Human Subjects & Clinical Trials Information Form

Research & Related Other Project Information

For assistance with the information required on this form, please refer to the appropriate application guide on the How to Apply page.

NOTE: The forms in these topics reflect FORMS-H, which must be used for applications with due dates on or after January 25, 2023 (see guide notice NOT-OD-22-195. Also see the annotated form set and summary of changes for Forms-H.) For due dates on or before January 24, 2023, use FORMS-G.

Steps for Filling out the Form

This page walks you through the PHS Human Subjects and Clinical Trials Information form, which consolidates human subjects, inclusion enrollment, and clinical trial information previously collected across multiple agency forms.

The human subjects section of the Research & Related Other Product Information form will need to be completed before opening the Human Subjects and Clinical Trials form. The first few answers in the R&R Other Product Information form will populate the first three questions in the Human Subjects and Clinical Trials Information form. (click to view an example of the R&R Other Project Information screen)

The top of the Human Subjects & Clinical Trials form has a reminder to complete the R&R Other Project Information form first. (Click to view)

The Summary page will be the first page of the Human Subjects and Clinical Trials form. This is where you will see the pre-populated answers from the R&R Other Project Information form regarding Human Subjects. Those pre-populated answers will determine the content and mandatory actions in the next section of the form.

The first question asks if the proposed research involves human specimens and/or data.

• If human subjects are involved, select the Yes radio button and add a Study Record or Delayed Onset Study for each proposed Human Subjects study and any Other Requested Information indicated in the FOA. (click to view if "Yes" to HS)

• An additional functionality available in ASSIST is to download a study to your local environment to provide to other collaborators to complete and then the completed study can be uploaded. The buttons for these functions are to the right of the Add New Study button.
• For Other Requested Information follow instructions in the funding opportunity (FOA) regarding the inclusion of other information or attachments. Additionally, for multi-core applications that share studies, use this area in the affected cores to reference the study in the Overall core.

  IMPORTANT: Studies must only be added once for each application regardless of how many times they are used by other cores.

NOTE: With regard to Project Exemptions from Federal regulations, those applicable to NIH are 1, 2, and 4. See this NIH infographic for more detail. A summary is listed below.
* Exemption 1 - research conducted in an educational setting involving normal educational practices.
* Exemption 2 - research using educational tests, surveys, interviews, or observations of public behavior unless identifiable and pose risks. (not collecting sensitive information). See the infographic for limits on involving children.
* Exemption 4 - secondary research using identifiable information or biospecimens if publicly available, or recorded such that subjects cannot be re-identified.

• Add one or more Study Records or Delayed Onset Studies. All study titles must be unique to your organization. For multi-component applications with shared protocols, the study should be included in the Overall and the study referred to using this box.

NOTE: A Delayed Onset Study, marked as an anticipated clinical trial, can fulfill FOA requirements

Tip: You will not be able to add a regular or delayed study if you answered "No" to the human subjects question in the R&R Other Project Information form.

• For Delayed Onset Studies, provide a Justification regarding the reasons why the study cannot be described at the time of submission.

  Tip: For Delayed Onset Studies, multiple studies may be grouped in a single record.

IMPORTANT: If you change your answer to the "Are Human Subjects Involved" question on the R&R Other Project Information Form after you have started entering information into the PHS Human Subjects and Clinical Trials Information form, your data in the PHS Human Subjects and Clinical Trials Information form may be lost. A warning pop-up will display: