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External IRB
Ceding Review to an Institutional Review Board
The External IRB team works within the Clinical Research Administration Office here at CU Anschutz Medical Campus and is separate from the COMIRB. Our work involves managing all protocol documents and information related to human subject research protocols submitted to commercial IRBs (i.e., Western IRB, Advarra, NCI Central IRB, etc.) and non-commercial IRBs (i.e., academic institutions). We are required to sign off on a number of items before you can submit your application to an external IRB.
All protocols using an external IRB must be submitted through the HSR Portal by filling out the Protocol Assessment Form.
Please note: If your study is deemed exempt or does not meet the definition of human subjects research, we are not allowed to rely on an external IRB. Additionally, unfunded studies may not rely on an external IRB.
Requests to Cede IRB Review
Please follow these steps below to submit a request.
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Select “Create new”
Add the study’s title, our local P.I., any study team members.
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Click “Save” and “Done”.
DO NOT hit “Submit”.
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Enter the study information into the Protocol Assessment Form, using the Record ID (a.k.a. the COMIRB number).
This is where you indicate which IRB you would like to use.
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Upload any study documents you have to the Protocol Assessment Form.
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Click “Submit”.
The External IRB team will follow these steps after receiving a request to cede IRB review.
Please Note: When studies are industry initiated and industry funded – the UCD Research Administration will charge a one time fee of $5000 for the study.
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The study will then be triaged to the necessary reviewers including the External IRB team.
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We will check for potential conflicts of interest and advise on the need for review and clearance from the COI office
Please note that each study requires review and confirmation.
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We will check on CITI training and advise on any need to update.
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In the absence of a standing agreement (such as with the WIRB or Advarra) we will reach out and obtain written approval from the reviewing site.
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We will review draft consent forms for payment, injury and HIPAA language and sign off on any deviation from our standards.
Please refer to the Biomedical Consent Template With Compound Option Procedures and HIPAA Authorization.
Consent Template
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Once everything is in place:
- if a commercial IRB, we will issue you a clearance to submit memo
- if another IRB type, we will work with you to understand expectations
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Upon receipt of any IRB approved documents, we will upload into the InfoEd record and look for outstanding items such as a final and fully executed contract.
Once injury language and contract language have been confirmed in sync, we will issue a “UCD sign off” and a notice of outside IRB approval and any relevant HIPAA certificates.
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For the rest of the study, any and all IRB approvals and approved documents should be forwarded to externalirb@ucdenver.edu.
ExternalIRB@ucdenver.eduResources
- Biomedical Consent Template With Compound Option Procedures and HIPAA Authorization
- UCD Process for Ceding to an External IRB
- Conflict of Interest (COI) Resources (Find instructions and tips for updating your COI here)
- CITIprogram.org (Required research ethics and compliance training)
- WIRB Training Materials:
- CHCO Study Templates:
Questions?
We are currently working remotely. Please contact us by email with any questions.