As you are likely aware, big changes are coming to NIH applications, and the critical deadline of January 25, 2018 is fast approaching. That’s when the new Forms E go into effect. These changes affect the content and format of most PHS applications so all PIs should read the new guide and ensure they are using the correct funding opportunity announcement. But the biggest changes will affect those doing clinical research.
NIH has created a series of initiatives to enhance the accountability and transparency of clinical research, with the goal of supporting the obligation that the burden and risk assumed by research participants leads to scientific knowledge. These initiatives thus target key points along the clinical trial lifecycle, from concept to reporting results.
Beginning with applications submitted on or after January 25, 2018, most funding announcements are being revised to clarify whether they allow clinical trials. This is true of almost all parent announcements as well as agency-specific opportunities. Thus, regardless of whether you are including a clinical trial in your application, this change will affect you.
The changes to the funding opportunity announcements are as follows:
- All funding opportunity announcements will specify the allowability of clinical trials in Section II. Award Information
- All clinical trial funding opportunity announcements will specify allowability of clinical trials in the announcement title
- Funding opportunity announcements that accept clinical trials will incorporate specific review criteria to ensure that reviewers appropriately consider clinical trial-related information
What are the implications if my study is NOT considered a clinical trial?
- Submit the application ONLY through a funding opportunity announcements that is specifically for “Clinical Trials Not Allowed” or one shown as “Clinical Trials Optional”.
- Answer the appropriate questions, and complete the CT/HS form as required. This CT/HS form MUST be completed in each application, regardless of human subject involvement.
What are the implications if my study is considered a clinical trial?
- Submit the application ONLY through a funding opportunity announcements that accepts clinical trials, which are specifically designated as either “Clinical Trial Required” or “Clinical Trial Optional”.
- Provide additional information in the application per NIH and specific agency instructions, which will be subject to different and distinct review criteria for clinical trials. These requirements can be lengthy, and instructions are referenced below.
- Does the study involve human participants?
- Are the participants prospectively assigned to an intervention?
- Is the study designed to evaluate the effect of the intervention on the participants?
- Is the effect that will be evaluated a health-related biomedical or behavioral outcome?
NIH has created case studies to demonstrate how the questions are applied. Mike Lauer, deputy director of extramural research at NIH, has clarified the guidance for using these case studies. The clinical trial definition has gotten some pushback (see the comments here) from the extramural research community, and some NIH institutes are issuing their own specific guidance, so it may be wise to consult with your program officer before deciding which funding opportunity announcement to use.
For more OHSU-specific information, see this handout on the RATE site (OHSU log-in required).
We would like to acknowledge our colleagues in the Office of Proposal and Award Management for their contributions in preparing this post.