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:

1. Council may vote in either en bloc or individual actions.
2. Council with give special consideration to well-funded Investigators.
3. Council may conduct expedited reviews as well as early concurrence voting.
4. Council may delegate selected activities to staff.
5. Council has the ability to form subcommittees to perform its duties.

Second-Level Review of Grant Applications

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:

1. Foreign grants including domestic grants with foreign involvement.
2. 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).
3. Unresolved human subject, animal subject and/or biohazard concerns identified by the initial peer review group.
4. 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.

Options Available to Council

Voting options include:

1. 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:
   1. High Program Priority (HPP) — Raised in order of consideration for funding
   2. Low Program Priority (LPP) — Lowered in order of consideration for funding
2. 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.
3. Deferred — This action could be taken if additional information is required prior to voting or if an error requires the re-review of an application.
4. 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.

Applications before Council from Program Directors/Principal Investigators (PD/PI) who have more than $2 million in total 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 $2M in total 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.

Expedited Review

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)

Early Concurrence

The chair of Council will select two members or more of Council to provide the en bloc early concurrence on behalf of the full Council for a specified 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 40 or otherwise within the fundable range for a specific group of applications;
• From neither a foreign institution nor that include a foreign component;
• 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.

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 or more 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 Council members will notify the executive secretary of the results of their review by the requested response date. Concurrence by the majority of selected 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.

Concept Review

As the center 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 for proposed Notices of Funding Opportunities (NOFO) or contract solicitations. 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.

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.  A list of all administrative supplements will be provided to Council members for informational purposes only. 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 and extensions 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, the Council will be informed of all such administrative actions at its next closed meeting.

Subcommittees

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.

Exceptional Circumstances

As circumstances require, based on programmatic considerations, the Director, NCATS, after consultation with Council, may make exceptions to these guidelines.

Exceptions to these procedures should be extremely rare because there needs to be consistent application of these procedures across extramural divisions. Nonetheless, circumstances may require the deviation from the prescribed procedure in order to achieve the mission of the NCATS. By NCATSAC delegated procedures, the Director, NCATS has authority to act upon unusual or extenuating circumstances. These actions are usually discussed by a subset of Council members selected by the Director and Executive Secretary of NCATSAC. Any actions of this exceptional nature must be appropriately documented as necessary for the official record, and should be reported to Council at its next scheduled meeting.

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 (https://oma1.od.nih.gov/manualchapters/management/1805/)
3. NIH Manual Chapter 1810-1, Procedures for Avoiding Conflict of Interest for Special Government and other Federal Employees serving as Advisory Committee Members (http://oma1.od.nih.gov/manualchapters/management/1810-1/)
4. NIH Manual Chapter 3005, Review and Evaluation of Intramural Programs (https://oma1.od.nih.gov/manualchapters/intramural/3005/)
5. NIH Manual Chapter 4204-204B, Peer Review Process (https://oma1.od.nih.gov/manualchapters/grants/4204-204B/)
6. NIH Manual Chapter 54104, NIH Research Grants Involving Foreign Institutions and International Organizations (https://oma1.od.nih.gov/manualchapters/grants/54104)
7. PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
8. NIH Manual Chapter 54513, Management and Procedures of National Advisory Councils and Boards in Their Review of Extramural Activities (https://oma1.od.nih.gov/manualchapters/grants/54513/)
9. NIH Manual Chapter 7410, Review and Documentation of Protections for Human Subjects in Grant Applications and Contract Proposals (https://oma1.od.nih.gov/manualchapters/comgc/7410/)
10. OER Policy & Guidance: Inclusion of Women and Minorities as Participants in Research Involving Human Subjects – Policy Implementation Page (http://grants.nih.gov/grants/funding/women_min/women_min.htm)
11. OER Policy & Guidance: Inclusion Across the Lifespan (http://grants.nih.gov/grants/funding/lifespan/lifespan.htm)
12. NOT-OD-12-140: Notice of Special Council Review of Research Applications from PDs/PIs with More than $1.0 Million Direct Costs in Annual NIH Support (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-140.html) and NOT-OD-22-049: Notice of Change to NIH’s Policy on Special Council Review of Research Applications (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-22-049.html)

Anna L. Ramsey-Ewing, Ph.D.    
Executive Secretary    
National Center for Advancing Translational Sciences Advisory Council

January 12, 2024