Date: January 22, 2007
Place: Building 31, Conference Room 10
National Institutes of Health
Bethesda, Maryland
U.S. DEPARTMENT OF HEALTH
AND HUMAN SERVICES
NATIONAL INSTITUTES OF HEALTH
The 184th meeting of the National Advisory Dental and Craniofacial Research Council (NADCRC) was convened on January 22, 2007, at 9:00 a.m., in Building 31, Conference Room 10, National Institutes of Health (NIH), Bethesda, Maryland. The meeting was open to the public from 8:30 a.m. to 12:30 p.m. followed by the closed session for Council business and consideration of grant applications from 1:30 p.m. until adjournment at 2:30 p.m. Dr. Lawrence A. Tabak presided as Chair.
Members Present:
Dr. Gilda Barbarino
Dr. Matthew J. Doyle
Dr. Marianne Bronner-Fraser
Dr. Eli Capilouto
Dr. Elias Boneta
Dr. Cecile Feldman
Dr. Mark C. Herzberg
Dr. Josephine Lai
Dr. Jon D. Levine
Dr. Anne S. Lindblad
Dr. Harold Morris
Dr. Malcolm Snead
Dr. Philip Stashenko
Dr. George Taylor
Members of the Public Present:
Ms. Gina Luke, American Dental Education Association, Washington, DC
Mr. Jack Bresch, America Dental Education Association, Washington, DC
Mr. Cliff Carey, American Dental Association, Washington, DC
Daryl Pritchard, American Associating for Dental Research, Alexandria, VA
Mr. Gary Schumacher, American Dental Association, Washington, DC
Federal Employees Present:
National Institute of Dental and Craniofacial Research:
Dr. Lawrence A. Tabak, Director, NIDCR
Dr. Isabel Garcia, Deputy Director, NIDCR
Dr. Robert C. Angerer, Scientific Director, Division of Intramural Research (DIR)
Dr. Jane Atkinson, Program Director, Clinical Trials Program, Center for Clinical Research (CCR)
Dr. Albert Avila, Extramural Training Officer, Office of the Director (OD)
Dr. Henning Birkdal-Hansen, Associate Director for Program Development, NIDCR
Dr. Norman S. Braveman, Executive Secretary, NADCRC, and NIDCR Board of Scientific Counselors, and Assistant to the Director, OD
Dr. Patricia A. Bryant, Program Director, Basic and Applied Behavioral/Social Science Research Program, Center for Health Promotion and Behavioral Research (CHPBR)
Dr. María Teresa Canto, Program Director, Health Promotion and Community-Based Research Program, CHPBR
Mr. Hong Cao, NIDCR
Mr. George J. Coy, Chief, Financial Management Branch (FMB), Office of Administrative Management (OAM)
Ms. Mary Daley, Chief Grants Management Officer, GMB, DEA
Mr. Bret Dean, Budget Analyst, FMB, OAM
Mr. William Foley, NIDCR
Dr. Kevin Hardwick, Extramural Training Officer, NIDCR
Ms. Kathy Hayes, NIDCR
Ms. Mary Kelly, Scientific Review Specialist, Scientific Review Branch (SRB), DEA
Ms. Sooyoun Kim, Scientific Review Specialist, SRB, DEA
Dr. Lynn M. King, Scientific Review Administrator, Scientific Review Branch (SRB), DEA
Dr. Eleni Kousvelari, Acting Director, CBI
Dr. John W. Kusiak, Director, Molecular and Cellular Neuroscience Program, CIBID
Ms. Yujing Liu, Scientific Review Administrator, SRB, DEA
Ms. Carol Loose, Budget Analyst, FMB, OAM
Dr. Nadya Lumelsky, Program Director, Tissue Engineering and Regenerative Dental Medicine Program, CBI
Mrs. Jayne Lura-Brown, Program Analyst, CHPBR
Ms. Amy McGuire, NIDCR
Dr. Pamela McInnes, Director, CIBID
Dr. Mostafa Nokta, Program Director, AIDS and Immunosuppression Program, CIBID
Dr. Ruth Nowjack-Raymer, Program Director, Health Disparities Research Program, CCR
Ms. Helen Pham, NIDCR
Dr. Bruce Pihlstrom, Acting Dir., CCR, and Program Dir., Clinical Trials Program, CCR
