic Clinical Trials and Research (NECTAR) project — part of the NIH Roadmap.
Introduction of and Charge to the Blue Ribbon Panel on Conflict of Interest Policies
When questions were raised about consulting payments or stock ownership involving several NIH senior scientists, Dr. Zerhouni requested formation of a panel on conflict of interest to conduct an independent review of all policies and procedures and report on its findings. He encouraged the panel to examine all aspects of interactions between the NIH as a scientific agency and the public, academia, industry and other constituents. As Dr. Zerhouni emphasized, there is no doubt that the NIH has a fundamental interest in preserving public trust and ensuring that its processes are not in any way influenced by private interests. At the same time, NIH also has other interests to translate research effectively while preserving public trust. This guarantee is important to the NIH's ability to continue to recruit outstanding scientists to government service.
Dr. Zerhouni introduced Dr. Bruce Alberts, Co-Chair of the COI Panel, to describe how the panel undertook its task.1 Noting that other investigations are addressing past activities, Dr. Alberts explained the panel's charge:
To review the existing laws, regulations, policies, and procedures under which the NIH operates regarding (a) real and apparent financial conflict of interest of NIH staff where compensation or financial benefit from outside sources is received, including consulting arrangements and outside awards, and (b) requirements and policies for the reporting of NIH staff's financial interests, including which interests are subject to public disclosure and what portion of NIH staff file public disclosures.
To make recommendations for improving existing laws, regulations, policies, and procedures, as appropriate.
The 10-member COI Panel (see box) met five times in 2004: February 17, March 1–2, March 12–13, April 5–6, and April 28. The panel heard testimony from more than 30 people (see Appendix C of the panel's report) and received public comments through an e-mail box created for the panel.
The COI Panel also posed specific questions to NIH staff (see Appendix D of the panel's report) and received responses from more than 300 people, submitted to a Web site created for that purpose. Dr. Alberts remarked that the answers, collected over a 5-week period, showed a fair amount of uniformity.
Members of the COI Panel
Bruce Alberts, Ph.D. (co-chair), President, National Academy of Sciences
Norman R. Augustine (co-chair), Chairman, Executive Committee, Lockheed Martin Corporation
Christine Cassel, M.D., President, American Board of Internal Medicine
Thomas H. Murray, Ph.D., President, The Hastings Center
Phillip A. Pizzo, M.D., Dean, School of Medicine, Stanford University
The Hon. Stephen Potts, Chairman, Fellows Program, Ethics Resource Center
Dorothy Robinson, Esq., Vice President and General Counsel, Yale University
Lawrence Sadwin, President, Lifestyle Security, L.L.C.
James Siedow, Ph.D., Vice Provost for Research and Professor of Biology, Duke University
Reed V. Tuckson, M.D., Senior Vice President, Consumer Health and Medical Care
Advancement, UnitedHealth Group
The COI Panel found that:
Government ethics rules are complex and not readily understood.
Most NIH policies and procedures are fundamentally sound, but improvements are needed.
Current requirements for internal disclosure do not always capture the information needed to manage conflicts of interest.
Current rules do not permit sufficient public transparency. This finding refers to those who file confidential disclosures despite their senior positions because their pay plan is under Title 42 of the Public Health Service Act.
Senior NIH employees should be subject to special restrictions because of their broad authority and leadership roles.
Of 17,526 NIH employees as of March 2004, 118 employees were involved in consulting arrangements with pharmaceutical or biotechnology companies. Dr. Alberts noted that these are small numbers compared with academia.
Nevertheless, criticisms of these arrangements have substantially increased the overall ethics pressure on everyone, with widespread apprehension that new rules, and expanded interpretations of rules, will soon make it unattractive to be an NIH scientist.
The scientists must become better partners with the ethics officials so the rules become more clearly understood and viewed as appropriate for each type of scientist across the NIH campus.
The panel's 18 recommendations address three main areas: outside activities, financial disclosure, and system management and reform.
Dr. Alberts introduced his co-chair, Mr. Norman Augustine, to discuss the COI Panel's recommendations.
On behalf of the panel, Mr. Augustine thanked the NIH staff for "truly remarkable support," including logistic assistance in answering thousands of questions. He singled out Dr. Lana Skirboll, Director, NIH Office of Science Policy, for special mention. "The panel recognizes that NIH is a national treasure. We were honored to undertake this task," he said.
The panel was aware that it had the potential to do harm by recommending and implementing COI rules that were either (a) too liberal, which would damage the credibility of the NIH and public confidence in it, or (b) too restrictive, which would make it difficult for the NIH to compete for world-class scientists and transfer results of research to industry for benefit of the U.S. public and the world.
Before presenting the recommendations, Mr. Augustine provided context to the panel's deliberations in each of the six broad areas in which the recommendations are grouped.
Senior Leadership, Employees With Direct Responsibility for Extramural Grants and Contracts, and Researchers Conducting Human Subjects Research
Mr. Augustine said that the COI ground rules appeared simple on first reading, but complexities soon arose in translating principles into rules and regulations. For example, Section 208 of Title 18 of the U.S. Code is a felony statute that prohibits government employees from participating personally and substantially in a matter that might have a direct and predictable impact on their family's financial holdings. Questions arose from most words — "participate," "personally," "predictably," etc. Recognizing that there are legitimate exceptions to any recommendations it could make, the panel addressed the authority to grant exceptions, and this may be the most important recommendation
An NIH employee is invited to deliver a lecture at a university and will receive a stipend for doing so. The stipend would be disallowed, because the employee cannot receive personal gain from NIH employment-related work.
Another employee receives a prestigious award that comes with a financial stipend and is asked to deliver a speech at the award ceremony. That stipend would be acceptable.
An employee has won an award that requires delivery of a speech about her work at the NIH. In this situation, a financial award would not be allowed.
The last case makes the panel uneasy, Mr. Augustine reported, by raising questions about the Nobel Prize and limits on a financial award that is acceptable. The panel foresees a number of situations that would create exceptions that should be considered on an individual basis. Government employees deserve to have lives outside their employment, Mr. Augustine observed, but the public also has a right to expect that non-employment-related activities should not have a significant impact on government work. At the same time, NIH employees are entitled to privacy in their lives and activities outside of government work. An important issue relates to the movement of people in and out of government service: Where is the line between pregovernment work and government work in the continuum of their professional work area?
Concluding that the goal of uniformity is not realistic across the entire government work force, the panel made recommendations in three areas:
Outside activities for certain employees should be tightened and made more restrictive.
Rules related to disclosure, especially public disclosure, need to be very broad. More disclosure is needed internally and externally.
Participation in activities of the larger scientific community where no COI exists should be encouraged, not prohibited.
The panel believes that the NIH has honestly and responsibly carried out COI rules and finds no fault with the objectives of the NIH leadership, Mr. Augustine emphasized.
One problem with the current rules, however, is that they tend to apply broadly, without distinguishing between different groups. (In its deliberations, the panel did not consider support staff for NIH scientific research, such as clerical, food service, and guards.) The most senior NIH employees — such as the NIH Director, heads of Institutes and Centers, and Clinical Directors — is the group that requires special attention. Other groups also deserve special controls, such as NIH employees who award grants and contracts and make financial arrangements and those who are responsible for research with human subjects. Another category — primarily employees who conduct intramural research, which represents approximately 5,000 scientists and research assistants — should be able to act as members of the scientific community and benefit and contribute without restrictions, if their activities are outside the bounds of clear conflicts.
Recommendation 1: NIH senior management and NIH extramural employees who are responsible for program funding decisions and recommendations and professional staff who manage 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.
The second recommendation, which deals with human subjects research, is consistent with guidelines developed by the Association of American Medical Colleges (AAMC) and other relevant guidelines. The panel notes that a waiver provision should be available, because situations calling for a waiver might arise, for example, when only one person is familiar with an essential piece of equipment or technique.
Recommendation 2: The Panel reaffirms current federal law, which states 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 in special circumstances, and with an appropriate waiver or authorization.
Compensated Outside Activities for Other Research-Related NIH Employees
Of the approximately 5,000 full-time equivalent (FTE) intramural employees of the NIH, only a small number have professional relationships with biotechnology or pharmaceutical companies. The panel considered simply banning consulting with industry, given these small numbers, but concluded that would be a grave error. The panel recognizes that there are good reasons for NIH scientists to participate in research with industry, provided no COI exists:
NIH scientists can benefit, and thus advance the public health, from what is happening in industry, and industry can benefit, and thus advance the public health, from what is going on at the NIH.
Congress has at least two laws to encourage transfer of knowledge from the NIH to industry, in the proper fashion.
To be able to compete for talent, the NIH needs COI regulations that are not greatly dissimilar from academia's, which allow appropriate interactions with industry.
Some of the NIH's most respected researchers engage in appropriate activities with industry, and many young employees do not want to be denied the opportunity to participate in similar activities.
Under certain limitations, the COI Panel finds it appropriate for NIH employees to participate in non-NIH activities. To avoid COI and conflicts of commitments, limits were recommended for income and time for such activities. Former NIH Director Harold Varmus presented the most compelling argument by asking, "When a scientist is in the shower in the morning, is he thinking about the NIH or an outside job?"
Again, the panel finds it appropriate to make some exceptions for certain types of compensation, such as patents and royalties. However, the panel deems it inappropriate for the categories of employees listed in Recommendation 3 to receive compensation in the form of equity in a company. Roughly 25 percent of NIH arrangements involve corporate equity now. Mr. Augustine explained the panel's concerns about equities:
They make the holder an owner of the company, in however minor a capacity.
There is no upper limit on the potential payoff from equity holdings.
The return on equity depends on outcomes. To the panel, this is the most disconcerting aspect of equities as remuneration.
For these reasons, the panel thinks that equities should no longer be allowed.
The panel made one exception to its dollar and time limitations for consulting. For health care practitioners, the panel recommends that the limit on outside time and remuneration be 100 percent of base salary for carrying out activities of their usual medical practice because there is a shortage of health care practitioners and because the NIH employees engaged in this type of outside activity are among the most underpaid NIH employees compared with their non-NIH counterparts. The panel concludes that medical care and patient services in outside settings do not present conflicts of interest.
Recommendation 3: In addition to existing requirements for engaging in outside activities, and the restrictions posed in Recommendations 1 and 2, the following requirements should be in place for all employees who are involved in the administration or conduct of NIH research programs:
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.
Employees eligible to engage in compensated outside professional activities should not (a) receive compensation in the form of stock options or other forms of equities for their services or (b) spend more than 400 hours per year on these activities (writing excepted).
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.
To request approval for participation in certain activities, such as compensated work with the pharmaceutical industry, NIH employees must complete an application that includes Department of Health and Human Services (HHS) Form 520. Dr. Zerhouni recently established the NIH Ethics Advisory Committee (NEAC) to strengthen NIH review of requests for approval of certain outside activities by NIH employees. The panel considers this an excellent practice that deserves to be continued. Form 520 must be updated if something material changes in employment or activity, but updates are often forgotten. The panel suggests that employees submit annual updates to capture these changes.
Recommendation 4: To improve the NIH's ability to manage and track approved outside activities:
All requests for outside activities (HHS Form 520) should be updated on an annual basis (with such updates indicating only those changes that have occurred).
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.
The NIH should publish an annual agency-wide statistical report on the number and types of outside activities approved for its employees.
Compensation for Teaching, Speaking, or Writing and Awards
Recommendations 5 through 8 deal with teaching, speaking, and writing, a category of activities the panel views as integral and commonplace to participation in the scientific community worldwide. Current rules could be interpreted as restricting that participation, and the panel hopes those rules can become more liberal. The rules may prohibit, or at least limit, such teaching, speaking, or writing if the subject matter of the activity deals in significant part with a matter to which the employee is presently assigned or was assigned within the last year. Hence, the government's expert on a matter may be limited in discussing that matter because he is still working on it, but another employee who has just read the published literature on the matter is likely not to be subject to such restrictions.
Today, those limitations probably are inappropriate, Mr. Augustine suggested. Under current Office of Government Ethics (OGE) restrictions, NIH employees who make presentations as a compensated outside activity cannot disclose that they are employees of the NIH. They are listed with no affiliation, only the designation "Bethesda, Maryland" (although their NIH affiliation can appear in a biosketch). This practice strikes the panel as contrary to the concept of full disclosure. The panel suggests use of a standard disclaimer. In terms of limits on income from patents or royalties from books and other writing, if a textbook is big seller, the panel sees no reason to place a ceiling on income from it.
Recommendation 5: The NIH should seek a change to OGE regulations to allow NIH scientists to receive compensation for teaching, speaking, or writing about their research providing that the information is to be shared in a public forum and that 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 providing that all ethics review and approval requirements are met.
Recommendation 7: The 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 the 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 the 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.
Disclosure and Transparency
The panel thinks it appropriate to move toward more disclosure. The public has access to information through a filing under the Freedom of Information Act (FOIA). Questioning whether FOIA requests truly constitute public disclosure, the COI Panel considered whether any activities related to one's work should be disclosed on a Web site. After consideration and advice, the panel concluded that approach would be unwise and would invite what it characterized as "fishing expeditions." Rather, the panel sought a middle ground.
As Mr. Augustine observed, another difficulty arises from artifacts of current law. Although the NIH has been criticized because some senior officials do not make public disclosures of some outside activities, current rules do not require such disclosures. The NIH has ameliorated that problem by asking for a special determination from OGE to enlarge the group of senior officials who are "reachable from the outside," he said. The panel considers that a positive step. However, every time the NIH changes responsibilities internally, the change would trigger submission of a new list to OGE, and that is an issue.
The hiring authority under which a person becomes an NIH employee, in part, determines who is required and permitted to file public disclosures. The standard civil service provisions of Title 5 cover about 13,000 NIH employees; Title 42 covers nearly 4,000 NIH employees. Title 42 presents a barrier to the issue of public financial disclosure, according to the panel. The public financial disclosure rules specify that a federal employee will file a public disclosure form only if the basic rate of pay for his position is fixed at a rate equal to or greater than 120 percent of the rate of basic pay of a GS-15 level 1, which is approximately $105,000. Because the Secretary of HHS determines Title 42 pay ranges and there is no minimum rate of basic pay for Title 42 appointments, employees under Title 42 are not required to file public financial disclosure forms unless, for example, they hold a position that otherwise qualifies them to file (e.g., IC Director). Mr. Augustine also mentioned a current debate between the NIH and Congress over whether the agency has the authority to hire the people it now hires under Title 42.
Yet another issue relates to financial disclosure: If neither of two forms (public or confidential) for potential COI is filed, the NIH has no way to know when a potential conflict exists. Some NIH employees who are not expected to file could have potential conflicts.
Recommendation 10: To increase the NIH's ability to manage conflicts of interest, it should 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: The NIH should ask OGE to make a regulatory change or seek statutory modifications to provide the 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, the 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 the 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.
Mr. Augustine also recognized that the panel generally did not support the process of recusals as a method for managing conflicts of interest, in part, because employees are not required to submit recusals in writing or provide that information to colleagues. In addition, the panel found that there is great confusion over the current rules surrounding recusals. Despite these concerns, the panel acknowledged that there may be instances where recusals may be appropriate, but under different requirements than are specified by current policies.
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.
Ethics Training and Administration
NEAC can write anonymous case studies to guide case law for NIH employees, and the panel hopes that will be done. The panel thinks that supervisors play an important role in preventing COI because they're familiar with their employees' work, Dr. Augustine said.
Recommendation 15: The NIH Ethics Office should prepare a user-friendly document and Web site 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.
Other Observations
The panel was surprised to find that remuneration was not cited as a significant factor in the desire of NIH employees to engage in outside activities. The principal motivation is participation in the larger scientific community.
Nevertheless, especially at the higher levels, there is considerable disparity between what NIH employees are paid and what those in the outside community are paid. The current salary cap of $200,000 has not changed since the year 2000, which means that inflation has not been accommodated. The Secretary of HHS has the authority to raise the salary cap. The panel believes this issue should be examined.
Recommendation 18: The NIH Director, working with Congress, should ensure that the agency has authority under Title 42, or some other hiring mechanism, to recruit senior scientific staff in the current highly competitive market. 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.
In conclusion, Mr. Augustine said that COI has become a serious issue at the NIH that is affecting morale; confusion is widespread and understandably so. The panel thinks the NIH has sincerely sought to apply the laws as it understands them. Nevertheless, there is room for substantial improvement in COI rules and policies, and Mr. Augustine expressed the hope that the panel's recommendations will be of assistance in that effort.
Discussion
Phillip Pizzo, a member of the COI Panel, thanked the co-chairs and asked to address one issue from his perspective as a former intramural scientist employed by NIH. Because of the clear variation and gradient of responsibilities across Institutes, the panel recognizes that no final recommendation can be configured; it is up to the Director to decide where boundaries lie. He noted the importance of "compartmentalizing" those whose responsibilities give them a broader swath of responsibility, as the panel did in defining senior scientists and the NIH leadership. Because their roles and responsibilities are different, defining their outside activities stringently also is important. Dr. Pizzo thinks the panel's recommendations represent a wise course for the NIH to follow.
Dr. Zerhouni, praising the panel for "extraordinary work done in so short a time," said he was impressed with the depth of analysis and debate and commended panel members for their willingness to undertake this task without pay. He also praised the panel for reaching out to and encouraging comments from the NIH Scientific Directors and Intramural Research staff. Dr. Zerhouni said that he is attempting to absorb the fundamental changes proposed by the panel.
In reference to the final recommendation, Dr. Waite learned on May 5 that the NIH salary caps for investigators are tied to an index. She suggested that the caps on salaries at the upper level can be tied to a different index that would allow a natural increase in the caps rather than an annual review of them.
Dr. Alberts observed that public service should not require people to make family sacrifices; salaries need not match those of the private sector, but salary considerations should be made.
Responding to a question from Dr. R. Sanders Williams about who tracks the 400-hour limit on consulting time, Dr. Christine Cassel said that the supervisor has overarching responsibility and, through reports to NEAC, these hours would be tracked. Dr. Zerhouni added that he did not know; limits have not needed to be managed for the past 9 years. OGE's change of rules does not specify limits.
Dr. Waite called the panel's discussion of the role of NIH employees as scientists and the value of their participation in professional activities as "a breath of fresh air." In response, Dr. Cassel said that the panel wanted to reinforce and strengthen the idea of the NIH as an academic institution; many employees do not have a chance to engage in the fullness of academic interaction. Rather than have NIH employees punch a time clock, she sees a requirement for some type of personal responsibility, which makes the supervisory role very important.
Dr. Williams concurred that the goal was not to become punitive or out of step with the environment of academic scientists. He also noted that Recommendation 5 seems to prohibit communication of unpublished findings, which he hopes is not intended to hold NIH scientists to a standard distinct from that of academia. At some scientific meetings, participants are expected to discuss data that are complete but not published, he commented. Overall, he was impressed by the report's emphasis on open and free communication of science.
Presentation of unpublished data can give one group an unfair advantage over another, Dr. Zerhouni pointed out. Dr. Augustine noted that Recommendation 5 refers to public venues.
Dr. Burgess joined other ACD members in commending the panel for an impressive report done in an extremely short time. He said that the recommendations, if followed, will increase transparency, which is important to maintain public trust and to help the NIH attract and retain the best basic and clinical scientists. Attracting and retaining junior and mid-level scientists is good, he said, but it is at the senior level that the scientist "brain drain" occurs. He asked why the panel differentiated between basic and clinical scientists in allowing additional consulting time and income, given that the salary differential between the biotechnology sector and academia for senior-level M.D. and Ph.D. scientists is probably similarly disparate for clinicians. This question was asked in the context of damage to employees' morale, he specified.
