Since 2014, the NIH has been working on reforms to improve transparency in the human subject research it funds. As part of this process, the agency released a revised definition of “clinical trial.” The NIH definition of a clinical trial is “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 University of Michigan has adopted this definition as the U-M clinical trial definition, and all Medical School clinical trials that meet this definition will be supported through a Clinical Trials Support Unit.
The NIH has produced guidance on this updated definition, including the tool on this webpage that asks four questions:
- Does the study involve human participants?
- 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?
If the answer to all four of these questions is “yes,” your study will be considered a clinical trial by the NIH. Very soon, your answers will be crucial to picking the appropriate NIH funding opportunity for your application, and those with due dates on or after Jan 25, 2018, should use the new human subjects and clinical trials form. Disallowed information cannot be included in an appendix, otherwise the application will be withdrawn due to noncompliance, and keep in mind that a single IRB should be used. This NIH webpage addresses these issues.
Correctly identifying whether your study is a clinical trial is crucial to complying with new NIH policies, many of which are now in effect, such as registering and reporting all NIH supported clinical trials in ClinicalTrials.gov, and participating in Good Clinical Practice training.
The NIH has developed a series of case studies to further help investigators determine whether their study meets this new definition, and additional helpful clarification can be found on the blog of Dr. Michael Lauer, the NIH Deputy Director for Extramural Research.
The Medical School Office of Research will continue to monitor how these changes affect the U-M clinical trial community, particularly as the January grant submission deadline approaches. If you have questions or concerns, please contact the Clinical Trials Support Office at firstname.lastname@example.org.