The 90th meeting of the Advisory Committee to the Director (ACD) of the National Institutes of Health (NIH) was held on June 2, 2005. NIH Director Elias A. Zerhouni, M.D., welcomed five new committee members: Nancy E. Adler, Ph.D., Professor of Medical Psychology, the University of California, San Francisco; David Botstein, Ph.D., Director, Lewis-Sigler Institute for Integrative Genomics, Princeton University; Alexander R. Lerner, Executive Vice President and CEO, Illinois State Medical Society; Christine E. Seidman, M.D., Professor of Medicine and Genetics, Harvard University; and Tadataka Yamada, M.D., Chairman, Research and Development, GlaxoSmithKline.
Dr. Zerhouni reported that Norka Ruiz Bravo, Ph.D., Deputy Director for Extramural Research, NIH, and Story Landis, Ph.D., Director of the National Institute of Neurological Disorders and Stroke, are chairing a committee to determine ways to ensure that the careers of young researchers flourish. He also noted that the NIH Neuroscience Blueprint was launched in 2005 with input from 15 NIH institutes and centers. This initiative is intended to create resources, tackle common scientific problems, and train the next generation of neuroscientists.
On February 3, 2005, the NIH announced new interim ethics regulations, addressing potential conflicts of interest, to ensure that NIH staff maintains the highest possible ethical standards and the NIH continues to be the most trusted source of scientific information. Dr. Zerhouni noted that the new regulations are the first step in eliminating conflicts of interest, while ensuring that the necessary interactions between NIH employees and outside scientist are preserved.
Dr. Zerhouni stated that the NIH Roadmap for Medical Research remains a top priority. He discussed the current NIH budget proposals and reported on meetings with committees of the U.S. Congress on priority setting and the future reauthorization of the NIH. The proposed FY 2006 budget calls for increased funding for research project grants, the NIH Roadmap for Medical Research, development of countermeasures against biological and chemical threats, the Neuroscience Blueprint, and research on HIV/AIDS vaccines.
Nora D. Volkow, M.D., Director, National Institute on Drug Abuse, provided an overview of the priorities and current issues guiding the work of her institute. She discussed key scientific findings, the major roadblocks in solving problems of drug abuse, and the development of the National Drug Abuse Treatment Clinical Trials Network.
Arthur D. Ullian, member of the ACD, provided an overview of international trends in the commitment to scientific research, outlining a need for the United States to strengthen its commitment, especially in the area of biotechnology. He described a trend, in the past 10 or 15 years, of greater science investment on the part of Asian countries, especially China, and flat investment by the United States. The ACD members suggested strategies for increasing the number of young persons pursuing careers in science and for the NIH to support research leading to the development of medical products.
Raynard S. Kington, M.D., Ph.D., Deputy Director, NIH, reviewed progress in the development of the new Office of Portfolio Analysis and Strategic Initiatives (OPASI) to evaluate and help plan the NIH portfolio. The office will help NIH leadership stimulate new trans-NIH initiatives and facilitate coordination at the NIH level. The OPASI could also serve as a repository, using new technologies to collect information, manage knowledge, and classify research.
Dr. Kington also reported on progress in the new program to establish a list of bona fide, prescreened awards for meritorious public service or achievement that NIH employees can accept in their official capacity.
Jeremy Berg, Ph.D., Director of the National Institute of General Medical Sciences, reviewed the NIH Director's Pioneer Awards program, which supports people who have highly creative ideas so that they may pursue innovative, pioneering research. He provided data on the nominations and process of the second year of the awards program.
Dr. Berg also reviewed the development of PubChem, the new publicly available NIH database that provides information on biological molecules and can serve as a starting point in the development of new medications. PubChem connects chemical information with biomedical research and clinical information and is integrated with other databases operated by the National Library of Medicine.
Dr. Ruiz Bravo reviewed progress in the new policy on public access to archives of publications funded by the NIH, which went into effect on May 2, 2005. NIH-funded researchers are asked to submit a copy of their final manuscripts upon acceptance for publication. The system will ensure the preservation of publications, allow scientists to mine publications for information, and help the NIH monitor scientific productivity and establish priorities.
Allen M. Spiegel, M.D., Director of the National Institute of Diabetes and Digestive and Kidney Diseases, reported on the trans-NIH obesity initiative. He presented data graphically that demonstrated the current obesity epidemic and referred to the recently developed NIH strategic plan for obesity, which calls for a new discipline to be formed by the merging of biological and psychosocial sciences to attack the problem of obesity.
