NIH defines a clinical trials as:
"A research study in which one or more human participants 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."
NIH's Definition of a Clinical Trial
Along with the NIH definition of a clinical trial, COUHES reviews research when the following two criteria are met:
- The research does not involve significantly greater than minimal risk.
- MIT has the appropriate resources necessary to facilitate the research.
Significantly greater than minimal risk to subjects means that there is a probability of an event that is serious, prolonged and/or permanent occurring as a result of study participation or there is significant uncertainty about the nature or likelihood of adverse events.
MIT has access to a wide array of resources to facilitate subject safety and compliance with Federal, State and local regulations. Investigators are encourage to contact COUHES with questions related to resources prior to proposal or COUHES submission.
The Clinical Trial Flowchart will help determine if the research meet NIH’s definition of a clinical trial and if the research is reviewable by COUHES. Research reviewable by COUHES does not ensure approval. All clinical trial activities are subject to the review, approval and oversight by COUHES. Investigators are required to seek approval prior to the involvement of human subjects and submit the appropriate application relevant to their research. See Definitions for submission details.
Clinical Trials that involve: (1) significantly greater than minimal risk, or (2) where MIT does not have access to the appropriate resources to facilitate the research should contact the COUHES office prior to proposal or COUHES submission.
NIH Sponsored
Investigators involved in an NIH sponsored clinical trial are required to comply with the following:
- Data Safety Monitoring Plan (DSMP)
- GCP Training (Must be within 3 years of IRB approval)
- ClinicalTrials.gov Requirements
- Request Single IRB Review (if applicable)
- Certificates of Confidentiality
Federally Funded (Non-NIH)
- Data Safety Monitoring Plan (DSMP)
- GCP Training (Must be within 3 years of IRB approval)
- ClinicalTrials.gov Requirements
- Request Single IRB Review (if applicable)
Investigators conducting Federally Sponsored research (NIH or other) are encouraged to review the guidance on NIH Genomic Data Sharing (GDS) Policy.
Other outside, internal, or no funding
Investigators involved in a clinical trial not sponsored by the NIH or other federal organization are required to comply with the following:
- Data Safety Monitoring Plan (DSMP)
- For non-federally funded Clinical Trials, COUHES determines whether GCP training is required.
In addition to the requirements set forth by COUHES, each funding entity may have specific requirements. Investigators are encouraged to check prior to COUHES submission.
Those applying for NIH funding should contact the Office of Sponsored Programs, their Program Officer, or the funding agency or center for specific questions about their proposal.
Please contact the COUHES office with questions: couhes@mit.edu or 617-253-6787.