Date: January 23, 2006
Place: Building 45, Conference Room E1&2
National Institutes of Health
Bethesda, Maryland
U.S. DEPARTMENT OF HEALTH
AND HUMAN SERVICES
NATIONAL INSTITUTES OF HEALTH
The 181st meeting of the National Advisory Dental and Craniofacial Research Council (NADCRC) was convened on January 23, 2006, at 8:35 a.m., in Building 45, Conference Room E1&2, National Institutes of Health (NIH), Bethesda, Maryland. The meeting was open to the public from 8:35 a.m. to 12:40 p.m., followed by the closed session for Council business and consideration of grant applications from 1:30 p.m. until adjournment at 3:00 p.m. Dr. Lawrence A. Tabak presided as Chair.
Members Present:
Dr. Eli I. Capilouto
Dr. Matthew J. Doyle
Dr. Augusto R. Elias-Boneta
Dr. Cecile Feldman
Dr. Linda G. Griffith
Dr. Mark C. Herzberg
Dr. Josephine Lai
Dr. Jon D. Levine
Dr. Anne S. Lindblad
Dr. Harold Morris
Dr. Michael Reed
Dr. Tracy A. Scott
Dr. Philip Stashenko
Dr. George Taylor
Members of the Public Present:
Dr. Carol Anderson, American Dental Education Association (ADEA), Washington, DC
Ms. Linda Berman, Social and Scientific Systems, Silver Spring, MD
Mr. Jack Bresch, Associate Executive Director, ADEA, Washington, DC
Dr. Aida A. Chohayeb, Women Network Collective Research, Washington, DC
Dr. Christopher Fox, Executive Director, International Association for Dental Research (IADR) & American Association for Dental Research (AADR), Alexandria, VA
Dr. Earl Kudlick, Associate Dean, Advanced Education and Research, Howard University, Washington, DC
Ms. Myla Moss, Director, Congressional Relations, ADEA, Washington, DC
Dr. Christian S. Stohler, Dean, Baltimore College of Dental Surgery, Dental School, University of Maryland, Baltimore, and Chair, Board of Scientific Counselors, NIDCR
Dr. Richard Valachovic, Executive Director, ADEA, Washington, DC
Federal Employees Present:
National Institute of Dental and Craniofacial Research:
Dr. Lawrence A. Tabak, Director, NIDCR
Dr. Robert C. Angerer, Scientific Director, Division of Intramural Research (DIR)
Dr. Albert Avila, Extramural Training Officer, Office of the Director (OD)
Ms. Carolyn Baum, Committee Management Specialist and Council Secretary, Office of the Director (OD)
Dr. Sangeeta Bhargava, Program Director, Immunology and Immunotherapy Program, Center for Integrative Biology and Infectious Diseases (CIBID)
Dr. Henning Birkedal-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 T. Cao, Grants Management Specialist, Grants Management Branch (GMB), Division of Extramural Activities (DEA)
Dr. Lois K. Cohen, Associate Director for International Health, NIDCR, and Director, Office of International Health (OIH)
Mr. George J. Coy, Chief, Financial Management Branch (FMB), Office of Administrative Management (OAM)
Mr. Kevin L. Crist, Grants Management Specialist, GMB, DEA
Ms. Mary Daley, Chief Grants Management Officer, GMB, DEA
Ms. Yvonne H. du Buy, Associate Director for Management, and Director, OAM
Dr. Isabel Garcia, Acting Director, Office of Science Policy and Analysis (OSPA), and Co-Director, Residency Program in Dental Public Health at NIDCR
Dr. Sarah Glavin, Evaluation Officer, OSPA
Dr. Kevin Hardwick, Extramural Training Officer, NIDCR
Dr. H. George Hausch, Chief, Scientific Review Branch (SRB), DEA
Dr. Kathy L. Hayes, Planning Officer, OSPA
Dr. Rosemarie Hunziker, Program Director, Technology Development and Industrial Relations Program, Center for Biotechnology and Innovation (CBI)
Ms. Lorrayne Jackson, Extramural Research Analyst and Outreach Specialist, OD
Dr. Lynn M. King, Scientific Review Administrator, SRB, DEA
Dr. Dushanka V. Kleinman, Deputy Director, NIDCR, and Acting Director, CHPBR
Dr. Eleni Kousvelari, Acting Director, CBI
Dr. Raj Krishnaraju, Scientific Review Administrator, SRB, DEA
Dr. John W. Kusiak, Director, Molecular and Cellular Neuroscience Program, CIBID
Dr. James Lipton, Senior Advisor to the Chief Dental Officer, U.S. Public Health Service
Dr. Dennis F. Mangan, Program Director, Microbiology Program, CIBID
Ms. Amy McGuire, Grants Management Specialist, GMB, DEA
Dr. Pamela McInnes, Director, CIBID
Dr. Richard L. Mowery, Program Director, Epidemiology Program, Center for Clinical Research (CCR)
Dr. Mostafa Nokta, Program Director, AIDS and Immunosuppression Program, CIBID
Dr. Ruth Nowjack-Raymer, Program Director, Health Disparities Research Program, CCR
Ms. Helen Pham, Grants Management Specialist, GMB, DEA
Dr. Bruce Pihlstrom, Acting Director, CCR, and Program Director, Clinical Trials Program, CCR
Ms. Diana Rutberg, Grants Management Specialist, GMB, DEA
Ms. Soheyla Saadi, Scientific Review Administrator, SRB, DEA
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
Ms. Anne Welkener, Grants Financial Analyst, DEA
Other Federal Employees:
