Date: January 26, 2009
Place: Building 31
Conference Room 10
National Institutes of Health
Bethesda, Maryland
The 190th meeting of the National Advisory Dental and Craniofacial Research Council (NADCRC) was convened on January 26, 2009, at 8:35 a.m., in Building 31, Conference Room 10, National Institutes of Health (NIH), Bethesda, Maryland. The meeting was open to the public from 8:35 a.m. to 11:33 a.m.; it was followed by the closed session for Council business and consideration of grant applications from 1:00 p.m. until adjournment at 2:30 p.m. Dr. Lawrence A. Tabak presided as Chair.
OPEN SESSION
Members Present
Dr. Carole A. Anderson
Dr. Marianne Bronner-Fraser
Dr. Rena D’Souza
Dr. Cecile A. Feldman
Dr. Franklin Garcia-Godoy
Ms. Katherine Hammitt
Dr. Karin N. Westlund High
Dr. KyungMann Kim
Dr. Laurie K. McCauley
Dr. Malcolm Snead
Dr. Philip Stashenko
Dr. Robert J. Weyant
Col. Kraig S. Vandewalle (ex officio)
Members Absent
Dr. Gilda Barabino
Members of the Public
Dr. Michael Barri, PPD (CRO), Wilmington, NC
Ms. Linda Berman, Social and Scientific Systems (SSS), Silver Spring, MD
Dr. Thomas W. Braun, University of Pittsburgh, PA
Mr. Jack Bresch, American Dental Education Association (ADEA), Washington, D.C.
Dr. Frederick A. Curro, New York University, NY
Dr. Chris Cutler, State University of New York – Stony Brook, NY
Ms. Deborah Darcy, ADEA, Washington, D.C.
Miss Blair Feldman, Association of Independent Research Institute (AIRI), Washington, D.C.
Mr. Rick Hansen, Digicon, Rockville, MD
Ms. Nasreen Jahed, SSS, Silver Spring, MD
Ms. Monette McKinnon, ADEA, Washington, D.C.
Dr. Dan Meyer, American Dental Association, Chicago, IL
Ms. Myla Moss, ADEA, Washington, D.C.
Ms. Linda Naini, SSS, Silver Spring, MD
Dr. Bruce Pihlstrom, Journal of the American Dental Association, Bethesda, MD
Mr. Jon Retzlof, AIRI, Washington, D.C.
Dr. Gary Schumacher, American Dental Association’s Paffenbarger Research Center, Gaithersburg, MD
Federal Employees Present
National Institute of Dental and Craniofacial Research
Dr. Lawrence A. Tabak, Director
Dr. Isabel Garcia, Deputy Director
Dr. Alicia Dombroski, Executive Secretary, and Director, Division of Extramural Activities (DEA)
Dr. Amy Bany Adams, Acting Director, Office of Science Policy and Analysis (OSPA)
Dr. Robert C. Angerer, Scientific Director, Division of Intramural Research (DIR)
Dr. Jane Atkinson, Division of Extramural Research (DER), Center for Clinical Research (CCR)
Mr. George J. Coy, Office of Administrative Management (OAM), Financial Management Branch (FMB)
Mr. Kevin L. Crist, DEA, Grants Management Branch (GMB)
Ms. Michelle Culp, Director, Office of Director (OD), Office of Clinical Trials Operations and Management (OCTOM)
Ms. Mary Daley, DEA, GMB
Ms. Trenita Davis, DER, CCR
Mr. Bret Dean, OAM, FMB
Dr. James Drummond, DER, Integrative Biology and Infectious Diseases Branch (IBIDB)
Dr. Olga Epifano, DER, Behavioral and Social Sciences Research Branch (BSSRB)
Ms. Wendy Fanaroff-Ravik, OD, OCTOM
Ms. Ki-Cha Flash, DEA, GMB
Dr. Leslie Frieden, DEA, Research Training and Career Development Branch (RTCDB)
Ms. Sue Hamann, OSPA
Dr. Holli Hamilton, DER
Dr. Kevin Hardwick, DEA, RTCDB
Dr. Emily Harris, DER, Translational Genomics Research Branch (TGRB)
Dr. Victor Henriquez, DEA, Scientific Review Branch (SRB)
Mr. Justin Hentges, DEA, GMB
Mr. Gabriel Hidalgo, OD, DEA
Dr. Jonathan Horsford, DEA, SRB
Dr. Lynn King, DEA, SRB
Dr. Raj Krishnaraju, DEA, SRB
Dr. John W. Kusiak, DER, IBIDB
Ms. Carol Loose, OAM, FMB
Dr. Dwayne Lunsford, DER, IBIDB
Ms. Jayne Lura-Brown, DER
Ms. Marsha Mason, OD, Division of Extramural Activities Support (DEAS)
Ms. Rosemary McCown, OD, OCTOM
Dr. Pamela McInnes, Director, DER
Dr. Marilyn Moore-Hoon, DEA, SRB