Responding to Dr. Burgess' questions, Dr. Pizzo confirmed that the first recommendation's ban on senior management engaging in activities with specific enterprises refers to industry at large; it is not limited to pharmaceutical and biotechnology companies. On the subject of salaries, he said that normative data, including those from AAMC, show that salaries for persons doing the same job are generally quite comparable in the public and private sectors. However, a considerable salary discrepancy does exist for those who are both scientists and clinicians (e.g., surgeons and anesthesiologists). The panel's different treatment of clinicians in the third item under Recommendation 3 represents an attempt to achieve equity for them. Data show that it is reasonable to tie compensation to function rather than degree, he added. Dr. Pizzo heard in interviews that NIH compensation is much lower than in universities. Although there may be sizeable salary differences between industry and academia, compensation, except at high levels, is not dramatically different in universities than at the NIH.
Mr. Arthur Ullian, citing a recent New York Times article that claimed that the United States has begun to lose its edge in science worldwide,2 called for an examination of why that is happening. The inquiry should consider whether there is a "hassle effect" rather than a salary effect of working at the NIH and should look beyond COI to other issues, such as the per-diem compensation for work-related travel.
Dr. Barron asked about the distinction between honoraria and reimbursement and partial defrayment of expenses in travel. Dr. Alberts, noting that accepting payment for travel expenses can be complex even when a scientist gives a seminar as an official duty, expressed the hope that this process can be simplified. An NIH grantee cannot use grant funds to pay travel costs for an Institute employee, and Dr. Waite found that prohibition problematic.
Dr. Zerhouni said that it is important to capture these ideas. He agreed with Mr. Ullian that a "hassle impact factor analysis" is needed to examine budgetary changes, FTE strictures — the entire NIH environment — described by one Scientific Director as "death by a thousand cuts." Dr. Zerhouni expressed concern about the NIH's ability to portray the life of its scientists in positive rather than negative terms. Scientists accept jobs at the NIH because of the universe there, not because of direct compensation, he said. The NIH and the ACD must look at the impact factor on the ratio between hassle and reward. "There is no doubt that the transaction cost of what we do has a tremendous impact on employee morale," he said. "This is a true issue."
NIH scientists told the panel that they did not want to be treated differently in the open, unconflicted exchange of information. However, limits were imposed (not by the NIH) on the number of NIH staff who can attend the XV International AIDS Conference, which will be held in July 2004 in Bangkok. This limitation creates real strictures. Dr. Zerhouni remarked that, although the appealing nature of employment at the NIH is an intangible, it is a genuine factor.
Dr. Burgess observed that the panel's recommendations are remarkably similar to the kinds of reporting and disclosure required in academia, with one exception. Although there are limits on consulting time in the academic world, there are no limits on the amount that can be paid for consulting.
Dr. Alberts addressed the assumption that scientists are likely to pay the most attention to the activity that pays the most, which may not be their NIH work. Stock options prompt recipients to be fully engaged with time and thought. That is precisely why the COI Panel recommended limits on amounts and types of compensation, such as equity, he said. All private academic institutions are grappling with the issue of conflict of commitment, Dr. Cassel added. Private-sector institutions benefit from an employee's participation in outside activities, even if the royalty or patent does not revert to the university. The panel felt that a commitment to work done at the NIH should predominate.
Responding to Dr. Waite's question about compensation of NIH scientists who have current consulting arrangements in terms of the panel's recommended limits, Dr. Augustine responded that the available data do not account for stock options. Nor does the panel have data to quantify how many employees hold outside activities for which the compensation would approach the recommended salary cap. Dr. Zerhouni said that about 200 scientists are involved in approximately 300 active agreements at the time of his COI testimony in January; many scientists terminated agreements or did not renew them, pending resolution of this issue. Approximately 90 — 95 percent of consulting activities have modest compensation per event. Mr. Augustine noted that about 25 percent of consulting agreements now in effect do involve some form of equity, and there are limitations on what the NIH can know. Form 450 is for internal use only at the NIH and specifies a modest threshold; there is no requirement for specific financial disclosure beyond a certain point.
The Office of Government Ethics does not have authority to manipulate the forms, according to the Hon. Stephen D. Potts; congressional legislation spells out what the forms must include. When he served as Director of OGE, this was a serious constraint in the office's attempts to modify the forms, especially to make them less invasive to employees' privacy. More information is required to be disclosed than is needed for a COI analysis, he said. In fact, Congress imposed new requirements on information to be included on the forms, which made OGE reluctant to press for more change. Excluding the form itself, there are 11 single-spaced pages of instructions on how to fill out the form, Dr. Augustine commented.
After thanking the panel for its efforts, Dr. Bettie Sue S. Masters expressed concern about conflict of commitment, particularly as scientists take on outside activities requiring larger amounts of time. She raised the question of how to elevate science with an environment that would foster the retention of U.S. primacy in the sciences, particularly in biomedical science.
Dr. Larry Smarr asked if the NIH has considered whether a prohibition on stock options might cause the NIH to lose the 25 percent of its scientists who work more closely with industry and have option arrangements. He also inquired whether other science-based agencies, such as the Department of Energy and National Aeronautics and Space Administration (NASA), have similar prohibitions.
Mr. Potts commented that a prohibition on options could put smaller companies, which may be able to pay a scientist in stock options but not in cash, at a disadvantage. The panel consensus was that, on balance, the NIH's reputation outweighed such considerations and that stock options should be prohibited. However, the NIH should carefully monitor the impact of this prohibition to make sure that it is not more severe than the panel anticipated.
Dr. Reed Tuckson noted that the recommendations made to the panel by the research community demonstrated remarkable agreement about nurturing and protecting academic work; the difficulties cited were on the academic side. He also expressed the hope that a ban on stock options will not affect recruiting and retention of NIH scientists.
Agreeing with both comments, Mr. Augustine emphasized that the panel's concern about equities is that their value is based on outcome. A ban on options does create a bias against small companies — a fact that concerned the panel, especially because so much innovation comes from small companies. However, even small companies can probably afford to pay cash for consulting agreements, which are not a large part of their costs, he said. Another issue is whether options should be recorded as expenses on the books, which is the subject of a current accounting debate. Disclosure of the true cost of stock options insofar as possible at the time can create prejudice against small companies that rely on options. The trend is toward expensing options to clear the books.
The panel's report reflects its support of translation of knowledge to the private sector, Dr. Tuckson commented. The relationship between the public sector and industry is important, and the panel feels that this one prohibition would create a clearer environment for appropriate activities to flourish. The NIH also can improve public understanding of Cooperative Research and Development Agreements (CRADAs), as Ms. Dorothy Robinson remarked.
Responding to a question from Dr. Williams, Mr. Augustine said that the panel did not address whether NIH scientists, as inventors, can accept stock options as part of a licensing agreement. He stated that the panel did not want to set a financial limit on royalties.
When Dr. Williams noted that royalties increasingly are not limited to cash but include equity arrangements, Dr. Gottesman said that the NIH would hold patents and allow inventors to receive royalties of up $150,000 per year. Recommendation 8 relates to inventions as outside activities. Such activities would not be approved if they overlapped in any way with NIH duties.
The NIH should not underestimate the need to focus on fair compensation for its senior leadership, Dr. Thomas Ansfield said. A system tied only to cost of living is not adequate; perhaps compensation should be tied to real estate prices or increases in the area of metropolitan Washington, DC, he suggested.
Dr. Zerhouni welcomed comments and emphasized that recruiting is an issue. Recommendation 1 identifies categories of employees who should be banned from outside work to ensure their unbiased ability to govern their Institute and programs. In that category, there are different levels of authority within the Institute for the same decision levels. He asked whether Clinical Directors specifically should have more reporting authority or function — whether the panel wished to keep an entire administrative level "completely clean."
Dr. Alberts responded that the panel tried to understand how each Institute and Center is governed but did not have time to do so completely. Its rationale is that high-level people, such as Scientific Directors, may have a major influence on a Deputy Director or Director; some are called on for input at this level of decision making and may have a conflict for a particular contract. This issue needs to be addressed, with distinctions made according to how different high-level people function at different Institutes and Centers.
Mr. Augustine concurred that, if a high-level person has no interaction with Company X but does with Company Y, the NIH should avoid any real or perceived conflict in an award to either company. The panel used a shorthand system in crafting Recommendation 1, which was probably "too short a shorthand," he conceded. Dr. Tuckson explained that the panel did not select titles arbitrarily. Rather, it examined functions for opportunity for actual or perceived conflict in decisions that affect grants, contracts, etc.
Dr. Zerhouni asked whether the panel would be willing to meet once more to clarify its recommendations for senior NIH positions. Those recommendations would profoundly change how the agency would be managed, and he wants to make sure that the NIH captures the spirit of the panel and ACD recommendations (e.g., how to manage 400 hours without increasing the transaction cost). "We need to circle back with staff and have one more opportunity for a reality check to make sure we're not missing anything," he said.
Returning to Recommendation 1, Dr. Cassel inquired about NIH employees at the top level, for whom recusal would be unworkable because their participation is needed for the function of the Institute or Center. The panel has a bias against recusal, Dr. Alberts said, because it would deprive the NIH of the expertise for which staff members were hired.
On the subject of the last recommendation, the panel recognized that the NIH has to deal with a competitive environment for recruiting talent and that NIH employees have to be able to live in the expensive Washington, DC, metropolitan area.
The panel's recommendations range from those that can be enacted immediately to others that would require congressional action, Dr. Cassel observed. She moved to present the report from the panel to the ACD and to ask what actions the ACD wishes to take. Declaring the ACD officially in receipt of the COI Panel's report, Dr. Zerhouni said that he looks forward to the Council's pleasure.
Dr. Alberts clarified that the first point under Recommendation 4 is not intended to eliminate the need to file updates whenever there is a change. It is meant only to require an update at least once a year to capture changes that are not filed otherwise, not to require a 1–year waiting period to note a change.
