National Advisory Council for Complementary and Integrative Health Council Operating Procedures

Approval Date: January 20, 2023
Expiration Date: January 18, 2024

On this page

• Background

1. Secondary Review of Applications
   1. Grant Applications with No Special Concerns
   2. Grants Needing Special Consideration
   3. Options Available to the Council
   4. Administrative Decisions and Actions Following Council
   5. Expedited Concurrence
   6. Exceptional Situations
2. Concepts for Research Initiatives
3. Policy and Research Priorities
4. NCCIH Reports to Council
5. Review of Council Operating Procedures

• References

Background

The National Advisory Council for Complementary and Integrative Health (NACCIH) is charged with the responsibility of advising and making recommendations to the Director, National Center for Complementary and Integrative Health (NCCIH), NIH, on matters relating to research activities and functions of the NCCIH. Among its responsibilities, NACCIH provides second-level peer review of all applications for research grants, training grants, career development awards, and other requests for support for which Council recommendations are required by law. In addition, NACCIH reviews and provides clearance for concepts for new research initiatives.

NCCIH and other National Institutes of Health (NIH) awarding Institutes are required by policy to establish standard operating procedures for interactions between Advisory Councils and the staff responsible for the day-to-day management of extramural portfolios. This document describes those Council Operating Procedures.

I. Secondary Review of Applications

Before each Council meeting an agenda, summary statements, assignment/special action worksheets, and other materials are provided to Council members either directly or through the Electronic Council Book module of IMPAC II. Both Council members and NCCIH staff may identify applications needing discussion or special Council action. Applications assigned to another NIH institute/center, which NCCIH may wish to co-fund, must also receive Council approval.

A. Grant Applications with No Special Concerns

Grant applications meeting the following criteria may be approved en bloc by Council without discussion or other specific action.

• Proposed project is relevant to the NCCIH mission and shows promise of making valuable contributions to human knowledge.
• No unresolved human subject, animal, or biohazard concern identified by the study section.
• Not foreign.
• No unresolved issues regarding the recruitment of women, minorities, or children or data monitoring identified by the study section.
• No unresolved appeal letters or other issues requiring attention or action of Council.

Applications with no special concerns will be eligible for funding as soon as the Executive Secretary of Council certifies that Council review is complete.

B. Grants Needing Special Consideration

In closed session, Council reviews grant applications needing special consideration. These include grant applications recommended by staff or Council for high or low program priority; foreign grant applications; grant applications with human subject or animal concerns, or unresolved issues concerning the inclusion of women, minorities, or children in clinical studies; appeal letters; and grant applications with concerns regarding the recommendations of the initial review group.

Both Council members and NCCIH staff may identify applications needing discussion or action. Any Council member may raise an application for further discussion prior to or during the meeting of the Council.

C. Options Available to the Council

1. The following options are available to the Council for each application that is identified for discussion:
   • Concurrence (CON) with the Initial Review Group recommendation and score
   • Deferral to obtain additional information for consideration by Council at a later time
   • Deferral for Initial Review Group (IRG) reconsideration of scientific/technical merit
   • Recommend for funding with changes in scientific scope, budget, and/or duration of support
   • Recommend for deferral for IRG reconsideration of the scientific/technical merit
   • Not Recommended by Council—removes the application from consideration for funding
   • Recommend for High Program Priority (HPP)—raises the application in order for funding consideration
   • Recommend for Low Program Priority(LPP)—lowers the application in order for funding consideration
   • Recommend for Other (OTH)—an unusual action that cannot be identified as CON, HPP, or LPP.
2. Special Council Review
   Councils will also specifically provide consideration prior to making an additional award to investigators currently receiving $2 million or more in total costs, per year of active NIH funding (see NOT-OD-22-049).  Emphasis will be placed on how the proposed work furthers NCCIHs mission and its high priority research areas outlined in the strategic plan and how innovation and distinct the proposed project is from other funded projects of the investigator.
3. Appeals
   Applications involving appeal letters that require Council action are individually considered. If NIH staff and the applicant cannot agree on a course of action, the Program Officer will make the appeal letter available to the Advisory Council along with the IC recommendation and any written comments from the SRO or review group. The Council may reject the appeal and let the initial review results stand or recommend that the application be re-reviewed by the same SRG or a different SRG.

NCCIH staff will record all Council funding recommendations.

D. Administrative Decisions and Actions Following Council

The Director, NCCIH, may delegate to grants management and program staff the authority to negotiate adjustments in dollars and/or the terms and conditions of grant and cooperative agreement awards recommended by the Council.

NCCIH staff evaluate and review all applications before issuing a grant award. Staff negotiate appropriate adjustments to reconcile inconsistencies between recommended budgets and recommended research activities. All adjustments reflect the latest determination of actual or estimated needs of the project, the Council's recommendations, program relevance, the current NIH cost management plan, and the availability of NCCIH funds to support the research effort.

The following staff actions do not require Council recommendations but may be presented to the Council for information purposes:

1. Change of principal investigator or program director on a project that will continue to receive support at the same grantee institution;
2. Change of institution by a principal investigator who will receive previously recommended support for the project continuing at a new institution;
3. Applications deferred for re-review prior to the Council meeting;
4. Additional support through administrative supplements to maintain a previously approved level of research to accommodate activities that staff believes is within the scope of the previously peer reviewed research project.

