NIH Regulatory Changes
Single IRB Policy
The National Institutes of Health (NIH) is implementing a variation of the Single IRB-of-Record (sIRB) policy beginning January 25, 2018. This applies to:
- NIH-sponsored multisite studies, where the same protocol is used at multiple sites
- Domestic research only
Read more about the Single IRB Policy changes and learn about Single IRB for UMN studies.
Clinical Trial Definition
The NIH has issued several policies and guidance designed to "enhance the accountability and transparency of clinical research.”
NIH's definition of a clinical trial is broader than before, encompassing a wider range of activity, including behavioral studies (studies that manipulate an independent variable to observe a hypothesized modification of a behavioral process), a type of study that was previously not considered a clinical trial.
Definition of an NIH clinical trial: A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. (January 25, 2015)
Timeline of Changes
- Revised clinical trial definition (January 25, 2015)
- Required Good Clinical Practice training (January 18, 2017)
- ClinicalTrials.gov registration and reporting of results (January 18, 2017)
- Use of the new Human Subjects and Clinical Trial form (part of the NIH funding application package, Forms-E) (January 25, 2018)
Where to Find Help
To help you identify whether your NIH-funded research is considered a clinical trial under this definition and, therefore, subject to all the related policies (e.g., NIH sIRB, ClinicalTrials.gov registration and reporting, etc.), the NIH offers the following resources: