Council Operating Procedures

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The National Advisory Council for Complementary and Alternative Medicine (NACCAM) is charged with the responsibility of advising, consulting with, and making recommendations to the Director, NIH, on matters relating to research activities and functions of the National Center for Complementary and Alternative Medicine (NCCAM). NACCAM provides final review of all applications for research grants, training grants, and career development awards assigned to the NCCAM for scientific merit and program priority, as well as other requests for support for which Council recommendations are required by law. Further, NACCAM reviews and provides clearance for concepts for NCCAM research initiatives.

I. Secondary Review of Applications

In closed session, the Council reviews grant applications, discussing topics such as selective pay, foreign grant applications, inclusion of women and minorities and children in clinical studies, human subject or animal concerns, appeal letters, and concurrence with or variance from recommendations of initial review groups.

Both Council members and NCCAM staff may identify applications needing discussion or action. 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.

NCCAM staff will record all Council recommendations.

Options Available to the Council

The Public Health Service Act requires that funding of a grant application may occur only after it has gone through the two-level peer review process.

The Council may not change the scores assigned by the Initial Review Group (IRG). The following options are available to the Council for each application that is identified for discussion:

  1. Concurrence with the Initial Review Group recommendation and score;
  2. High Program Priority—raises the application in order for funding consideration;
  3. Low Program Priority—lowers the application in order for funding consideration;
  4. Other—includes changes in recommended budget and/or duration of support, deferral to obtain additional information for consideration by Council at a subsequent meeting, or deferral for IRG reconsideration of the scientific/technical merit;
  5. Not Recommended by Council—removes the application from consideration for funding.

Note: Administrative Decisions and Actions That Do Not Require Council Recommendation

NCCAM staff evaluates and reviews all applications before issuing a grant award. Staff negotiates 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 NCCAM 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.

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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, NCCAM 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.

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

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III. Policy and Research Priorities

Council members serve as a national resource in developing, recommending, and setting of NCCAM 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 NCCAM and its constituencies.

IV. NCCAM Reports to Council

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

V. Council Operating Procedures

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

1/30/03

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