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Grant Runner PHS Human Subjects & Clinical Trials

This form is required for all NIH applications using Grant Runner.

Select PHS Human Subjects & Clinical Trials from the left navigation menu to open the form. The form consists of several sections:

  • Human Subjects Section with responses from R&R Other Project Info Form
  • Human Specimens section
  • If Yes to Human Subjects section, conditionally displays
  • Add Studies
  • Other Requested Info

Responses from R&R Other Project Info Form

This section displays the answers to the Other Project Info form’s Human Subjects questions.

Use of Human Specimens and/or Data

human specimens question answered yes and showing required explanation attachment

In this section, you must indicate if your research will involve human specimens or data.

If you answer “Yes” then a link to add an attachment will display.  Attach a PDF formatted file explaining any use of human specimens and/or data not considered to be human subjects research. See your funding opportunity announcement and agency-specific instructions for additional guidance.

If Yes to Human Subjects

If you answered “Yes” to Are Human Subjects Involved on the Other Project Info form, this section will display.

Add Studies

Add a record for each proposed Human Subject study by selecting Add New Full Study or Add New Delayed Onset Study. There is also an option to import a study. For specific details on the steps involved, please see the Adding HSCT Studies article.

Other Requested Info

other requested info attachment

Attach any other relevant documents as requested by the sponsor. The attachment should be a PDF formatted file. See your funding opportunity announcement and agency-specific instructions for additional guidance.