Dr. Joseph Antonucci, Senior Scientist, Biomaterials, Materials Science and Engineering Lab, National Institute of Standards and Technology (NIST), Department of Commerce (DOC), Gaithersburg, MD
Dr. Clifton M. Carey, Director of Administration, ADA Foundation’s Paffenbarger Research Center, NIST, DOC, Gaithersburg, MD
Dr. Frederick Eichmiller, Director, ADA Foundation’s Paffenbarger Research Center, NIST, DOC, Gaithersburg, MD
Dr. Lori Henderson, Group Leader, Biomaterials, Materials Science and Engineering Lab, NIST, DOC, Gaithersburg, MD
Dr. William Maas, Director, Division of Oral Health, Centers for Disease Prevention and Control, Chamblee, GA
Dr. Ravi K. Sawhney, Office of Science Policy and Planning, Office of Science Planning, Office of the Director, NIH
OPEN PORTION OF THE MEETING
I. CALL TO ORDER
Dr. Lawrence A. Tabak, Director, NIDCR, called the meeting to order and welcomed everyone. He invited the guests to introduce themselves. Dr. Tabak introduced three new Council members: Drs. Cecile A. Feldman, Philip P. Stashenko, and George W. Taylor, Jr. He acknowledged the recent appointment of Dr. Matthew J. Doyle to the Board of Overseers, New Jersey Dental School, University of Medicine and Dentistry of New Jersey, Newark.
Dr. Henning Birkedal-Hansen, Associate Director for Program Development, NIDCR, announced that Ms. Lorrayne Jackson, Extramural Research Analyst and Outreach Specialist, Office of the Director (OD), would retire from NIDCR on February 3. He and Dr. Tabak thanked Ms. Jackson for all her efforts over the years and for her generosity in sharing her knowledge and wisdom in training.
Dr. Norman S. Braveman, Executive Secretary, NADCRC, announced that Ms. Carolyn Baum, Committee Management Specialist and Council Secretary, OD, had officially left NIDCR on January 8 to take a position in the Office of the Director, NIH. In her new role as Program Analyst, Office of Federal Advisory Committee Policy, she will continue to be involved in the management of NIH advisory committees. Dr. Braveman thanked Ms. Baum, and the Council applauded her, for all her hard work as Council Secretary.
Dr. Tabak noted several additional changes at NIDCR. He indicated that Dr. Dushanka V. Kleinman had resumed her duties as Deputy Director after having been on detail to the Office of the Director, NIH, to work on the NIH Roadmap initiative. Dr. Ann Sandberg, Acting Director, Center for Integrative Craniofacial Research, retired on December 2 after more than 30 years at NIDCR.
Dr. Tabak noted several additional changes at NIDCR.
Dr. Tabak thanked Drs. John W. Kusiak and Dennis F. Mangan for serving as acting directors, respectively, of the Center for Integrative Craniofacial Research and the Center for Infectious Diseases and Immunology. He reported that Dr. Pamela McInnes has been selected as Director, Center for Integrative Biology and Infectious Diseases. Formerly, Dr. McInnes was Deputy Director, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases.
II. APPROVAL OF MINUTES
The minutes of the Council’s meeting on September 23, 2005, were considered and unanimously approved.
III. FUTURE COUNCIL MEETING DATES
The following dates for future Council meetings were confirmed:
May 22, 2006
September 18, 2006
January 22, 2007
May 18, 2007
September 24, 2007
IV. REPORT OF THE DIRECTOR
Dr. Tabak highlighted several items in the written Director’s Report, which was provided to Council and was made available at the meeting (see Attachment III).
Dr. Tabak noted that NIH has established an Office of Portfolio Analysis and Strategic Initiatives (OPASI) within the Office of the Director, NIH. The office will address a longstanding need across NIH to help institutes and centers (ICs) better manage their portfolios and will coordinate trans-NIH scientific initiatives such as the NIH Roadmap. The intent is for OPASI to provide transparent decision-making for the NIH and public related to planning and priority setting and to enhance the ability of NIH to integrate and balance public health needs and burden of illness with scientific opportunities.
Dr. Tabak thanked the dental professional organizations for disseminating information about the 2006 NIH Director’s Pioneer Award program in the extramural community. He noted that NIDCR program directors can provide insight on the award program to potential applicants. Dr. Tabak thanked NIDCR staff and, particularly, Drs. Bruce L. Pihlstrom and Richard L. Mowery of the Center for Clinical Research, for their work on the new NIH Institutional Clinical and Translational Science Awards (CTSAs).
Dr. Tabak reported that NIH has awarded contracts to enable researchers to have unprecedented access to transgenic, “knock-out” mouse lines. He noted that the availability of these lines and comprehensive data on the mice is a spectacular opportunity for researchers.
Details on these and additional items are provided in the written Director’s Report.
V. BUDGET REPORT
Dr. Tabak reported on a reorganization of the NIDCR extramural program and on the NIDCR budget for Fiscal Year (FY) 2005 (“the year that was”) and FY 2006.
Effective in January 2006, the extramural program consists of four centers and the Division of Extramural Activities (DEA). The four centers are as follows: Center for Integrative Biology and Infectious Diseases (Director, Dr. Pamela McInnes); Center for Biotechnology and Innovation (Acting Director, Dr. Eleni Kousvelari); Center for Clinical Research (Acting Director, Dr. Bruce L. Pihlstrom); and Center for Health Promotion and Behavioral Research (Acting Director, Dr. Dushanka V. Kleinman). An organization chart and description of these centers and other NIDCR components are available on the NIDCR Web site (www.nidcr.nih.gov).
At the beginning of FY 2006 (October 1, 2005), the extramural program had been reorganized into five centers and the DEA. In January 2006, the Center for Integrative Craniofacial Research and the Center for Infectious Diseases and Immunology are combined into one center—the Center for Integrative Biology and Infectious Diseases.
FY 2005 Budget. In FY 2005, the NIDCR appropriation totaled approximately $389.3 million, of which approximately $312.1 million was allocated to the extramural program, $57.7 million to the intramural program, and $19.4 million to research management and support services. Extramural funds were used to support noncompeting and competing research grant applications, Small Business Innovation Research and Small Business Technology Transfer Research (SBIR/STTR) awards, research centers, research career awards, infrastructure development, research training, and research contracts.
Dr. Tabak noted that as is typically the case across NIH the largest proportion of the NIDCR budget (78 percent) continued to be used to fund research project grants. The remaining portion was distributed to training and career development (9 percent), infrastructure development (3 percent), research centers (4 percent), and research contracts (5 percent). In FY 2005, 16 percent of the budget was discretionary (i.e., available to support new activities), and 84 percent supported existing commitments. NIDCR contributed approximately $34.9 million to NIH for central assessments (e.g., support of study sections).
Dr. Tabak reported that, in FY 2005, NIDCR emphasized initiatives in three priority areas in order to increase clinical research, to capitalize on advances in bioengineering, genomics, and proteomics, and to support HIV/AIDS research. Among the initiatives, NIDCR launched the Practice-Based Research Networks (PBRNs) and issued a number of program announcements (PAs) to broadly stimulate research in strategic areas identified in the NIDCR Strategic Plan and Implementation Plan.
FY 2006 Budget. Dr. Tabak noted that the NIDCR appropriation for FY 2006 again totals approximately $389.3 million—virtually the same as for FY 2005. NIDCR is emphasizing the same three priority research areas. Initiatives to increase clinical research include Phase III clinical trials in infectious diseases, NIDCR clinical pilot data/trial planning grants, validation of new techniques for clinical assessment of enamel demineralization, a neurodevelopmental supplement for the Obstetrics and Periodontal Therapy (OPT) clinical trial, clinical research on osseointegrated dental implants, funding of the National Research Service Award (NRSA) for clinical research, and participation in two NIH Roadmap initiatives in training and career development [Predoctoral Clinical Research Training Programs (T32) and Multidisciplinary Clinical Research Career Development Programs (K12)]. Dr. Tabak encouraged the dental community to take advantage of these two NIH Roadmap programs.
In FY 2006, NIDCR initiatives to capitalize on recent advances in bioengineering, genomics, and proteomics include, for example, research on the role of neuronal/glial cell interactions in orofacial pain disorders, Phase II studies of salivary diagnostics, building a tooth by bridging biology and materials sciences, and research on Sjögren’s syndrome as a model complex disease. In HIV/AIDS research, NIDCR is supporting, for example, determination of the protein profiles of oral mucosal tissues in the context of HIV/AIDS.
Planning for the future. Dr. Tabak noted that the President’s Budget for FY 2007 will be released in early February 2006. To prepare for the future, NIDCR continues to plan and articulate to the extramural community the Institute’s scientific priorities and the alignment of these priorities with improved health. NIDCR priorities will include, for example, the identification of molecular determinants of pre-malignant oral cancer progression, ontogeny of mucosal response in humans, and pharmacogenetics of fluoride, as well as continued efforts to build a tooth.
Dr. Tabak thanked Mr. George J. Coy, Chief, Financial Management Branch, Office of Administrative Management, and his staff for preparing the background data on the budget.
Discussion
The Council asked how NIDCR will be able to maintain the same number of grants, given the flat budget. Dr. Tabak remarked that NIDCR will focus on research priorities, shift funds as needed to “free up” additional monies for support of investigator-initiated research, and sharply focus the activities of research centers on areas of highest priority (i.e., oral health disparities). He emphasized that NIDCR must continue to support the very best science, to be as transparent in its decision-making as possible, and to work toward improving the health of the American people. In addition, NIDCR will pay attention, in particular, to the needs of new investigators—to ensure that those who have benefited from NIDCR-supported research training and mentoring in recent years are able to become scientifically independent (see section VII below). Finally, NIDCR will focus on research that is unique to the mission of the Institute and not duplicate that which already exists or is funded by other ICs.