The 90th meeting of the Advisory Committee to the Director (ACD) of the National Institutes of Health (NIH) was held June 2, 2005, on the NIH campus and Webcast globally. The next meeting will be held December 1–2, 2005.
NIH Director Elias A. Zerhouni, M.D., welcomed five new committee members: Nancy E. Adler, Ph.D., Professor of Medical Psychology, University of California, San Francisco; David Botstein, Ph.D., Director, Lewis-Sigler Institute for Integrative Genomics, Princeton University; Alexander R. Lerner, Executive Vice President and CEO, Illinois State Medical Society; Christine E. Seidman, M.D., Professor of Medicine and Genetics, Harvard University; and Tadataka Yamada, M.D., Chairman, Research and Development, GlaxoSmithKline.
Dr. Zerhouni introduced and welcomed Wendy Chaite, J.D., a member of the NIH Director's Council of Public Representatives (COPR), who has agreed to serve as liaison to the ACD. Ms. Chaite replaces Mr. Lawrence Sadwin. ACD member Thomas J. Ansfield, M.D., continues to serve as ACD liaison to the COPR. Dr. Zerhouni noted that ACD members Steven M. Paul, M.D., J. Michael Bishop, M.D., and Phillip L. Williams could not attend the meeting.
The average age at which an investigator first becomes an NIH grantee has now risen to 40 years. Dr. Zerhouni reviewed ongoing efforts to investigate this trend and to ensure that the NIH is supporting young investigators as they move through the system. Many past examples have demonstrated the creative and important research advances that young investigators can produce. A study group that includes members of the ACD and the National Academy of Sciences has produced a report, Bridges to Independence, which examines issues involving young researchers. Norka Ruiz Bravo, Ph.D., Deputy Director for Extramural Research, and Story C. Landis, Ph.D., Director of the National Institute of Neurological Disorders and Stroke (NINDS), currently co-chair a committee that will determine ways to ensure that the careers of young researchers flourish. In late 2005, this committee will propose programs to support that goal.
Dr. Zerhouni reported that on February 3, 2005, the NIH announced new interim ethics regulations that address potential conflicts of interest. The regulations apply to all Federal NIH employees, with some exceptions, such as the ACD members, who are considered special government employees. Key goals of the new policy are to ensure that NIH staff maintains the highest possible ethical standards and the NIH continues to be the most trusted source of scientific information. Another is to avoid unintended consequences and undue burdens on employees. The regulations were posted on the NIH Web site during a period of comment. Dr. Zerhouni's office received hundreds of comments from NIH employees, and he and NIH Deputy Director Raynard S. Kington, M.D., Ph.D., have discussed these comments and the regulations. The NIH will work with the Department of Health and Human Services (HHS) and the Office of Government Ethics (OGE) to consider the comments and to adjust the proposed rules.
Dr. Zerhouni noted that the new regulations are the first step in resolving conflict of interest issues at NIH. He expressed a desire to ensure that the regulations also preserved necessary interactions between NIH employees and outside scientists, such as professional organizations, academia, and industry, and did not harm the vitality of the NIH's intramural program. He expressed his opinion that the NIH should be treated differently than a regulatory agency and that the new regulations, as currently written, conformed to such a model. Regulations for NIH employees should be more selective and should not impede interactions. Dr. Zerhouni recognized that this has been a difficult time for NIH employees and that scientists at the NIH are committed to the overall goal of ensuring trust.
On May 2, 2005, the new policy on public access to archives of publications funded by the NIH went into effect. This program is designed to increase the public's access to articles published by NIH-funded researchers. Dr. Zerhouni stated that an implementation group was currently evaluating the program and Dr. Ruiz Bravo would report on it at this meeting.
Dr. Zerhouni stated that the NIH Roadmap for Medical Research remains a top priority. This innovative approach to accelerate fundamental discovery and translation of knowledge into effective prevention and treatment involves a new construct in which scientists work across the NIH. Dushanka V. Kleinman, D.D.S., M.Sc.D., of the National Institute of Dental and Craniofacial Research (NIDCR), has been successfully coordinating this effort.
Dr. Zerhouni noted that Jeremy M. Berg, Ph.D., Director of the National Institute of General Medical Sciences (NIGMS), would be reporting on Roadmap activities involving the NIH Director's Pioneer Awards and the PubChem database. The ACD members would be asked to help select finalists for the Pioneer Awards toward the end of 2005. Dr. Zerhouni gave his encouragement to the new PubChem molecular database program, which will help to ensure access to scientific information to support research. Science today requires integrated information databases to be used during research, for example, to maximize research synergies. The NIH is in a good position to ensure maximum access to data while reducing redundancy.
