NIH Human Subjects Forms

Instructions for NIH proposals involving Human Subjects

First, link to the Funding Opportunity Announcement.

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

Human Subjects = No

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, the justification attachment (PHS_HumanSubjectsAndCT_InvolveHumanSpecimensExp) is not needed.
Human Subjects = Yes

Exempt:  If human subjects are involved but the project is exempt, add a Compliance entry for Human Subjects, select status = EXEMPT, and the exemption #. If you selected exemption 4, nothing further should be needed; otherwise, follow NIH instructions.

Not exempt:  The investigator must prepare one or more full study records and/or one or more delayed onset attachments. The study title for each study record and delayed onset attachment 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. Add the attachment completed in accordance with NIH instructions.

  • Human study record blank form - open with Adobe Reader. Complete in accordance with NIH instructions and follow the troubleshooting tips compiled by SPA. A separate Compliance entry and study record will be needed for each study.
  • 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.” There must be a separate attachment and separate Compliance entry for each delayed onset study.

Delayed onset: Click the box. Add the unique Study Title. Upload the Delayed Onset attachment in the Human Study Attachment field. Add Entry

Clinical trial: 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. Click the Clinical Trial box in the KR compliance entry. Upload the study record. Add Entry

If there is a second study record or delayed onset study, add a second Compliance entry for human subjects.

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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