VI. COUNCIL DISCUSSION ON TRAINING
Dr. Braveman introduced a presentation and follow-up discussion of a proposed “NIDCR Oral Health Scholars” Program. Previously, at the Council’s meeting on June 10, 2005, several Council members proposed, and the full Council discussed, the creation of this program in response to issues raised at the NIDCR Meeting on Research Training, held on June 9.
Presentation
Dr. Mark C. Herzberg summarized the problem, challenge, goals, and potential outcomes of an NIDCR Oral Health Scholars Program. The concept had been developed by three current Council members: Drs. Herzberg, Linda G. Griffith, and Matthew J. Doyle.
Dr. Herzberg noted that the mission of craniofacial, oral, and dental health research in the United States is in jeopardy because of two problems: (i) too few academically qualified young people are seeking careers in academic dentistry and (ii) an extraordinary number of academic faculty positions in dental schools are unfilled. A number of specific observations suggest that dental schools could do more to build the pipeline of academic faculty and to encourage research and scholarship as integral to the training of dental professionals. That is, few schools have bona fide joint D.D.S./M.S. and/or D.D.S./Ph.D. training programs and many dental school admissions committees tend to select against students who have a research experience or career interests. Few dental schools have high levels of research activity, particularly among clinician faculty members. Another disincentive for aspirants into careers in academic dentistry is the discrepancy in salaries between academia and practice, which has increased significantly over the past decade. Collectively, these issues may “drive” individuals away from research careers.
Dr. Herzberg proposed a specific challenge: to provide the top 20 percent of students in each dental school class with 20 percent time for a significant research or scholarly experience (other than advanced clinical training) in each of the 4 years of dental school. The NIDCR Oral Health Scholars Program is a suggested possible first step for meeting this challenge. The goals would be to create a quantum increase in academic dental medicine research and to change the culture of dental education to value research and scholarship in admissions and training.
Participation in the program would enable a dental student to extend the last 2 years of dental school to 3 years in order to obtain a master’s degree. The top quintile of dental schools (as determined by their research funding) would be designated “NIDCR Oral Health Scholars” schools, and each of the schools would have a critical mass of 7–10 dental students per class participating in the program. Each program would be required to have a diversity plan and to support a range of research areas. Partnership with the American Dental Association (ADA) would be sought to fund the program.
To encourage dental schools to participate in the program, the ADA, together with the American Dental Education Association (ADEA) and the American Association for Dental Research (AADR), could bestow a “seal of approval” on schools meeting certain requirements. The ADA could also work to change the requirements for dental school accreditation to include, for example, an honors program or a formal program of scholarship and research. Potential outcomes of the scholars program include competition among dental schools to increase their research base (i.e., research-active faculty and funding), establishing the foundation for a D.D.S./Ph.D. program analogous to the Medical Science Training Program (MSTP). The scholars programs, including D.D.S./Ph.D. programs, would become the new standard of excellence in dental education.
Discussion
Dr. Herzberg invited the Council to discuss the proposed program and to define a specific action plan which NIDCR could seek to influence with NIDCR research training funds. Dr. Tabak asked representatives of the ADEA, AADR, and ADA to comment first.
ADEA. Dr. Richard Valachovic, Executive Director, ADEA, said that the ADEA is very supportive of the concept of creating some mechanism to address the issues raised and of using the leverage of NIDCR leadership. He noted, however, that dental education and dental institutions are very complex and are facing many challenges. He commented on the difficulty of adding courses and programs to an already confining timeframe (the “4-year dilemma”) of dental school and the specific challenges dental schools are facing in terms of dental school costs, an aging faculty, and the changing demographics of students and faculty.
Dr. Valachovic noted ADEA’s four strategic directions for 2004–07—recruitment, development, retention, and renewal of dental and allied dental faculty; financing of dental and allied education; meeting the oral health care needs of a diverse population; and curriculum development and design. He noted that ADEA has established the Commission on Change and Innovation in Dental Education to address the need for clinical practice, research, and teaching within the dental school curriculum.
Regarding the specific content of the proposed program, Dr. Valachovic suggested that providing the top 20 percent of students with 20 percent time for research or scholarship may be too large a challenge for most dental schools to meet, and he questioned how the top 20 percent of students would be determined. Dr. Valachovic stated that ADEA would not be able to participate in the ranking of institutions (via a “seal of approval”) and that the suggested changes in accreditation are unlikely to occur.
AADR. Dr. Christopher Fox, Executive Director, IADR/AADR, said that the IADR/AADR board was very supportive of the proposed program and the 20–20 formula. He noted that the approach is innovative and that IADR/AADR could assist in establishing the program. Dr. Fox agreed with the need for academic dental faculty, but noted that ADA and ADEA data suggest that the number of young people seeking careers in academic dentistry is not too few.
Dr. Fox provided a handout describing three opportunities for dental students: an AADR Bloc Travel Grant, funded by NIDCR; AADR Student Research Fellowships; and an ADEA/AADR Academic Dental Careers Fellowship Program, funded by the ADA Foundation. Under the fellowship program, ADEA and AADR will annually support 1-year fellowships, with assigned mentors, for 10 dental students. The IADR/AADR has approximately 4,500 members; 43 percent of IADR members are AADR members, and 20 percent of AADR members are students.
