For a general overview of the processes and procedures of the Office of Research and the University of Michigan research enterprise please review our Research Information Packet. Originally created for new faculty, this document includes information on a variety of topics that could prove valuable for all research faculty. Topics include PEERRS, IRB, UCUCA, shipping hazardous material, research parking spaces, travel, postdoctoral fellows, and more.
The National Institutes of Health (NIH) has expanded their definition of a clinical trial and has added new requirements during the funding opportunity application process.
NIH Definition of a 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.
The information below has been gathered to assist our investigators who are applying for NIH funding for studies that fit the definition of a clinical trial. Not sure if your research would be considered a clinical trial? Visit the NIH Clinical Trials Decision webpage.
The link above will take you to the general instructions for NIH Awards. Information related to the new clinical trial guidelines, Forms-E, can be found on page 223.
This new form, created by the University of Michigan, is designed to help investigators complete the information required in NIH Forms-E. The School of Kinesiology Office of Research will request that researchers complete this form during the application process.
Certain boilerplate language has been developed, or is in the process of being developed, by the Medical School for specific pieces of Forms-E. The document link above will take you to a list of these items and include the recommended language. This list will be updated as new language is created.
The link above with take you to a sample showing the new clinical trial section completed.
If you still have questions regarding whether your study will be deemed a clinical trial you can contact the medical school staff below for assistance.