Mr. Thomas G. Murphy, OD, Associate Director for Management, and Director, OAM
Mr. John Prue, Director, Office of Information Technology (OIT)
Dr. Melissa Riddle, DER, BSSRB
Ms. Delores Robinson, OD, DEA
Dr. Isaac Rodriguez-Chavez, DER, IBIDB
Ms. Diana Rutberg, DEA, GMB
Dr. Yasaman Shirazi, DER, IBIDB
Dr. Lillian Shum, DER, IBIDB
Mr. Romeo Tengey, DEA, GMB
Ms. Dianne Thorpe, OD, Administrative Officer, and OAM, Administrative Management Branch (AMB)
Mr. Jeffrey Thurston, DEA, GMB
Dr. Rebecca Wagenaar-Miller, DEA, SRB
Mr. Robert Berendt, Contractor
Dr. Lois K. Cohen, Consultant
Dr. Alison Davis, Contractor
Other Federal Employees:
Dr. Mary Fran Deutsch, Office of the Director (OD), NIH, Office of Extramural Research (OER), Office of Policy for Extramural Research Administration (OPERA)
Dr. Christine Lam, National Institute of Neurological Disorders and Stroke (NINDS), Division of Intramural Research
Dr. Jason Wan, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Laboratory of Molecular Biology
I. WELCOME AND INTRODUCTIONS
Dr. Isabel Garcia, Deputy Director, NIDCR, called the 190th meeting of the Council to order. She noted that Dr. Lawrence Tabak, Director, NIDCR, is now also serving as Acting Principal Deputy Director, NIH, during the transition to a new administration, and would be delayed in joining the Council meeting. Dr. Garcia invited all guests to introduce themselves.
Dr. Garcia welcomed a new Council member, Dr. Robert J. Weyant, Professor and Chairman, Department of Dental Public Health, School of Dental Medicine, University of Pittsburgh. She welcomed again four new members who had attended the previous Council meeting, on September 26, 2008, and who now have official appointments: Dr. Franklin Garcia-Godoy, Dr. KyungMann Kim, Dr. Karin N. Westlund High, and Colonel Kraig S. Vandewalle (ex officio). Dr. Garcia congratulated Council member Dr. Carole A. Anderson, who was recently appointed Dean of the College of Dentistry at The Ohio State University.
Commenting on NIDCR staff, Dr. Garcia thanked Dr. Alicia Dombroski for taking on a new role as Executive Secretary of the Council, in addition to her serving as Executive Secretary, Board of Scientific Counselors, and Director, DEA. Dr. Garcia also welcomed two new staff members: Mr. John Prue, Chief Information Officer and Director, OIT, and Dr. Amy Bany Adams, Acting Director, OSPA.
Dr. Dombroski introduced three new DEA staff members: Ms. Leslie Frieden, extramural training officer, RTCDB; Mr. Gabriel Hidalgo, program analyst, OD; and Mr. Jeffrey Thurston, grants management specialist, GMB.
II. FUTURE MEETING DATES
May 22, 2009 [NOTE: This date is changed from May 18, 2009.]
September 24, 2009
January 25, 2010
May 20, 2010
September 27, 2010
III. APPROVAL OF MINUTES
Dr. Dombroski invited the Council to consider and approve the minutes of the September 26, 2008, Council meeting. The Council unanimously approved the minutes.
IV. STRATEGIC PLANNING UPDATE
Dr. Isabel Garcia
Dr. Garcia presented an update on the NIDCR Strategic Plan 2009–2013. She addressed the process, components, and remaining steps. The strategic planning process began in December 2007 with formation of an NIDCR steering committee consisting of representatives from all NIDCR divisions and the Office of the Director. In early January 2009, the steering committee reviewed a second draft of the strategic plan and, on January 16, forwarded a third draft to the Council and NIDCR executive staff for review. Revisions from this review will be incorporated into a final draft that will be posted February 1 on the NIDCR website (www.nidcr.nih.gov) for 3 weeks of public comment. Dr. Garcia urged the Council members to inform their colleagues about the website posting and encourage their comments.