ADA. Dr. Frederick Eichmiller, Director, ADA Foundation’s Paffenbarger Research Center, National Institute of Standards and Technology, U.S. Department of Commerce, said that the ADA Foundation strongly supports the proposed program as being timely and of high priority. He noted that the foundation has high goals to improve dental education, which include raising $100 million for dental education. He emphasized that the foundation’s work and the dental profession increasingly depends on science and that building the science infrastructure for dental research is critical.
Council Discussion. Dr. Tabak opened the Council’s discussion. He emphasized the following two critical elements for developing the critical mass and momentum envisaged for the proposed program: build in sustainable activities, and continuously expose a significant number of dental students to these opportunities. The Council’s discussion addressed several topics, as follows.
DENTAL SCHOOL ACCREDITATION PROCESS. The Council noted that accreditation standards for academic institutions “drive” curricula and institutions may thwart change via the accreditation process. Members noted further that accreditation should not be used to force dental schools to integrate research into their curricula and that a “seal of approval” would harm relations between schools. The Council noted that the ADA Commission on Dental Accreditation is currently reviewing accreditation standards for dental schools. Suggested changes would be timely and could be forwarded to the commission.
CULTURAL CHANGE AND FLEXIBILITY. The Council emphasized the need to promote a cultural change among students and schools; that is, to augment both the number of students seeking careers in academic dentistry and the capacity of faculty to be supportive of these students. A program to foster these changes would have to be sufficiently flexible for both students and schools. Efforts should be made to identify students who are inquisitive and interested in science, but may not necessarily be science majors, and to offer alternative career paths for at least a subset, if not all, students. The Council commented that the 20–20 formula is an appropriate goal, but may not be applicable to, or achievable for, all dental schools. Members suggested that the proposed program should be available to all schools, rather than limited to the top quintile of schools, and that schools should be allowed to form partnerships with others that have a greater infrastructure for research.
PERSUASIVE, SUSTAINABLE PATHWAYS. The Council emphasized that the development and integration of advanced education programs (such as the proposed program), which require achievement of a master’s degree and offer opportunities for specialty (e.g., Ph.D.) training, must be carefully conceived and packaged. For example, the role and goal of a master’s degree as part of advanced research training need to be clearly defined. A considered approach is necessary to “piece together” a viable program of pathways that will persuasively engage dental students to take advantage of various, available research options; ease their financial concerns (e.g., through loan repayment and retirement programs); and offer long-term (5–10 years) support for the development of research careers.
RESEARCH, RESEARCH TRAINING, AND CLINICAL PRACTICE. The Council emphasized that the issue for dental schools is not research vs. practice, but research and practice. Members noted the need to guard against creating academic silos of research or focusing too strongly on replacing aging faculty. Rather, emphasis should be given to training future clinicians in research, in order to better integrate basic and translational research into clinical practice. Dental students should be given opportunities to learn research methodologies and fundamental skill sets for basic and clinical research.
TRAINING OF FACULTY MENTORS. The Council remarked that many faculty in dental schools do not have the capability to nourish young researchers. Efforts to train faculty to be mentors are critically needed, for mentors can “drive” a research program. Mentoring is essential in dental schools, as in other academic institutions, and support must be provided to build and sustain mentoring relationships between faculty and students.
BROAD OPPORTUNITIES FOR RESEARCH TRAINING. The Council noted that the opportunities available to dental students for research training must be broad, in both venues and disciplines. The Council said that the aim of the proposed program is not to be restrictive or exclusive, but to protect the full range of possibilities and to accommodate innovative approaches. Dental students should be able to take advantage of intensive research training offered in their institutions or other academic health centers and research institutions, including, for example, NIH and the Howard Hughes Medical Institutes (HHMI). Dental students also should be able to pursue training (including Ph.D. training) that is not specific to dental school and is offered in other departments or schools (e.g., public health, engineering, arts and sciences). The Council noted that a major problem will be convincing dental faculty of the advantages of research training and adjunct programs for their students.
NIDCR staff commented that dental schools and students are not taking full advantage of major NIH and HHMI opportunities that are available. The NIH opportunities include the recently developed K12 and T32 programs, as well as the NRSA programs (see also section VII below). The Howard Hughes Medical Institutes Research Scholars Program provides a “year-out” research experience for medical and dental students. Foreign-trained dentists, yet offer another pool of talent for dental research, are not eligible to apply for the NIH Training in Neuroimaging: Integrating First Principles and Applications (T90) program, which is similar to the NRSA program for U.S. students. The Council suggested that the outstanding postdoctoral training programs offered by NIDCR could incorporate research experiences in the NIH intramural program.
PROGRAM COLLABORATION. The Council urged NIDCR and the professional dental organizations (ADEA, IADR/AADR, ADA) to continue their discussion of ways to collaborate synergistically on the development of research training programs for dental students.
In closing the discussion, Dr. Tabak said that NIDCR staff will develop the concept of the NIDCR Oral Health Scholars Program and will report back to Council for further discussion at its next meeting, on May 22, 2006.
