The mission of the National Institute of Dental and Craniofacial Research (NIDCR) includes the support of basic, clinical and translational research as well as the support of research training and the development of research careers. To help achieve the goals of the NIDCR, the National Advisory Dental and Craniofacial Research Council (NADCRC) has the responsibility of advising, consulting with and making recommendations to the Secretary, DHHS, and the Director, NIDCR, on matters relating to the directions of research, research support, training and career development supported by the Institute. Included in this responsibility is the completion of the secondary review of research grant applications with a focus on NIDCR scientific program priorities and program balance as well as the conduct of research by the Division of Intramural Research, NIDCR.
I. Council Membership
The Council currently consists of 15 members. Two are non-voting, ex officio members (from the Department of Defense and the Veteran’s Administration). The Secretary, DHHS, selects the council Chairman and appoints 13 members whose training and interests as scientists or members of the public uniquely prepare them to serve in this capacity. Appointed members serve four-year terms and are not eligible for reappointment to the same Council until two years after the date of expiration of their term of office. A member may serve for 180 days after the date of expiration of her/his term or until a replacement is selected.
A council quorum consists of a majority of the appointed members.
II. Secondary Review of Grant Applications
The Council will provide secondary review for all research (conference and training?) grant and cooperative agreement applications. With the exception of expedited and en bloc review, the following actions/applications are considered individually by Council members at each meeting:
- Method to Extend Research in Time (MERIT) awards;
- Special actions from either staff or council;
- Applications from foreign institutions that are eligible for funding;
- Applications with pending concerns related to human subjects, animal welfare, and/or the inclusion of children, women and/or minorities that are eligible for funding;
- Concept clearances for proposed Funding Opportunity Announcements (i.e., Requests for Applications, Program Announcements ) and contracts;
- Applications of special interest or posing special policy issues;
- Unresolved appeals of peer review issues; and
- Grant applications involving budgets in which any one-year exceeds $500,000 in direct costs (e.g., P-series), all Phase III clinical trials, and those applications that include substantive NIDCR staff involvement (e.g., U-series).
In general, two Council members are assigned as primary and secondary reviewers for each of these actions and, following a presentation by staff of the issue(s) to be addressed, will lead the council discussion.
All other applications will be voted en bloc by Council.
NIDCR staff are authorized to:
- Provide secondary review of all individual fellowships (F30, F31, F32, and F33). This review will be conducted by the Executive Staff of the NIDCR. Their actions will be documented in the minutes of their meetings, included in the official grant file and reported to the Council for information at the next meeting.
- Review and approve or disapprove NON-COMPETITIVE supplements to existing grants as long as the supplement does not support an expansion of the scientific aims of the ongoing project. Non-competitive supplements exceeding $100,000 in direct costs will be reported by staff to Council at the next meeting for information only.
III. Options Available to Council
The Public Health Service Act requires that a grant application may be funded only after it has been reviewed and the Council has concurred with the recommendation of the scientific review group (SRG). The Council may not change the scores assigned by the SRG. The following options are available to Council for each application reviewed:
- Concurrence with the SRG recommendation;
- Non-concurrence with the SRG recommendation based on scientific/technical merit. The application may be deferred for SRG reconsideration of scientific/technical merit;
- Non-concurrence with the SRG recommendation based on other than scientific/technical merit considerations (e.g., appropriateness of SRG membership; mismatch between percentile or priority score and written summary of the initial review);
- Deferral to obtain additional information for Council consideration at a subsequent meeting;
- Recommendation of high program priority (HPP). Such a recommendation is generally made if an application poses a unique or special opportunity and addresses an important issue of program balance; and
- Recommendation of low program priority (LPP). Such a recommendation is generally made if an application has little or no relevance to the current NIDCR program of research.
Council members wishing to designate an application as HPP or LPP are asked to contact the Executive Secretary well in advance of the meeting so that staff can provide members with any needed background information (e.g., summary statement, grant application, communications) and the agenda can be modified to reflect the need to address the application individually.
IV. Options Available to NIDCR Staff
Options available to NIDCR staff are intended to facilitate decision making. They are in keeping with the Institute’s stated policy of adjusting funding plans during the fiscal year by giving additional consideration to: filling scientific gaps in the Institute’s research portfolio; potential scientific overlap with grants already supported; whether or not the applicant is a new investigator; and the level of other support available to the applicant.