Another Roadmap issue is the reengineering of the clinical and translational research enterprise. Dr. Zerhouni has strongly supported this effort, led by Barbara M. Alving, M.D., Acting Director of the National Center for Research Resources (NCRR), to challenge medical science communities to develop a "home" for clinical and translational researchers at academic health centers. In time, the program will comprise a national network of institutions, with appropriate infrastructure, informatics systems, and other resources to facilitate the translation of discoveries efficiently and effectively.
President Bush's FY 2006 budget for NIH is $28.6 billion. Dr. Zerhouni testified on the NIH's FY 2006 budget before the House Appropriations Subcommittee on Labor, HHS, and Education on March 9, and before the Senate Subcommittee on April 6. He presented the following five priorities for the NIH's FY 2006 budget:
Research project grants (an increase of $56 million for 247 additional new and competing grants).
The NIH Roadmap for Medical Research (an addition of $98 million, to total $333 million).
Development of countermeasures against biological and chemical threats (an increase of $56 million, to total $1.8 billion).
The neuroscience blueprint ($26 million).
The development of a vaccine for HIV/AIDS (an increase of $100 million, to total $607 million).
On March 17, 2005, Dr. Zerhouni testified before the House Energy and Commerce Subcommittee on Health and the Environment on the reauthorization of the NIH and evaluation of its portfolio. Dr. Zerhouni expressed his view that the NIH must enhance the process of determining priorities and allocating resources as part of a balanced and coordinated research portfolio, especially in light of the trend toward longer life and multiple medical issues for individual U.S. citizens. After consulting with scientific leaders inside and outside the NIH, he began a process to create a new Office of Portfolio Analysis and Strategic Initiatives (OPASI), within the Office of the Director. This effort to address the overall NIH portfolio will play a central role in the future reauthorization of the agency.
Dr. Zerhouni noted that Allen M. Spiegel, M.D., Director of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), would speak at this meeting about the obesity initiative, a trans-NIH program. An initiative to enhance children's activity and nutrition (called WE CAN!) was launched recently. It is a joint effort of the NIDDK, the National Heart, Lung, and Blood Institute (NHLBI), the National Institute of Child Health and Human Development (NICHD) and the National Cancer Institute (NCI)
The NIH launched its Neuroscience Blueprint during 2005, with input from 15 NIH institutes and centers. Dr. Zerhouni explained that this initiative would capitalize on collaborations to create resources, tackle common scientific problems, and train the next generation of neuroscientists. Story C. Landis, Ph.D., Director of the NINDS, will speak about the program at the fall ACD meeting.
Dr. Zerhouni announced the following changes in NIH leadership:
David B. Abrams, Ph.D., has been appointed Director of the Office of Behavioral and Social Sciences Research (OBSSR).
Elizabeth G. Nabel, M.D., has been appointed Director of the NHLBI.
Antonio Scarpa, M.D., Ph.D., has been appointed Director of the Center for Scientific Review (CSR).
Judith L. Vaitukaitis, M.D., has joined the Director's staff as Senior Advisor on Scientific Infrastructure and Resources.
Barbara M. Alving, M.D., has been appointed Acting Director of the NCRR.
David A. Schwartz, M.D., has been appointed Director of the National Institute of Environmental Health Sciences (NIEHS).
Discussion
Dr. Botstein asked for clarification of the new public access policy. Dr. Zerhouni stressed that the repository would offer public access while falling under the ordinary rules of copyright. The papers are to be placed in the repository, with permission of the journals that published them, within a certain time following the publication date. The NIH took into consideration the need to accommodate papers published in small journals, recognizing that such journals could be negatively affected by a policy that was overly restrictive. The NIH will strive for flexibility in implementing the new policy and will evaluate the program.
R. Sanders Williams, M.D., asked about the proposed regional translational research centers. Dr. Zerhouni explained that the NIH would continue separate investments and maintain flexibility, while supporting a significant mechanism that featured the integration of tools, such as informatics, leading to stronger translational clinical research. He cited the issue of biomarkers as an example of research that is not basic science and not supported, as such, and that would benefit from a more integrative approach.
