Council of Councils Meeting
July 1, 2010
Concept Clearance for Common Fund Programs by the Council of Councils
This standard operating procedure (SOP) is based on NIH policy requirements (see Appendix) and operational requirements stemming from Anti-Deficiency and Reprogramming Laws. It also incorporates guidance from the 2006 NIH Reform Act in establishing the Council of Councils as the appropriate body to provide Concept Clearance for Common Fund Programs:
“ESTABLISHMENT–The Director of NIH shall establish within the Office of the Director an advisory council to be known as the ‘Council of Councils’ (referred to in this subsection as the ‘Council’) for the purpose of advising the Director on matters related to the policies and activities of the Division of Program Coordination, Planning, and Strategic Initiatives, including making recommendations with respect to the conduct and support of research described in subsection 402 (b)(7) of the Public Health Service Act.”
Purpose:
The purpose of Concept Clearance is to ensure that Common Fund Initiatives adequately address the objectives defined for Common Fund Programs. Each Common Fund Program addresses cross-cutting needs or opportunities that require multi-IC coordination and strategic planning (see Appendix). These goals are addressed through one or more initiatives that may be implemented through extramural grants, contracts, or other transactions, or through the NIH intramural program. The role of the Council of Councils is to review plans for extramural funding initiatives to ensure that the specific approaches described for the initiatives will lead to the desired outcomes.
Documents:
Concept Clearance is expected to involve the review of several concepts at once. To ensure that Council members receive adequate information without being overwhelmed, concepts will typically be presented through a combination of text documents provided two weeks in advance of the discussion and a slide presentation provided a few days in advance of the meeting and presented at the time of discussion.
Text documents will describe the following in a maximum of 3 pages:
- Scientific needs or opportunities to be addressed by the Program as a whole
- Goals of the specific initiative (concept) to be considered
- External input that led to the establishment of the Program and to the development of the initiative
- Results of a review of ongoing work related to the initiative (both within the NIH portfolio and work supported by other entitie
- Milestones for completion of the objectives of the initiative and a timeframe
Appendices may be provided with detailed information as appropriate. Slide presentation content will be at the discretion of the presenting individuals with review by DPCPSI prior to the Council meeting.
The Council must not receive details of initiatives that would constitute privileged information and would therefore leave Council members ineligible to apply. The Council will also not receive budget information associated with the Program as a whole or individual initiatives, and the award mechanisms associated with each initiative will not be discussed.
Acknowledging that Common Fund processes must be nimble enough to provide the NIH Director with flexibility to address rapidly emerging needs and opportunities, the specific documentation to be provided and the level of discussion to be held may vary for rapidly emerging issues.
Timing:
Although Council of Council review of concepts may occur during the early stages of initiative development, the purpose of Council review will generally be to provide input on a plan that is close to finalization. (Early external input will typically be gathered through workshops, Requests for Information, or other venues.) The Concept Clearance by Council is therefore expected to occur when the Concept is mature enough to enable Council members to have a solid understanding of the goals to be accomplished through each initiative.
The Anti-Deficiency and Reprogramming Laws require Common Funds to be allocated between defined budget mechanisms by summer of each year. To facilitate budget management in support of these laws, new initiatives must be issued by May (to receive second level review at February Council meetings) or August (to receive second level review at May Council meetings). In order to accommodate programs that target either of these timeframes, an early May meeting of the Council of Councils will generally be held for the purpose of Concept Clearance.
Discussion by Council:
The discussion of Concepts by the Council will generally be conducted at NIH, although teleconferences may suffice for rapidly emerging issues or in other situations where face to face meetings are impractical. Each concept to be considered will be presented with time allowed for questions. A clearance decision for each concept will be obtained following discussion.
Clearance:
Concepts will be cleared by the Council with a simple majority vote. In the event that a concept is judged by the Council to be unlikely to achieve the stated goals for the initiative and/or to be inconsistent with the goals for the Program as a whole, the Council will provide specific guidance to the NIH Director concerning changes that could be incorporated to make the initiative more likely to achieve the stated goals. The concept would not require re-review if these changes were later incorporated.
Appendix: Policy Requirements for Concept Clearance and Use of the Common Fund
From Manual Chapter 54110, Clearance of RFAs and PAs
https://policymanual.nih.gov/54513
A. Concept Clearance.
Each IC must document the clearance of RFA concepts, i.e., purpose, scope, and objectives. This clearance must include advice from the public and may be obtained through, for example, consultation with national advisory councils and advisory boards, Congressional mandate, or workshops convened specifically for advisory purposes. The purpose of the PA must include programmatic justification of the mechanisms to be included.
From Manual Chapter 6315-1, Initiation, Review, Evaluation, and Award of Research and Development Contracts
https://policymanual.nih.gov/6315-1
a. Project Concept
NIH Scientific Peer Review regulations require that ICs obtain peer review of each R&D contract project concept before issuing a Request for Proposals for biomedical and behavioral research (42 CFR 52h.10). The concept identifies the basic purpose, scope and objectives of the project.
Before issuing an RFP, the CO ensures that a peer review group/SRG (e.g. Advisory Council or Board, Board of Scientific Counselors, Program Advisory Group (PAG), Special Emphasis Panel) approved the project concept under requirements of 42 CFR 52h. Under certain circumstances, the IC Director or designee may defer or waive project concept review. See a.(2) and (3) below).
From Manual Chapter 54513, Management and Procedures of National Advisory Councils
https://policymanual.nih.gov/54513
E. Policy.
Extramural Program Review - Consistent with the charter of each council or board (hereafter, Council), the Director of each IC may establish a system for the Council to: 1) periodically review extramural programs, and 2) make recommendations about research activities. The periodicity and depth of these programmatic reviews may be established by the IC Director with advice from the Council. The purpose of this review by Council is to:
- provide advice on the use of grant, cooperative agreement, and contract funds in the IC's portfolios and conduct of research and related activities;
- obtain information and provide advice on program management and administration;
- ensure IC responsiveness to public needs;
- encourage initiatives for the support of high quality science; and
- assist the IC in establishing objectives and priorities, in identifying resource allocation factors, and in enhancing program management and effectiveness.
The Core requirements for Common Fund programs can be found in the 2006 NIH Reauthorization. The text below is from Section 402(b)(7):
- identify research that represents important areas of emerging scientific opportunities, rising public health challenges, or knowledge gaps that deserve special emphasis and would benefit from conducting or supporting additional research that involves collaboration between 2 or more national research institutes or national centers, or would otherwise benefit from strategic coordination and planning;
- include information on such research in reports under section 403; and
- in the case of such research supported with funds referred to in subparagraph (B)—
- require as appropriate that proposals include milestones and goals for the research;
- require that the proposals include timeframes for funding of the research; and
- ensure appropriate consideration of proposals for which the principal investigator is an individual who has not previously served as the principal investigator of research conducted or supported by the National Institutes of Health