NIH Delays Implementation of Revised Definition of a Clinical Trial and Associated Requirements

The National Institutes of Health has issued Delayed Enforcement and Short-Term Flexibilities for Some Requirements Affecting Prospective Basic Science Studies Involving Human Participants (NOT-OD-18-212) delaying the implementation of its revised definition of a clinical trial and associated requirements until September 24, 2019.

During the interim period:

• NIH will delay enforcing that investigators register and report their studies in clinicaltrials.gov. Note: Basic research studies involving human participants are still expected to register and report their studies through portals other than clinicaltrials.gov.
• NIH has instituted a period of leniency for applications submitted to the incorrect funding opportunity announcement (FOA) based on study-type designation (e.g., clinical trials required, clinical trials optional, clinical trials not allowed). NIH will not administratively reject any applications submitted to an incorrect study-type FOA, and applications will be reviewed based on the review criteria of the FOA to which they are submitted.
• NIH will expect clinical trials that do not meet the definition of a prospective basic science study involving human participants to continue to comply fully with the clinical trials policies.

NIH also will assess its approach to registration and reporting for these studies and seek feedback from the research community on its registration and reporting requirements. NIH will continue to expect all personnel involved in the conduct, oversight, or management of prospective basic research studies involving human participants to obtain Good Clinical Practice (GCP) training.

NIH also plans to issue FOAs specifically for prospective basic science studies involving human participants. These FOAs are anticipated to be published in November 2018 with due dates beginning January 25, 2019. Therefore, those submitting on or after the February 2019 due dates will have FOAs specifically designed for these prospective basic science studies with humans.