New NIAID Policy: Investigator-Initiated Clinical Trials

Notice Number: NOT-AI-05-021

Key Dates
Release Date: May 19, 2005
Effective Dates:

Related Announcements
Issued by
National Institute of Allergy and Infectious Diseases (NIAID), (

This notice informs potential applicants of changes in NIAID policies and procedures for the acceptance, peer review, and funding of investigator-initiated clinical trials.

NIAID will support investigator-initiated clinical trials exclusively through a two part grant process: (1) a clinical trial planning (R34) grant followed by (2) a clinical trial implementation cooperative agreement.

Clinical trial applications in response to a Request for Applications (RFA) and clinical trials proposals in response to a Request for Proposals (RFP) will follow the guidelines and instructions in the RFA or RFP.

It is anticipated that a study proposed in the combined planning grant and subsequent cooperative agreement will meet the requirements for prior approval of the REVISED POLICY ON THE ACCEPTANCE FOR REVIEW OF UNSOLICITED APPLICATIONS THAT REQUEST $500,000 OR MORE IN DIRECT COSTS for any one year

Clinical Trial Planning (R34) Grant

Beginning with the September 1, 2005 application receipt date for AIDS applications and the October 1, 2005 receipt date for non-AIDS applications, NIAID will support clinical trials planning (R34) grants for complete planning and design of, and documentation for, all investigator-initiated Phase I, II, III, and IV clinical trials. The R34 grant will provide up to one year of support. Pre-approval from NIAID will be required for submission of an R34 application. R34 applications will be peer reviewed by NIAID study sections. For R34 awardees who, based on the results of the planning effort, propose to implement the trial, the product of the R34 will be an application for clinical trial implementation cooperative agreement.

The R34 grant will provide support for the establishment of the research team, the development of tools for data management and oversight of the research, the definition of recruitment strategies, and the finalization of the protocol and investigators brochure and all essential elements of the study required in a manual of operations for the clinical trial. The Clinical Trial Planning Grant is not designed for the collection of preliminary data or the conduct of pilot studies to support the rationale for a clinical trial.

It is expected that receipt of an R34 grant will lead to the timely submission of an application for support of the full-scale trial, incorporating the elements developed under the planning grant. Prospective applicants should note that funding of a Clinical Trial Planning Grant does not guarantee or imply funding for a subsequent application.

Clinical Trial Implementation (Cooperative Agreement) Grant Because the initial R34 awards will not be made until late in 2005 or early 2006, the first receipt dates for clinical trial implementation applications will be May 1, 2006 for AIDS applications and June 1, 2006 for non-AIDS applications. NIAID will accept, peer review, and consider for funding applications for implementation of investigator-initiated clinical trials only from R34 awardees. These receipt dates will permit R34 awardees that complete their planning effort in less than 12 months to submit applications as soon as possible. Each clinical trial implementation application will use the PHS 398 grant application with special instructions and must include the Institutional Review Board (IRB) approved study protocol, investigators brochure or equivalent, and a manual of operations or equivalent and meet all National Institutes of Health (NIH), Food and Drug Administration (FDA), and Office of Human Research Protections (OHRP) requirements. In order not to delay the initiation of the clinical trial, the peer review and award of the clinical trial implementation grant will be completed within four months of the receipt of the application.

In this issue of the NIH Guide, NIAID has published two Program Announcements:


Inquiries concerning investigator-initiated clinical trials should be sent to:

Office of the Director,
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
6700-B Rockledge Drive, MSC 7610
Bethesda, MD 20892-7610
Phone: (301) 496-7291
FAX: (301) 402-0369
E-mail: or

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NIH Funding Opportunities and Notices

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