NIH Gives Some Leeway to Those Conducting Prospective Basic Science Studies

Funding News Edition: August 15, 2018
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NIH recognizes that many fundamental research studies involving human participants are being redefined as clinical trials without sufficient notification and consultation with researchers.

Credit: NIAID

Good news: NIH is implementing short-term policy flexibilities for some requirements affecting prospective basic science studies involving human participants. These are studies that meet both NIH’s Definition of a Clinical Trial and the federal definition of basic science.

NIH recognizes that many fundamental research studies involving human participants are being redefined as clinical trials without sufficient notification and consultation with this segment of researchers.

By “fundamental research,” NIH means that the study aims to gain a better understanding of fundamental aspects of phenomena or observable facts. This type of research differs from a mechanistic clinical trial in that a mechanistic trial aims to prospectively study the effect of an intervention on a process or mechanism. This is not considered to be a study of something fundamental.

To address researchers’ concerns, NIH is doing the following through September 24, 2019:

  • Delaying enforcing the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information, which expects investigators to register and report their studies in ClinicalTrials.gov
    • NIH will continue to expect registration and reporting for prospective basic science studies involving human participants, with additional flexibility to allow reporting on existing basic science portals, with the expectation that data will eventually be moved to ClinicalTrials.gov. 
    • The Consolidated Appropriations Act, 2018 mandated the delayed enforcement so NIH could have more time to consult with the basic science community about the best reporting standards for basic research. NIH issued a request for information to seek feedback on the Dissemination Policy for prospective basic science studies involving human participants; see the August 10, 2018 Guide notice. Responses are due by November 12, 2018.
  • Being lenient about applications submitted to the incorrect funding opportunity announcement (FOA) based on the study type designation
    • For due dates through September 24, 2019, NIH will not administratively reject any application submitted to an incorrect FOA based on study-type designation.
    • NIH plans to issue FOAs specifically for prospective basic science studies involving human participants. It will post a Notice of Intent to publish these FOAs this October. NIH expects the FOAs to be published a month later for due dates starting January 25, 2019.
      • Note: NIH anticipates that for most mechanistic studies (those with specific applications towards products or processes in mind), applicants will still use the existing Clinical Trial Required Parent Announcements. However, the new FOAs will target behavioral/psychological studies using human participants.

In addition to the items above, the July 20, 2018 Guide notice covers these three bases:

If you have questions, email NIH Grants Information at grantsinfo@od.nih.gov.

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