Tips for Describing Human Subjects Studies in Multi-project Applications

The PHS Human Subjects and Clinical Trials Information form is new to all of us and will take some time to get used to this new approach to collecting human subjects information. If your Program Project or Center multi-project application involves human subjects research, here are a few things to keep in mind.

You’ll find the new form in the Overall component and also within other component types (e.g., Cores, Projects). Follow the funding opportunity announcement (FOA) and application guide instructions carefully to help determine where to include your human subjects information.

There are generally two scenarios:

1. Scenario 1: If the work being done on a human subjects study (think unique protocol) is contained within a single component, then complete a full or delayed onset study record within that component. No information is required on the PHS Human Subjects and Clinical Trials Information form in the Overall component.
2. Scenario 2: If work on the same study spans multiple components, then include the details for the study in the Overall component to avoid duplication. When completing the PHS Human Subjects and Clinical Trials Information form in the Overall component, complete a full or delayed onset study record and use the Other Requested Information Attachment to identify the components in which the work is being done. When completing the PHS Human Subjects and Clinical Trials Information form in the components working on the study, use the Other Requested Information attachment to indicate the study details are included in the Overall component.

Regardless of where your human subjects study record is included:

• Use your Specific Aims and Research Strategy attachments on the Research Plan form to tell your story and the PHS Human Subjects and Clinical Trials Information form to provide supporting details for your story. Moving study details to the new form frees up valuable space in your page-limited research plan – use it wisely!
• Be sure to complete PHS Human Subjects and Clinical Trials Information form Sections 1-3 for all human subjects studies and Section 4 if you answer Yes to Clinical Trial Questionnaire questions 1.4.a-1.4.d.
• If you answer Yes to Clinical Trial Questionnaire questions 1.4.a-1.4.d in a full study record or check the ‘Anticipated Clinical Trial’ box on a delayed onset study record, be sure the FOA supports clinical trials and is designated as ‘Clinical Trial Optional’ or ‘Clinical Trial Required’.
• Only include Other Clinical Trial-related Attachments in Section 5 when explicitly requested in the funding opportunity announcement (FOA).
• Read the application instructions. Even if you’ve previously submitted applications in the past, we’ve updated our requirements for various fields and attachments to accommodate the new form and avoid duplication.
• Take advantage of available resources, including: our Clinical Trials Requirements page, Clinical Trial Decision Tool, and Annotated Form Sets.
• If using ASSIST for your submission, check out our new Preparing Your Application Using ASSIST page with short videos on key ASSIST features and a link to a detailed Prepare and Submit a Multi-project Grant Application using ASSIST PowerPoint presentation.

Most importantly, don’t panic over the new requirements. The new form is designed to lead you through our human subject and clinical trial information collection requirements. Take it component-by-component, form-by-form, field-by-field and you’ll be fine.