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.