Development of the plan has proceeded through four phases. First, NIDCR sought input broadly from its community of stakeholders via the NIDCR website, the Federal Register, and “listening sessions” held during the annual meetings of the American Association for Dental Research, the International Association for Dental Research, and the NIDCR Patient Advocates Forum. Second, internal NIDCR working groups provided insights on common and diverse points of view about dental research and research training. The information gathered during the first two phases was then used during the third phase which consisted of development of several drafts of the document. Public comment will be incorporated during the fourth and final phase before preparing the final plan for printing and dissemination.
Dr. Garcia highlighted several main features of the plan. She noted that the plan is driven by NIDCR core values, reiterates the mission of NIDCR, and sets forth specific goals and strategic objectives. In brief, the NIDCR mission and core values are to support research, research training, and information dissemination that is driven by the science; aims to improve the oral, dental, and craniofacial health of all people; and upholds the public trust. NIDCR views the plan as a dynamic framework to support science planning and decision-making on critical areas of investment and as a vehicle for identifying and communicating the most promising scientific opportunities to improve oral health.
The draft plan has four goals, and strategic objectives aligned with each goal, to improve oral, dental, and craniofacial health by (i) bringing the best science to bear on problems; (ii) strengthening the pipeline of researchers dedicated to solving problems; (iii) identifying innovative clinical research avenues; and (iv) applying rigorous, multidisciplinary research approaches to eliminate health disparities. Dr. Garcia noted the strategic objectives for each goal and said that implementation details will be developed once the plan is completed. She welcomed the Council’s input and ideas on implementation of the goals and objectives.
As immediate next steps, NIDCR is seeking comments on the draft plan via its website, email notices to interested parties, and a stakeholders’ meeting on February 9. Following the public comment, NIDCR will incorporate the input received, prepare a disposition report of comments, and finalize and complete the strategic plan in April 2009.
In closing, Dr. Garcia thanked the steering committee for its commitment and contributions and the specific individuals involved in developing the plan.
Discussion
The Council’s discussion opened with remarks by two lead discussants, Drs. Laurie McCauley and Cecile Feldman. Dr. McCauley congratulated the steering committee for achieving a clear, concise, and valuable planning document. She noted that the draft plan reflects and responds to stakeholders’ input, is dynamic and progressive while building on NIDCR traditions, and is very workable with easy-to-track and measurable goals. Prominent, positive aspects include the plan’s emphasis on inter- and multidisciplinary approaches to clinical research, strengthening the workforce, embracing the newest technologies, and focusing on areas of scientific promise. Two key messages are the need to integrate dentistry fully into the primary health care network and to balance the uniqueness of dentistry with the desire to partner with diverse specialties and attract scientists from other fields into oral health research.
Dr. Feldman agreed with Dr. McCauley, saying that the process for obtaining input has been very positive; the directions set forth in the plan are clear, encompassing, and flexible; and the plan is extremely well written. She called attention to similarities in the strategic objectives for goals 3 and 4 and suggested a minor tweaking to group aspects of objectives 3.1, 3.3, 4.3, and 4.4 under a new goal—to facilitate the translation of research discoveries into clinical practice.
In general discussion, Dr. Garcia-Godoy asked about the utilization of practice-based research networks (PBRNs) in relation to the plan. Dr. Garcia said that PBRNs would serve as a vehicle for transferring research results into dental practice, as intended in their initial design. Dr. Stashenko urged NIDCR to obtain input from industry, as this sector could play an enormous role in determining the commercial viability of emerging technology. Dr. Garcia stated that industry representatives have been invited to the February 9 stakeholders’ meeting. Dr. D’Souza noted the more active role envisaged for schools of dentistry in this plan, in relation to strengthening the pipeline of researchers and pursuing innovative clinical research. Dr. Garcia emphasized that this plan is more selective, by giving priority to four broad research areas, than the previous NIDCR strategic plan.
V. REPORT OF THE DIRECTOR, NIDCR
Dr. Isabel Garcia and Dr. Lawrence Tabak
Dr. Garcia presented highlights from the written Report of the Director and an update on the NIDCR budget. The full, written Report of the Director was provided to the Council (see Attachment III) and is available on the NIDCR website (http://www.nidcr.nih.gov/AboutUs/Councils/NADCRC/DirectorsReport/).