Ms. Dede Rutberg, NIDCR
Dr. Yasaman Shirazi, Program Director, Epithelial Cell Regulation and Transformation Program, CIBID
Dr. Lillian Shum, Program Director, Mineralized Tissue and Salivary Gland Physiology Program, CIBID
Dr. Rochelle Small, Program Director, Developmental Biology and Genetics Program, CIBID
Ms. Traci Walker, Committee Management Assistant, OD
Dr. Peter Zelarowski, NIDCR
Other Federal Employees:
Ms. Carol Bassim, VA
Dr. William J. Martin, II, NIEHS
Dr. Antonio Scarpa, CSR
Dr. Cheryl Kitt, CSR
Dr. Liz McNair, NIEHS
OPEN SESSION
I. WELCOME AND INTRODUCTIONS
Dr. Lawrence A. Tabak, Director, NIDCR, called the meeting to order and welcomed everyone. He invited the meeting guests to introduce themselves, after which he introduced two new Council members: Dr. Gilda Barabino, professor of chemical engineering at Northeastern University, whose research interests include molecular mechanisms of adhesion in sickle cell disease and cartilage tissue engineering; and Dr. Malcolm Snead, professor at USC in the School of Dentistry, who is involved in developmental biology and biomineralization. Dr. Tabak announced that Dr. Isabel Garcia was attending her first Council meeting in her new role as Deputy Director of NIDCR.
II. APPROVAL OF MINUTES
Dr. Braveman, executive secretary of the Council, invited approval of the minutes of the September 18, 2006 Council meeting. On motion duly made and seconded, the minutes were unanimously approved.
III. REPORT OF THE DIRECTOR, NIDCR
The Director’s Report was distributed at the meeting. Dr. Tabak highlighted several elements.
NIH Reform Act of 2006
Dr. Tabak announced that the President had signed the NIH Reform Act of 2006 into law and that the law contains a number of important provisions that affect future research. It establishes a formal strategic planning process for the entire NIH research portfolio, which is supported by a common fund to promote trans-NIH research activities. There will be a scientific management review of the NIH structure every seven years and that structure will be limited to the current 27 institutes and centers. The law creates a comprehensive electronic reporting system that will catalog all NIH research projects, relying on a standardized format. Finally, the NIH Director is authorized to support interdisciplinary research through grants for demonstrations projects bridging the biological sciences with other disciplines, including chemistry, physics, math and computational sciences. Within that provision the NIH Director is authorized to award grants and contracts that support other high impact, cutting edge research.
NIH Funds Largest Long-Term Study of Health and Disease in Hispanic/Latino Populations
The Hispanic Community Health Study (HCHS) is the largest longitudinal epidemiologic study undertaken by NIH. It will involve recruitment of up to 16,000 participants between the ages of 18 and 74 will be followed for the initially authorized period of 6 ½ years. Funding will total $61 million. Seven NIH organizations will participate -- NHLBI (primary funding agency), NCMHD, NIDCD, NIDDK, NINDS, the NIH Office of Dietary Supplements and NIDCR. Dr. Maria Canto, director of the Health Promotion and Community-Based Research Program, is the responsible program officer from NIDCR.
Changes for RO1 Applicants
Dr. Tabak announced that, effective February 5, 2007, applications for all RO1 grants must be submitted on a standard electronic application.