On the issue of increased average age of investigators who receive first-time NIH grants, Dr. Seidman wondered whether a key problem was the desire or need for researchers to become experts in multiple fields before setting out on their careers. She suggested that perhaps an effort should address the trend toward silos (focused areas of training and research) and ways to move toward more collaborative work. Dr. Zerhouni agreed, calling for a study of successful models and methods for cross-fertilizing among scientific disciplines and methodologies. Change in this area could lead to benefits for many of the initiatives discussed at this ACD meeting. Dr. Botstein proposed consideration of a reduction in the strong current support for M.D.-Ph.D. programs. Annelise Barron, Ph.D., encouraged continuing attention to subsets of researchers (e.g., women and minorities).
Senator Connie Mack asked whether the new conflict-of-interest regulations seemed to be having harmful effects on recruitment, retention, or morale of NIH employees. Dr. Zerhouni responded that his office had seen no effects on retention, as evidenced by stability in the NIH's leadership. He was confident that the new rules would not affect recruitment, noting that many people simply are asking questions about them. Morale had been affected somewhat, and naturally so, yet the new policy was only one of many factors affecting NIH employees and would likely lessen in its importance to morale as the policy solidified. Dr. Zerhouni explained that the productivity of NIH employees appeared to be healthy. One area experiencing stress is the extramural program, where much grant activity is under way in an environment of a flat workforce.
Nora D. Volkow, M.D., Director, National Institute on Drug Abuse (NIDA), provided an overview of the priorities and current issues guiding the work of her institute. The estimated annual costs to our society for the use of drugs are huge — for illicit drugs these are approximately $280 billion (including costs from crime, loss in productivity, health care, incarceration and drug enforcement operation costs), and for nicotine they are approximately $158 billion. The vector in drug abuse is the drug, yet other factors, especially genetics, development, co-morbidities, and the environment, play roles. The greatest factor is likely an interaction of those influences.
Brain development is a priority area for NIDA since drug experimentation and addiction usually start during adolescence or even childhood. Researchers have established that the brain is not fully formed until the early 20s, yet the actual differences in the adolescent brain have not been investigated. Aspects (regions) of the not-fully formed brain might explain the higher rates of drug use during this period. Animal studies have also shown that, in the case of nicotine, the cerebral changes induced by its repeated administration are much larger when the exposure occurs during adolescence than when exposure occurs later in life.
Co-morbidity of drug abuse with other mental illness is another priority for NIDA. This is because persons who abuse drugs experience a high rate of co-morbidities with other mental illnesses. Similarly, a high percentage of patients with mental illness have a problem with drug abuse. An example is the high prevalence of smoking in schizophrenic patients, which could reflect the abnormalities in the levels of nicotine receptors reported in the brains of schizophrenic patients. Indeed, schizophrenic patients improve their cognitive abilities when they smoke. A better understanding of the neurobiological mechanisms underlying co-morbidities could provide insights into the prevention and treatment of drug abuse, but also other mental illnesses.
Dr. Volkow cited key problematic issues, or roadblocks, in the drug abuse area. First, pharmaceutical companies have not substantially taken up the burden of the costs of addressing the issue (developing medications). As a result, the NIDA has been carrying that burden. Second, primary care physicians are reluctant to pursue evaluation and treatment for drug abuse, in part, because of a lack of reimbursement. Third, treatments for drug abuse are not widely used, indicating a problem in the translation of research results.
In response to the third issue, the NIDA has developed the National Drug Abuse Treatment Clinical Trials Network, which fosters dialogue between centers and providers to facilitate translation of research results. It has also developed the Criminal Justice Drug Abuse Treatment Studies to address drug abuse in the jail and prison populations.
Drug abuse facilitates risky behavior, and a link between drug abuse and HIV/AIDS must be examined. Dr. Volkow presented data that demonstrated an increasing percentage of HIV/AIDS caused by heterosexual contact, which is linked to drug abuse. Therefore, a reduction in drug abuse could contribute substantially to a reduction in the burden of HIV/AIDS. In general, addressing drug abuse requires a systems approach that includes social issues, behavior, neuronal circuits, protein expression, and the human genome.