Highlights
Leadership Role at NIH. Dr. Garcia elaborated on Dr. Tabak’s new role as Acting Principal Deputy Director of NIH. She noted that, while serving as Director of NIDCR, he is also fully engaged in NIH activities, including the enhancement of peer review (see his report in section VI below). Dr. Tabak continues to co-chair the Research Teams of the Future component of the NIH Roadmap for Medical Research, as well as the NIH-wide Pain Consortium, and serves on the NIH Scientific Management Review Board, whose role is to develop recommendations for enhancing the NIH mission.
Human Microbiome Project Awards. Dr. Garcia highlighted the Human Microbiome Project, a part of the NIH Roadmap, as an opportunity for NIDCR to partner with others in the broad NIH community. In October 2008, NIH announced its first awards for this 5-year project. The oral cavity is one of five anatomical sites from which tissue samples will be collected to characterize microbial genomes; the four other sites are the digestive tract, nose, skin, and vagina. Dr. Pamela McInnes, Director of the NIDCR Division of Extramural Research, is assuring that research in the oral cavity is well represented in this effort.
NIH Genes, Environment and Health Initiative (GEI). Six GEI studies of genome-wide associations to determine genetic factors influencing the risks for specific common disorders are under way and are being overseen by the National Human Genome Research Institute (NHGRI). NIDCR is supporting and overseeing two additional studies to probe associations in dental caries and oral clefting.
NIDCR Grantee Receives Prestigious Award. Dr. Suchitra Nelson, an NIDCR grantee at Case Western Reserve University, received the 2007 Presidential Early Career Award for Scientists and Engineers (PECASE). She was one of 12 NIH-supported researchers honored at a ceremony at the White House on December 19. Her research is focused on factors that lead to dental caries in low-birthweight infants.
NIDCR Dental Public Health Residency Program. Dr. Garcia thanked Dr. Kathy Hayes and the team of program faculty, residents, and administrators involved in this program for a successful review and site visit by the Commission on Dental Accreditation (CODA) in November 2008. The reviewers recommended to CODA that the program continue to be fully “accredited without recommendations.” Drs. Garcia and Hayes co-direct the program.
New Oral Cancer Education Materials. Dr. Garcia commended the NIDCR Office of Communications and Health Education (OCHE) for development and dissemination of an engaging series of education materials designed to raise African American men’s awareness of their risk for oral cancer and the importance of early detection. NIDCR developed the series, entitled “Oral Cancer: What African American Men Need to Know,” in partnership with the National Cancer Institute (NCI) and based on insights gained from focus groups with African American men.
NIDCR Spanish Website. NIDCR has launched a Spanish website that is accessible, yet distinct, from the English website. The stand-alone Español site (www.nidcr.nih.gov/Espanol) features information specific to dental, craniofacial, and oral health of Hispanic Americans and an opportunity to contact NIDCR for information via telephone or email.
NIDCR Budget
Dr. Garcia summarized NIDCR expenditures and key initiatives in fiscal year (FY) 2008 and listed proposed initiatives for FY 2009 and beyond.
FY 2008 Budget. The NIDCR budget for FY 2008 (which ended September 30, 2008) totaled $391,136,000. As in previous years, approximately 79 percent of the budget was allocated to extramural research, 15 percent to intramural research, and 6 percent to research management and support (RMS). Compared with 10 years ago (FY 1998), there was a slight increase in the percentage of funds allocated to research project grants (RPGs) (61 percent vs. 56 percent), contracts (6 percent vs. 4 percent), and RMS (6 percent vs. 5 percent), while the percentage allocated to careers and training remained the same (4 percent and 3 percent, respectively), and the percentage allocated to centers decreased (5 percent vs. 10 percent), as did that allocated to intramural research (15 percent vs. 18 percent).
In FY 2008, NIDCR supported 766 research grants, of which 639 were RPGs (468 noncompeting and 171 competing). For RPGs, the success rate was 18.7 percent (compared with 21.8 percent for NIH) and the NIDCR payline was through the 14.3 percentile. The $309.3 million extramural budget was distributed as follows: 77 percent to RPGs, 8 percent to careers and training, 8 percent to contracts, and 1 percent for other awards (e.g., conferences). Only about one-fifth of the funds supported new commitments (i.e., portfolio turnover), while four-fifths supported existing (i.e., noncompeting) projects. Dr. Garcia noted that the percentage of discretionary funds (for new commitments) continued to decline, with some fluctuation, from 22 percent in FY 2002 to 19 percent in FY 2008.
