NIAID’s IICT Policies Still Apply Following NIH Clinical Trial Policy Changes

On January 25, 2018, NIH implemented policy changes for applications proposing clinical trials that

  • Refine what research projects NIH classifies as clinical trials
  • Limit applications proposing clinical trials to only funding opportunity announcements (FOAs) that specifically allow clinical trials
  • Update the forms and information required from applicants proposing clinical trials

Learn more about the NIH policy changes at Clinical Trial Requirements for Grants and Contracts. Pay close attention to Does your human subjects research study meet the NIH Definition of a clinical trial? for guidance on whether your research project qualifies as a clinical trial.

These policies complement NIAID’s policies for investigator-initiated clinical trials (IICTs).

NIAID uses the following suite of FOAs to receive applications proposing IICT research:

*For the NIAID definition of high risk, see How do I determine level of risk and choose an award type for my application?

Additional Steps for IICT Applications

NIAID has a prior consultation process for IICTs; before you apply, staff can confirm NIAID’s interest in your research, make sure you are aware of all rules and requirements for clinical trials, verify your budget is commensurate with your proposed research, and share resources with you that can improve and strengthen your application. We explain the process further at Investigator-Initiated Clinical Trial Resources.

In short, you should contact the NIAID program officer listed in the IICT FOA as a scientific/research contact at least 10 weeks before the receipt date; 12 weeks for the extended R01.

He or she will discuss with you in detail the items listed at Investigator-Initiated Clinical Trial Planning and Implementation Awards SOP.

Content last reviewed on March 21, 2018

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