Designation of applications as HPP or LPP:
NIDCR staff may recommend to NADCRC any application for designation as HPP or LPP. Staff will present background information and justification for the recommendation at the Council meeting for discussion. Two members of Council, designated as primary and secondary reviewers, will provide their assessment of the recommendation leading to a discussion and vote by the entire Council.
Determining priority funding order:
NIDCR staff may use up to approximately 10% of the funds available for a given funding cycle to determine the priority funding order for new or competing renewal applications. This will occur only after NADCRC has completed secondary review of applications and concurred with recommendations of the SRG. The following funding mechanisms are included in this policy: R03, R21, R01 applications, all SBIR and STTR applications (R41, R42, R43, R44), Career Award (K series) applications, and any applications submitted in response to Requests for Applications (RFA).
Applications so designated will be vetted through the NIDCR Executive Staff Committee. Decisions by the Executive Staff Committee will be documented in the minutes of their meeting and the applications will be funded in a timely manner. A list of all applications so funded will be provided to members of Council for informational purposes at the next meeting of the NADCRC.
Upward or downward administrative adjustments of budgets:
NIDCR staff may adjust recommended budgets upward or downward for any application. Consistent with federal grants policy, upward adjustments may not be for the purpose of expansion of the scientific aims of the project or for the purpose of altering the scientific content of the project. Downward adjustments will be consistent with NIH and NIDCR policies and in a manner that the research can be accomplished adequately at a cost less than that recommended by Council, and not of such magnitude as to unduly curtail progress in the research.
Staff will report budget adjustments exceeding $100,000 in direct costs at the next possible meeting of the Council for informational purposes only. Confirmation of each administrative action is, however, not required.
V. Expedited Award of Meritorious Applications
The NADCRC agrees that the most meritorious applications from the R-, U-, P-, T-, and K-series can be awarded immediately following an SRG meeting and prior to the next meeting of Council provided that the applications are from domestic institutions and have:
- Scores or percentiles within the Institute’s funding plan;
- No concerns identified by the SRG regarding human subjects or vertebrate animals; and
- No concerns identified by the SRG regarding the inclusion of children, women or minorities.
Three members will be selected to complete the expedited review on behalf of the Council. They will be informed by electronic mail of the availability of the summary statements involved in the expedited review as soon as possible after the initial scientific peer review is completed. The designated Council members will have 72 business hours to complete their review and inform designated NIDCR staff of their recommendations. Options available to the three voting Council members are:
- Concurrence with the initial scientific peer review;
- Non-concurrence with the initial scientific peer review; or
- Defer for discussion by full Council at which time Council may vote to concur or not concur with the initial scientific peer review (note there is no option for deferral or for re-review).
All Council members will have access to the summary statements provided to the three voting members, including the date by which the Institute is expecting a response, and may comment directly to one of the three Council members if a concern is noted.
Applications receiving a majority of votes for concurrence from the three voting Council members will be considered for expedited funding. A report of those applications on the en bloc list that has undergone expedited review will be presented at the next Council meeting for information.
VI. Concept Review
In order to insure that the Institute continues to address its mission through the support of most currently relevant research and research training, it may be necessary to develop specific research initiatives in order to solicit applications on a given topic. Descriptions of planned research initiatives are presented to Council in the form of Concept Clearances. These documents present, among other things, the current scientific needs and opportunities. Two council members are asked to serve as primary and secondary reviewers of the concepts and interact with NIDCR staff in developing a presentation to the full Council. Following discussion of the concept, Council members may take the following actions:
- Approval with or without modifications;
- Disapproval; or
- Deferral for further development and discussion.
VII. NIDCR Intramural Research
Each year at the September meeting of the NADCRC, during a closed session, the Board of Scientific Counselors (BSC) will report to the Council. Written reports of BSC reviews conducted during the previous year along with the Scientific Director’s response will be presented. The Chairman of the BSC will provide a verbal summary of the written BSC reports and recommendations. The Scientific Director, DIR, NIDCR will provide a verbal summary of the response to the BSC. Since these reports are for the information of Council, no vote is required.
Approved January 25, 2008