Intramural research accounted for approximately $59.5 million of the FY 2008 budget. Of this total, approximately $38.7 million (or 9.9 percent) supported research activities and facility renovations, while $21.8 million was tapped for NIH central assessments (e.g., support of the Clinical Center). Overall, approximately $37 million of the total NIDCR budget was tapped for NIH central assessments (e.g., facilities’ rent, information technology support, program evaluation, study section support, conference services).
NIDCR initiatives in FY 2008 included six awards as part of the oral health disparities centers program, continued support for Phase III clinical trials, and issuance of a Program Announcement (PA) for multidisciplinary research on oral manifestations associated with HIV/AIDS. NIDCR also issued five Request for Applications (RFAs) for grant support in the following research areas: development of complex models of oral health behavior; osteoimmunology – crosstalk between the immune system and bone; translational application of gene silencing strategies to oral and craniofacial disorders; oral mucosal vaccination against HIV infection; and a systems approach to salivary gland biology.
FY 2009 and Beyond. Dr. Garcia stated that NIDCR is operating, under a Continuing Resolution, at the same budget level as in FY 2008. For FY 2009 (which began on October 1, 2008), NIDCR anticipates receiving a small percentage increase over FY 2008, which could raise the total budget to approximately $400 million. NIDCR also could receive additional monies from the administration’s economic stimulus package.
Dr. Garcia noted that NIDCR has many research needs and, with new funds, could advance research in a number of areas. Initiatives that NIDCR wishes to fund in FY 2009 include genome-wide studies of Sjögren’s syndrome, a PA for interdisciplinary research on oral manifestations of HIV/AIDS in vulnerable populations (e.g., children, adolescents), and RFAs for the Face Base Consortium, to explore the functional genomics of craniofacial development and orofacial clefts, and for harnessing inflammation for reconstruction of oral and craniofacial tissues. New funds also would support a second round of research projects to develop complex models of oral behavior and to apply gene silencing strategies to oral and craniofacial disorders.
In the near future, NIDCR hopes to direct research to additional areas of special opportunity. These would include metagenomic studies of the oral microbiome in health and disease, genome-wide studies of chronic pain, developing and sustaining the research workforce, continued studies of possible oral mucosal vaccination against HIV infection, and efforts to extend the life of dental restoratives. Dr. Garcia said that, in spite of budget uncertainties, NIDCR is poised to take advantage of unprecedented research opportunities and to spend resources well to move projects forward.
Discussion
Dr. Tabak arrived at the meeting in time to entertain questions from the Council about the FY 2009 budget. Drs. Bronner-Fraser and Snead asked about the possible nature, use, and effect of additional, stimulatory funds for research. Dr. Tabak said that NIDCR is preparing for every contingency. The Congress may, for example, appropriate additional funds to increase the NIDCR baseline or as a one-time infusion of research dollars. He envisioned that NIDCR could use a one-time infusion, for example, to support infrastructure development, supplements to extend grants, ancillary studies on existing grants, efforts to “jump start” particularly challenging and promising research, and/or research applications that receive a high score but are below the NIDCR payline.
Dr. Tabak announced that Dr. Garcia received a flag grade promotion to Rear Admiral in the U.S. Public Health Service Commissioned Corps, effective February 1, 2009. He also took the opportunity to thank Dr. Garcia and the entire NIDCR executive staff for their support while he serves dual positions at NIDCR and NIH.
VI. UPDATE ON ENHANCEMENTS TO PEER REVIEW
Dr. Lawrence Tabak
Dr. Tabak presented an update on the implementation of recommended actions to enhance NIH peer review. This effort, Enhancing Peer Review (see http://enhancing-peer-review.nih.gov), has evolved in three phases: a diagnostic phase (June 2007 – February 2008), design of an implementation plan (March – June 2008), and phased implementation of selected actions (beginning in September 2008). For the last phase, the NIH Peer Review Oversight Committee (PROC) established four subgroups that focused, respectively, on four priority areas: (1) engage the best reviewers, (2) improve the quality and transparency of review, (3) ensure balanced and fair reviews across scientific fields and career stages, and (4) evaluation – continuous review of peer review. Dr. Raynard Kington, Acting Director, NIH, and Dr. Tabak served as chair and co-chair, respectively, of the PROC and the evaluation subgroup, and the NIH institutes and centers (ICs) participated broadly in all four groups.
