The National Institutes of Health (NIH) has made changes to its policies on studies involving human subjects that may impact current agency-funded research and future proposals.
Faculty should take the time to answer the following questions about their current or proposed research:
- Does the study involve human subjects?
- Are the participants prospectively assigned to an intervention?
- Is the study designed to evaluate the effect of the intervention on the participants?
- Is the effect that will be evaluated a health-related biomedical or behavioral outcome?
Faculty who answer yes to all four questions has research that meets the NIH definition of a clinical trial.
NIH has a web page clarifying their clinical trial definition and providing case studies and FAQs about clinical trials.
Faculty whose research meets the NIH definition of a clinical trial should become familiar with the new PHS Human Subject and Clinical Trail Information form and the FORMS-E application package, which will replace FORMS-D.
All the information you need to know can be found on the Clinical Trial Requirements for NIH Grantees and Contractors web page. Other helpful resources can be found in the NIH Guide to Grants and Contracts and the NIH Extramural Nexus.