Mr. Sadwin said that he felt compelled to thank the NIH scientists for their passion and concern. Although the NIH was good before, it will be better for the panel's work, he said. Agreeing with Mr. Sadwin, Dr. Waite moved that the ACD accept the report and encourage the NIH Director to seek assistance from the panel in interpretation and fine-tuning. Dr. Masters seconded the motion, and it was approved.
Concluding the discussion, Dr. Zerhouni commented that one of the most satisfying aspects of his job as NIH Director, and the Institute and Center Directors concur, is the remarkable ability of the NIH to attract talent, such as peer review panels and special advisory groups, to serve. He again thanked the COI Panel and said that the NIH could not maintain excellence or do its work without these voluntary advisors.
Dr. Zerhouni introduced Mr. John Burklow, Associate Director for Communications, and praised him for an outstanding job in reorganizing communications efforts and helping to launch the NIH Roadmap for Medical Research.
Mr. Burklow explained how the communications office, responding to Dr. Zerhouni's charge to make the NIH more proactive in helping the public learn about and understand NIH research, is "connecting science to people." He referred to the NIH Strategic Communications Plan and NIH Communications Implementation Plan, included in ACD members' notebooks. Together, the plans address goals and strategies for achieving clear and consistent communications at the NIH that (1) make medical research personally relevant, (2) position the NIH as a trusted source of health information, and (3) explain the NIH's role in medical research.
Mr. Burklow described progress since the previous ACD meeting. Graphics have given the NIH home page a more appealing look, and Google is now the search engine. Improvements are "an evolving process," he said; his office is always looking at new ways to provide health information on the Web site. Mr. Burklow thanked Mr. Dennis Rodrigues, Chief of the NIH Online Information Branch, for assistance in these efforts.
The 2003 NIH Almanac has been made into an interactive CD rather than a "phone book" written piece; the NIH Overview of Research Activities puts a human face on research, with stories about research advances and the scientists who were pivotal in achieving them; and new ad templates for clinical trial and staff recruitment present a more consistent look across the NIH for recruiting activities.
Press releases now make the connection between research and the NIH in the lead and include a quote from the NIH Director when appropriate. Word on Health, a package of news and features, is sent to hundreds of papers across the United States on subjects as diverse as dry mouth and AIDS. The piece on dry mouth generated 412 newspaper articles in 28 states with a readership of more than 23 million; the AIDS feature produced 236 newspaper articles in 22 states with a readership of more than 15 million. At the September 30, 2003, launch of the NIH Roadmap, representatives of the media had access to scientists. More than 50 reporters attended that press conference, and they wrote accurate stories.
Media outreach featuring the NIH Director continues. In February, the "News Hour with Jim Lehrer" aired a feature about the NIH Roadmap; the communications team worked with the station from the time of the Roadmap launch. The New York Times, Scientific American, National Journal, The Chronicle of Higher Education, and The Scientist were among the publications that published interviews with the NIH Director. Exemplifying the broad interest in the NIH, "Nightly Business Report" also interviewed Dr. Zerhouni.
In other print coverage, a March issue of Parade magazine had a cover story on young investigators that noted that all the featured scientists are or have been supported by the NIH. Parade seems to be moving more toward health as a regular topic, Mr. Burklow commented. NIH history also made news with a full-page story in USA Today on home pregnancy tests and a Washington Post feature on the long careers of chemists Theresa and Earl Stadtman.
The NIH reaches radio listeners through a weekly radio news service. More than 20 reporters attended the first NIH Director's media briefing, held in March. Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases (NIAID), gave a presentation, and Dr. Francis Collins, Director of the National Human Genome Research Institute, described advances in diabetes from genetic research.
The communications staff from across the Institutes and Centers worked to place accurate cover stories in Newsweek on stroke and in Time magazine on diabetes, and in the May 10 issue of Time, the National Institute of Mental Health (NIMH) will be prominently mentioned in a story on the secrets of the teen brain. Both Newsweek and Time have had several other cover stories on health and medical topics. Mr. Burklow pointed out that the NIH supported research is often involved in the topic of such press stories, even if NIH is not named.
In the area of outside collaborations and outreach, the NIH is partnering with the Association of American Medical Colleges (AAMC) to solidify ties with the extramural community. AAMC represents 126 accredited U.S. medical schools, almost 400 teaching hospitals, and their thousands of faculty members, medical students, and residents. A new Web site called "Get Involved at NIH" is designed to elicit feedback on NIH activities as well as involvement of the community in NIH activities.
Several national communications campaigns have won awards. The Heart Truth Red Dress campaign (National Heart, Lung, and Blood Institute), in which a red dress serves as a symbol for women and heart disease, won the PRWeek Award of the Year. This very successful campaign reached 350 million people. Real Men, Real Depression also won a PRWeek award, and JAMA devoted an entire issue to the topic of men and depression. After NIMH's recent work with the Marine Corps, the Corps will use and distribute the depression materials worldwide.
The National Library of Medicine and National Institute on Aging teamed up to create a new Web site, NIHSeniorHealth.gov, which Sen. Tom Harkin helped launch. In December, the National Eye Institute worked with extramural resources to gain maximum exposure for a story on a study of prevention of blindness in premature babies. This effort, characterized by Mr. Burklow as a model for media outreach, achieved more than 20 million print impressions, radio broadcasts to an audience of more than 4 million people, and television broadcasts that reached more than 6 million viewers.
Mr. Burklow presented a graph of 5 years of NIH print media coverage showing an increase in the number of stories from 1999 through 2003. As he explained, this is part of the NIH effort to connect science to people by translating research results and improving understanding of what public support for medical research is accomplishing.
Discussion
Dr. Zerhouni lauded Mr. Burklow's efforts to bring consensus across the Institutes and Centers. A recent poll showed that less than 2 percent of the public knows that the NIH is the federal source for funding of biomedical research. A great deal of effort is needed to coordinate the impact from these educational campaigns, he said, from speaking engagements to trips and other activities. Dr. Zerhouni would like to facilitate that process for the Institute and Center Directors and foster a "communicating science" culture that permeates the NIH, not just at the Director level. Mr. Burklow wants to identify NIH scientists who are most interested in communicating to the public and organize training for them, to connect the researcher and the person affected by the research.
Dr. Vijayanagar was pleased to see good public relations on behalf of the NIH. At a recent event attended by prominent businessmen from Florida, including a previous governor, he was surprised to find how little they knew about the NIH. He has found a widespread perception that most new drugs emerge from the pharmaceutical industry; knowledge of the NIH role in that process is largely lacking in the public. He asked what percentage of new drugs coming to market are NIH-coordinated and what percentage are purely from industry scientists.
The NIH has examined that issue, Dr. Zerhouni replied. For cancer, 67 of 106 drugs had an Investigational New Drug application to the Food and Drug Administration sponsored by the National Cancer Institute (NCI). For heart drugs, the figures are quite different. Of 500 such pharmacological targets on the market today, a relatively small number trace back directly to the NIH, but for basic science, the percentage is higher (e.g., two NIH researchers identified the metabolism of cholesterol). Additionally, the NIH has a higher percentage of interaction with biotechnology companies as a funder of research than with pharmaceutical companies.
Dr. Zerhouni expressed regret that Mr. Phillip Williams, an ACD member, was unable to attend the meeting, because he has been pushing for more attention to NIH communications since Dr. Zerhouni became NIH Director. Mr. Burklow also acknowledged Mr. Williams as a guiding force behind the communications activities described in his presentation. Mr. Donald Tykeson, a COPR member, had suggested that the NIH might develop a tag line something like "NIH, the nation's medical research agency," and that suggestion is under consideration.
Answering Dr. Barron's question about partnering with industry to create ads, Mr. Burklow said there has been a longstanding avoidance of paid advertising, but HHS may reconsider that stance. Dr. Williams commented that the NIH should not bear the full burden of communicating what it does; the extramural community also has a responsibility in that area.
Dr. Harris asked whether the NIH has considered reversing the process in which it uses Google to navigate sites, to target information more specifically. Agreeing that would be worth considering, Mr. Burklow noted that the NIH also uses Spanish-language publications and other means of targeting its information to specific audiences.
To put the NIH's low public recognition in perspective, Dr. Smarr said that he also serves on the NASA advisory committee, and many people have not heard of the space station. The image average Americans retain of the Mars Rovers is the scientists' and engineers' slaps of "high fives" signifying that the equipment worked. He suggested that the NIH train extramural scientists to work with the press and be good communicators of science. "The average smart scientist will almost surely do more harm than good," he commented. "They have to learn what the Fourth Estate is about and what its rules are."
Dr. Burgess inquired about coordination from the Director's office to reach minority communities, which have low participation rates in clinical trials and a health disparity gap that is still widening for many diseases. She praised bilingual efforts and suggested use of the BET network, Hispanic television, Indian Country Today, and other avenues to reach the 30 percent of the population whose health has not improved over the last decade and whose participation as scientists is dropping rather than rising.
The Office of the Director has a Hispanic communication initiative, Mr. Burklow replied, but most work is done in the Institutes and Centers. Although he is working closely with them to disseminate information, more can be done, he said. Dr. Raynard Kington, NIH Deputy Director, added that the Institutes and Centers have a variety of programs, including an outreach activity through the Office of the Director involving powwows throughout the Native American community.
Dr. Barron suggested that the National Science Foundation (NSF) offers a good model for outreach. NSF asks that grant applications include a section on the broader impact of the proposed research (e.g., outreach and impact on minorities), sending the message to young investigators that this component must be substantial for their grant application to be successful. An NIH request that applications include a brief discussion of outreach would bring that issue to the table, she said.
Dr. Norka Ruiz Bravo responded that the new NIH 398 Form, R01 form, and "everything else form" will ask for a statement on the public health relevance of the research, written in lay language. An abstract will be published in the CRISP (Computer Retrieval of Information on Scientific Projects) database for easy access. Dr. Zerhouni acknowledged the need to find a balance for the "hassle factor" of a new requirement, and Dr. Barron suggested that the requirement might apply only to investigators receiving their first R01 grant.