Dr. Tabak discussed the aims and recommended actions for each priority area. The recommended actions will be implemented in 2009.
Priority Area 1 – Engage the Best Reviewers. To improve retention of peer reviewers, the NIH will give new reviewers additional flexibility in their tour of duty so that, for example, they could serve 6 years instead of 4 years and conduct reviews two times instead of three times a year. To help recruit the best reviewers, the NIH is making available to all ICs a toolkit setting forth the best practices in recruitment. To enhance training of reviewers, the NIH will offer training related to the changes in peer review to reviewers and scientific review officers. To allow flexibility through virtual reviews, the NIH will conduct pilot tests of the feasibility of using high-bandwidth support for review meetings.
Priority Area 2 – Improve the Quality and Transparency of Review. The four recommended actions for this area are to improve the scoring transparency and scale, provide scores for streamlined applications, shorten and restructure applications, and address concerns related to research involving human subjects. Dr. Tabak stated that, beginning in May 2009, the NIH will commence a review of criteria-based scoring. As set forth in the NIH Guide notice NOT-OD-09-024, the NIH is moving to adoption of a new rating scale and use of a structured summary statement that includes reviewers’ criterion scores and critiques. Each reviewer would use a 9-point rating scale matched to descriptors (from exceptional to poor) to assign a criterion score [for significance, investigator(s), innovation, approach, environment] and an overall impact score (high, moderate, or low). The NIH anticipates that the distribution of priority scores would be the same, although the new scale will have 81 possible values (10–90), compared with the previous scale’s 401 possible values (100–500). Dr. Tabak noted that having fewer bins for a similar number of applications will necessitate increased decision-making regarding each application and that NIDCR may need to revise some “select pay” processes to accommodate the change.
In response to applicants’ requests for more information on the scoring of “streamlined” applications (i.e., those that are not considered to be in the top half), reviewers will begin in January 2009 to assign scores for each criterion while continuing to provide critiques so that applicants can better assess whether to resubmit or amend their application. Beginning in January 2010, investigator-initiated research grant applications (R01s) will be shorter (12 pages) and restructured to align with review criteria; the length of other applications (e.g., R23s) also will be shortened appropriately. For human subjects research, the NIH will encourage applicants and reviewers to focus not on the details, but on the major ideas, and will provide guidance on additional clarifications that may be needed prior to a Council’s or funding consideration. Expansion of section E, human subjects’ eligibility, is being considered.
Priority Area 3 – Ensure Balanced and Fair Reviews. The NIH is adopting new policies to fund meritorious science earlier and to review like applications (new and continuing) together in the same study section. For all new applications, beginning in January 2009, the NIH will decrease the number of allowed resubmissions (amendments) from two to one (see NIH Guide notices NOT-OD-09-003 and NOT-OD-09-016). The NIH will also design, test, and evaluate a pilot prebuttal procedure that would give applicants an opportunity to address factual errors that may arise during review and impede a fair judgment. In addition, the NIH recently modified its New Investigator Policy to identify early-stage investigators (ESIs) (i.e., individuals who completed their last academic degree or clinical training within the past 10 years) and establish goals to encourage funding for new investigators and ESIs (see NIH Guide notices NOT-OD-08-121, NOT-OD-09-013, and NOT-OD-09-034). Where possible, the NIH will cluster new-investigator applications (including ESI applications) for review. The NIH also is considering review of like applications in clinical research together in the same study section.
Priority Area 4 – Continuous Review of Peer Review. Dr. Tabak noted that the NIH has constituted a new evaluation group to lay the foundation for continuous review of peer review activities. A series of pilot tests and analyses of historical data are under way, and baseline surveys are being developed. One pilot adopting the 1–9 scoring scale will be tested in study sections in February 2009.
In closing, Dr. Tabak said that the Enhancing Peer Review web site is being updated continually, and he encouraged Council members to access the site for updates on implementation, responses to queries, timelines, information on the pilot tests, relevant NIH Guide notices, and training and communication materials. The site’s features include question-and-answer web chats, a peer review listserv, web-based training sessions, and the Nexus and Peer Review Notes publications.
Discussion
The Council addressed several items. Dr. McCauley asked about the feedback NIH has received on the recommended actions and changes that NIH has made in this regard. Dr. Tabak said that feedback has been mixed (about 75 percent positive, 25 percent negative) and has raised legitimate concerns (e.g., the feasibility of virtual review, the need for additional space in applications for human subjects research) that the NIH is addressing. He emphasized that enhancing peer review is a continually evolving process.
