NCATS Advisory Council: General Operating Procedures
Advisory Councils at the National Institutes of Health (NIH) provide second-level review of all grant applications under consideration for Institute or Center funding. Each Council is required to establish general operating procedures for the review of grant applications. These procedures must be in writing and should be reviewed once a year.
The sections below explain the operating procedures associated with the National Center for Advancing Translational Sciences Advisory Council (hereafter referred to as Council) for the following activities:
- Council may vote in either en bloc or individual actions.
- Council with give special consideration to well-funded Investigators.
- Council may conduct expedited reviews as well as early concurrence voting.
- Council may delegate selected activities to staff.
- Council has the ability to form subcommittees to perform its duties.
En Bloc and Special-Action Voting
Prior to a Council meeting, Council members review an electronic summary of the peer review results for grant applications assigned to NCATS for funding consideration. Council members consider the adequacy of the review and are asked to concur with the review. Most of the concurrence voting occurs through en bloc actions. Specific Council discussion and consideration are required for special actions that include, but are not limited to, applications meeting the following criteria:
- Foreign grants including domestic grants with foreign involvement.
- Principal Investigator (PI) covered under NIH's Special Council Review Requirement (PI currently awarded $1.0 million in direct costs through certain NIH research mechanisms).
- Unresolved human subject, animal subject and/or biohazard concerns identified by the initial peer review group.
- Unresolved issues regarding recruitment of women, minorities, or children or data monitoring identified by the initial peer review group.
In addition to the applications identified above, the NCATS director or any Council member may ask that any individual application or group of applications be discussed.
Voting options include:
- Concurrence — Concurrence with initial review recommendation
A Council may not change the numerical ratings (e.g., impact/priority scores, percentile, criterion scores) resulting from the initial review; however, the Council may recommend that program staff change the order of consideration of certain applications for funding. The following codes shall be used to indicate Council action in relation to the numerical rating:
- High Program Priority (HPP) — Raised in order of consideration for funding
- Low Program Priority (LPP) — Lowered in order of consideration for funding
- Other — An unusual action that cannot be identified as Concurrence, HPP or LPP, such as changes in recommended budget and/or duration of support. Use of this code is optional at the IC's discretion.
- Deferred — This action could be taken if additional information is required prior to voting or if an error requires the rereview of an application.
- Not Recommended by Council — Non-concurrence with initial review
Special Council Review of Pending Applications from Well-Funded Investigators
In an effort to continue responsible stewardship of public funds and to support meritorious and innovative research, NIH has instituted a policy of Special Council Review (SCR) of applications from well-funded investigators (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-140.html).
Applications before Council from Program Directors/Principal Investigators (PD/PI) who have more than $1 million in direct costs from active NIH Research Project Grants (RPGs) grants will be subject to additional consideration. Council members will receive a list of those PIs and their applications that fall under this requirement. It is important to recognize that this is a threshold for special review only: investigators who have research support in excess of $1M in direct costs may continue to receive additional awards as warranted.
When making funding recommendations, staff and Council members will take into account factors such as: how innovative and distinct the pending project is from the PD/PI’s other grants; the type of research (since costs requirements differ substantially by field); the public health priority of the research; and how the absence of an award impacts other collaborative or translational research efforts.
Staff may request expedited electronic review for eligible applications.
All Council members will be asked to participate in the expedited review and will be notified of the applications under consideration and will have secure access to the summary statements.
Expedited electronic review may be designated for, but not limited to:
- Applications that require the immediate 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)
The chair of Council will select two members of Council to provide the en bloc early concurrence on behalf of the full Council for a specified group or group of applications.
The executive secretary of Council will determine which applications, meeting the following criteria, are eligible for the en bloc early concurrence voting process:
- Have a ranking percentile (1–10 percent), or for those mechanisms without percentile rank, with priority scores no greater than 25;
- Not from a foreign institution;
- No unresolved human subject, animal, or biohazard concern identified by the study section or NCATS staff;
- No unresolved issues regarding the recruitment of women, minorities, or children or data monitoring identified by the study section or NCATS staff; and
- No unresolved appeal letters or other issues requiring attention of full Council.
STEP ONE: All Council members will be provided with a list of the names, institutions, project titles, requested dollars and priority scores/percentile ranks proposed for the en bloc early concurrence. If any Council member determines an application should come to the full Council for discussion or should not be expedited for any reason, he or she needs to notify only the executive secretary by the response date and the application will be removed from the early concurrence en bloc list.
Two designated Council members will receive and review the list of the names, institutions, project titles, requested dollars and priority scores/percentile ranks for all eligible early concurrence en bloc applications, as well as summary statements. The selected two Council members will notify the executive secretary of the results of their review by the requested response date (usually within one week of receipt of materials).Concurrence by the two members is required for approval. Any single vote for non-concurrence will result in that application going before the Council for full consideration at its upcoming meeting.
A report of the Early Concurrence en bloc recommendations will be presented at each Council meeting.
Applications receiving early concurrence will be eligible for funding as soon as the executive secretary of Council has certified that the review is complete.
Delegations of Authority
The Council delegates the following authority to the NCATS staff for the administrative actions described below.
Program staff, in consultation with Grants Management staff, may take administrative action without prior Council approval to award funds in excess of the amount recommended by Council for research and training grants and cooperative agreements to support increased operational costs not anticipated at the time the Council recommended approval of the project.
Administrative increases and extensions should be provided only when necessary for the successful conduct of the project and must not represent changes in the basic goals or intent of the project. Generally, these administrative increases will be no more than 25 percent of the current year’s awarded direct costs and those at or over 25 percent will be brought to Council for consideration. These increases may cover unanticipated costs of a project and can include, but are not limited to:
- Cost increases due to state, university, or labor union stipulated salary increases in fringe benefits
- Increased federally negotiated facilities and administrative cost rates or loss of equipment originally available to the project from other sources
- Increased cost of equipment and related services (e.g., data analysis)
- Making minor modifications for the purpose of taking advantage of serendipitous and other unanticipated opportunities to increase the value of the project consistent with the originally approved objectives and purposes of the project
- Preparing and disseminating materials concerning the project and for the purpose of ensuring that important findings from the project are made widely available in a timely and effective manner
- Orderly termination of a project
- Bridge funding
- Administrative correction to an error in the submission of an application
Consistent with NIH policy, administrative supplements may be made for the purpose of extending the period of support to ensure orderly termination of a project or to support a project for a limited time, pending a decision or action to continue or discontinue support (e.g., when there is an Initial Review Group or Council deferral) where support would terminate before completion of review. Extensions of projects made for this purpose should be for periods as brief as possible, but usually should not exceed one year.
All administrative supplements must be endorsed by the NCATS director. In addition, Council will be informed of all such administrative actions at its next closed meeting.
As necessary, subcommittees may be established by the executive secretary or other designated government official within the Council's jurisdiction. The advice/recommendations of a subcommittee must be deliberated by the parent advisory committee. A subcommittee may not report directly to a federal official unless there is statutory authority to do so.
A member of a standing subcommittee may serve as a voting member of another standing subcommittee, but may not be counted toward determining a quorum. The quorum for a standing or ad hoc subcommittee is three.
Danilo A. Tagle, Ph.D.
Acting Executive Secretary
National Center for Advancing Translational Sciences Advisory Council
Cures Acceleration Network Review Board
On Sept. 16, 2013, NCATS Director Christopher P. Austin, M.D., led a joint meeting of the NCATS Advisory Council and Cures Acceleration Network Review Board.