NIH Announces More Than 50 Awards in the Pathway to Independence Program
In the first round of awards for the Pathway to Independence Program, NIH Director Dr. Elias Zerhouni authorized more than 50 awards to new postdoctoral students, who will use the funds first for a mentored research process and then will be supported in part in their first research grant project. This type of award should help younger researchers financially navigate a first, single research project, a challenge that has traditionally prevented individuals from accepting grants early in their careers. Dr. Tabak noted that the Council had previously discussed this opportunity with the expectation that clinical researchers in dentistry would be interested. In fact, the first applications came mainly from non-clinical researchers, although clinical researchers are equally welcome and it is hoped that the ratio would improve in the future.
Dr. Tabak commented that the inflationary adjustment for existing grants is no longer available. Institutes will have some discretion to use funds freed up by the policy for specific research support. NIDCR will consider support for younger researchers – new RO1 grantees who have limited financial resources during the first grant period, funding for those who renew a single RO1 grant and may need some additional financial support, and transitional support for researchers with a single grant who might lose support for that grant.
IV. BUDGET UPDATE AND DISCUSSION
Before discussing the budget, Dr. Tabak provided an update on several NIDCR organizational changes. Dr. Dushanka Kleinman, Deputy Director, recently retired and Dr. Isabel Garcia was appointed as her replacement. Dr. Tabak explained that there had been changes affecting all of NIH with regard to extramural activities and that there had been some consolidation of activities within the NIDCR organization. Most of the activities of the Center for Health Promotion and Behavioral Research had been moved into the Center for Clinical Research, and some of the activities of the Center for Biotechnology and Innovation had been subsumed in the Center for Integrative Biology and Infectious Diseases. Dr. Eleni Kousvelari was appointed Associate Director for Biotechnology and Innovation and is responsible for the salivary diagnostics program, the salivary proteomics program, the soon-to-be-launched “Build the Tooth Initiative,” and the TNJ Implant Registry. Therefore, the current organization chart has two centers and two divisions (intramural and extramural activities).
Turning to the budget, Dr. Tabak reviewed the 2006 budget, a total of $385.6 million, which provides $307.2 million (80% of the total budget) for extramural research, $56.9 million for intramural research, and $21.5 million to operate the Institute. NIDCR supported 670 research project grants (RPGs) with a pay line of 16.1% and a success rate of 18.6%. The total appropriation was $389.1 million, all of which went to NIDCR activities except for a contribution of $3.5 million to the NIH Roadmap program.
To provide a historical perspective, Dr. Tabak noted that in 1998, 56% of the budget went to RPGs versus an increase to 63% in 2006. During that time the budget for training/career support (about 10%), centers (4%) and contracts (6%) remained about the same. Dr. Tabak noted that 81% of the budget funding is reserved for prior commitments to grants and other programs, leaving a discretionary budget of 19%. It is the main reason for the attention paid to turnover, which is important to maintain a satisfactory level of discretionary funding. Finally, there is a $56.9 million intramural budget, of which $37.1 million (about 9.6% of the total NICDR budget) goes directly to research grants, the remainder to the cost of doing business as an institute within the NIH.
In summary, in 2006 NICDR increased its funding commitment to research including a number of clinical research programs – Phase III infectious disease trials, funding for clinical pilot data/trial planning grants, validation of new technology for the clinical assessment of enamel demineralization, a neuro-developmental supplement for an OPT clinical trial, clinical research on osseointegrated dental implants, and support to the AIDS Clinical Network (co-funded by NIAID). In the integrative biology and bioengineering area NIDCR supported an RFA on the role of neuronal/glial cell interactions on orofacial pain disorders, a RFA to look at Sjogren’s syndrome, an RFA to support the Phase II salivary diagnostics study, a planning grant to support the Building a Tooth Initiative, and an RFA to look at protein profiles of the oral mucosal tissues in HIV/AIDS.
Dr. Tabak explained that the 2007 budget is somewhat complicated by the fact that there is a full-year continuing resolution now in effect for $389.3 million, and the President has published his budget request of $386.1 million (both include a reserve of about $4.7 million for NIH Roadmap) – and there could be a completely different proposal, all of which makes planning tentative. Nevertheless, NICDR is moving forward on several important programs – a pathophysiology and epidemiology study of biophosphonase-associated osteonecrosis of the jaw, an RFA to improve the oral health of women and their infants, an RFA for the study of the ontogeny of host-innate immune-oral microbes, development of new models of pain related to the trigeminal system, an RFA for nanocomposite materials for dental restorations, a PA on immunology of biofils (an under-studied area), a study on the long-term use of antiretroviral therapy on the oral mucosa, and support for the center grants for the Building a Tooth Initiative.
