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Frequently Asked Questions
Human Subjects and Clinical Trials Information
Initial Posting: April 24, 2018
Last Revised: April 24, 2018


  A. Human Subjects and Clinical Trials Information Form

  1. How do you define a “study” for the purposes of providing information on the PHS Human Subjects and Clinical Trials Information form?

    We recognize that it may be difficult to determine whether two or more closely related protocols should be considered a single study. Generally, if you have research activities that use the same human subjects population, follow the same research protocols, and intend to combine the data for analysis in aggregate, this would be considered a single study for the purposes of the PHS Human Subjects and Clinical Trials Information form.

    When in doubt, at the time of application NIH supports grouping studies that use the same research protocol and the same human subjects population into a single study record, to the extent that the information provided is accurate and understandable to NIH staff and reviewers.  You are also encouraged to discuss how to group your studies with your NIH Program Officer.

     

  2. Where can I find the new PHS Human Subjects and Clinical Trials Information form?

    Like all NIH application forms, the new PHS Human Subjects and Clinical Trials Information form is accessed through the submission method you are using. ASSIST, Workspace and all system-to-system solutions provide a way to access and complete the forms.

    ASSIST allows you to complete the forms online within ASSIST or to download a study record form for offline completion and later upload the completed form into your ASSIST application.

    Workspace provides the ability to download and upload study record forms, but does not yet offer a webform for online data entry.

    Forms downloaded from ASSIST can NOT be uploaded to Workspace and vice versa. Forms downloaded directly from the Grants.gov website form repository page can NOT be uploaded to either ASSIST or Workspace applications for submission.

    See this video for tips on accessing application forms. 

  3. My application proposes several aims that are part of the same study (e.g. a focus group, a survey, and an intervention). Do I need separate study records for each part of the study?

    Aims and hypotheses may be grouped together on a single study record, as long as the information is provided in such a way that is accurate and understandable to NIH staff and reviewers.  You are encouraged to discuss how to group your studies with your NIH Program Officer.

  4. How will the PHS Human Subjects and Clinical Trials Information form interact with ClincialTrials.gov?

    Entering the study’s ClinicalTrials.gov identifier (NCT) will pre-populate fields on the PHS Human Subjects and  Clinical Trials Information form, including much of Section 4 – Protocol Synopsis.  Following entry of the NCT number, existing data on the PHS Human Subjects and Clinical Trials Information form will be replaced by data from the Clinicaltrials.gov record and updates to those fields should be made directly in ClinicalTrials.gov.

    In the future, NIH plans to develop functionality to allow use of data entered on the PHS Human Subjects and Clinical Trials Information form when registering the trial in ClinicalTrials.gov.

  5. What should I include in attachment 3.5 Overall Structure of the Study Team?
    In the Overall Structure of the Study Team attachment include information on the administrative structure and function of the study team.  The section may include study team composition and key roles (e.g. medical monitor, data coordinating center), the governance of the study, and a description of how study decisions and progress are communicated and reported.
  6. How do I answer question 4.2.c. “Intervention Type” for a behavioral research trial that does not look like the examples given in the application guide (psychotherapy, lifestyle counseling)?

    NIH recognizes the breadth of behavioral clinical trials, which may include basic and translational research, as well as studies that examine the safety, efficacy and effectiveness of interventions.  Researchers conducting behavioral research should select “behavioral” if that is the best fit for your trial.

  7. My study involves a device or a behavioral intervention. How should I answer question 4.2.d. regarding study phase?

    Applicants should apply the Clinicaltrials.gov definition of study phase when completing the PHS Human Subjects and Clinical Trials Information form.  Trials involving devices or behavioral interventions would answer this question by selecting “Other.”  

    When answering the second part of question 4.2.d on whether your study is an NIH-defined Phase III clinical trial, use the NIH-defined Phase III clinical trial definition.  Keep in mind that the NIH-defined Phase III clinical trial definition includes non-drug studies (e.g. device studies, behavioral interventions, etc.)

  8. Do I need to list every outcome in question 4.3. “Outcome Measures”? What about unanticipated analyses that may occur over the course of the study?

    The outcome measures section should include primary, secondary, and other important measures.  It is not expected that every outcome will be listed.  Furthermore, NIH recognizes that some studies may include exploratory analyses not specified in the application.

    Keep in mind that the outcomes listed on the PHS Human Subjects and Clinical Trials Information form are expected to synchronize with your study’s ClinicalTrials.gov record.

  9. If my study does not fall under the NIH single IRB policy, must I provide a justification for answering “No” to question 3.2 on the Human Subjects and Clinical Trial Information form?
    If your study does not fall under the NIH single IRB policy for any reason you should answer “No” to question 3.2. This includes studies that involve multiple sites that are conducting different protocols.  There is no need to provide a justification for your answer. Response to the Single IRB question is not a review criteria. If there are questions they will be addressed after peer review.
  10. When submitting a K99/R00 application which involves human subjects, do I need to complete a study record in the PHS Human Subjects and Clinical Trials Information form for each phase?

    The K99/R00 is a single application for both phases of the award, and the reviewers evaluate both phases. The research plan for the R00 phase of the award should be described in sufficient detail for reviewers to evaluate the merit of this phase of the application. A single study record covering both phases is typically sufficient. You can point out any minor differences between K99 and R00 within the study attachments. At the time of the K99 application submission, inclusion enrollment data should be provided for the K99 phase only.

    If you anticipate substantial differences in the study information for each phase, you can complete a separate full study record or a delayed onset study record for the R00 phase. Additional information for delayed onset studies can be provided when submitting the R00 application for administrative review.

  11. Do I need to create a study record for the part of my research that uses human specimens?
    No. When you answer No to the Human Subjects Involved question on the R&R Other Project Information form, we give you the opportunity on the PHS Human Subjects and Clinical Trials Information form to add an attachment to explain why the application does not involve human subjects research.

    However, when a part of your research uses human specimens and other parts involve human subjects that attachment is no longer available to you. You will have at least one study record for the human subjects aspects of your application. You can simply add a blurb in the Protection of Human Subjects attachment (item 3.1) of the existing study record.


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