Staff may also negotiate the following award: (1) change of institution, (2) change of principal investigator, (3) phase-out or interim support, or (4) additional support either to meet the increased cost of maintaining the level of research previously recommended, or to accommodate activities or to meet needs judged by staff to be within the scope of the previously peer reviewed project.

E. Expedited Concurrence

The National Institutes of Health (NIH), in an effort to improve the efficiency of making awards, authorized the use of an expedited review process by initiating OER Policy Announcement 1999-01 entitled "Council Operating Procedure for Expedited En Bloc Concurrence." NCCIH will make use of an expedited concurrence of en bloc actions to provide NCCIH staff with the opportunity to make awards meeting specific circumstances in a more timely, and responsive manner.

All grant and cooperative agreement applications, excluding those from foreign organizations, which have no concerns noted that would represent an administrative bar to award (e.g., for human subjects, animal welfare, biohazards or inclusion of women, children and appropriate minority distribution), will follow a process of expedited concurrence. Through this process the power to review applications is delegated to specifically designated Council members (the early concurrence committee) acting on behalf of the Advisory Council as a whole. The early concurrence committee shall consist of the Council Executive Secretary and six members of the NACCIH.

The Executive Secretary will alert the concurrence committee members with responsibility for expedited concurrence when review outcomes for eligible applications are available in the Electronic Council Book. The Executive Secretary will provide the following information electronically to the members: Application Number, Principal Investigator, Project Title and Priority / Percentile Score when available.

Electronic or written concurrence by a minimum of two members with no votes for non-concurrence within seven days of notification of posting is required for expedited concurrence approval. Any member may bring an application to full NACCIH consideration without the need for justification. Any single vote for non-concurrence within the allotted time period will result in that application going for regular consideration to the NACCIH under its normal procedures for concurrence. Members not acting upon an application within the allotted time period after posting will be considered to have abstained from a vote on that application. Expedited listings lacking enough votes for final action will be presented to the regular NACCIH meeting for review.

The full NACCIH will be provided with a list of all applications eligible for expedited concurrence, as well as the outcome of the vote by the concurrence committee members on those applications. The Executive Secretary will report the expedited concurrence recommendations during the closed session of the full Advisory Council meeting when reviewed applications are discussed. The NACCIH may reconsider the parameters for expedited eligibility at the first Council meeting of each calendar year. The early concurrence process is established with the understanding that the Director, NCCIH, will not make awards of grants with scores beyond established pay lines without specific discussion with the Council.

F. Exceptional Situations

By NACCIH delegated procedures, the Director, NCCIH, has authority to act upon unusual or extenuating circumstances. As circumstances require, based on programmatic considerations, the Director, NCCIH, after consultation with Council, may make exceptions to these guidelines. Exceptions to these procedures should be extremely rare. Nonetheless, circumstances may require the deviation from the prescribed procedure in order to achieve the mission of the NCCIH. These actions are usually discussed by a subset of Council members selected by the Director and Executive Secretary of NACCIH. Any actions of this exceptional nature must be appropriately documented as necessary for the official record, and will be reported to Council at its next scheduled meeting.

II. Concepts for Research Initiatives

In open session, Council conducts concept review of potential research initiatives. These concepts originate from the scientific community, constituency organizations, and Congress.

Using information from the sources listed above and their knowledge of the research portfolio, NCCIH staff prepares concept summaries for review by the Council. The Council may recommend approval, modification, deferral, or disapproval of a concept. Approved concepts are the bases for programs initiated through Requests for Applications, Requests for Proposals, and Program Announcements.

NCCIH staff will record and maintain documentation reflecting Council discussion and recommendations.

III. Policy and Research Priorities

Council members serve as a national resource in developing, recommending, and setting of NCCIH policy and research priorities. On occasion, special working groups may be formed by or at the request of Council to examine and address critical scientific or policy issues of importance to NCCIH and its constituencies.

IV. NCCIH Reports to Council

NCCIH will inform Council of current scientific, budgetary, legislative, or other issues that may have an impact on NCCIH and its constituencies.

V. Review of Council Operating Procedures

At the January/February Council meeting each year, Council will review the Operating Procedures for NACCIH and make recommendations for revision, where appropriate.

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
3. NIH Manual Chapter 1810-1, Procedures for Avoiding Conflict of Interest for NIH Special Government Employee SGE Advisory Committee Members
4. NIH Manual Chapter 3005, Review and Evaluation of Intramural Programs
5. NIH Manual Chapter 4204-204B, Peer Review Process
6. NIH Manual Chapter 54104, NIH Research Grants Involving Foreign Institutions and International Organizations
7. NIH Manual Chapter 54107, Review of Applications and Award of Grants Involving Human Subjects
8. NIH Manual Chapter 54206, Responsibility for Care and Use of Animals
9. NIH Manual Chapter 54513, Management and Procedures of National Advisory Councils and Boards in Their Review of Extramural Activities
10. OER Policy Announcement 1999-01—Council Operating Procedure for Expedited En Bloc Concurrence
11. OER Policy & Guidance: Inclusion of Women and Minorities as Participants in Research Involving Human Subjects—Policy Implementation Page
12. OER Policy & Guidance: Inclusion of Children Policy Implementation