Discussion
Dr. Zerhouni noted that drug abuse (including alcohol abuse) drives about 30 percent of the disease burden in the Nation. Dr. Barron asked whether the NIH and policymakers coordinated their efforts on the issue of drug abuse. Dr. Volkow responded that the best course, in her experience, was for the NIH to pursue good science. Policy would follow naturally from that. Dr. Zerhouni cited the Office of National Drug Control Policy, within the Office of the President, which helps to coordinate the efforts of federal agencies. Another point of cooperation is an integrative effort by the Substance Abuse and Mental Health Services Administration (SAMHSA), NIDA, and the National Institute on Alcohol Abuse and Alcoholism (NIAAA), which targets the intersection of science and service. Dr. Volkow added that the NIDA works with other agencies, for example, to blend themes in drug abuse prevention efforts. An example is a current trial on co-morbidities of Attention Deficit Hyperactivity Disorder (ADHD) and substance abuse, which seeks an integration of effort with the National Institute of Mental Health (NIMH).
Dr. Volkow cited a NIDA program that addresses drug abuse in prisons, "NIDA Goes to Jail," which currently works to translate scientific findings for judges. Prisons and educational systems are important places in which to apply new and effective strategies. The NIDA has an interest in the full spectrum of addictions, including behavioral compulsions such as pathological gambling.
Dr. Yamada stated that the pharmaceutical industry has an interest in the addiction prevention field. Dr. Volkow welcomed the industry's interest and called for a linkage of compulsive behavior treatments.
Role of the NIH in Maintaining Economic Leadership Worldwide
Arthur D. Ullian, ACD member, provided a statistical overview of international trends in the commitment to scientific research. The total U.S. investment in science has been flat in recent years, while the investment of a number of Asian countries (e.g., China and South Korea) has been increasing. In 1970, the United States generated 90 percent of the scientific literature in information technology (IT). In 2004, it generated less than 50 percent. The U.S. allocation of national resources committed to research and development decreased between 1985 and 1999. U.S. high-technology exports declined from 23 percent to 19 percent of the world total during the 1990s.
Between 1992 and 2002, China increased its output of Ph.D.s in science and engineering by 14 percent each year, as the number of U.S. graduates fell. Mr. Ullian noted that Asian companies now control more than 60 percent of the world semiconductor market and spend more than the United States and Europe combined on nanotechnology. Asian companies intend to take the lead in nanotechnology, biotechnology, and information technology. Foreign companies have established 400 research and development centers in China. China currently has 100 biotech companies, 20,000 biotech researchers, and a 10-year plan to establish 20 world-class research-and-development centers. Mr. Ullian suggested the possibility that China could be the center of international biomedical research within a generation.
The NIH could play an important role in advancing U.S. performance in biotechnology by addressing current gaps in product development. For example, many promising scientific projects remain unfulfilled in university laboratories. With NIH support, scientists could bring these projects nearer to the product stage, where they would be more likely to attract private capital investors to pick them up for market development. This would lead to both faster development and increased sales in domestic and global markets. Harvard's Laboratory for Drug Discovery is one example where this model of extended research (through trial phases) is already taking place. Academic research taken through the trial stages has the advantage of costing far less than in private industry, and could be replicated in other academic medical centers if specific funding were available through NIH.
Discussion
Dr. Botstein raised the issue of undergraduate education, specifically, the small percentage of U.S. undergraduates pursuing science. Dr. Barron proposed that the NIH increase funding for principal investigators (PIs) to involve undergraduates in research, thereby increasing scientific opportunities for students. Another strategy would be to change the criteria for reviewing some innovative grants (e.g., R21, R43) to allow for less preliminary data. Younger investigators have less data and would benefit from such a change.
The NIH intramural research program features a successful program that supports both undergraduate and post-baccalaureate students. Dr. Williams encouraged the NIH to support more research by medical students. Dr. Zerhouni stated that one goal of the new initiative for translational research is to analyze structures such as those mentioned. Senator Mack encouraged the NIH to consider new approaches rather than new funding. The attitude in the Congress today is that the NIH budget was recently doubled and now is the time for results.
Dr. Seidman reminded the group of the need to energize both seasoned and young researchers. She suggested the need to reduce obstacles to patient-oriented research. Dr. Yamada encouraged investment in information technology, considering it a "scientific offensive weapon." To improve information technology in the clinical research arena requires developing infrastructure. Larry L. Smarr, Ph.D., noted that the NIH has in fact worked hard to increase support for IT. Dr. Ansfield added that we must prioritize within the field of IT.
Dr. Zerhouni asked the group to consider the perceived position of the NIH. When a reduction in national mortality occurs, as in the case of HIV/AIDS, does the Congress look favorably on the NIH? The numbers in the health care system suggest that the NIH has been doing a good job. It is unreasonable to expect that large increases in the NIH budget (such as the doubling) can lead to huge cost savings (such as halving health care costs). We must look at investments in light of the challenges being met.
