NIH Human Subjects Forms

Instructions for NIH proposals involving Human Subjects

Link to the Funding Opportunity Announcement in the S2S section of the proposal in Kuali Research (KR), to generate the correct questionnaires and attachment types.

S2S questionnaire responses must be consistent with Compliance entries in KR.

Decision Tree: Answer the questions on this form to ascertain whether the Human Subjects Study Record form is needed for your proposal and, if so, how much of the form must be completed.

Human specimens and/or data: The S2S questionnaire asks, Does the proposed research involve human specimens and/or data?

  • When the response to this question is yes, and there is no Compliance entry for human subjects, you must provide a justification for your claim that no human subjects are involved. Upload the justification in the Attachments section as Attachment Type: PHS_HumanSubjectsAndCT_InvolveHumanSpecimensExp
  • When the response to this question is yes, and there IS a Compliance entry for human subjects, follow the instructions below (no justification attachment is needed).

Exempt human subject studies: If human subjects are involved and the project is exempt, add a Compliance entry for Human Subjects, select status = EXEMPT, and the exemption #. Add the completed Human Study Record attachment. For Exemption #4, complete Section 1 and Questions 3.1 and 3.2 on the form. For other exemptions, complete Sections 1, 2, and 3.

Non-exempt human subject studies: The investigator must prepare one or more full study records and/or delayed onset attachments. The study titles for each study record and delayed onset study must be different.

Add a Compliance entry for Human Subjects. Select the status, usually Approved or Pending. The Protocol number and the Approval Date are required when you select the status of Approved.

For protocols that can be described, whether they will begin immediately upon award or later, add the completed Human Study Record attachment. If the study meets the NIH definition of a clinical trial, check the box. If you answered "Yes" to all the questions in the Clinical Trial Questionnaire (section 1.4 of the Human Subjects Study Record), this study meets the definition of a clinical trial.

  • Human study record blank form — open with Adobe Reader. Complete in accordance with NIH instructions and follow the troubleshooting tips compiled by SPA. Refer to the table below as a quick reference to the sections that will need to be completed. A separate Compliance entry and study record will be needed for each study.

For studies that meet the NIH definition of a delayed onset trial, i.e., definite plans for the study cannot be described in the proposal, check the box Delayed Onset, add a unique study title, and upload the Delayed Onset attachment in the Human Study Attachment field.

  • A delayed onset attachment is a standard PDF file attachment. Delayed onset means: "Human subjects research is anticipated within the period of award but definite plans for this involvement cannot be described in the application.” If you have multiple delayed onset studies, you can include them together in a single Delayed Onset Study.

Refer to the table below (from the NIH application guide) for information about what sections of this form are required, based on your answers to Question 1.4 "Clinical Trial Questionnaire."

Screenshot from NIH proposal instructions

If an Other Requested Information attachment is required by your Funding Opportunity Announcement, create a PDF document with the information requested in the FOA and upload it in Attachments using Attachment Type: PHS_HumanSubjectsAndCT_OtherRequestedInfo

NOTE: To be clear, if you have a Compliance entry for Human Subjects, the only human subjects-related file uploaded on the Attachments tab would be the Other Requested Information attachment, and that is uploaded only if required by the FOA.

To review the form and attachments, go to the Basics section of the proposal, S2S Opportunity Search, Forms tab. Select the PHS_HumanSubjectsAndClinicalTrialsInfo_V1.0 and click Create PDF (lower right section of screen).

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