Finally, Dr. Tabak briefly mentioned a number of longer-term initiatives that the Institute is considering – translational applications of gene silencing to oral and craniofacial disorders, osteoimmunology, a systems approach to salivary gland biology, continued research on oral SIV transmission, a metagenomic analysis of the oral microbiome, and re-competition for the Health Disparity Centers.
Dr. Tabak invited discussion. In response to a question about the NIH reauthorization of about $30 billion, Dr. Tabak explained that the authorization, although a positive sign of Congress’ confidence in the NIH agenda, requires the second legislative step of appropriation of funding. That appropriation could be the authorized amount or more or less.
Asked about whether the increases in research grant money is mirrored by an increase in the number of research projects, Dr, Tabak explained that that the projects have increased along with the budgetary increases, but at a slower rate. Costs per project have increased on average, but there is an increase in both the total funding and in the number of projects.
V. BIENNIAL REPORT TO COUNCIL ON TRACKING AND INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH
Dr. Maria Canto, Program Director, Health Promotion and Community-Based Research Program, CHPBR, reported that the NIH Revitalization Act of 1993 requires a report to the Council every two years. The report includes enrollment data for women and minorities for all NICDR protocols. This report also includes a comparison of extramural and intramural protocols from 2002 to 2005, which reveals an increase in protocols of about 1.1%. The data for 2006 is limited to the extramural program. Dr. Canto stated that NICDR is in compliance with the Act.
During discussion it was noted that reporting of enrollments for clinical trials appears to be only 67%. Dr. Canto commented that a report is required for all new money protocols. She added that there may be minor differences in the statistics for the intramural and extramural programs, but it should be remembered that most of the protocols are extramural.
There was a comment that the ratio of minorities appears to be relatively high, but Dr. Canto suggested that NIDCR is probably comparable to other institutes. Dr. Braveman noted that when the protocols undergo peer review, the recruitment program is carefully considered. The standards are similar for all institutes, so the rate of minority recruitment also should be similar. Asked about the impact of the practice-based research networks, it was observed that the program is new and has not developed much data on recruitment. Each of those programs is tracked and there should be better data in the future. The lack of intramural data is a matter of processing data that has already been collected; there have been some delays related to changes in the database.
On motion duly made and seconded, the report was unanimously accepted.
During the break after this presentation and discussion, Dr. Tabak received the following information related to the number and costs of RPGs from 1998 to 2006. RPGs increased from 520 to 670, centers dropped from 31 to 10, K awards remained flat and F awards doubled from 16 to 35, and average RO1s went from $258,000 to $393,000.
VI. THE NIEHS ONES PROGRAM: ENCOURAGING NEW INVESTIGATORS
Dr. Braveman explained that the Institute has a keen interest in developing the next generation of biomedical researchers. There are programs at other institutes that may serve as models for NIDCR, one of which is the NIEHS “ONES” program. Dr. William J. Martin II, NIEHS, discussed the program.
Dr. Martin explained that NIEHS developed a strategic plan last year that included an element that would reflect a commitment to increase the number of young scientists, and especially physician scientists, at NIEHS. The foundation of that program is the Outstanding New Environmental Scientists Award (ONES) and it was implemented last year as part of the strategic plan. Those eligible for the award must be new scientists with no more than eight years since receiving a doctorate, be able to demonstrate evidence of independent productivity, be able to show some financial support from his or her institution, and have no history of RO1 funding. The research accomplished or planned must relate to a specific human disease or disorder which has an environmental stressor element. The applicant must develop a written statement of career goals, a narrative of personal research experience, an external advisory committee (that underscores the importance of mentoring as part of the program), an institutional commitment to support 80% research time and a separate budget for equipment and career enhancement (up to $375,000 over five years, which gives the investigator substantial control over his lab environment). The investigator’s focus must be on human disease with an environmental impact and the time commitment must be at least 50%. There is funding for travel to NIEHS forums, including an expectation that the investigator would make occasional presentations. The external advisory committee would consist of at least one institutional member, an outside members and perhaps one or two others, and it would maintain a continuing mentoring relationship with the investigator.
