Clinical trial applications must now be submitted to FOAs that specifically state that they allow clinical trials. Be certain you understand how NIH defines a clinical trial, and that you choose the appropriate FOA. Those FOAs that allow clinical trials will be reissued at least 60 days before the first due dates in 2018. Make certain you are looking at the most recent FOA. To read two of Mike Lauer’s recent blog posts on the topic, click here and here. For NIH definition of a clinical trial, click here.

Requirement for single IRB in multi-site research goes into effect for applications due on/after Jan 25, 2018. For non-exempt human subjects research, NIH will require a singe IRB for all multi-site trials. For details and a list of resources provided by NIH, click here

Are you doing a clinical trial in a program project or center grant? Guess what? New forms and guidance for that as well, depending on whether the clinical trial is restricted to one component or spans multiple components. Oy. The good news is that moving this info to these new forms will free up precious real estate in the Research Plan. Click here for details.

And what the heck is Delayed Onset, you ask? It means you know there will be a clinical trial, but cannot describe it yet. It is not when a clinical trial is planned and can be described, but will have a delayed start. Click here for more info and links.

Most clinical trial-related material is no longer allowed in the Appendix. For deadlines on or after Jan 25 2018, NIH has whittled the list of allowable appendix materials to the following:

  • Blank data collection forms, blank survey forms and blank questionnaire forms — or screenshots.
  • Simple lists of interview questions. (For clarification, these blank forms and lists are not and do not include items such as:  data, data compilations, lists of variables or acronyms, data analyses, publications, manuals, instructions, descriptions or drawings/figures/diagrams of data collection methods or machines/devices.)
  • Blank informed consent/assent forms
  • Other items only if they are specified in the FOA as allowable Appendix material

The notice, NOT-OD-17-098, states that “Some FOAs further restrict allowable appendix materials and/or may specify that some materials listed above must be provided in another part of the application.”

Tough grant cycle for clinical trial applicants! Stay calm and focused, and get your draft to your pre-award support people early! They are there to help.

Reminder: Use FORMS-E for due dates on/after Jan 25, 2018. Please use the new FORMS-E grant application package for due dates on or after Jan 25. See NOT-OD-17-119 for details. The reminder notice NOT-HS-18-003 has a handy list of related resources. Here is a summary of the changes in the new forms package:

  • Consolidation of human subjects, inclusion enrollment, and clinical trial information previously collected across multiple agency forms
  • Expansion and use of discrete form fields for clinical trial information to
    • provide the level of information needed for peer review;
    • lead applicants through clinical trial information collection requirements;
    • present key information to reviewers and agency staff in a consistent format; and
    • align with ClinicalTrials.gov (where possible) and position us for future data exchange with ClinicalTrials.gov
  • Incorporation of recent Grants.gov changes to R&R Budget and SBIR/STTR Information forms
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