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Funding

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Guidelines for Applications with Direct Costs of $500,000 or More in Any One Year

Updated January 24, 2007

A. Purpose of This Document

This document outlines the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) policy and procedures for complying with the NIH policy regarding acceptance of grant applications that request direct costs of $500,000 or more in any year. It is intended to formalize and standardize the process to ensure that all investigator requests for acceptance of such applications are handled in a consistent and timely manner. Obtaining NIAMS agreement to accept an application is only the first step in the process of applying for funding; as with all grant applications, the ultimate decision regarding funding is dependent upon the results of peer review for technical/scientific merit and subsequent action by the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council.

B. Policy

Beginning in May 1996, the NIH has required that an applicant planning to submit an application requesting $500,000 or more in direct costs for any year first obtain agreement from Institute/Center staff that the Institute or Center will accept the application for consideration for award. In implementing this policy, the NIAMS makes the following specific requirements:

The NIAMS will consider accepting such applications only for the June 5/July 5 (Cycle II) and October 5/November 5 (Cycle III) receipt dates. A potential applicant must seek NIAMS acceptance of such an application no later than March 5, for a June 5/July 5 submission, and no later than July 5, for an October 5/November 5 submission.
Revised or competing continuation applications that have previously been reviewed by NIAMS Special Emphasis Panels must be received by the earlier date for each cycle, i.e., June 5 or October 5.

Applicable Mechanisms

NIAMS applies the policy specifically to the R01 mechanisms. This policy applies to new applications, revisions of applications previously accepted for review but not funded, and applications for competing continuation of funded projects. It also applies to supplemental applications that would increase the direct cost to over $500,000 per year.

Exclusions

This policy does not apply to applications submitted in response to Requests for Applications (RFAs) or Program Announcements that include specific receipt dates and/or acceptance procedures. Applications submitted in response to the Omnibus Solicitations for Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) applications are also exempt.

C. Criteria for Acceptance

General Criteria

The following general criteria will enter into the consideration of all applications subject to this policy:

The proposed research is relevant to the NIAMS mission.
The proposed research complements ongoing program activities of the Institute and is likely to have a positive impact on program balance.
The results of the proposed research will provide a valuable addition to the existing knowledge base.
For all proposed research involving human subjects: (i) the outcome will have public health applicability, and (ii) the investigator's dissemination plan is adequate.
The annual costs for each year of support for the proposed research are reasonable.
For clinical research, study population plans comply with the NIH Policy on Inclusion of Women and Minorities as Subjects in Clinical Research and the NIH Policy in Inclusion of Children as Participants in Research Involving Human Subjects.
For phase III clinical trials, plans exist for a data and safety monitoring board.

D. Format and Processing of Requests for Acceptance

Programmatic review of the Requests for Acceptance will occur two times a year.

March 5 is the deadline for a Request for Acceptance for an application contemplated for June 5 or July 5 submission. The March 5/June 5 dates apply to new, supplemental, competing continuation or amended R01 applications to be reviewed by the Institute. Competing continuation or amended R01 applications to be reviewed by the Center for Scientific Review may be submitted for the July 5 receipt date, but requests for acceptance must still be received by March 5.

July 5 is the deadline for a Request for Acceptance for an application contemplated for October 5 or November 5 submission. The July 5/October 5 dates apply to new, supplemental, competing continuation or amended R01 applications to be reviewed by the institute. Competing continuation or amended R01 applications to be reviewed by the Center for Scientific Review may be submitted for the November 5 receipt date, but requests for acceptance must still be received by July 5.

Requests for Acceptance for unsolicited research applications requesting direct costs of $500,000 or more in any year WILL NOT be accepted for the February 5/March 5 application dates.

An applicant planning to submit a research application to which this policy applies is required to contact NIAMS Program Staff well in advance of the intended receipt date to discuss the intended proposal. The applicant may then submit a Request for Acceptance by either March 5 or July 5.

The Request for Acceptance should include

a descriptive title of the proposed research;
name, address, and telephone number of the Principal Investigator;
identities of other key personnel and participating institutions;
description of the proposed research; and
budgetary information.

In addition, the Request for Acceptance should address

the relevance of the proposed research to the NIAMS mission and
why the information gained through this research will provide a valuable addition to the existing knowledge base.

The Institute recognizes that a request will often be preceded by informal discussions with NIAMS scientific staff regarding the proposed research; however, no official action will be taken until the request, in the form of the complete package, described above, is received by the appropriate Program Director and the Request for Acceptance reviewed along with other Requests for Acceptance for that date.

Twice a year the NIAMS staff will meet with the NIAMS Director to discuss the potential scientific impact of the proposed large budget research applications on the total NIAMS portfolio. The decision on whether to accept the proposal will be sent to the potential applicant at least 2 months prior to the requested submission deadline. If the NIAMS agrees to accept assignment of the application for potential funding, the staff will notify the Center for Scientific Review before the application is submitted. The Principal Investigator must include a cover letter with the application, identifying the NIAMS program staff member who has mediated NIAMS agreement to accept assignment of the application.