Drs. Bronner-Fraser, D’Souza, and Hammit mentioned several concerns about the decreased number of allowed grant application resubmissions (amendments). That is, reviewers may significantly help an applicant define his or her research, a new submission may be little more than a resubmission, and new investigators’ skills in grantsmanship may be limited. Dr. Tabak emphasized that mentoring of new investigators is a responsibility of senior investigators and that reiterative resubmissions is not helpful to young investigators and is tremendously wasteful. He noted that the Center for Scientific Review (CSR) uses both text-search mining software and individuals to assess whether an application is new or resubmitted, and a CSR committee meets regularly to adjudicate specific issues.
Dr. Snead asked Dr. Tabak to elaborate on the piloting of prebuttal procedures. Dr. Tabak said that the intent is to clarify the nature of errors that may be made during review of applications as to whether they are errors of fact or, perhaps, reviewers’ opinions. The overall aim is to ensure that research of potentially high impact is not displaced and that applicants have an opportunity to respond to immediate questions. In response to a question from Dr. Weyant, Dr. Tabak said that NIH is training peer reviewers in the new procedures.
VII. CONCEPT CLEARANCE
Dr. Alicia Dombroski and Dr. Isaac Rodriguez-Chavez
Dr. Dombroski read instructions to the Council for their review and approval of a concept clearance.
Oral Mucosal Vaccination Against HIV Infection
Dr. Rodriguez-Chavez presented a proposed concept to reissue and expand an RFA issued by the NIDCR in 2007 to stimulate and support state-of-the-art research that will harness oral mucosal and innate immunity to develop protective HIV vaccines delivered through the oral mucosa. He noted that developing a safe and efficacious HIV vaccine is a global priority. For the expanded RFA, NIDCR proposes the following six priority areas: (i) Link oral mucosal and innate immunity with systemic adaptive immunity; (ii) develop HIV vaccine antigens in oral expression vectors that are stable in the oral cavity and that have the ability to trigger anti-HIV immunity; (iii) study the role of oral dendritic cell (DC) and natural killer cell (NK) subset changes during disease progression or upon oral mucosal HIV vaccination; (iv) study DC–NK cross-talk in the oral cavity and the relationship to systemic adaptive immunity upon oral mucosal HIV vaccination; (v) determine similarities and differences between DC–NK cross-talk in the oral mucosal site, compared with other mucosal sites of the body; and (vi) characterize soluble defense molecules produced in oral secretions upon oral mucosa HIV vaccination.
Discussion
Speaking as the Council’s lead discussants, Drs. Westlund High and Stashenko strongly supported the proposed concept. Dr. Westlund High said that NIDCR had made a clear case for cogent issues that need to be added to the 2007 RFA (the Council had received a detailed writeup of the concept). Agreeing that the priority areas are very worthwhile, Dr. Stashenko noted that NIDCR has historically been at the forefront of research on oral mucosal immunity and, with the failure of many HIV vaccines, NIDCR could take a lead role in newly focusing on development of a mucosal vaccine.
Dr. Snead asked about the integration of NIDCR research with other NIH-supported research on HIV vaccines. Dr. Rodriguez-Chavez responded that the proposed NIDCR concept of Oral Mucosal Vaccination Against HIV is complementary, for example, with a recent RFA issued by the National Institute of Allergy and Infectious Diseases, entitled Basic HIV Vaccine Discovery Research (see http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-08-053.html). This RFA includes identifying correlates of vaccine-induced immune protection, defining early events at the portal of entry, determining the nature of neutralizing antibodies, and identifying mechanisms of HIV/SIV control, as well as other research on new vectors and immunology. Dr. Westlund High noted that the NIDCR concept has the full support of the Director, Office of AIDS Research, in the Office of the Director, NIH.
The Council unanimously approved the concept.
VIII. COUNCIL OPERATING PROCEDURES
Dr. Alicia Dombroski
Dr. Dombroski called the Council’s attention to two proposed changes in the NADCRC operating procedures for 2009 (a draft was provided to the Council). First, the operating procedures would specify that the outcome of the Board of Scientific Counselors (BSC) reviews in June and December would be reported to the Council at its January and May meetings. Second, grant applications involving budgets in which any one year exceeds $500,000 in direct costs (e.g., the P series grants) and applications that include substantive involvement of NIDCR staff (e.g., the U, or cooperative agreement, grants) would no longer be reviewed individually by the Council at each meeting; they would continue to be reviewed en bloc.
