Policy & Compliance


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Frequently Asked Questions
Clinical Trial-specific FOAs
Initial Posting: January 2, 2018
Last Revised: January 2, 2018


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      A. General

    1. What is the purpose of posting clinical trial-specific funding opportunities?
      For due dates on or after January 25, 2018, NIH will require that all applications involving one or more clinical trials be submitted through a Funding Opportunity Announcement (FOA) specifically designed for clinical trials. The purpose of this policy is to improve our ability to identify proposed clinical trials, ensure that key pieces of trial-specific information are submitted with each application, and uniformly apply trial-specific review criteria. Learn more.
    2. If I’m not sure whether NIH would consider my proposal a clinical trial, what should I do?
      We have provided a tool to help you determine whether your human subjects research study meets the NIH definition of a clinical trial.
    3. How can I tell if a funding opportunity announcement (FOA) allows applications proposing clinical trials?
      In October 2017, all existing FOAs were updated to specify the allowability of clinical trials in Section II. Award Information. In addition, FOAs that allow clinical trials will include “Clinical Trial Required”, “Clinical Trial Optional”, or “Basic Experimental Studies with Humans Required” in the FOA title.
    4. Does the title of every funding opportunity announcement (FOA) indicate whether applications proposing clinical trials are allowed?
      No. All FOAs which allow clinical trials include  "Clinical Trial Required",  "Clinical Trial Optional", or “Basic Experimental Studies with Humans Required”  in the FOA title.  
       
      However, the following FOAs DO NOT include a clinical trials allowability indicator in the title (but do specify this in Section II. Award Information):
      • Fellowship & Training FOAs – since these FOAs are always “Clinical Trial Not Allowed” there is no need to differentiate FOAs
      • FOAs that do not allow clinical trials and were posted prior to October 2017
    5. What is different about funding opportunity announcements (FOAs) that allow applications proposing clinical trials?
      FOAs that accept clinical trials include specific review criteria to ensure that reviewers appropriately consider clinical trial-related information.
    6. How can I find funding opportunity announcements (FOAs) that allow applications proposing clinical trials?
      In Spring 2018, the search feature of the NIH Guide for Grants and Contracts was enhanced to include clinical trial allowability as a search criteria. This added functionality allows all FOAs to be sorted by clinical trial allowability.
    7. Does the clinical trial policy regarding FOAs apply to all activity codes?
      Yes. There are a small number of NIH programs for which clinical trials don’t make sense [e.g., Shared Instrumentation (S10), Resource Awards (X01)]. These programs will simply be marked as "Clinical Trials Not Allowed."
    8. I originally applied to the Parent R01, which has since been expired. When I resubmit to the new Parent R01 – Clinical Trial Required, may I submit an A1 (resubmission) or must the application be submitted as new (A0 application)?
      An application submitted as new to one Program Announcement (like the Parent R01) may be resubmitted as an A1 (resubmission) to any other Program Announcement, so long as that program announcement accepts resubmissions and it is submitted within 37 months of the A0 (original, new) submission.

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      B. Training, Fellowship, and Career Development Awards

    1. Do funding opportunity announcements (FOAs) for Training (T) awards allow clinical trials?
      Institutional Training awards do not support independent clinical trials (with the exception of some D43 and K12 awards). This does not mean Trainees appointed to Training Awards can’t gain clinical trial experience.
       
      • All Training (T) FOAs are designated as “Clinical Trials Not Allowed” in Section II. Award Information,  but indicate that appointed trainees are permitted to obtain research experience in a clinical trial led by a mentor or co-mentor
      • Training FOAs do not typically include the new PHS Human Subjects and Clinical Trials Information form
        • Some D43 and K12 FOAs are designated as “Clinical Trials Optional” in Section II. Award Information. These FOAs include the PHS Human Subjects and Clinical Trials Information form, but only allow Delayed Onset Studies.
        • R25 FOAs include the PHS Human Subjects and Clinical Trials Information form and allow full or delayed onset study records.
    2. Do funding opportunity announcements (FOAs) for Fellowship (F) awards allow clinical trials?

      The NIH encourages fellows to receive training in clinical research, including clinical trials, however NIH supported fellows are not permitted to conduct a clinical trial independently.