VII. COUNCIL DISCUSSION: PRIORITY SETTING FOR THE NEW K/R MECHANISM
Dr. Kevin Hardwick, Extramural Training Officer, NIDCR, described a proposed new NIH career transition program. The purpose of the program is to develop new investigators. At the NIH, “new investigators” is defined as investigators who have not previously received an NIH Individual Research Project Grant (R01), Method to Extend Research in Time (MERIT) award (R37), research center grant (P award), or Cooperative Agreement (U award).
Background Data
Dr. Hardwick presented data which show that the proportion of competitive R01s made by NIH to new investigators has declined since FY 1962, to approximately 20–25 percent in FY 2003. For NIDCR, the proportion in FY 2005 was 23 percent (or 24 of 105 R01s).
In FY 2005, NIDCR awarded research project grants to 74 new investigators. Most of these grantees received a Small Research Grant (R03) (45 percent) or an Exploratory/Developmental Grant (R21) (20 percent). Some (32 percent) received their first R01, and 3 percent received a Research Project—Cooperative Agreement (U01).
In FY 2005, dentists represented 29 percent of all NIDCR principal investigators. The largest number of dentists (160) had a combined D.D.S.-Ph.D., followed by those with a D.D.S. (78) and a combined D.D.S.-M.D. (15). Overall, the largest number of principal investigators had a Ph.D. (475). The proportion of new investigators who were dentists was higher, at 38 percent. Among the 74 new investigators receiving an R01, 25 percent were dentists.
Across NIH, the age at which new investigators received their first major independent research support [R01, New Investigator Award (R23), or First Independent Research and Transition Award (R29)] increased between FY 1980 and FY 2003—to age 42 for Ph.D.s and age 44 for M.D.s and M.D.-Ph.D.s. NIDCR data, as reported voluntarily by grantees, show that 62 percent of NIDCR principal investigators earned their first doctoral-level degree more than 20 years ago [these data exclude recipients of fellowship or career development awards].
New Pathway to Independence Award program (K99/R00)
Dr. Hardwick reported that the Director, NIH, established a New Investigator Committee to develop action items that could (a) increase and maintain a healthy cohort of new and talented, NIH-supported independent investigators and (b) facilitate an investigator’s ability to receive their first R01 award earlier in their research career. The committee recommended that NIH develop and implement a career transition program that would provide 5 years of support in two phases: Phase I (1–2 years) of mentored support for advanced fellows, and Phase II (3 years) of independent research support contingent upon securing an independent research position and administrative review.
In response to the committee’s recommendation, NIH developed a new Pathway to Independence Award program. At NIDCR, this new award will replace the NIDCR Individual Scholar Development and Faculty Transition Award (K22). Dr. Hardwick noted that investigators who have a K22 would continue with that funding until the completion of their K22 award period. He further noted that the K22 has been used variously at NIH and that ICs using the award have issued their own PAs. This situation resulted in an inconsistency across NIH and confusion in the extramural community.
Dr. Hardwick reported on NIDCR use of the K22 mechanism. He noted that NIDCR has awarded a high number of K22 awards, compared with other ICs. NIDCR introduced the K22 in 2001 and adapted it to provide support in two phases. Since 2001, NIDCR has funded 45 K22 awards, of which 42 are still active. The 45 awardees included 18 dentists, 25 Ph.D.s, 1 M.D./Ph.D., and 1 M.D. The 42 still-active awardees include 22 principal investigators in dental training institutions, of whom 13 have a dental degree. Dr. Hardwick also noted that NIDCR investigators with a K22 have been successful in obtaining subsequent NIH research project grants—12 K22 awardees have received 14 research project grants (R01s, R03s, and R21s).
The new Pathway to Independence Award (K99/R00) will be available to new investigators who have obtained their most recent doctoral degree within the previous 5 years. Similar to NIDCR’s K22 award, the K99/R00 will offer support in two phases—Phase I will provide mentored support, and Phase II will provide independent support at an institution to which the scholar has been recruited to a tenure-track, full-time, assistant professor position. Dr. Hardwick noted that the award provisions will be comparable to those of the NIDCR K22 award. Compared with the K22, the funding for a Phase I K99/R00 will be slightly less, and the funding for a Phase II K99/R00 will be limited to 3 (not 4) years, will be significantly more than the K22, and will include full indirect costs.
Dr. Hardwick noted that NIH will announce the new K99/R00 award in a single NIH-wide PA, to which ICs can add specific language detailing their criteria and priorities. NIDCR is proposing to include language that will specify that the research must be relevant to NIDCR priorities and the candidate must demonstrate commitment to a career in oral health research. In addition, NIDCR will specify that funding priority will be given to individuals with a D.D.S. or D.M.D. and that researchers with a D.D.S. who earned a Ph.D. on a previous Individual Mentored Clinical Scientist Development Award (K08) or Individual Mentored Patient-Oriented Research Career Development Award (K23) will be eligible for the new program. [NIH officially announced the Pathway to Independence Award on January 27, 2006.]
Discussion
Dr. Tabak noted that NIDCR anticipates that the new award program will be popular. Because of budget constraints and the inability to assure that dental researchers will be on study sections reviewing applications for the program, NIDCR is specifying that priority be given to applicants who have a commitment to oral health research and/or a dental degree. The NIDCR language that will be included in the PA is intended to encourage applications from dental school graduates and new dental researchers.
