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University of Colorado Denver

COMIRB Homepage
 

Step 1

Decide Whether Your Project Requires COMIRB Review


​All research involving human subjects must be submitted to COMIRB for review. The text below will guide you through the process of deciding whether your project meets the definition of "human subject research;" you may also wish to use the decision tree from OHRP in determining whether your project requires IRB review.​
 
Definitions 
Policy on Research Using Banked Data or Specimens​
Multisite Studies
Additional Resources
Submitting to COMIRB

The responsibility for the initial determination as to whether an activity constitutes human subjects research rests with the investigator. Since the University will hold them responsible if the determination is not correct, investigators are urged to request a confirmation that an activity does not constitute human subjects research from the COMIRB Office if there is any uncertainty. Informal requests may be made verbally, by phone contact, by email or through written communication. All requests must include sufficient documentation of the activity to support the determination. Informal requests represent the opinions of COMIRB personnel and are not formal endorsements of the project as Non-human Subject Research. 

If an investigator wants COMIRB to make a formal determination that research does not meet the definition of human subject research, this must be submitted formally (through use of the Exempt and Non-human Subject Research application) to COMIRB for its consideration.  Click the following link for directions on submitting to COMIRB for a human subject research determination.  

If you believe your project requires COMIRB review, please click the following link to decide whether to apply for Exempt, Expedited or Full Board review.


 

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