      • All Fellowship (F) FOAs are designated as "Clinical Trials Not Allowed" in Section II. Award Information, but indicate that applicants are permitted to propose research experience in a clinical trial led by a sponsor or co-sponsor.
      • In completing the fellowship application, a fellowship applicant may answer all Clinical Trial Questionnaire questions in a study record as Yes. However, since the study is not considered an independent clinical trial, applicants are not allowed to provide information in Sections 4 and 5 of the study record in the PHS Human Subjects and Clinical Trials Information form.
      • Fellowship applicants proposing to gain mentored training experience in a clinical trial are instructed to provide details of their contribution to the study in the Research Strategy rather than in the clinical trial specific fields on the PHS Human Subjects and Clinical Trials Information form.
      • NIH expects the individual receiving support for the clinical trial (i.e., the sponsor/primary mentor or a co-sponsor) to assume responsibility and oversight of the trial and the fellow’s activities regarding the trial (e.g. reporting). However, the fellow may participate with the sponsor in some or all of these activities as part of their training.
    3. Do funding opportunity announcements (FOAs) for Career Development (K) awards allow clinical trials?
      Career Development awards may support either independent clinical trials or a mentored research training experience, depending on the FOA.
       
      • FOAs that indicate "Independent Clinical Trial Required"or "Independent Basic Experimental Studies with Humans Required" in the title and in Section II. Award Information will support independent clinical trials conducted by the applicant.
        • When completing the PHS Human Subjects and Clinical Trials Information form, the candidate must answer Yes to all four of the Clinical Trial Questionnaire questions on at least one study record and complete the clinical trial specific fields in Section 4 and, when applicable, Section 5.
      • FOAs that indicate "Independent Clinical Trial Not Allowed" in the title and in Section II. Award Information permit the applicant to propose research experience in a clinical trial led by a sponsor or co-sponsor
        • NIH expects the mentor or individual receiving support for the larger trial to have the overall responsibility of the trial.
        • Although a career development candidate may answer all Clinical Trial Questionnaire questions in a study record as Yes, the study will not be considered a clinical trial and they will receive an error if information is provided in study record sections 4 or 5.
        • Career Development applicants proposing to gain mentored training in a clinical trial are instructed to provide details of their contribution to the study in the Research Strategy rather than in the clinical trial specific fields on the PHS Human Subjects and Clinical Trials Information study record form (Section 4).
    4. I am submitting a K99/R00 application. The K99 will not include a clinical trial but the R00 will. Which Funding Opportunity Announcement (FOA) should I use?
      You would use the Clinical Trial Required FOA but should designate that it will be a delayed onset clinical trial study. When completing your application, follow the Delayed Onset Study instructions to complete the Delayed Onset Study Justification attachment. Be detailed about the information you need before you can develop definite plans for the involvement of human subjects, factors affecting the availability of the information, why that information is not currently available, and when the information is expected to become available during the course of the project. Please see additional information.
    5. I am planning on submitting a Career Development (K) application and want to develop clinical trial research experience by taking part in a clinical trial for which my proposed mentor is not the PI. Is this allowable?
      In general, the PI of the clinical trial in which a prospective K applicant wishes to gain clinical trial research experience should be part of the mentorship team for the applicant. If the clinical trial is a large multi-site trial, a proposed mentor or consultant should, at minimum, be a site lead PI for the clinical trial. Please refer to this FAQ for additional information.
    6. Why are Trainees or Fellows not allowed to lead an independent clinical trial?
      In many disciplines, a fellow or trainee may not yet possess the skills or knowledge to independently lead a clinical trial (and to navigate all the components, complexities, and reporting requirements of clinical trials). In addition, neither fellowships nor training grants include sufficient research funds to support the majority, if not all types, of clinical trials.
    7. Is there a pre-determined list of responsibilities that a fellow/trainee must assume if he/she is proposing to gain clinical trial research experience?

      No. This will vary by discipline and specific skills and expertise that the trainee/fellow possesses.

      Fellows and trainees can gain clinical trial research experience through mentored training in specific components of clinical trial research including (but not limited to): developing a clinical protocol; applying the principles of informed consent and requirements for human subjects research; learning about random assignment of participants to different intervention arms; analyzing trial endpoints; and/or implementing quality control standards when implementing a clinical trial.

    8. Who is responsible for the conduct of the clinical trial within the context of Fellowship (F) and Training (T) applications?
      The individual receiving support for the clinical trial (i.e., the sponsor/primary mentor or a co-sponsor) is the responsible individual of record for oversight of the trial though trainees and fellows can take part in all components of a clinical trial. Oversight includes (but is not limited to): interacting with relevant Institutional Review Board (IRB) staff; reviewing all informed consent documents; reporting potential serious adverse events; and maintaining responsibility for patient safety. However, the trainee or fellow can gain experience in all these components in conjunction with the mentor or individual leading the trial. Delineating the roles and responsibilities that both the fellow and sponsor are undertaking is important.