VIII. NADCRC OPERATING PROCEDURES REVIEW
Dr. Braveman reviewed the operating procedures of the NADCRC. The written procedures (dated January 2006) were sent previously to all Council members.
Dr. Braveman noted that this set of Council operating procedures is more detailed than previous versions. He discussed specific changes that were made in the sections governing secondary review of grant applications (section II), options available to Council (section III), options available to NIDCR staff (section IV), expedited award of meritorious applications (section V), concept review (section VI), and intramural review (section VII). Dr. Braveman noted that Requests for Applications (RFAs), PAs, and contracts will now all be referred to as Funding Opportunity Announcements (FOAs).
The Council unanimously concurred with the procedures governing the Council’s operations. Dr. Braveman asked the Council members to inform NIDCR of any issues that may arise during the year which could be addressed when staff prepare the operating procedures for next year.
IX. CONCEPT CLEARANCE—New Models of Pain Relevant to the Trigeminal System
Dr. John W. Kusiak, Director, Molecular and Cellular Neuroscience Program, Center for Integrative Biology and Infectious Diseases, NIDCR, presented a concept for Council’s approval. This concept was a revision of an earlier concept presented to the Council at its September 2005 meeting. Drs. Josephine Lai and Jon D. Levine served as Council leads for the discussion. Each Council member received the detailed, written concept.
Dr. Kusiak noted that the first goal of the proposed initiative is to stimulate research on patients with chronic painful disorders that will aid in the understanding of pain and therapeutic mechanisms. The second goal is to stimulate research to develop and utilize new animal models of chronic orofacial pain conditions that will provide insight into the underlying biological mechanisms underlying these disorders. In addition, the initiative would encourage development of similar measures of pain in humans and animals that are non-invasive and objective and that permit a behavioral or a functional assessment of the pain.
Dr. Kusiak noted that successes in treating experimental pain in laboratory animal studies have not always been followed by successful therapeutic outcomes in clinical trials of chronic orofacial pain conditions. From a research perspective, this failure suggests that researchers have not been able to identify appropriate new targets and pathways critically involved in pain. Clinically, this inability translates into a lack of effective analgesic drugs and an urgent need to develop new therapies for treating these chronic pain conditions. Better informed research is needed because the current models and measures of chronic pain in basic studies may not accurately reflect or mirror clinical pain disorders.
Dr. Kusiak noted that the initiative would stimulate research that aims to define novel, experimental animal models and measures of pain that reflect the chronic pain state in humans. It would also stimulate research that utilizes patient studies to characterize pathological mechanisms relevant to chronic pain conditions. The results obtained from the two approaches would inform and complement each other and lead to innovative research addressing biological mechanisms involved in chronic pain conditions. The initiative is consistent with the NIDCR Strategic Plan.
Drs. Lai and Levine supported the concept and agreed that it is very focused on the target of orofacial pain and should remain so. With regard to the written concept, they suggested minor word changes and encouraged NIDCR to reverse the order of the two objectives, with patient studies as the first goal and animal studies as the second.
Discussion
The Council and staff noted two particular needs: development of behavioral animal models of pain perception, and definition and development of objective biochemical markers of perceived pain in humans. The Council encouraged NIDCR to specify these needs in the proposed concept.
The Council unanimously approved the concept.
X. UPDATE ON ELECTRONIC SUBMISSION AND SF424
Ms. Diana Rutberg, Grants Management Specialist, Grants Management Branch, Division of Extramural Activities, NIDCR, described the changes under way at NIH to allow electronic submission of competing grant applications. NIH has been moving toward this change for more than a decade—to reduce the administrative burden and costs of paper applications, improve the quality of demographic information used by NIH and the extramural community, increase the speed of processing and reviewing applications, and shorten the time from receipt of applications to award of grants.
With electronic submission, all competing grant applications will have to be submitted through the central Federal site (http://grants.gov). Ms. Rutberg noted that applicants can obtain information on areas of interest at this site, and applicant institutions will be required to register on the site. Funding Opportunity Announcements will be published on the site (as well as in the NIH Guide for Grants and Contracts) a minimum of 60 days before the due date, as is currently done. Unsolicited or investigator-initiated applications would be submitted in response to generic parent announcements that refer to a mechanism of support (e.g., R01, R21), rather than a science area.
Ms. Rutberg said that Standard Form (SF) 424 will replace Public Health Service (PHS) form 398. She noted that SF424 is being used by all Federal grant-making agencies for electronic submission of applications. All applicants can access eRA Commons, a secure Web site where research organizations and grantees can receive and transmit administrative information about their applications and grants. Ms. Rutberg noted that electronic submission using grants.gov and the SF424 does not apply to noncompeting applications.
To get started, potential applicants (institutions only) will need to register with grants.gov (http://grants.gov/GetStarted) and both institutions and individuals (PIs) will need to register with eRA Commons (http://era.nih.gov/commons). In addition, they will need to download from grants.gov the necessary software viewer (PureEdge) that supports electronic application forms. The software can be downloaded without registering, but applicants must be registered in order to submit an application. Ms. Rutberg provided a list of other service providers that can assist applicants who cannot or do not choose to use PureEdge.
