The National Advisory Neurological Disorders and Stroke Council (NANDSC) advises the Director of the National Institute of Neurological Disorders and Stroke (NINDS) on research activities and policies. The NANDSC provides the final review for all applications for research grants, training grants, and career development awards assigned to the NINDS, as well as for other requests for support for which Council approval is required by law. The NANDSC also provides concept clearance for proposed research initiatives.
At the January/February Council meeting each year, Council reviews these Operating Procedures NINDS and, where appropriate, makes recommendations for revision.
The operating procedures document the circumstances in which the institute and the national advisory council have agreed it is desirable to discuss individual applications. Some of the more common circumstances are:
- specific classes of applications, such as clinical trials and applications requesting unusually large fiscal commitments;
- the expression of widely different opinions in the initial review, or the identification of issues involving ethics, animal welfare, biohazards, or recombinant DNA;
- applications from foreign organizations;
- applications that are deferred for additional information or re-review;
- applications identified by institute staff or members of the NANDSC as requiring special consideration because they are of high program priority; and
- applications identified by members of the advisory council as being of special concern or as posing special policy issues.
The national advisory council may vote en bloc concurrence with the recommendations of the IRGs for the applications for which no review or policy issues have been identified.
A national advisory council may vote to recommend that the institute consider paying certain applications out of scientific merit priority score order. These applications are designated as having High Program Priority (HPP). Similarly, in cases of high scientific merit but Low Program Priority (LPP), the national advisory council may vote to recommend that institute staff consider not funding specific applications. This latter procedure is rarely used in NINDS. While these various recommendations by council are considered seriously by the institute, the final legal authority for payment of grant applications rests with the NINDS Director.
In addition to application review, the NINDS Director may utilize the expertise and experience of Council members for the following activities.
- Program planning
- Concept clearance for special initiatives
- Review of Board of Scientific Counselor reports on intramural research programs
- Review of objectives, priorities and accomplishments of the Institute's extramural program
Staff may request expedited electronic review of specific applications. All Council members will be asked to participate in the expedited review and will be notified of the applications under consideration. Expedited electronic review may be designated for, but not limited to:
- Applications that require the availability of time-limited, unique resources;
- Applications that were administratively deferred or re-reviewed due to a successful appeal;
- Applications received in response to Request for Applications (RFAs).
Early Concurrence Process
NINDS has adopted the Early Concurrence Process as one means of shortening the time between application receipt and award. The main purpose of the early concurrence process is to focus Council attention at the actual Council meeting on those applications that truly require active Council consideration. Another important purpose of this process is to allow earlier funding of grants. Three members of the NANDS Council are selected by the Council Executive Secretary and asked to act on behalf of the full Council to implement early en bloc concurrence with initial review group recommendations for each Council round (approximately eight weeks before each Council meeting) for eligible applications within the payline. All Council members are welcome to participate in the voting. The members vote using the Early Concurrence Voting Module of the NIH Electronic Council Book. If there any applications that any Council members wish to designate for discussion, these are noted and brought up at the Council meeting. If one of the three designated Council members is unable to vote (e.g., is in conflict), two “Yes/Approve” votes will be sufficient for approval of the application(s). If any of the three members votes “No/Not Approved”, the application in question will be removed from the early concurrence process and discussed at the Council meeting. Results of this process are discussed at each Council meeting.
Concepts for Research Initiatives
In open session, the Council conducts concept review of potential research initiatives. These initiatives are proposed by NINDS staff and originate from consultation with the scientific community, constituency organizations, and Congress. Council may recommend approval, modification, deferral, or disapproval of a concept. NINDS staff will record and maintain documentation reflecting Council discussion and recommendations.
NINDS Division of Intramural Research
At the May Council meeting, the Director of the Division of Intramural Research provides an update on the intramural research program and the recommendations of the previous year’s Board of Scientific Counselors reports.
Delegation of Authority
The Institute staff may take the actions listed below without Council review. Council may request information on these actions at any time.
- Transfer of Research Grant for an Investigator Who Moves to a New Institution
Make research grant awards equal to the anticipated direct cost committed support for continuing work under the same principal investigator when he or she moves from one institution to another. Approval will not be automatic; NINDS staff may consult with the appropriate study section or Council as necessary.
- Approval of New Principal Investigator or Program Director
Approve a new or interim principal investigator or program director to continue an active grant.
- Extension of Project Period Dates
Take necessary action on extensions of project period end dates without additional funds.
- Authority to Restore Year(s)
Make awards that appropriately restore years deleted by an initial review group.
The Institute may take the following actions without Council review but will document actions and present them to Council annually for its information.
- Awards for Orderly Termination or Interim Support
Make appropriate awards for orderly termination or interim support of competing continuation applications that were either not recommended for further consideration (NRFC) or recommended with a priority score too poor for payment. This procedure is to be used in those cases where sudden termination of the grant would cause a serious loss of scientific material or impose a hardship to already employed personnel. In such cases, (1) the award usually should be for a period of less than twelve months, (2) careful review should be given to the need for salaries and consumable supplies, (3) usually no funds should be provided for additional equipment or travel, and (4) in the case of training grants, stipend support should be provided for completion of training for those trainees already appointed.