Office of Portfolio Analysis and Strategic Initiatives (OPASI)
Dr. Kington reviewed progress in the development of a new office to evaluate and help plan the full NIH portfolio. Such attention to the portfolio would help NIH leadership to stimulate new trans-NIH initiatives and facilitate coordination at the NIH level.. The Institutes and Centers (ICs) have historically done a good job in their separate portfolio planning. The NIH now needs to work on a more strategic level to plan the trans-NIH portfolio. The work of OPASI is intended to coordinate activities among NIH ICs.
The goal of OPASI is to create a 21st-century decision support system, including strategic analysis, which will complement the grants management system. One challenge of the office is the increasingly large and complex portfolios of the ICs. The OPASI could serve as a repository, using new technologies to collect information, manage knowledge, and classify research. The office will aid efforts to coordinate the work of the NIH. It could, for example, be of service as the NIH draws up plans for the obesity initiative and seeks other new research opportunities within the NIH Roadmap for Medical Research.
Dr. Kington reported that the plans for OPASI were being fleshed out. It is in the President's FY 2006 budget. The eventual scale of the office (budget and personnel) has not been determined. Dr. Botstein encouraged the NIH to keep the size (personnel) of the office small — perhaps it could become smaller and more efficient over time.
Discussion
Dr. Yamada characterized the OPASI as a great idea and suggested that it might drive programs. Dr. Kington responded that it could help to drive programs by providing input when yearly budgets were being developed and it would serve to develop strategy. Also, OPASI could help to extend the efforts of the NIH Roadmap for Medical Research.
Dr. Zerhouni stated that the NIH directors have expressed a need for a permanent portfolio analysis process. OPASI will respond to that need and institutionalize the response. Nevertheless, the directors do not want a top-down system in which decisions come from above. He suggested the need for a balance between the trans-NIH perspective afforded by OPASI and the local understanding within the individual ICs. The OPASI will provide coordination and strategic planning to complement IC-based priority setting activities.
Richard J. Hodes, M.D., Director of the National Institute on Aging (NIA), supported the idea of OPASI, noting a substantial inability on the part of the ICs to plan because of a lack of information. The OPASI could bring science to bear on the process of evaluating the NIH portfolio.
The ACD members wondered whether all grants are available online. The CRISP system lists all funded grants. [CRISP stands for Computer Retrieval of Information on Scientific Projects and is an NIH-supported searchable database of federally funded biomedical research projects.] Dr. Seidman asked whether non-NIH grants might eventually be brought into the CRISP database, to produce a broader picture of what is being funded nationally. Dr. Botstein expressed a desire to be able to access all the grants for his institution.
Dr. Zerhouni raised the issue of governance, in light of the discussion of OPASI and grants databases. He asked the ACD members to consider their possible role as a "glue" component in a governance model for the NIH, which is an open structure. Dr. Williams proposed that portfolio analysis be a regular feature of the ACD meetings.
Work Group Report on Outside Awards for NIH Employees
Dr. Kington reported on progress in the program to identify bona fide awards for meritorious public service or achievement. The program will establish a standardized list of outside awards that NIH employees may accept in their official capacity. A work group led by Joan Y. Reede, M.D., M.P.H., M.S., of Harvard Medical School, has been screening awards and adding those considered appropriate to the list. The group has also been developing an expedited process for adding awards to the list.
To be accepted as bona fide for the list, an award must be part of an established program of recognition — made/funded on a regular basis, with selection pursuant to written standards. Awards that have no cash component and little intrinsic value are not considered for the list and are not considered problematic. Highly prestigious awards, such as the Nobel Prize, are allowed.
If a cash award not on the approved list is given to a researcher, he or she has the option of accepting the honor but not the cash component. The list is not intended to be comprehensive (for example, it might miss many international awards). Rather, it is intended to serve as an aid to investigators. The ACD members wondered whether the list should be made more comprehensive and whether the NIH should be more proactive in developing it — for example, forwarding the list to associations to obtain further recommendations.
The ACD members voted to approve the list of bona fide awards as presented in its current form.
NIH Director's Council of Public Representatives (COPR) Liaison Report
The Council of Public Representatives (COPR) report was presented by the new liaison to ACD, Wendy Chaite, J.D. Ms. Chaite briefed the Committee on the two most recent COPR meetings and future plans of the group.