Ms. Rutberg encouraged the Council members to familiarize themselves with electronic submission and to practice using grants.gov. Demonstration software for the full application cycle will be available on grants.gov by March–April, and NIH will announce in the NIH Guide specific plans for moving different mechanisms to electronic submission. Ms. Rutberg noted that NIH anticipates that all grant applications will be submitted electronically by the end of FY 2007 (September 30, 2007). Currently, NIH is using electronic submission for SBIR/STTR and R13 applications, whereas all other applications are still submitted on PHS 398.
Ms. Rutberg provided a list of NIH Web sites, e-mail addresses, and telephone numbers that Council members may contact for assistance with electronic submission. She also noted that NIDCR staff can help at any time and will be available at the AADR/ADEA Electronic Submission Workshop, to be held on March 10 during the annual IADR/AADR meeting, in Orlando, Florida. In conclusion, Ms. Rutberg observed that electronic submission is a major change that will involve a steep learning curve in the extramural community.
Discussion
Council members who have tested the system indicated that they faced many problems including those involving software and availability of personnel through the “help desk.” They noted that, too often, servers are not operational or are dysfunctional and staff are not available or able to help. The Council’s greatest concern was the fact that PureEdge is not compatible with the non-Windows operating system of Macintosh computers, which are widely used in academia. Ms. Rutberg noted that NIH is aware of these difficulties and is addressing these problems by adding and retraining staff and by contracting out the resolution of the software issue. Dr. Tabak noted that NIDCR is trying to be proactive in providing assistance to potential applicants. He urged Council members and extramural investigators to attend the AADR/ADEA workshop, familiarize themselves with the new procedures long before attempting to submit an application electronically, and call on NIDCR staff as needed. Dr. Tabak stated that NIH has registered its concerns about the use of incompatible software, and he encouraged applicant institutions and individuals to do likewise.
XI. IMPLEMENTATION PLAN OF THE NIDCR STRATEGIC PLAN
Dr. Birkedal-Hansen reported on the status of the Implementation Plan of the NIDCR Strategic Plan 2003–08. The initial draft of the Implementation Plan was posted for public comment from September 6 to October 30, 2005. Dr. Birkedal-Hansen summarized the process for development of the draft plan, which included internal staff analysis of the NIDCR research portfolio, the convening of 10 working groups in different program areas, a 1-day meeting on research training, and the convening of a separate working group on mucosal immunity.
Dr. Birkedal-Hansen distributed a handout which summarized the public comments and issues raised by the 29 respondents and indicated the NIDCR disposition with regard to each comment. He noted that, in many cases, the comments have led to changes in the wording of the plan and that, for other comments, NIDCR is taking them under advisement and will consider them further. The plan will be posted on the NIDCR Web site, and any further comments that are received will be addressed as NIDCR updates the plan.
Dr. Birkedal-Hansen emphasized that the Implementation Plan is a “living document” and, as such, will be updated continuously. He thanked the Council members for their participation and assistance in developing the plan. He invited Drs. Eli I. Capilouto and George W. Taylor, Jr., to provide comment on behalf of the Council.
Dr. Capilouto commented on the extensive nature and specificity of the Implementation Plan. He noted that the plan includes approximately 130 subgoals for some 50 goals set forth in seven overarching research areas of the NIDCR Strategic Plan. Dr. Capilouto observed that the 70+ comments made by the 29 respondents reflect the Council’s earlier discussions concerning research priorities, funding support, and omissions in the plan.
Dr. Taylor invited Council’s discussion on the process and priorities of the plan and on ways to track progress. He suggested that NIDCR could track progress in the plan by linking the subgoals to grant applications and awards. Dr. Birkedal-Hansen indicated that this tracking will be incorporated into the periodic updating of the plan. He also noted that the science will “drive” priorities, for some research areas may develop faster than others, and that NIH Roadmap initiatives will become a more important part of the plan as it evolves. Dr. Kleinman noted, in addition, that OPASI will be utilizing an informatics approach to track the linking of NIDCR initiatives with NIH priorities.
Dr. Herzberg congratulated NIDCR staff for crystallizing NIDCR interests and priorities into a modifiable Implementation Plan.
The Council unanimously approved acceptance of the NIDCR Implementation Plan.
CLOSED PORTION OF THE MEETING
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).
The Chairman, Board of Scientific Counselors, reported on the results of the review of the Gene Therapy and Therapeutics Branch and the Molecular Structural Biology Unit in the Division of Intramural Research by the Board of Scientific Counselors in December 2004. The Scientific Director, NIDCR, presented the NIDCR response to this report.
Before closing the session, Dr. Braveman presented the guidelines pertaining to confidentiality of information and materials presented and conflict of interest. He noted that members are required to absent themselves from the meeting during discussion of and voting on applications from their own institutions, or other applications in which there was a potential conflict of interest, real or apparent. Members were asked to sign a statement to this effect.
XII. REVIEW OF APPLICATIONS
Grant Review
The Council considered 451 applications requesting $86,309,797 in total costs. The Council recommended 331 applications for a total cost of $55,028,744 (see Attachment II).
ADJOURNMENT
The meeting was adjourned at 3:00 p.m. on January 23, 2006.
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, January 2006
NOTE: A complete set of open-portion handouts is available
from the Executive Secretary.