In the early days the program faced a number of challenges. New, inexperienced investigators require a lot of personal attention when developing proposals, and it is important that the selection process is consistent and fair. In addition, because there is such a wide range of possible research topics, expert review of narrow technical proposals is complicated by occasional lack of qualified reviewers. Finally, it is important to overcome push-back based on a perception that the program is novel and may be threatening to some. The review section chair must buy into the process, and there must be a continuing orientation of panel members to encourage the process.
Dr. Martin stated that the first pass of the program involved 70 applications, 61 of which were considered responsive and 28 were scored. The top ten visited a high level interview panel that included members of the Advisory Council, the Deputy Director, Scientific Director and senior extramural and intramural staff. Eight of the top ten were chosen for funding. The studies involved a wide range of interests -- neuroscience, DNA damage and repair, carcinogenesis, and air pollution.
Dr. Martin commented on the applicability of the ONES program NIH-wide, concluding that it was probably more appropriate to the smaller ICs where it is possible to develop stronger personal relationships with the young researchers, and where a bonding element might encourage the researcher to stay with one institute for a longer period of time. The establishment of the second mentor in the intramural program is also easier to manage in the smaller IC.
During discussion, Dr. Martin explained that the 80% commitment was admittedly challenging, but it is deemed acceptable because of the institutional commitment that supports the investigator. Asked about the interview process, Dr. Martin explained it had two aspects, first to assess the applicant’s qualifications and his or her defense of those qualifications, and second to allow the applicant to demonstrate a commitment to the environmental sciences and especially to the Institute.
Asked about the second mentor program, Dr. Martin explained that the genesis of this very new program came from within the senior intramural scientists who expressed an interest in being available to the young scientists. The program is not prescribed and is entirely voluntary for both individuals and there is no reward or recognition for the mentor. Asked about the composition of the ONES program, Dr. Martin noted that only two of the eight were physician scientists, which reflects the NIEHS environment. Hopefully more physician scientists will apply in the future.
Dr. Tabak expressed appreciation for Dr. Martin’s presentation and invited the Council to consider his remarks in light of whether a program like ONES would make a positive addition to the suite of opportunities for new NICDR investigators. He noted that the second mentor concept could be an effective safety net for an investigator who may not be gaining as much from his primary mentor as possible. He suggested that he would establish a subgroup of the Council to work with staff to look at the applicability of Dr. Martin’s ideas to NICDR. The Council expressed a generally positive feeling for the suggestions.
VII. CENTER FOR SCIENTIFIC REVIEW: NEW APPROACHES IN PEER REVIEW FOR NEW INVESTIGATORS
Dr. Anthony Scarpa, Director, Center for Scientific Review, discussed challenges and opportunities at CSR, which receives about 80,000 applications annually, reviews about 55,000 relying on over 2,000 reviewers. NIDCR submits about 1.3% of those applications, which are reviewed by 134 study sections. Peer review is the foundation of U.S. dominance in research quality and it offers protection from outside influence in setting the NIH research agenda. But even with a good system there is room for improvement. The process is slow and cumbersome to both researcher and reviewer. There is a clear need for more high quality reviewers, and it favors traditional research rather than cutting edge research. Clinical research does not fare as well under the present peer review system as does more traditional laboratory-based research. The process has weakened over time. It started with small study sections that included very highly respected scientists, including Nobel Prize scientists and members of the National Academies, who read every application. It now has a very large number of study groups that are concerned only with a limited number of applications.
