Human Subject Study Record Attachment

PHS HUMAN SUBJECTS & CLINICAL TRIALS INFORMATION NIH HUMAN SUBJECT STUDY RECORD ATTACHMENT

Overview: This guide will address how this form is populated under different scenarios: not human subject research; not human subject research but involves human specimens/data; and human subject research (with or without clinical trials).

To start: All National Institutes of Health (NIH) funding opportunity announcements (FOAs) list whether they allow, require, or disallow clinical trials in the FOA’s title and in “Section II. Award Information.” You must select an FOA (solicitation) that accepts the type of research you wish to propose. Normally this is communicated clearly in the solicitation (FOA). For the Parent R01 solicitations, the options are expressed as follows:

• NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
• NIH Research Project Grant (Parent R01 Clinical Trial Required)

Depending on the solicitation selected, and the responses provided in the “Grants.gov S2S Questionnaire” and the Compliance section, Kuali will validate accordingly.

For proposals that do not include human subject research (and therefore do not also involve clinical trials), there are two scenarios:

Scenario #1

If no human subjects, data, or human subject specimens are planned:

• Correlate to the correct solicitation (Clinical Trial Not Allowed)
• Grants.gov S2S Questionnaire: Answer No to whether or not human specimens or data is involved
• Compliance panel: Do not include a Human Subject option
• These responses map to the sponsor form set and when printed it will look like this:

Scenario #2:

If human subject data, or human subject specimens are planned, and the correct solicitation was selected (Clinical Trial Not Allowed):

• Grants.gov S2S Questionnaire: Answer Yes to whether or not human specimens or data is involved
• Compliance panel: Do not include a Human Subject option
• Human Subjects Explanation attachment is required for the Human Subjects Clinical Trials form when human specimens and/or data are involved. Select Attachments and then Proposal and load a document type PHS_HumanSubectsAndCT_InvolveHumanSpecExp. For help with this document, see the General Instructions For NIH & Other PHS Agencies
• Job done. These responses map to the NIH formset and when printed it will look like this:

For proposals that do include human subject research:

STEP 1 – Navigate to the Basics section in Kuali. Enter the S2S Opportunity page and select the Forms tab. Here you will see that the PHS Human Subjects and Clinical Trials Information form is marked Mandatory, Included, and Available.

• Click on the highlighted form link and save the document to your desktop
• Open this form
• In order to access the Human Subject Study Record form, select Yes to the question “Are Human Subjects Involved?”
• This activates the ability to download the document – select Click here to extract the Human Subject Study Record Attachment.

• Complete the Human Subject Study Record form following the NIH Guidelines for Study Records; save to your desktop

STEP 2 – Navigate to the Compliance section in Kuali.

• Select +Add compliance entry and choose Human Subjects from the Type dropdown
• Select Pending from the Approval Status dropdown
• Select Delayed Onset or Clinical Trial as applicable
• Select the Human Study Attachment browser
• Upload the completed Human Subject Study Record and click Save and Continue

STEP 3 – Complete the Grants.gov S2S Questionnaire

• Answer Yes to Does the proposed research involve human specimens and/or data?

All of the above steps will lead to a successful validation of a proposal that includes human subject research.