Dr. Zerhouni concluded the discussion by observing that Mr. Burklow's presentation illustrated ways in which the NIH is following up on recommendations from the ACD and COPR, and he commended the NIH Communications Directors as well as Mr. Burklow.
The NIH peer review process and funding decisions are seen as excessively conservative, and the NIH has a risk-averse image. These are some reasons that many innovative applications are not submitted to the NIH. As part of the NIH Roadmap for Medical Research, Dr. Ellie Ehrenfeld and Dr. Stephen Strauss (NCCAM) co-chaired a "high-risk" research working group of broad visionary consultants with diverse expertise across scientific disciplines to consider ways to address these issues. A brainstorming session led to a proposal for a group of three novel programs to identify, encourage, and support people and programs that may produce tomorrow's technological and scientific breakthroughs: the Exceptional Projects Program, the Grand Challenges Program, and the NIH Director's Pioneer Award (NDPA).
The NDPA was selected for implementation. Originally called the "NIH Innovator's Award," it was renamed because Dr. Zerhouni intended it for people who would break new ground with new ideas and approaches, to give them the time and resources to develop and test far-ranging ideas. The award is for $500,000 in direct costs per year for 5 years, and it is open to researchers at all career levels. The NDPA will give its recipients the freedom to set their own research agenda without adhering to a traditional study section-approved research plan.
The Pioneer Awards will be made through a nomination process that includes self-nomination. Nominations for the pilot phase of the program were received in early spring and are being reviewed by NIH staff for eligibility and by outside experts for identification of promising candidates.
Dr. Ehrenfeld estimates that one-third of the nominees will be invited to apply for this award. The solicited applications will be relatively short. In lieu of a standard research plan, applicants will write an essay of three to five pages explaining their views about the major challenges in biomedical and behavioral research to which they think they can make a seminal contribution. Outside evaluators will rate these applications according to a new scoring system, also developed with the help of non-NIH experts.
After this phase, approximately 20 finalists will be invited to the NIH to present to an interview review panel. The NIH requires a second level of review, which the ACD will provide. ACD members will review the panel's evaluation of finalists and advise Dr. Zerhouni. Final selections will be made and announced by the end of September 2004. ACD reviews will be done electronically, because the next scheduled ACD meeting is not until December.
Dr. Ehrenfeld emphasized that the NDPA is an experiment, and the first year's process will be evaluated to inform future cycles. The outside community has been "extraordinarily responsive in this process," she said.
Discussion
In response to questions, Dr. Ehrenfeld clarified that approximately 1,300 nominations had been received and evaluated for eligibility and administrative compliance internally. Of these, more than 900 advanced for external review and current screening. Thanks to a more enthusiastic response than anticipated to the call for nominations, she expects the "real applicants" to number in the range of 300, which, according to previous review experience with other programs, will likely be evaluated as roughly one-third "yes," one-third "no," and one-third "maybe."
Dr. Barron asked whether the second NDPA award criterion ("The program is not intended to support ongoing research projects or simply expand the funding of persons already well supported.") would count against applicants and whether they might be asked to suspend some of their activities. Dr. Ehrenfeld explained that the nominees have all agreed that they would be willing to commit the majority of their scholarly activities to the NDPA. Evaluators have been trained to weigh the current success of nominees, and nominees can transfer their principal investigator (PI) role to a senior colleague in their laboratory. The NIH, which does not want to penalize nominees for previous success, is willing to work with them; however, the NDPA is not intended to supplement support for an existing successful program. The Pioneer Award requires applicants to document and demonstrate that they are interested in breaking new ground to pioneer something new.
Dr. Waite suggested that, if 10 of 300 nominees are expected as awardees, it would be beneficial to do more culling early in the process. Dr. Ehrenfeld noted that the figures are estimates only; the final numbers will be based on recommendations of outside evaluators. After the first screening, perhaps only 10 percent will be recommended. If that number is high (e.g., 500), it will be culled. This first year is a pilot phase of a planned 5-year program that runs through 2008, but the procedures and processes may change, she said. Five to 10 new awards will be made in each of the 5 years, for a maximum of 10 ongoing awards in 2005, 20 in 2006, 30 in 2007, and 40 in 2008. For now, nominees can be senior or junior scientists, and they can nominate themselves. After an evaluation of data from the pilot phase, the nomination criteria may change.
Asked how information about the award was communicated, Dr. Ehrenfeld said announcements appeared in the NIH Guide and Federal Register and on the NIH Web site. Notices also were sent to the scientific community via very broad spectrum of professional societies and published in their newsletters. Additionally, a large advertisement appeared in Science. The response suggests that word of mouth worked well, she said. As Dr. Zerhouni pointed out, the award was advertised beyond the biomedical community, to "cast a wide net" that might encourage lateral moves into biomedical research for groups such as mathematicians, engineers, and computer scientists, and to reach those in behavioral and clinically related science areas where investigators think the NIH grant review process does not treat them fairly.
Dr. Vijayanagar praised the NDPA concept, and Dr. Smarr suggested that the NIH determine in advance what percentage of applications it wants to fund (e.g., 10 percent). Although the response was far greater than anticipated and it is too late to change procedures for this year, Dr. Ehrenfeld noted that the process is designed not to be burdensome to applicants. They will be asked only for an essay of three to five pages, which should not involve a major effort for those who have been thinking about an innovative research concept.
Dr. Barron commented that many awards are available at both ends of the career spectrum — for young investigators and for established investigators — but there are far fewer funding opportunities for mid-career scientists who may be considering a change of direction. It will be interesting to analyze the career levels of the applicants, Dr. Ehrenfeld said.
When Dr. Williams requested more information about the final review step that identifies the awardees, Dr. Ehrenfeld explained that a small number of people will be invited to appear before a "broad visionary panel" of outside experts, selected for the expertise needed, which will hear presentations and interview finalists at the NIH. The ACD will provide a second level of external review of the interview panel's findings. In this pilot phase, the NIH will rely heavily on feedback from evaluators, Dr. Ehrenfeld said.
Dr. Harris inquired about the factors that will be used in 2008 to measure the program's success. An evaluation of the process will start immediately, Dr. Ehrenfeld said; however, evaluation of whether the program identified people who break new ground cannot be done for at least 5 years. The NIH is beginning now to work with evaluation professionals on how to evaluate outcome. It may be that a high success rate would indicate that those chosen would have succeeded without the program.
Dr. Masters raised the issue of finding some way to support the 90 percent of nominees, excluding senior principal investigators, who are not selected for the NDPA if they have exciting and viable ideas. She expressed the hope that an invitation to apply for this award will benefit their careers as the award itself becomes prestigious.
Dr. Zerhouni thanked Dr. Ehrenfeld as a champion of the Pioneer Award program and commented that this award represents several "firsts" for the NIH. It is part of the NIH Roadmap, a trans-NIH activity, which is not traditional at the NIH. There was consensus across Institutes and Centers that this program would be part of a pool of high-risk investments, different from the traditional study group-reviewed applications. Initially, it was thought that the most relevant Institute might have stewardship, but after consideration, it became clear that the concept of a cohort to test a long-term NIH approach would not work if it were managed through the Institutes. The funding for five to 10 awards annually is a minimum commitment through the Roadmap, which is budgeted through fiscal year 2009. That number can be adjusted. Another innovation is in putting the ACD to work in new way, as the second level of review for the NDPA.
The complexity of imaging makes it an area where interdisciplinary team science is needed to advance the field, Dr. Zerhouni said. He then introduced Dr. Daniel Sullivan, Associate Director of NCI's Cancer Imaging Program, to present results from the 2003 NIH Bioengineering Consortium (BECON) symposium on "Catalyzing Team Science."3
One of BECON's activities in recent years has been to encourage applications from groups of individuals, particularly partnerships between bioengineers and clinicians. In doing so, BECON members recognized that these investigators face significant hurdles, one of which is gaining appropriate recognition and reward when they work as members of a team. BECON chose to focus one annual symposium on this topic of credit for team members, on the premise that inadequate rewards for members of a research team are a systems problem.
That system includes investigators, government funders (notably the NIH in the area of biomedical research), leadership of academic institutions, and editors and leaders of publications. Although intellectual property (IP) and the industry model are important elements, the decision was made not to attempt to cover such large topics at this symposium.
The symposium concluded that change is needed in all three spheres — funding, academia, and publications — and that the issues are multiple, complex, and interrelated. Because universities are responsive to the policies of funding agencies, the NIH can begin to effect desired change within academia by modifying some rules and regulations. Symposium participants made the following recommendations for each group, to enhance team science:
NIH should (1) allow more than one PI on individual grants; (2) allow multiple performance sites to get appropriate recovery of indirect costs; (3) develop improved funding mechanisms for team science; and (4) give more attention to the special review needs of team science.
Academic institutions should (1) develop measures of team contributor value other than PI status and authorship, (2) create career paths for those who provide infrastructure for the team, and (3) streamline the administration of team science.
Journals should (1) specify the contributions of co-authors; (2) identify guarantors of article content, because it may be unreasonable for all team members to do so given their different expertise; and (3) establish and make clear policies for sharing of data and materials.
Allowing for more than one PI requires the NIH to develop definitions and criteria. The symposium participants identified several needs, including:
Increased coordination across the Institutes and Centers for programs and mechanisms that deal with team science.
Pilot grant mechanisms that allow teams to form, to allow leadership and ability to organize a team to be assessed in advance.
NIH training grants that provide infrastructure support and curriculum development for interdisciplinary education.
The NIH also should consider changes in the review process for team science, for example, by:
Developing criteria to evaluate team science.
Populating study sections with members who have experience in team science.
Using preproposals to triage applications for large team projects.
Requiring, as part of the application process for team science, (1) plans to qualitatively assess contributions to science so that team members achieve due recognition, (2) adequate staff support including a Ph.D.-level administrator if necessary, (3) an administrative and management plan, (4) an evaluation plan that specifies criteria for success, (5) a plan for development of junior faculty, (6) a plan for management of intellectual property, and (7) a phase-out plan.