Dr. Scarpa stated that revitalization of the review system would require a process change (streamlining and expediting the review process) and a culture change that would encourage bold new research areas on the cutting edge of science. Although some of the changes would require the cooperation of many interests in the research community, there are a few changes that CSR is able to effect. First, communications has been improved with a monthly notice that goes to most offices involved in the review process. Second, there is a program to make the operations of 250 SRAs more compatible by issuing standard operating procedures. To address efficiency, there is a transition under way to require electronic submission of applications that, in itself, will increase uniformity in the application review process. By March of 2007, over 60% of applications will be received in electronic format. Even more exciting is the anticipated launch of artificial intelligence software (probably by June 2007) that will be able to match the grant application to over a million previously reviewed grants that will provide information on the reviewers of similar applications, which should reduce the time it takes to get the application into the system. Finally, for budgetary reasons, reviewers will be provided less expensive non-refundable airline tickets with the privilege of changing the reservation (which incurs a small fee). The pilot test has resulted in a savings of over $4 million so far this year.
Another important change has been the development of a pilot study to whether or not the review cycle can be shortened, since the delay involved in re-submitting revised reviews has been a burden to many applicants, especially new investigators. By returning summary statements within one month (one week for new investigators), the applicant can get back in line for the next review cycle, four months earlier than before.
A biennial IRG review process has been instituted that allows CSR to identify issues and make appropriate changes in the structure and functioning of each IRG. If serious issues are revealed the process might include review by the Advisory Council and the solicitation of input from various members of the scientific community. In addition, six workshops are scheduled in the major discipline areas to convene members of the review groups, NIH staff, and representatives of the relevant professional societies to discuss the present review system in each area and to develop a set of recommendations for improvement.
The volume of applications has exploded in the last five years, rising to 80,000 in 2005 from about 40,000 in 2002. The growth has been similar in the number of applications per researcher (1.2 to 1.4 applications). Finally, because of the difficulty in recruiting permanent reviewers, the number of ad hoc reviewers has soared making management of reviewers more challenging, especially bringing the reviewers together for a meeting. The CSR has begun testing electronic platforms to reduce the amount of travel – telephone conference calls on grants requiring only a few reviewers, video conferencing and asynchronous electronic discussions 9 (not real time so that reviewers have time to consider documentation without delaying the review process).
A key advance is in the offing with a plan to reduce the length of the review document. The concept has been received favorably by most of those interested in the issue, including a solid 74% who responded positively to an NIH survey (5,076 responses).
During discussion, Dr. Scarpa responded to a question about transparency, noting that the process has become much more open than in the past. There is a rationale for assigning applications to reviewers that is available through several public companies to help applicants understand the process. There is also the opportunity for the applicant to request a specific IRG and if the request is reasonable it is usually favorably considered. There is also a more aggressive program to solicit outside opinion from individuals and professional societies.
Asked about an evaluation of the results of the expedited review/re-review process, Dr. Canto stated that 13.2% requested expedited re-review; about 60% improved their scores significantly. There was a brief discussion about the process involved in re-application when an A2 grant is rejected.
CLOSED SESSION
This portion of the meeting was closed to the public in accordance with the determination that it was concerned with matters exempt from mandatory disclosure under Sections 552b(c)(4) and 552b(c)(6), Title 5, U.S. Code and Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2).
X. REVIEW OF APPLICATIONS
Grant Review
ADJOURNMENT
The meeting was adjourned at 2:30 p.m.
CERTIFICATION
I hereby certify that the foregoing minutes are accurate and complete.
________________________ _________________________
Dr. Lawrence A. Tabak Dr. Norman S. Braveman
Chairperson Executive Secretary
National Advisory Dental and National Advisory Dental and
Craniofacial Research Council Craniofacial Research Council
ATTACHMENTS
I. Roster of Council Members
II. Table of Council Actions
III. Director’s Report to the NADCRC, September 2006
NOTE: A complete set of open-portion handouts is available
from the Executive Secretary.