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Investigators are strongly encouraged to consult with the NIAMS prior to submitting an application to any of the NIAMS clinical funding opportunity announcements (FOAs). Consultation prior to submission of an application allows the Program Officer to discuss with the investigator the extent to which the potential project fits with NIAMS program priorities.

In the pre-submission consultation phase, if the proposal does not meet the goals and mission of the NIAMS, applicants will be so informed. The NIAMS reserves the right to determine that support for clinical trials may be directed through other available mechanisms supported by the NIAMS.

NIAMS staff will:

  • Consider whether the proposed clinical project meets the goals and mission of the Institute.
  • Consider whether it is appropriate for an investigator-initiated application.

NIAMS staff will NOT:

  • Evaluate the technical and scientific merit of the proposal. Technical and scientific merit will be determined during peer review.

Consultation Preparation

Investigators who anticipate submitting an application to any of the NIAMS clinical FOAs should consider the items below in preparation for a pre-submission consultation with a NIAMS Program Officer:

  • Anticipated date of submission.
  • Study title.
  • Study PI(s).
  • Primary institution and potential collaborating sites.
  • Brief description of the objectives of the clinical study.
  • Brief rationale for the proposed clinical study.
    • Scientific basis.
    • Clinical significance.
  • Total cost estimate of the clinical study, by year.
  • Estimated start date and duration of the clinical study.

Total cost estimate of the clinical study, by year. Estimated start date and duration of the clinical study.

Investigators who anticipate submitting a U01 Clinical Trial Implementation (U01) grant should:

Letter of Intent Submission

Investigators are strongly encouraged to notify the NIAMS prior to submission of the application for either an R34 or a U01 through a Letter of Intent (LOI). Instructions for preparing the LOI are provided in the FOA. LOIs should be submitted to the Scientific/Research contact listed below, who will share the request with the appropriate Program Officer.

Shahnaz Khan, M.P.H.
Clinical Research Manager, Division of Extramural Research
6701 Democracy Blvd. Suite 800
Bethesda, MD 20892
Phone: 301-451-9893
khanshah@mail.nih.gov

In addition to technical merit, the NIAMS will consider program priorities in making funding decisions. Applications that do not meet the criteria outlined above or that are judged to be of low program priority will not receive funding even if found to be scientifically sound in peer review. One benefit of consultation prior to submission of an application is that the Program Officer can discuss with the investigator the extent to which the potential impact fits with NIAMS program priorities.

The NIAMS reserves the right to determine that support for clinical trials may be directed through other available mechanisms supported by the NIAMS.

Consultation for Applications with Direct Costs of $500,000 or Greater in Any Year

Pre-approval is required prior to submission of an application which will have direct costs of $500,000 or more in any given year, as per NIH policy. Applicants should refer to the NIAMS Letter of Request (LOR) policy for information about what to include in their LOR. LORs are due at least 10 weeks prior to the application deadline. Due dates for the LOR are also included in the Milestone Checklist.

Last Updated: February 2021