The October 2004 Public Trust Workshop entitled Inviting Public Participation in Clinical Research: Building Trust through Partnerships that COPR coordinated with the NIH shaped much of how COPR has decided to move forward in 2005. The final version of the COPR Public Trust Report is posted on the COPR Web site and has been distributed to all workshop participants, COPR members, and alumni.
Ms. Chaite noted, that since its inception, COPR has produced four formal reports with recommendations to the NIH Director. COPR used the April meeting to listen and learn about NIH activities that directly relate to the important areas outlined in several COPR reports and discussed areas where COPR could make additional suggestions for change. Ms. Chaite shared COPR's plans to find strategies for establishing appropriate benchmarks and tools that they can use to show how (or whether) COPR is being effective. In addition, the COPR members identified priority issues that they will spend the next six months exploring in greater depth.
Ms. Chaite expressed gratitude for being asked to serve as the COPR liaison to ACD and looks forward to exchanging information between these two important advisory councils.
Jeremy M. Berg, Ph.D., Director of the National Institute of General Medical Sciences (NIGMS), reviewed the NIH Director's Pioneer Awards program, which supports scientists of exceptional creativity who propose pioneering approaches to major challenges in biomedical research. The program encourages submissions from scientists in all disciplines relevant to the NIH mission. Now in its second year, the program has been revised to accept only self-nominations.
Dr. Berg reviewed the nomination process, including the required materials to be submitted. Applicants are expected to commit at least 51 percent of their time to the proposed research and must offer justification of why their work is appropriate for the Pioneer Award rather than traditional grant mechanisms. The program especially encourages submissions from women, minorities, and early to mid-career investigators. The proposed research must differ from the researcher's current projects.
The program received more than 830 nominations in 2005, and, following review, 285 nominees were invited to apply for phase 2 of the review process. In the first phase, 74 percent of the nominees were males and 26 percent females. The top 20–25 candidates will be invited for interviews during August, and the ACD members will review the final candidates in September. On September 29, 2005, the NIH will announce the 2005 Pioneer Award recipients at a scientific symposium that will feature individual talks and a roundtable discussion by the 2004 award recipients.
PubChem
The creation of new molecular libraries is a key element of the New Pathways to Discovery theme of the NIH Roadmap for Medical Research. Dr. Berg described the development of PubChem, a free, publicly available database that supports the molecular libraries initiative. PubChem connects chemical structure information with the biomedical research literature and experimental results regarding the biological properties of small molecules. The database is managed by — and integrated with other databases of — the National Library of Medicine's National Center for Biotechnology Information (NCBI).
PubChem focuses on biomedically relevant molecules, distinguishing it from the database of the Chemical Abstracts Service (CAS, of the American Chemical Society), which includes all chemical substances. While there has been some controversy about the overlap of the two databases, Dr. Berg noted that they offer very different content and features. For example, PubChem does not include experimentally determined chemical properties and patent information, and CAS does; PubChem features biological assay results and integrates the information with other information such as protein target structures maintained by NCBI, CAS does not. PubChem's developers would be pleased to link to the CAS databases, as well as other databases that contain information useful for researchers interested in the interfaces between chemistry and biomedical research.
Dr. Ruiz Bravo reviewed the progress of the new policy for public access to archives of publications funded by the NIH, which went into effect on May 2, 2005. NIH-funded researchers are asked to submit a copy of their final manuscripts upon acceptance for publication (that is, submit to PubMed Central at http://nihms.nih.gov). The authors specify when the articles should be made public in the archive subsequent to the journal publication. After receiving many public comments, the NIH decided to set a policy for the timing of submission ranging from immediately to 12 months following the journal publication.
The policy applies to all publications of research funded by the NIH (award mechanisms, cooperative agreements, contracts, and other mechanisms), accepted after the May date. The articles submitted for the archive are final versions, as accepted for publication, and containing all changes resulting from the journal's peer review process.
The policy does not apply to book chapters, editorials, reviews, conference proceedings, and publications resulting from non-NIH-funded research. Dr. Ruiz Bravo stated that the NIH hopes to add about 60,000 articles to the archive each year. This new program addresses current general trends such as new developments in information technology tools, the public's increasing use of the Internet to obtain medical information, and the interest of the U.S. Congress. The system should ensure the preservation of publications, allow scientists to mine publications for information, and help the NIH monitor scientific productivity and establish priorities.
Dr. Yamada wondered whether the system could include non-NIH-funded research publications. Dr. Ruiz Bravo noted that the NIH mandate addresses NIH work, although eventually the system could link to other archives. The NIH system is also consistent with U.S. copyright law. Authors and/or publishers retain copyright of the posted articles, and readers are expected to observe usual restrictions on usage (in which, for example, personal or fair use is allowed).
