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Fee Policy for COMIRB Review

Guidelines on COMIRB Application Fees


Faculty and Affiliate Researchers:

 As you know, COMIRB currently has 4 biomedical boards and 1 social and behavioral board. The option for investigators to use WIRB for commercially sponsored research has relieved the pressure on the COMIRB biomedical panels over the last few years but each panel is now at capacity. In order to keep pace with the growing protocol volume, UC Denver will be forming an additional pediatric panel during the current fiscal year.   With this increased capacity, COMIRB will be able to balance protocol volume across  all panels as we continue our efforts to improve services for the research community while ensuring human subjects protections.

In order to cover the cost of this additional panel, COMIRB fees will be increasing as outlined below. The increase will take effect October 1, 2010 and have been made to adjust for the annual WIRB increase in rates as well as enable COMIRB to expand as outlined below.

 

Submission NEW COMIRB fees as of October 1, 2010
WIRB Initial

$3,500

WIRB Continuing Review

$2,500

COMIRB Initial

$2,500

COMIRB Continuing Review

$2,000

COMIRB Expedited

$950

 

Federally funded protocols are charged the full review fee (and are not eligible for fee waiver) when the grantee is any of the affiliated institutions listed below.

 

     Denver Health and Hospital Authority (DHHA)

     Denver Veterans Affairs Medical Center (DVAMC)

     The Children’s Hospital (TCH)

     University of Colorado Hospital (UCH)

     Colorado Prevention Center (CPC)

 

Studies NOT Charged A Review Fee:

 

Federally funded protocols are not charged the review fee when the grantee is University of Colorado Denver (i.e., the ICR’s go to UCD).  In order to be considered the grantee, UCD must receive at least 51% of the grant. 

 

Examples of studies that fall under this category are:

 

     Studies receiving National Institutes of Health (NIH) grants

     Studies receiving federally funded training grants

     Clinical Translational Research Center (CTRC) “A” protocols 

     Studies at the Pediatric Clinical Translational Research Center (CTRC)

     Subcontracted Federal agreements with entities such as:

1. Adult AIDS Clinical Trials Group (AACTG)

2. Bacteriology and Mycology Study Group (BAMSG)

3. Center for Disease Control (CDC)

4. Gynecological Oncology Group (GOG)

5. Radiation Therapy Oncology Group (RTOG)

 

Fee Waiver or Reduction:

Some studies MAY qualify for a fee waiver or reduction.  In order to apply for a waiver or reduction you will need to submit a COMIRB Fee Waiver/Reduction Application.  Situations or studies that may qualify for such a waiver or reduction are:

 

     Extraordinary circumstances

     Student Projects

     Investigator-initiated studies without funding

     Pilot studies

     Foundation funded protocols with very limited funding

 

Protocols that are NOT ELIGIBLE for a fee waiver or reduction are:

 

     Industry-sponsored or industry-initiated protocols (including CTO protocols)

     Federally funded protocols where UCD is not the grantee (that is, where UCD does not receive at least 51% of the grant).

   

Fee structure for protocols eligible to use WIRB

            UCD and Affiliate fee structure for use of WIRB

 

WIRB Review Fees

Effective Oct 1, 2010

Full-Board Initial Review

$3,500

Full-Board Annual Continuing Review

$2,500

 

To determine if your protocol is eligible to use WIRB

Review - Industry Protocols for Review by WIRB

WIRB Website

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