- Awards for Interim Period Due to a Deferral
Make an award for an appropriate amount and period of time when a recommendation of deferral on a competing continuation application results in a loss of continuity of the active research or training program.
- Authority to Increase Grant Award Ceilings
Make supplemental awards or adjustments when additional funds are necessary above the amount previously recommended to carry out the scientific, administrative and fiscal intent of the grant as previously awarded, with the following limitations.
a. Council approval is not required for supplements under the NIH programs to promote reentry into biomedical and behavioral research careers and to increase involvement in biomedical research of underrepresented minorities and individuals with disabilities.
b. Administrative Supplements for up to and including $100,000 direct costs per year may be made to grants, cooperative agreements, career awards, and training grants.
- Authority to Obtain Early Council Concurrence and Issue Expedited Awards
NINDS may obtain early council concurrence in order to allow issuance of awards, where possible, in advance of the formal council meeting. Applications eligible for early council review include research project grants (R01s, R03s, R15s, and R21s), certain specialized center grants (e.g., P20s and P30s), and cooperative agreements (e.g., U01s) from domestic institutions that fall within the approved payline. (Applications that must be considered by the full Council are ineligible for this expedited process, including clinical trials and other applications that exceed $1,000,000 direct costs per year, applications in response to an RFA, applications in response to a PAS beyond the payline, and applications from foreign institutions.) Approximately eight weeks before the council meeting, applications eligible for early concurrence will be brought to the attention of a subset of Council members. With the approval of these Council members, NINDS may issue expedited awards for those applications for which all administrative requirements have been satisfactorily met.
- Authority to Make Administrative Decisions during an Emergency
In the event of a federally-declared emergency, NINDS may make certain administrative decisions regarding the selection and funding of competing grant applications. Every effort will be made to use electronic and en bloc procedures to secure Council approval. If such approaches are not feasible, then the following delegated authorities will apply:
a. NINDS will make awards to new (type 1) or competing (type 2) applications consistent with the funding policies for a given fiscal year. These funding actions could be taken for any application that does not require individual discussion. Any application that normally requires individual consideration and special action by the Council will be deferred until its next meeting, or, if possible, resolved by telephone conference.
b. On a case-by-case basis, the Director, NINDS, with the concurrence of the Chief Grants Management Officer, NINDS, may fund any grant application deemed by the Director to be critical to national security or public health.
c. Council will be informed of administrative decisions made under this authority at the subsequent Council meeting.
Second Level of Peer Review
In the closed portion of the meeting, all research grants and cooperative agreements must undergo Council review and approval prior to being awarded. Based on budgetary information available, staff provides the NANDSC with a projected "payline" for research project grant mechanisms, (e.g., the R01, R03, R21, and R15). This procedure assumes that all applications within a given percentile rank will be paid regardless of program relevance. The payline is projected, however, to leave additional funds for the payment of special initiatives including selected applications outside the payline. These applications are selected on the basis of program relevance or related reasons, and are known as "High Program Priority" (HPP) applications. Please note that although it is NIH policy to use the percentile rank rather than the priority score in determining the payline, both of these numbers (priority scores between 10 and 90 and percentiles from 1.0 and above in whole numbers) are printed on summary statements and computer-generated percentile lists supplied to the NANDSC. (Some types of applications, such as Institutional Training Grants and applications in response to an RFA are not ‘percentiled.’ Such applications are not interdigitated with applications that are percentiled.)
When funds are available, approximately two weeks before NANDSC meets, program staff select applications that they believe are worthy of the HPP designation. Lists of such recommendations are made available to the NANDSC in advance of the meeting so that staff may ask Council’s advice regarding potential payment of these applications. NANDSC members can also nominate, prior to the Council meeting, applications to be discussed for consideration. At the Council meeting, both staff and Council-nominated applications can be discussed. Council feedback concerning these applications is critical to the decision-making process of NINDS staff. It must be recognized, however, that the budgetary situation may change after the NANDS Council meeting and that more applications are nominated for HPP consideration than can be awarded. Staff may also make awards beyond the payline on applications that had not been identified for high program priority if budgetary balances should be unexpectedly large; this situation, however, is quite rare.
The following options are available to Council for all applications under review:
- Concurrence with all recommendations of the Scientific Review Group (SRG)
- Concurrence with SRG scientific/technical assessment with alternate recommendation for non-scientific portions of application
- Non-concurrence with scientific/technical assessment and deferral of the application for review by the same SRG again or a different study section
- Non-concurrence with scientific/technical assessment and a recommendation for no further action. These applications cannot be considered for funding by staff.
- Deferral for additional information
Applications that raise no special issues need not be discussed individually. On these, Council may vote en bloc concurrence with the recommendations of the study section.