Policies and Guidelines for Investigator-Initiated Clinical Trials — Frequently Asked Questions (FAQs)

Updated October 5, 2016

  1. Where can I find Funding Opportunity Announcements and Key Dates for the NIAMS Clinical PARs (Clinical R21, Clinical Observational R01, R34 and U01)?

    Exploratory Clinical Trial Grants (R21)
    Clinical Observational (CO) Studies in Musculoskeletal, Rheumatic, and Skin Diseases (R01)
    NIAMS Clinical Trial Planning Grants (U34)
    NIAMS Clinical Trial Implementation Cooperative Agreement (U01)

  2. Which PAR is most appropriate for my proposal?

    It depends. Please speak to your Program Director for guidance.

  3. What if I have already met my planning milestones — do I have to apply for a R34 first?

    A R34 Planning Grant is not required before applying for an U01. However, planning milestones should be complete or mostly complete before submitting an U01 application. Please speak to your Program Director for guidance.

  4. My trial is for a single site. How do I apply?

    Through the U01 mechanism or the Exploratory R21. The NIAMS Clinical Trial Implementation Cooperative Agreement (U01) and Exploratory R21 mechanisms are appropriate for either a multi-site or a single-site clinical trial application.

  5. Do I have to submit both a Letter of Intent (LOI) and a Letter of Request (LOR) when applying to one of these mechanisms?

    No. A Letter of Intent (LOI) is not required, but it is highly encouraged for R34 applications and U01 applications that have budgets under $500,000 in direct costs per year.

    A Letter of Request (LOR) is only required for U01 applications that will have budgets of $500,000 or greater in direct costs in any given year. A Letter of Request (LOR) requires substantially more detail than a LOI and must be submitted for the NIAMSís consideration at least 10 weeks in advance of the application due date. You will be notified by the NIAMS if your LOR is accepted and you may submit a U01 application (Note: permission is only needed if the application has a budget requesting direct costs equal to or greater than $500,000 in direct costs in any given year).

  6. What are the due dates for the Letter of Request (applications with budgets of $500,000 or greater in direct costs in any given year) for a U01 Clinical Trial Application?

    Application Due Date Letter of Request (LOR) Due Date *required 10 weeks prior to the application due date)
    March 1, 2017 December 28 2016
    July 3, 2017 April 24, 2017
    November 1, 2017 August 23, 2017
    March 2, 2018 December 22, 2017
    July 2, 2018 April 23, 2018
    November 1, 2018 August 23, 2018
    March 1, 2019 December 22, 2018
    July 1, 2019 April 22, 2019
    November 1, 2019 August 23, 2019
  7. What are the due dates for the Letter of Intent (U01 applications with budgets of less than $500,000 in direct costs in any given year and all R34 applications)?

    The Letter of Intent is requested 30 days prior to the application due date.

  8. The R34 FOA states that individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide. What does this mean?

    For the R34, a resource sharing plan is not required.

  9. Should the modular budget form be used for the R34, since direct costs should be $150,000 per year or less?

    The NIAMS Clinical Trial Planning Cooperative Agreement (R34) (PAR-16-446) must use the modular grant application (Source of information: https://grants.nih.gov/grants/funding/modular/modular.htm)

  10. How should appendices be submitted?

    Appendices are not allowed.

  11. A PI who previously submitted an U34 did not get funded. Can he or she apply for a new R34?

    Yes.

  12. Does the F&A for consortiums count against the direct cost limitation?

    No. In calculating direct cost level, the applicant should not include the F&A costs associated with any consortium/contractual arrangements. Those costs may be requested above the direct cost limit. Fields are provided to separately capture consortium F&A costs for each budget year.

  13. What is the page limit for my application?

    Please follow the page limitations described for each PAR. Refer to https://grants.nih.gov/grants/guide/url_redirect.htm?id=11132

  14. If I have already completed a U34, how should I seek permission to apply for a U01 without applying for an R34?

    Please speak directly to a NIAMS Clinical Research Manager or a NIAMS Program Director regarding the accomplishments of your U34 and how documentation should be submitted.

  15. Can I submit an R01 clinical trial application?

    See NOT-AR-16-015. NIAMS will accept applications submitted in response to either the NIH Parent R01 (PA-16-160) or Parent R21 FOA (PA-16-161) that include a clinical trial in which the primary objective is mechanistic, rather than a clinical outcome. This revised policy applies not only to the current Parent FOAs, but also to subsequent reissuances. Note that NIAMS will not accept applications submitted in response to the NIH Parent R01 FOA or the Parent R21 FOA that include a clinical trial in which the primary objective is to test a clinical outcome: such trials will only be accepted through NIAMS-specific FOAs specifically designed for clinical trials. Please speak to a Program Director for further guidance on this policy.

  16. Would the NIAMS accept an investigator-initiated study application for a clinical trial if the planning milestones were completed through funding resulting from a foundation grant or other private source of funding (not an NIH-funded R34 or U34 planning grant)?

    Yes. Please request a pre-submission consultation with a NIAMS Program Director and the Clinical Research Managers to discuss the planning milestones that have already been accomplished. Please also refer to the NIAMS website for more information about clinical trial planning and implementation milestones.

  17. Where do I submit my LOI or LOR?

    Please submit to the Scientific/Research contact listed in the R34 and U01 FOA:

    Ms. Shahnaz Khan
    National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
    Telephone: 301-451-9893
    Email: Khanshah@mail.nih.gov