Other suggestions to the NIH for improving the climate for team science emerged from the symposium:
Work with academic institutions to streamline the administration of team science, including subcontracting mechanisms, Institutional Review Board policies, IP policies, material transfer agreements, and COI.
Re-examine how indirect costs are calculated and assigned and the impact of current and proposed indirect cost procedures on team science.
Index grants by both terms and people.
Provide a unified portal for access to databases that list funded investigations.
Develop definitions of different types of teams, inventory examples of successes and failures of team science within the NIH, other funding agencies, industry, etc., and post them on the Web.
Organize training workshops for training leaders and managers of science teams.
Establish a prestigious prize for team science accomplishments.
Symposium participants also recommended the use of default models for IP and involvement of technology transfer personnel as integral members in teams, but there were philosophical differences on whether or not academia should emulate industry models for rewarding team research.
Following up on this symposium, BECON has created a Subcommittee on Interdisciplinary Research and Team Science, communicated with the Roadmap Implementation Committee, and will incorporate ideas from the symposium into the Program Announcement for Bioengineering Research Partnerships when it is renewed. BECON will work with the Research Business Model (RBM) Committee and NIH Co-PI Committees. The RBM group is a subcommittee of the Committee on Science (http://rbm.nih.gov), which was set up to harmonize business models across all federal agencies. A key issue is acknowledgment of co-PIs in agency information systems. BECON will canvass other agencies and make transagency conceptual proposals about definitions.
The NIH Co-PI Implementation Committee, in conformity with RBM guidelines, will develop an implementation plan specific to the NIH. Both committees have met, and Dr. Sullivan said that he hopes a series of options will be proposed by the end of summer.
Discussion
Dr. Waite raised the issue of where co-authors fit in counts of publication citations and whether it is possible to have levels of authorship or some other acknowledgment that shows the amounts and kinds of contributions. Such issues were discussed a great deal at the symposium, and there were clear differences of opinions among editors, Dr. Sullivan said. Some would like to identify the contributions of team members; others find it hard to categorize such contributions.
Dr. Masters noted that inside and outside the United States there is much reliance on citations for career advancement. The issue of how to recognize young researchers and their contributions is also an issue in postdoctoral training and must be addressed. The BECON report addressed R01 types of research; Dr. Masters wondered how many R01 grants involve multidisciplinary activity.
After expressing appreciation for the BECON report, Dr. Smarr said he would like the information encapsulated in a brochure. He also commented that the University of California has four institutes that support only team science, and this was a topic at a recent governing board meeting held across four campuses. The traditional award and recognition processes have deeply embedded barriers to team science that make it "almost suicidal" for young investigators to involve themselves in such efforts, he said; the NIH can show universities how to work in this way.
Duke University School of Medicine has taken some of the recommended steps and is working on a revision of tenure and promotion guidelines to accommodate team metrics, Dr. Williams said, and he inquired about the extent to which the NIH is following the recommendations in the BECON report. It would help to change the provision for crediting only one PI, but other barriers exist to team science across departments and institutions. Increasingly, team science is the way for good science to proceed, but efforts to promote team science should not disenfranchise a single PI working with a small group, he said.
Dr. Ruiz Bravo concurred that these issues extend beyond the NIH. For example, what is the definition of a co-investigator and who decides? If co-investigators receive credit, funds spread around institutions would change the ranking tables.
The NIH has 900 tenured investigators and 600 staff scientists in the intramural program, Dr. Gottesman said. About 10 years ago, the NIH created a new position of "staff scientist," and it has been a considerable boon to team science. Although the NIH recently revised criteria for tenure to include criteria for people who contribute to team science, it is difficult to change an institutional culture, he remarked.
Dr. Burgess said he thinks that team science is more common than is credited here. A change in culture may be called for at medical centers, because they traditionally do little team science, but at nonmedical centers (e.g., arts and science departments), promotions committees are accustomed to reviewing team science (e.g., involving engineers). Many of these issues have been sorted out, and people are getting credit for contributions they have made, he contended.
Dr. Zerhouni said that much of the mail he receives labels team science an oxymoron and the quality of science in team proposals unimpressive. Other researchers are hampered by the inability to recognize colleagues who provide disciplinary insight they could not. The test of whether team science succeeds, he believes, will be examples of breakthroughs from team science that could not have been made otherwise. In his own career, he had trouble building a lab without a mechanism to recognize important team members whose contributions were essential to breakthroughs. His solution was to have every team member compete for his or her own R01grant, because no other mechanism was available, but that approach actually creates incentives to work on the R01 rather than on team science. It is important to keep the R01 individual investigator initiative while breaking down barriers to team science, he said.
Dr. Zerhouni concluded with a question about whether BECON had considered a scenario in which its recommendations were implemented and a co-PI was recruited elsewhere: What would happen to the grant and the co-PI? That issue had been raised earlier in committee meetings and will be explored further, Dr. Sullivan said.
Dr. Ruiz Bravo, Deputy Director for Extramural Research, listed the numerous "customers" of the Office of Extramural Research (OER): scientists, other agencies, institutions, the White House, HHS, interest groups (e.g., specific disease areas and people concerned with IP issues and Federation of American Societies for Experimental Biology), Congress, NIH Institutes and Centers, and many more.
OER will be dealing with the following realities:
The end of the doubling of the NIH budget.
Evolving public health challenges, such as aging and obesity.
Evolving research approaches, such as the NIH Roadmap, that move away from single-focus, single-PI studies.
An evolving research work force, with investigators getting their first research grants at a later age, postdocs staying in labs longer, new investigators funded at a rate that is about 10 percent lower than that of experienced PIs.
Evolving policy and operations challenges, driven to a large extent by the preceding factors.
The extramural program is working toward a paperless grant process and hopes that modular R01 grants for the February 2005 review cycle can be submitted electronically. Dr. Ruiz Bravo encouraged researchers to prepare for electronic submission of grants by calling her or contacting Scarlett Gibb, Chief of the eRA Communication and Outreach Branch (301-435-0690, ext. 603; [email protected]).
OER is working toward several other goals as well. It would like to give the extramural community access to data on grants and the tools to analyze them; however, this raises important privacy issues and involves great sensitivity when a department or institution drops in the ranking tables. An OER committee is investigating knowledge management tools and best practices to reduce the time from submission to award. Finally, Dr. Ruiz Bravo would like to determine how best to obtain formal, considered customer input on the kinds of research supported by OER.
Discussion
Dr. Masters approved OER's efforts to develop access to data, which are very important to the NIH and its ability to make the data available to advocate groups. Because OER cannot control how data are packaged once they are accessible, a system of checks and balances will be necessary.
Dr. Zerhouni expressed appreciation of Dr. Ruiz Bravo for taking on challenges involving transition, reorganization, and an ambitious electronic process for grants in a period when the number of both grantees and regulations has risen.
After thanking the ACD for sharing Dr. Ansfield with COPR, Mr. Sadwin highlighted recent COPR activities. One is the creation of work groups to address current issues without neglecting continuing activities.
Mr. Sadwin also thanked Drs. Patricia Grady and Yvonne Maddox for their participation in the Public Trust Initiative. With the NIH Public Trust Initiative staff, COPR will host a public trust dialogue meeting in October 2004 to stimulate an exchange among key stakeholders in the research enterprise, such as patients, scientists, academic research centers and institutions, voluntary groups, and the media, about enhancing trust and participation in the research process. COPR hopes this dialogue meeting will culminate in recommendations (e.g., for toolkits or guidance for researchers, institutions, and patients) from which it can produce a report to Dr. Zerhouni.
Another noteworthy item is the recent release of a COPR report, titled Enhancing Public Input and Transparency in the National Institutes of Health Research Priority-Setting Process, which was distributed at the ACD meeting. Dr. Zerhouni has urged COPR members to continue their work on the issue of public trust and to focus on implementation of the report and to present it to the Institute and Center Directors at one of their regular meetings. COPR will also consider other strategies, such as presenting and distributing the report to Institute and Center councils and the constituency groups that work with the NIH.
In conclusion, Mr. Sadwin said that COPR remains focused, thanks to Dr. Kington and Dr. Zerhouni, energized, and committed to enhancing public input while supporting the efforts of the NIH Director.
Discussion
Dr. Zerhouni praised COPR for its hard work and asked Mr. Sadwin to describe how COPR has been reorganized. Mr. Sadwin explained that the original COPR members did considerable work in starting the group but were not able to focus on specific issues in the way that Dr. Zerhouni had envisioned. COPR responded by forming an agenda issues working group, which communicates via teleconference to address topics that arise between COPR's twice-yearly meetings. The first work group was formed in response to the Institute of Medicine report, Scientific Opportunities and Public Needs: Improving Priority Setting and Public Input at the National Institutes of Health (2003).
Responding to a question from Dr. Masters about how COPR and work group members are chosen, Mr. Sadwin said some self-selection is involved, and the process is very collegial.
Dr. Zerhouni added that, as with the ACD, COPR seeks balance, with nominations from patient groups and a constant stream of public members. He felt it was important the two advisory groups basically have the same rules. The ACD has a mandated mission; COPR's charge of public input is both more diffuse and encompassing. The agenda committee and work groups with specific goals have made a difference, he said. COPR provides a perspective that, by tradition, the NIH did not get in an organized fashion, because advisory councils had to be weighted toward content expertise.
Dr. Vijayanagar praised the new report and its recommendations. He also asked for elaboration of the first recommendation, "Go beyond the NIH campus to engage the American public where they live." As Mr. Sadwin explained, that recommendation for outreach arose from COPR's view of the importance of doing a "road show" away from the NIH campus to explain what the agency does.
