Other Regulatory Changes
The National Institutes of Health (NIH) is implementing a variation of the Single IRB-Of-Record policy beginning January 25, 2018. The NIH sIRB policy applies to:
- NIH-sponsored multi-site studies, where the same protocol is used at multiple sites.
- Domestic research only.
NIH Clinical Trial Policies
The NIH has issued several other policies and guidance designed to “enhance the accountability and transparency of clinical research”:
- Revised clinical trial definition (1/25/2015)
- Required Good Clinical Practice training (1/18/2017)
- ClinicalTrials.gov registration and reporting of results (1/18/2017)
- Use of the new Human Subjects and Clinical Trials form (part of the NIH funding application package, Forms-E) (1/25/2018)
NIH’s definition of a clinical trial is broad, encompassing a wide range of activity which now may include behavioral studies (e.g., studies that manipulate an independent variable to observe a hypothesized modification of a behavioral process).
NIH Definition of a Clinic 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.
https://grants.nih.gov/policy/clinical-trials/definition.htm
Where to Find Help
To help you identify whether your NIH-funded research would be 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:
- FAQs and case studies
- NIH Deputy Director’s blog
- NIH Clinical Trials Policy website