Operating Procedures of the National Advisory Dental and Craniofacial Research Council

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 conduct of the secondary review of 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 consists of 15 members.  Two are non-voting, ex officio members (one each 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 provides secondary review for all research grant, conference grant, program project, cooperative agreement, institutional training, and career development award 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;
• Eligible-for-funding applications from foreign institutions;
• Eligible-for-funding applications with pending concerns related to human subjects, animal welfare, and/or the inclusion of children, women and/or minorities;
• Eligible-for-funding applications with biohazard concerns, such as adequate protection of research personnel and/or the environment, biosafety, biocontainment and the security of Select Agents;
• Eligible-for-funding applications from investigators with >$1.0 million direct costs in research support from NIH.
• Applications of special interest or posing special policy issues;
• Unresolved appeals of peer review; and,
• Phase III clinical trials.

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 members are authorized to:

• Provide secondary review of all individual fellowships (F30, F31, F32, and F33).  This review is conducted by the Executive Staff of the NIDCR.  Their actions are documented in the meeting minutes, included in the official grant file, and reported to the Council for information at the next meeting. 
• Review and approve or disapprove administrative supplements to existing grants provided the supplement does not support an expansion of the scientific aims of the ongoing project. 
   

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 voting 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 considerations other than scientific/technical merit  (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 staff can provide members with background information, 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 are consistent 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 and avoiding potential scientific overlap with current awards, and by considering an applicant’s status as a new investigator or early stage investigator and the level of other support available to the applicant.

Designation of applications as HPP or LPP:

NIDCR staff may recommend to the 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. All members of Council will have the opportunity to discuss and vote to approve or disapprove the final recommendation. 

High Program Priority funding:

Approximately 10% of the annual funds available may be used for funding of new and competing renewal applications that represent important opportunities for the Institute’s mission but are not within the nominal payline for the Institute. This will occur only after NADCRC has completed secondary review of applications and concurred with recommendations of the SRG. Applications so designated by staff are discussed by members of the NIDCR Executive Staff Committee at NIDCR Extramural Budget Meetings. Decisions by the Director, NIDCR are documented in the meeting minutes. A list of all applications so funded is provided to members of Council for informational purposes at the next NADCRC meeting following the conclusion of each fiscal year.

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 made 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 are consistent with NIH and NIDCR policies and are designed so that the proposed research can still be conducted but in a cost-effective manner. Staff will report budget adjustments exceeding $100,000 in direct costs at the next meeting of the Council for informational purposes only. 

V. Expedited Secondary Review of Meritorious Applications

The NADCRC agrees that the most meritorious applications from the R, U-, P-, T-, and K-series can undergo expedited Council review 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;
• Summary statements available;

• No concerns identified by the SRG regarding:
  • protection of human subjects;
  • representation of gender, children and/or minorities;
  • care and use of vertebrate animals;
  • biohazards, such as hazardous materials or procedures that may not provide adequate protection to research personnel and/or the environment; and
  • appropriate biosafety, biocontainment, and security of Select Agents.

Three members are selected to complete the expedited review on behalf of the Council. They are 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 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
• Deferral 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 further deferral or for re-review)

All Council members have access to the summary statements provided to the three voting members, are provided 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 are considered for expedited funding. A report of those applications on the en bloc list that have undergone expedited review is presented at the next Council meeting for information.

VI. Concept Review

As the Institute continues to address its mission through the support of the 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 for proposed Funding Opportunity Announcements. These documents present the objectives and rationale for the concept, and the current scientific needs and opportunities. Two Council members are asked to serve as primary and secondary reviewers of each concept. Following discussion of the concept, Council members may take one of the following actions:

• Approval with or without modifications;
• Disapproval; or,
• Deferral for further development and discussion.

VII. NIDCR Intramural Research

Each year at the January and May meetings of the NADCRC, during a closed session, the Board of Scientific Counselors (BSC) reports to the Council on the outcome of the BSC reviews conducted at the Spring and Winter BSC Meetings. Written reports of the BSC reviews along with the Scientific Director’s response are presented. The Chairman of the BSC provides a verbal summary of the written BSC reports and recommendations. The Scientific Director, DIR, NIDCR provides a verbal summary of the response to the BSC.  Since these reports are for the information of Council, no vote is required. 

VIII. Council Operating Procedures

At the January meeting, Council will review and approve the Operating Procedures for the NADCRC and make recommendations for revision, where appropriate.

References

1) Public Health Service Act as amended, 42 USC 52h, 42 USC 241, 42 USC 284a

2) NIH Manual Chapter 1805, Use of Advisors in Program and Project Review and Management 

3) NIH Manual Chapter 1810-1, Procedures for Avoiding Conflict of Interest for NIH Special Government Employee SGE Advisory Committee Members

4) NIH Manual Chapter 3005, Review and Evaluation of Intramural Programs

5) NIH Manual Chapter 4204-204B, Peer Review Process

6) NIH Manual Chapter 54104, NIH Research Grants Involving Foreign Institutions and International Organizations

7) NIH Manual Chapter 54107, Review and Documentation of Protections for Human Subjects in Extramural Grant Applications and Research and Development Contract Proposals

8) NIH Manual Chapter 54206, Responsibility for Care and Use of Animals

9) NIH Manual Chapter 54513, Management and Procedures of National Advisory Councils and Boards in Their Review of Extramural Activities

10) OER Policy & Guidance: Inclusion of Women and Minorities as Participants in Research Involving Human Subjects – Policy Implementation Page

11) OER Policy & Guidance: Inclusion Across the Lifespan - Policy Implementation

12) OER Policy and Guidance: Appeals of NIH Initial Peer Review 

13) OER Policy and Guidance:  Special Council Review of Applications from PD/PIs with More than $1.0 Million Direct Costs in Annual NIH Support