Dr. Smarr mentioned that the California Institute for Telecommunications and Information Technology ("Cal IT squared") turned its Web site into something resembling a multimedia newspaper. A simple story, written in lay language and accompanied by a photograph, appears on the Web site announcing anything noteworthy (e.g., when a faculty member receives a grant). The goal is to change at least one or two things daily; nothing remains on the site longer than a week, which means that people have to return to the site for new items. The NIH might find it useful to dedicate even a part of its Web site to something similar, with highly timely information and news, he suggested, because news media are likely to troll such Web sites looking for news in an easy format. Much like sections of a newspaper, his institution's Web site has themes, such as culture, science, and technology.
Dr. Zerhouni expressed enthusiasm for that suggestion and asked that it be noted.
Correcting a figure stated earlier, Dr. Barron said that 5 percent of the public is aware of the NIH and what it does and asked whether COPR had ideas for engaging people more broadly across income levels. Mr. Sadwin replied that when Dr. Zerhouni said that only 3 percent of the people who could participate in a clinical trial choose to do so, COPR began thinking about outreach. The public liaison office of each Institute and Center is a resource, he said, but the fact that each of the 27 NIH components has its own logo is an issue for COPR. He noted with approval that the NIH logo now appears with individual Institute and Center logos. A survey showed that only 19 percent of the public recognizes the American Heart Association, he commented.
Dr. Masters raised a question about Recommendation 9, "Continue to search for mechanisms that encourage public input into the research priority-setting process and that are easily accessible and provide information-sharing opportunities." Noting that patient advocate groups have generated new Institutes and Centers, she asked how activities (e.g., stem cell research) might be coordinated so that patient advocates can use the information effectively.
In response, Mr. Sadwin said that he was unable to answer her questions but was thrilled by the ACD's interest and would like the opportunity for more regular input from the ACD on this subject.
Dr. Zerhouni thanked Mr. Sadwin and said that his office would follow up in a few months with a progress report, to satisfy the interest expressed at the ACD meeting.
Introducing Mr. Richard Turman, Associate Director for Budget, Dr. Zerhouni said he had done an outstanding job this year in presenting the NIH's case. When the year began, presidential guidance was to increase domestic spending no more than a half percent; defense and homeland security would have first priority. Ultimately, however, the NIH budget was increased 2.6 percent, for which Dr. Zerhouni gave Mr. Turman major credit.
Mr. Turman provided context for his presentation of fiscal year (FY) 2004 and 2005 budget figures. In January, it was not clear how FY 2004 would end, he said; the numbers changed until February 2. One thing is clear, however: as Dr. Ruiz Bravo emphasized, the era of budget doubling is over. The rolling average NIH budget increase over 30 years has been 8 to 9 percent per year, with a doubling roughly every 10 years. The years when the budget grew 14 to 15 percent coincided with the period of federal budget surpluses.
For FY 2004, the NIH discretionary budget appropriation was $27.9 billion — an increase of $805 million (3 percent) over FY 2003. Recycling of one-time costs for extramural facilities and buildings and facilities from FY 2003 to FY 2004 allowed research activities to increase by 6.7 percent.
For FY 2004, there were an estimated 10,135 new and competing research project grants — 258 fewer than in FY 2003. Mr. Turman noted that the total number of research project grants grew by 1,000 because of the noncompeting grants, which are for 4 years.
In FY 2003, the success rate for grant applications was about 30 percent; it is estimated to be approximately 27 percent for FY 2004. The total number of applications will remain unknown until the end of the year, but the number grew rapidly in FY 2003, Mr. Turman said. The NIH Roadmap was funded at $129 million, representing less than one percent of the budget.
The FY 2005 budget shows an increase of $729, for a total of $28.6 billion in discretionary budget appropriations. The total program level budget is $28.8 billion, an increase of $764 million (2.7 percent), which includes $47 million in HHS for research on nuclear and radiological countermeasures.
The FY 2005 budget is based on an estimated 10,393 new and competing research project grants, 37,744 total research project grants, and a success rate that stays at 27 percent. The aggregate average cost increase for these grants will be capped at 1.3 percent. The FY 2005 budget accommodates an increase of $40 million (10 percent) for obesity initiatives, to address recommendations of the Obesity Task Force; $237 million for the NIH Roadmap; and $1,694 million for biodefense.
The Institutes and Centers and the Director's Discretionary Fund share responsibility for funding the Roadmap. The NIH and Institute and Center Directors have made a corporate decision to create a common pool of resources for all current and future investments in the Roadmap.
The NIH represents about 40 percent of HHS discretionary funding. In FY 2005, the NIH will receive 89 percent of the increase requested for HHS. The NIH has accounted for about 20 percent of the discretionary appropriations bill of the Subcommittee on Labor, Health and Human Services, which funds the agency. That bill also funds the No Child Left Behind, education, and labor programs. In FY 2004, the NIH received 35 percent of the increase in that allocation; the FY 2005 budget calls for the NIH to receive more than half of the increase.
The Congressional Budget Resolution appears likely to total somewhat less than the President's budget for government-wide discretionary spending. The question is whether Congress will follow these priorities; budgets for the Centers for Disease Control and Prevention and some other agencies were reduced. Mr. Turman said that he expects to see a resolution in the fall, but he cannot be more specific at this point.
Discussion
In a paper they co-authored in Science several years ago, Mr. Turman and Dr. Masters speculated that the NIH needed a 4-percent annual budget increase to maintain its momentum. She asked Mr. Turman to comment on that assumption in light of current budget realities. Dr. Zerhouni will have to work with the resources available and determine the mix of priorities needed to fund the best science and maintain the momentum of discovery, he responded.
Observing the absence of high-end instrumentation grant programs in the budget presentation, Dr. Masters said that the Roadmap desperately needs that kind of support. Mr. Turman said that he is working on that. The National Center for Research Resources (NCRR) has most of those funds, and within NCRR, several items were increased (e.g., General Clinical Research Centers), but both shared and high-end instrumentation were maintained at the FY 2004 funding levels.
Mr. Ullian suggested that econometric models be developed to help Congress make appropriations based on facts rather than feelings or pressure from lobbyists. That could probably be done without great expense through a Request for Proposals, he said. The focus should be on information about what Congress is getting for its investment in the NIH. Numerous advances in health care delivery have reduced Medicare costs by $26.5 billion annually, he said. Investment in NIH basic research translates into a significant return to industry, on the order of four times the initial investment. Mr. Ullian recommended that the NIH promote the fact that of all federal investments other than in the military, investment in the NIH is the only one that provides a genuine return.
Expressing interest in Mr. Ullian's idea, Dr. Zerhouni said some people suggest that research increases rather than decreases the costs of health care. The NIH has been considering this subject in the Office of the Director and Office of Science Policy. It is a profound question and almost a multiparametric problem, he said. Without the biotechnology work, there would be no recombinant DNA, and the country would not have 2,000 companies with 250,000 jobs and a $600 billion market value. The investment of that entire period of time was much less than the $600 billion return. The research investment is insignificant compared with the size of those business ventures.
Mr. Turman noted that when Sen. Connie Mack chaired the Joint Committee on Tax, it prepared an analysis of the economic benefits of biomedical research. At about the same time, the Lasker Foundation provided funding for a similar report.
Answering a question from Dr. Burgess about the portion of the Roadmap budget provided by the Director's Discretionary Fund, Dr. Zerhouni said that the Director has authority to transfer only one percent of the budget. Because the Roadmap had not existed before, its budget had to come from a mix of the Director's Discretionary funds and transferred funds. Congress has been quite supportive of the Roadmap initiative and is pleased to see that the NIH has a common goal, he said. Except for a $10 million component historically reserved for emergency needs, the entire Director's Discretionary Fund is earmarked for support of the Roadmap — $35 million for FY 2004 and $60 million for FY 2005.
Dr. Burgess asked whether the budget assumes a higher increase for the NIH over time or a steady 2.6 percent annual increase. He also asked whether there was a sense that the Institute and Center Directors have sufficient enthusiasm for the Roadmap to continue to contribute to it if budgets tighten in the years ahead.
Dr. Zerhouni replied that no matter what happens, the Roadmap budget is within the discretionary budget of each Institute and Center Director, and they have made the commitment without relying on budgetary increases beyond current appropriations. However, some Institutes and Centers that forecast differently have less discretion in their budget. Although they operate in a collegial fashion, he acknowledged that there are points of tension where common ground is needed. Medium-sized Institutes and Centers see an advantage to initiatives to advance their own science, such as molecular libraries, that they could not fund by themselves.
Dr. Kington added that the premise was to do what had to be done to advance the science, no matter what — the things that everyone needed to move to the next stage but that no Institute or Center could do alone.
In response to perceived concerns about the future of R01 grants, Dr. Ruiz Bravo said that the NIH is committed to fund R01s, which have been the source of much innovation over the years — the NIH's "bread and butter." The Roadmap represents an evolutionary process.
In response to a question from Dr. Barron about application success rates before FY 2004, Mr. Turman said the rates had been 31 to 32 percent in earlier years and 30 percent in FY 2003. The most sensitive indicator is the number of applications, he explained. In the mid-1990s, the number of grant applications dropped year to year, but it increased 15 percent and 10 percent in the past 2 years. Some institutions told investigators to apply in FY 2003 because of the known drop in the NIH budget increase; therefore, applications may decrease again. The success rate is a function of many factors, including choices the NIH makes about research project grants as a percentage of the total budget.
Responding to Dr. Barron's question about the success rate during lean years before 1998, Mr. Turman said he had tables going back 15 years that he could send to the ACD. Dr. Masters recalled that the success rate dropped to the teens during those years, and Dr. Waite pointed out that even if the success rate did not grow, the average size of the grant did.
Dr. Zerhouni reported that the average grant size grew from $250,000 to $396,000. The teams, budgets, and numbers of grants per PI are now larger, catching up with costs that were not covered. The real effect was to allow institutions to renew their facilities, build new space, and encourage researchers. Additionally, budgets did not double for every Institute and Center, and there are new Institutes and transfers away from the NIH. As a result, the real "doubling" was 80 percent, not 100 percent, he explained. Although the NIH increased the number of grants by 40 percent, the number of applications rose by more than 40 percent in FY 2003, Centers contracts rose, and the extramural total increased 60 percent during the period of budget doubling. Dr. Zerhouni reported that early on, he requested an accounting of where the doubled budget was spent. The $28 billion for the NIH represents roughly $100 per American per year, far less than the pharmaceutical industry spends. Caution is needed to use the right strategies to make the right investments.