Dr. Ruiz Bravo stated that the NIH has developed a mechanism for informing coauthors when a multiple-authored paper has been submitted to the archive. There are also mechanisms for dealing with retractions and other contingencies. An ongoing dialogue with the Public Access Policy Working Group of the National Library of Medicine Board of Regents will aid in assessment and quality control of the system.
Allen M. Spiegel, M.D., Director of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), reported on the Trans-NIH Obesity Research Task Force (ORTF) and the strategic plan developed by the ORTF. Dr. Spiegel presented data graphically, demonstrating the obesity epidemic. The prevalence of obesity has increased significantly during the past 20 years in both adults and children, and in all racial/ethnic groups. Obesity has an inverse correlation with education and therefore, perhaps, socioeconomic status. It involves both environment and genetic susceptibility in ways that are complex. Dr. Spiegel showed evidence for an effect of a mother's obesity during early pregnancy on the subsequent (in preschool years) obesity of her child. The medical complications associated with obesity are many and significant.
The NIH recently developed and published a strategic plan for obesity (available at www.obesityresearch.nih.gov). It called for a comprehensive approach involving support of research ranging from basic molecular genetic studies to behavioral and population-based research. To successfully attack the problem of obesity, a new discipline that merges biological and behavioral/social sciences approaches will need to be developed. Dr. Spiegel noted the relationships between the NIH's current obesity and nutrition research and a spectrum of forces/institutions, including the U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), the Centers for Disease Control and Prevention (CDC), the Health Resources and Services Administration (HRSA), the food industry, the biotech and pharmaceutical industries, the exercise industry, the nonprofit sector (foundations), and government policies (federal, state, and local).
Discussion
The ACD members discussed general issues of obesity. They agreed on the need for better collaboration between science and policy. Dr. Zerhouni cautioned that the policy arena is large and complex, and includes areas relating to both politics and economics (e.g., job issues). Dr. Spiegel noted that the FDA is developing new labeling strategies and the NIH could help influence the FDA's results by offering scientific evidence. The participants agreed that food and exercise were both important and should be on the research agenda. Behavior modification is a key element.
Adjournment
Dr. Zerhouni thanked the participants and adjourned the meeting.
The Advisory Committee to the Director of the National Institutes of Health convened on June 2, 2005, to learn about progress in implementing the NIH Roadmap for Medical Research, the Director's Pioneer Awards Program, and the PubChem database; to learn about activities of the National Institute on Drug Abuse; to hear of progress in developing the new Office of Portfolio Analysis and Strategic Initiatives; to learn about the development of a list of bona fide awards that NIH employees may receive and to vote to approve the list; to receive an update on the development of a publicly accessible archive of articles published by investigators who receive NIH funding; and to discuss the NIH's role in helping the United States to maintain economic leadership, especially relating to biotechnology, and finally an update on the trans-NIH obesity initiative.
List of Abbreviations and Acronyms
ACD
Advisory Committee to the Director
COI
Conflict of Interest
COPR
Council of Public Representatives
CSR
Center for Scientific Review
FDA
Food and Drug Administration
FTE
full-time equivalent
FY
Fiscal Year
HHS
Department of Health and Human Services
HRSA
Health Resources and Services Administration
NCI
National Cancer Institute
NCRR
National Center for Research Resources
NDPA
NIH Director's Pioneer Awards
NEAC
NIH Ethics Advisory Committee
NIA
National Institute on Aging
NIAAA
National Institute on Alcohol Abuse and Alcoholism
NIAID
National Institute of Allergy and Infectious Diseases
NICHD
National Institute of Child Health and Human Development
NIDA
National Institute on Drug Abuse
NIDCR
National Institute of Dental and Craniofacial Research
NIDDK
National Institute of Diabetes and Digestive and Kidney Diseases
NIEHS
National Institute of Environmental Health Sciences
NIGMS
National Institutes of General Medical Sciences
NIH
National Institutes of Health
NIMH
National Institute of Mental Health
NINDS
National Institute of Neurological Disorders and Stroke
NSF
National Science Foundation
OBSSR
Office of Behavioral and Social Sciences Research
OGE
Office of Government Ethics
OPASI
Office of Portfolio Analysis and Strategic Initiatives
PI
Principal Investigator
RFA
Request for Applications
SAMHSA
Substance Abuse and Mental Health Services Administration
