Protocol Number may no longer be requested on-line through Protocol Manager. When you submit your Request for Protocol Review, you will be notified of the number assigned to your protocol.

The Colorado Multiple Institutional Review Board is a consortium of health care facilities in Colorado comprised of:

• University of Colorado Health Sciences Center
• Colorado Prevention Center
• Denver Health Medical Center
• Denver Veterans Affairs Medical Center
• The Children's Hospital
• University of Colorado Hospital

COMIRB is a board established to review biomedical and behavioral research involving human subjects conducted at or supported by each of the above institutions.

All of the information and forms necessary for preparing a Human Subject protocol can be accessed from this site , or by calling the COMIRB office.

Federal-wide Assurance #:	FWA00005070
IRB Registration #:	IORG0000433

COMIRB/UCDHSC, MS F490 13001 E. 17th Place, Room N3214 P.O. Box 6508 Aurora, CO 80045

Phone:	(303) 724-1055
Fax:	(303) 724-0990
E-Mail:	COMIRB@uchsc.edu
	Please contact Angela Wishon Angela.Wishon@uchsc.edu with any questions, concerns, or to convey suggestions regarding the human research protection program at the University of Colorado Denver

COMIRB Review Fees

Full Board Initial Review	$ 2,000
Full Board Continuing Review	$ 1,500
Expedited Initial Review	$ 950
Expedited Continuing Review	No Charge
Exempt Initial Review	No Charge
Exempt Continuing Review	N/A
Amendments and Updates	No Charge

Research supported through a Federal Grant award are not charged a review fee.

Complete Fee Policy

How many copies do we submit for COMIRB forms: Amendment (PAM), Alteration/Update (UPD), and Safety Report (SAF)?

Only one copy should be submitted. However, if you are submitting these documents at continuing review, each packet should contain one copy. (i.e. full board reviews should submit 18 copies)

Which form should I use to submit revisions to my protocol summary and consent form?

Any revisions to the protocol summary, whether they come from the sponsor or from the local office, should be submitted on a “Protocol Amendment Form.” Revisions to the consent form or other study documents should be submitted on an “Alteration and Update Form.” In some cases you will need to submit both forms for changes that result in revisions to the protocol summary and consent form.

What form do we use to submit a protocol violation/deviation?

Protocol Deviations and Violations should now be reported through the Protocol Manager using the Unanticipated Problem reporting mechanism.

What is the deadline for submitting new protocols?

There are no deadlines; protocols are accepted at any time and scheduled for the next available review after they pass the COMIRB pre-review process.

What are the review dates for the Panel Meetings for the year?

Each panel meets on an every other week schedule at least, and more often when needed. Protocols are assigned to the next meeting nine days in advance of the meeting to allow reviewers time to fully review the entire protocol.

Should we wait to get our grant approved before submitting the protocol to COMIRB?

It is recommended that a high probability score for funding be obtained prior to submitting the protocol to COMIRB review.

What is the estimated time line from submission of protocol to approval?

6 to 8 weeks for full committee review; 2 to 3 weeks for expedited/exempt review.

Why is COMIRB 201 no longer required?

COMIRB 101 has changed to an online self-study program. Due to the comprehensiveness of this new CITI Basic online course, it alone is sufficient for COMIRB educational requirements.

Do I have to renew CITI Basic Course annually?

No. COMIRB will require periodic re-certification (approx. every 3 years) through the CITI Refresher Course. Registered users will be notified via e-mail when re-certification is necessary. it will also be posted on this website.

How do I close my study?

For full board and expedited studies, please request a continuing review form from the COMIRB office and submit the completed form along with a letter requesting closure. For exempt studies, please submit a letter explaining that study activities have been completed and a statement that the investigator has closed the protocol.

Can I close my study if all I have left to do is analyze my results?

No, you must continue providing continuing reviews on your research until all data analysis is completed. For a study in this phase, question one of the Continuing Review form regarding status of the study should be marked “data collection.” A continuing review of a study in this phase can receive expedited review.

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