Dr. Burgess commented that every campus he visits seems to be constructing new buildings; academic administrators saw the early doubling as a potential windfall for the institution and began plans for buildings that are just now being completed. He does not think that the increase in number of grant applications will stop. In addition, he commented that academic research centers are hiring heavily on tenure tracks, but that now, tenure means the university will cover only 80 percent of salary. This puts considerable pressure on scientists to cover the remainder of their own costs through grants, he said.
New Institute Director Presentation: National Institute Of Mental Health (NIMH)
Dr. Thomas Insel, who has been Director of the National Institute of Mental Health (NIMH) for almost a year and a half, introduced himself and responded to an earlier question from Dr. Burgess about the Institutes' and Centers' commitment to the NIH Roadmap. Dr. Insel said that, although Dr. Zerhouni is responsible for the idea, the details of the Roadmap emerged from a great deal of discussion across the Institutes and Centers. The Roadmap represents their highest priorities, allowing them to leverage investments, and he described their enthusiasm as "tremendous." The previous week, there was a review of one of first molecular library RFAs, for cellular imaging. The Roadmap funding was sufficient for three grants, but another six were funded because of enthusiasm for the projects. Dr. Insel expects to see much greater investment in the Roadmap over time rather than less.
Dr. Insel then returned to the subject of his Institute, whose mission is to reduce the burden of mental disorders through research on mind, brain, and behavior. According to 2002 data from the World Health Organization, across all disorders, mental illnesses as a group cause by far the greatest disability (26.1 percent of all years lost to disability), because they are disabling chronic diseases that usually start in adolescence. Alcohol and drug use, which are often associated with mental disorders, are second, with 11.5 percent of total years lost. In the 15- to 44-year-old age group, mental illnesses are responsible for almost 40 percent of all disability.
These are tremendously disabling chronic illnesses, Dr. Insel said, and they are sources of mortality as well as morbidity. Suicide is the cause of more deaths (30,000 per year) than homicide (18,000) or AIDS (20,000), and the figure for suicide is probably underestimated because many single–occupant motor vehicle deaths may be "surreptitious suicides."
Strikingly, the nation's largest institution for people with mental disorders is the Los Angeles County jail, which spent $10 million for psychotropic medications in 2001. Of the roughly 13 million people jailed every year, 7 percent have a serious mental illness. The suicide rate in jails is nine times that of the general population. In fact, Dr. Insel said, people with mental disorders are found almost everywhere but in the mental health system: the criminal justice system, where 15 percent of youths have a major depressive disorder (MDD); nursing homes, where mood disorders and suicide are common; schools, where students exhibit attention deficit hyperactivity disorder, eating disorders, and suicide; and primary care, which has seen a 3-fold increase in treatment of MDD since 1990. Rural areas have a great disparity for health care, particularly mental health care. Of the nation's 1,669 federally designated health care shortage areas, 85 percent are rural.
In addition to the devastating personal and emotional costs, the economic costs of mental illness are enormous. Approximately $71 billion goes toward the treatment of mental illnesses in the United States, and most of that is within the public sector. Antipsychotic drugs are now a $10 billion-per-year industry, and Medicaid pays more than half of those costs, for a total of about $5 billion in 2004. Unlike the rest of medicine, mental disorders carry even greater economic costs because of the associated social services: $79 billion in indirect costs for Social Security benefits (SSI and SSDI), for which people with mental illness represent the single largest group of recipients. The United States pays a total of about $150 billion in annual costs for mental illness and now invests $1.4 billion in mental health research through NIMH.
The first presidential commission on mental health in 20 years, which was particularly focused on services, issued a report titled Achieving the Promise: Transforming Mental Health Care in America in July 2003. It says that the United States is facing a catastrophe in the major mismatch between where the problem is — where the patients are — and where it is putting resources. The report discussed transforming the system and the need for research that leads to recovery.
Dr. Insel presented a list of four things needed in that research for recovery from mental illness:
Provide the evidence base and implement what we know.
Develop biomarkers to validate diagnosis, identify who is at risk, and devise prevention strategies.
Develop new treatments that are truly effective, safe, accessible, and targeted to individual needs. Unlike neurology, which has very good diagnostic tests but less effective treatments, psychiatry has surprisingly good treatments for most disorders but lacks the kind of pathophysiology that is being developed for many neurological illnesses.
Go for the cure. For the first time, the field is beginning to discuss what is needed over the next 10 to 15 years to consider a cure for schizophrenia, autism, and bipolar disorder.
Dr. Insel moved on to two projects in the NIMH intramural research portfolio. He showed brain scans of subjects with childhood-onset schizophrenia and controls, followed for 5 years, to understand the thickness of the cortex. These scans show a 10 percent or greater loss of brain matter, suggesting that schizophrenia is a degenerative brain disorder and its pathophysiology attributes may resemble those of other degenerative disorders.
Other research on schizophrenia is delving into the genetics of susceptibility. There is reason to suspect a heritable component; schizophrenia is more common in identical than in fraternal twins. Researchers are now beginning to flesh out the genetic risk architecture, he said. It appears that no one gene is causative, but some are associated with increased risk. NIMH is devoting considerable effort to understanding where these genes are expressed in the brain, when they are expressed during development, and what their role might be in the pathophysiology of this illness. An intramural program spearheaded by Dr. Daniel Weinberger is examining this area in a broad way. The work by Weinberger was recognized by Science magazine in December 2003 as the second science breakthrough of the year, after the discovery of dark matter at the edge of the universe.
Over the new few months, NIMH will be reorganizing to develop a different process for its extramural efforts. The focus will be on translation — both from bench to bedside and from bedside to practice. "The need for bridging science and service is urgent. We need to make sure that what we know is what we do — that science informs practice," Dr. Insel said. This has not happened everywhere in the mental health field. In discovery to recovery, translation is key, he said.
Genomics and imaging now provide strategies to make it possible to consider prevention, recovery, and possibly even cures for mental disorders. Scientists understand that these are all brain diseases that affect different parts of the brain. This is an exciting time in the mental health field, Dr. Insel concluded, and he expects to see remarkable advances over the next 5 years.
Discussion
After thanking Dr. Insel for alleviating his concern about the Roadmap, Dr. Burgess mentioned a study of childhood depression in an eastern band of Cherokee in North Carolina. This Native American community built a casino, brought families out of poverty, and saw an immediate improvement in depression. He wondered how much depression may be related to poverty. Poverty is one of the factors associated with mental disorders, Dr. Insel replied, but in the North Carolina study, it was conduct disorder not depression that decreased. Scientists do not yet know what "loads" for depression. They understand some predisposing factors but not why some people do and others do not develop depression.
Responding to a question from Dr. Masters about knowledge of the molecular basis of autism, Dr. Insel said that science is only beginning to understand the causes of this disorder. Although the prevalence is believed to be increasing, it is difficult to know with certainty in the absence of good incidence data. Autism is the most heritable of all major neuropsychiatric disorders, but no specific autism-associated genes have been identified. The current thinking is that autism is a developmental disorder that begins prenatally in a significant percentage of children, he said. Some children develop well then regress, for reasons that are not yet understood. There is concern about mercury in vaccines and other issues in relation to autism. Dr. Insel recognized a "desperation in the community" for answers about autism and acknowledged that there is a great deal of work to do.
Dr. Barron suggested that the NIH may need to partner with Congress to increase the minimum wage, given the connection between childhood poverty and depression. Partnering has the potential to compound the effects of outreach dramatically, she said. Dr. Insel agreed that there are many opportunities to partner but noted that depression is not entirely a social disease of poverty; it has a biological basis as a brain disease.
Dr. Zerhouni said that Dr. Insel has "changed the thinking about how to approach mental health" and expressed appreciation for his leadership of NIMH.
Dr. Kirschstein referred to a handout, "Who Will Do Science in the Twenty-first Century and Where and How Will They Do It?" Science asked that this paper, which she co-authored with Drs. Joan Schwartz and Walter Schaffer of the NIH and Dr. Maryrose Franko of the Howard Hughes Medical Institute (HHMI), be submitted to Science's Next Wave online publication for postdocs and other students, and it will probably appear in the May 14 issue of Science. A second handout lists people chosen by the National Academy of Sciences as a committee for a meeting to be held June 16. Dr. Thomas Cech, president of HHMI, will chair the meeting, and the National Postdoctoral Association will be represented. Dr. Kirschstein encouraged those present to attend this meeting. From that meeting, her group hopes to bring a final proposal to the ACD about adding to the career options for young people, many of whom are choosing to go to industry early in their careers. She asked that those who left the ACD meeting before her presentation receive a copy of her handouts.
The Advisory Committee to the Director of the National Institutes of Health convened on May 6, 2004, to discuss the report of the Blue Ribbon Panel on Conflict of Interest and its recommendations; to learn about progress in implementing the NIH Roadmap and selecting finalists for the pilot phase of the NIH Director's Pioneer Awards; to hear updates about communications outreach, the Extramural Program, and the NIH budget; and to learn about current activities of the National Institute of Mental Health.
The ACD officially received the report of the COI Panel and acknowledged and commented on the issues raised and activities described at the meeting.
I hereby certify that, to the best of my knowledge, the foregoing minutes are accurate and complete.
Raynard S. Kington, M.D., Ph.D. Executive Secretary, Advisory Committee to the Director, Deputy Director, NIH
Elias A. Zerhouni, M D. Chairman, Advisory Committee to the Director, Director, NIH
2. Broad WJ. U.S. is losing its dominance in the sciences. The New York Times, May 3, 2004.
3. Catalyzing Team Science: Report from the 2003 BECON Symposium provides more details about the event, which was held June 23–24, 2003, at the NIH Natcher Conference Center.