The Council unanimously approved the two changes.
IX. BIENNIAL REPORT TO COUNCIL ON TRACKING AND INCLUSION
OF WOMEN AND MINORITIES IN CLINICAL RESEARCH
Dr. Jane Atkinson
Dr. Atkinson presented the 2009 Biennial Advisory Council Report Certifying Compliance with the NIH Policy on Inclusion Guidelines. This report describes NIDCR’s extramural activities to meet the requirements for inclusion of women and minorities in clinical research, as stipulated in the NIH Revitalization of 1993. Dr. Atkinson briefly described the background for the report and highlighted NIDCR data from FY 2006 and FY 2007.
NIH Revitalization Act of 1993. This Act requires that NIH ensure that women and minorities and their subpopulations be included in all clinical research and that they be included in Phase III clinical trials in numbers adequate to allow for valid analyses of differences in intervention effects. The Act stipulates that cost is not allowed as an acceptable reason for excluding these groups and that NIH must initiate programs and support for outreach efforts to recruit and retain these groups as participants in clinical studies. Every 2 years, the ICs must report on their compliance with this NIH policy.
FY 2006 and FY 2007. Dr. Atkinson summarized tabular data on applications reviewed and awarded, enrolled subjects, and Phase III trials. During FY 2006 and FY 2007, approximately 93 percent of NIDCR-supported applications submitted to the Initial Review Group for peer review met the inclusion requirements for target enrollment. Between 97 percent and 100 percent of applications awarded in the eight Council cycles met the inclusion requirements as submitted, and those that did not were required to resolve satisfactorily any related issues prior to funding.
In FY 2006, more than 63,000 human subjects were enrolled in NIDCR-sponsored research studies covered by the tracking system that year. The aggregate enrollment data demonstrate that about 53.1 percent of the subjects were women and 46.5 percent were male (0.4 percent, unknown). Hispanic participation was approximately 17.4 percent, and ethnicity was unknown or not reported for 13.9 percent. By race, approximately 55.6 percent were white, 18.1 percent were black or African American, 7.2 percent were Asian, and 0.8 percent was American Indian, Alaskan Native, or Hawaiian. Subjects of more than one race accounted for about 4.9 percent, while 13.4 percent were of unknown race or refused to indicate race.
In FY 2007, 124,953 human subjects were enrolled in NIDCR-sponsored research studies covered by the tracking system that year. Two studies used data from 51,083 persons for secondary data analyses, which are not usually included when tracking enrollment in human subjects research. If these individuals are excluded, the total number of subjects enrolled in FY 2007 would be 73,473—an increase of more than 10 percent over FY 2006. For the 73,473, the aggregate enrollment data demonstrate that about 52.2 percent were female, 40.5 percent were male, and 7.3 percent were of unknown gender. Hispanic participation for this group was approximately 19.4 percent, while 18.2 percent did not report ethnicity. By race, this group was 51.1 percent white, 19.8 percent black or African American, 10.6 percent Asian, and 0.7 percent American Indian, Alaskan Native, or Hawaiian. Subjects of more than one race accounted for about 5.0 percent, while approximately 12.8 percent were of unknown race or did not specify race.
With respect to Phase III trials, the vast majority of subjects enrolled were female (about 87 percent in FY 2006 and 85 percent in FY 2007). The high percentage of enrolled women is because three Phase III trials were testing therapies in pregnant women or women of child-bearing age. Minorities composed approximately 45 percent of all subjects enrolled in these trials in FY 2006 and 34 percent in FY 2007. The results of one NIDCR-sponsored Phase III trial were published in FY 2007. This study tested the effect of nonsurgical periodontal treatment on preterm birth, and the analyses showed no difference in outcomes by racial group.
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
The Council considered 250 applications requesting $46,006,667 in total costs. The Council recommended 201 applications for a total cost of $32,950,724 (see Attachment II).
ADJOURNMENT
The meeting was adjourned at 2:30 p.m. on January 26, 2009.
CERTIFICATION
I hereby certify that the foregoing minutes are accurate and complete.
________________________ _________________________
Dr. Lawrence A. Tabak Dr. Alicia Dombroski
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 2009
NOTE: A complete set of open-session handouts is available
from the Executive Secretary.