Notice Number: NOT-OD-18-128

Key Dates
Release Date: January 18, 2018

September 29, 2023 - Notice of Information: Recruitment and Retention Monitoring and Reporting of Clinical Research Awards Supported by the National Institute on Drug Abuse. See Notice NOT-DA-23-033.

Issued by
National Institutes of Health (NIH)

Purpose

This notice corrects application form instructions related to human subjects involvement for Training (T) grant applications submitted to due dates on or after January 25, 2018. Human subjects information beyond answering the human subjects questions on the R&R Other Project Information Form is not required for Training grant applications (except D43 and K12).

Instruction Issue:

Current instructions for field "1. Are Human Subjects Involved?" of the R&R Other Project Information Form indicate all grant applicants must complete some information on the PHS Human Subjects and Clinical Trials Information form.

However, most FORMS-E Training grant application packages do not include the PHS Human Subjects and Clinical Trials Information form. Further, the Research Training Program Plan form found in FORMS-E packages no longer includes a Humans Subjects attachment.

Applicants who answer Yes to the "Are Human Subjects Involved?" question are left without instructions on where to include any additional information.

Instruction Correction:

The "Additional Instructions for Training" callout box for field "1. Are Human Subjects Involved?" of the G.220 - R&R Other Project Information Form should include the following additional text:

Most Training grant application packages do not include the PHS Human Subjects and Clinical Trials Information form. Although not required, applicants can provide additional information regarding potential or current involvement of appointed trainees in human subjects research in the "Proposed Training" section of the "Program Plan" attachment on the PHS 398 Research Training Program Plan form.

Inquiries

Please direct all inquiries to:

NIH Grants Information
Email: grantsinfo@od.nih.gov (preferred method of contact)
Telephone: 301-945-7573