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      C. Basic Experimental Studies with Humans (BESH) FOAs

    1. What types of studies fall under the ‘Basic Experimental Studies with Humans Required’ FOAs?

      Basic science experimental studies involving humans, referred to in NOT-OD-18-212 as “prospective basic science studies involving human participants” include studies that meet the NIH definition of a clinical trial and also meet the definition of basic research.  Types of studies that fit within this FOA include studies that prospectively assign human participants to conditions (i.e., experimentally manipulated independent variables) and assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind. See the Comparison of Funding Opportunity Types by Clinical Trial Allowability for additional guidance.

    2. What policies and requirements do I follow for ‘Basic Experimental Studies with Humans Required’ FOAs?

      NIH continues to expect Good Clinical Practice (GCP) training in accordance with NOT-OD-16-148, for all personnel involved in the conduct, oversight, or management of clinical trials, including studies that are submitted to Basic Experimental Studies with Humans Required FOAs. Note that there are free and short-duration training modules available, including one targeted towards behavioral research offered by OBSSR. Additionally, all applications will require completion of the full PHS Human Subjects and Clinical Trials Information form. NIH is, however, delaying enforcement of its policy, published in the Federal Register on September 21, 2016, that establishes the expectation that investigators will register and report their studies in ClinicalTrials.gov. Through September 24, 2019, NIH will continue to expect registration and reporting for studies submitted to Basic Experimental Studies with Humans Required FOAs, with additional flexibility to allow reporting on existing basic science portals, with the expectation that data will eventually be transported to ClinicalTrials.gov. See NOT-OD-18-212 for additional information.

    3. For the ‘Basic Experimental Studies with Humans Required’ FOA, how should one answer the 4 questions in the clinical trial questionnaire in the PHS Human Subjects and Clinical Trials Information form?

      Given that the Basic Experimental Studies with Humans Required FOA is for studies that meet both the NIH definition of a clinical trial and the definition of basic research, applicants should answer ‘Yes’ to all 4 questions in the clinical trial questionnaire.

    4. What is the definition of basic research?
      NIH defines basic research as “the systematic study directed toward greater knowledge or understanding of the fundamental aspects of phenomena or of observable facts without specific applications towards processes or products in mind.” (32CFR 272.3)
    5. How do basic experimental studies with humans differ from mechanistic studies?
      Studies that fit within the ‘Basic Experimental Studies with Humans Required’ FOA are a subset of trials that have been considered “mechanistic trials”. There are some mechanistic trials, for example those that are studying how an intervention produces its effects, that do not fit within the ‘Basic Experimental Studies with Humans Required’ FOA and must continue to come into a Clinical Trial Required FOA. See the Comparison of Funding Opportunity Types by Clinical Trial Allowability for additional guidance.
    6. Do ‘Basic Experimental Studies with Humans Required’ FOA applicants use the PHS Human Subjects and Clinical Trials Information form?
      Yes. Since these applications meet both the NIH definition of clinical trial and the definition of  basic research, these applicants are required to fill out the full Human Subjects and Clinical Trials Information form.
    7. Do ‘Basic Experimental Studies with Humans Required’ FOA applicants need Good Clinical Practice (GCP) training?
      Yes. Since these applications meet both the NIH definition of clinical trial and definition of basic research, NIH continues to expect GCP training in accordance with NOT-OD-16-148 for all personnel involved in the conduct, oversight, or management of basic experimental studies with humans.
    8. What review criteria will be used to review applications submitted to the ‘Basic Experimental Studies with Humans Required’ FOAs?
      Since these applications meet both the NIH definition of a clinical trial and the definition of basic research, they will be subject to the same review criteria as all ‘Clinical Trial Required’ FOA applications. See here for additional information.
    9. Do FDA Phase 0/Phase 1 studies or studies about the mechanism of action of a treatment fall under the ‘Basic Experimental Studies with Humans Required’ FOAs?
      No; any FDA Phase 0 or 1 trial is by default considered to have a process or product in mind, and therefore, should submit under a ‘Clinical Trial Required’ FOA. Similarly, trials that examine the mechanisms by which an intervention works or the processes that account for an intervention’s effects on clinical outcomes are considered to have a process or product in mind, and thus should also submit under a ‘Clinical Trial Required’ FOA.
    10. How can I find out what NIH institutes and centers (ICs) are accepting applications for Basic Experimental Studies with Humans FOAs?
      Given that not all NIHs institutes or centers (ICs) participate in parent FOAs, it is important to check the “participating organizations” section of the FOA for the list of participating ICs. We also recommend talking to the Scientific/Research Contact listed on the FOA for help determining the most appropriate FOA for your application. 

This page last updated on January 2, 2018 
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