Key Dates

Related Announcements

PAR-21-083 - NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required)
PAR-21-082 - NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44 Clinical Trial Required)
PAR-20-139 - Investigator Initiated Extended Clinical Trial (R01 Clinical Trial Required)
PA-20-183 - Research Project Grant (Parent R01 Clinical Trial Required)
PA-20-194 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)

Issued by

National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

This Notice defines the types of investigator-initiated clinical trial applications that should be submitted to NIAID in response to the NIH Research Project Grant (Parent R01 Clinical Trial Required), the NIH Research Project Grant (Parent R21 Clinical Trial Required), Investigator Initiated Extended Clinical Trial (R01 Clinical Trial Required) and NIAID investigator-initiated cooperative agreement funding opportunity announcements (FOAs) and their reissuances. Also, this Notice clarifies that NIAID’s mission-relevant support for clinical trials, defined in NOT-OD-15-015, “Notice of Revised NIH Definition of “Clinical Trial”, is contingent on submission of that clinical trial application to the appropriate FOA, based on NIAID's determination of level of risk. Applicants are encouraged to refer to the NIAID Clinical Trial Research page and NIAID Investigator-Initiated Clinical Trial Resources for more information.

Determination of the appropriate funding announcement is based on the assessment of risk. A "high-risk" clinical trial is defined by the NIAID as having one or more of the following attributes:

• provision of a non-routine intervention, that is, an intervention or non-routine use of an intervention that would not otherwise be provided for the condition under study in the local facility where the study is being conducted;
• administration of an unlicensed product; or
• administration of a licensed product for an unapproved indication.

Applicants proposing "high-risk" clinical trials are encouraged to apply to:

• PAR-21-083, “NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required)”

Small business applicants proposing clinical trials are encouraged to apply to the FOA below. Clinical trials that are not "high-risk" are accepted, but this program encourages "high-risk" clinical studies.

• PAR-21-082, “NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44 Clinical Trial Required)”

Applicants proposing clinical trials that require an extended project period of 6 or 7 years should apply to:

• PAR-20-139, “Investigator Initiated Extended Clinical Trial (R01 Clinical Trial Required)”

Consultation with NIAID staff at least 10 weeks prior to the application due date is strongly encouraged for submission to the FOAs described above. The purpose of this consultation is four-fold:

1. Assure that the proposed clinical trial meets NIAID’s goals, fits within its mission, and addresses a high priority research area.
2. Determine the risk level for the proposed trial.
3. Review the information and documents needed for inclusion in the application.
4. Identify other mechanisms to support the clinical trial, e.g., through a different FOA or one of NIAID's clinical trial networks.
    

For clinical trials that are not "high-risk", applicants are encouraged to apply for the following NIH parent announcements:

• PA-20-183, "NIH Research Project Grant (Parent R01 Clinical Trial Required)"
• PA-20-194, "NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)"

Applicants to the NIH parent clinical trial FOAs are strongly encouraged to consult the NIAID Scientific/Research Contact listed on the NIH Research Project Grant (Parent R01 Clinical Trial Required) and NIH Research Project Grant (Parent R21 Clinical Trial Required) FOAs prior to submission to confirm the appropriateness of the proposed project for these funding opportunities.

Inquiries

Please direct all inquiries to:

Martin Gutierrez
Division of Acquired Immunodeficiency Syndrome (DAIDS)
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-292-4844
Email: [email protected]

Ellen Goldmuntz, M.D., Ph.D.
Division of Allergy, Immunology and Transplantation (DAIT)
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3502
Email: [email protected]

Greg Deye, M.D.
Division of Microbiology and Infectious Diseases (DMID)
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3371
Email: [email protected]