Notice Number: NOT-OD-17-043

Key Dates
Release Date: February 17, 2017

Issued by
National Institutes of Health (NIH)

Purpose

In September we announced a new policy requiring all applications involving one or more clinical trials be submitted through a Funding Opportunity Announcement (FOA) specifically designed for clinical trials (NOT-OD-16-147). The policy improves our ability to identify clinical trials, ensure appropriate clinical trial data collection, and uniformly apply trial-specific review criteria. This notice updates the community on our evolving plans in this area, including an adjustment to the effective date.

New Effective Date

Effective January 25, 2018, all grant applications with plans to conduct clinical trials must be submitted in response to an FOA which specifically states that clinical trials are allowed.

After that date, applications planning a clinical trial that are submitted to a non-clinical trial FOA will be returned without review.

High-level Plan

• Spring 2017
  
• Complete Office of Management and Budget approval process for new "PHS Human Subjects and Clinical Trials Information" form which consolidates human subject information currently collected across several PHS forms and expands our data collection requirements for clinical trials.
  
• Provide additional information to the community on our new form and implementation plans.
  
• Fall 2017
• Expire existing clinical trial FOAs by January 24, 2018.
  
• Update remaining active FOAs to include the latest approved forms and to indicate that clinical trial applications are not allowed for due dates on or after January 25, 2018.
  
• Issue new clinical trial FOAs with clinical trial-specific review criteria, forms, and instructions for due dates on or after January 25, 2018.

Contracts

Requests for proposals (RFPs) will be updated with comparable clinical trial data collection requirements for proposal due dates on or after January 25, 2018.

Inquiries

Please direct all inquiries to:

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