External IRB Submission Guide

The following steps outline the process for researchers at CU Denver and CU Anschutz seeking to rely/cede on an external IRB for human subjects research. 

Clearance to submit is your green light submit to your external IRB of choice (your reviewing IRB). You must obtain UCD sign-off before proceeding with research activities (other approvals may be required).

Once you have submitted your study information through the HSR Portal and indicated your intention to rely on an outside IRB, the External IRB Team will verify institutional requirements before establishing reliance. 

After you submit your study in the HSR Portal and indicate reliance on an outside IRB, the External IRB Team will confirm institutional requirements before establishing reliance. There are two more stages to institutional approval for your study: 1) Clearance to Submit and 1) UCD Sign-off. 

1

Initial Submission

  • This is the study’s unique tracking number for UCD and is required even when COMIRB is not the IRB. 
  • Select the Anschutz campus from the InfoEd eRA login page, https://era.cu.edu/login.asp  
  • Click Human Protocol and then Create New Human Protocol. 
  • Add key personnel (PI, primary contact, co-investigators) 
  • Click “Save” and “Done”. DO NOT hit “Submit”. 
2

Human Subjects Research (HSR) Portal

  • Access the HSR Portal Link
  • It will ask you to enter your newly obtained COMIRB number. 
  • If you select “Other” external IRB, please add in the comments the name of the IRB you would like to rely on. 
  • Upload any study documents you have to the PAF. 
  • Click “Submit”. 
3

Proceed to Clearance to Submit

Email the consent form with COMIRB’s institutionally required language to the External IRB Team at [email protected]

More details provided in the next tab “What happens after I submit a request to cede IRB review? (Clearance to Submit)” 

Clearance to Submit

You will receive a Clearance to Submit Letter once the following requirements are met. This letter serves as your green light to submit to the Outside IRB. 

Please Note: When studies are industry initiated, and industry funded – the UCD Research Administration will charge a one-time fee of $5000 (not including F&A) for the study. 

1

The study will be triaged to the necessary reviewers including the External IRB team.

2

The External IRB Team 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. 
  • COI Disclosures: Must be current for all key study team members: PI, Co-Investigators, and Primary Contact. 
3

External IRB Team will check on CITI training and advise on any need to update.

  • CITI Training: Must be current for all key study team members: PI, Co-Investigators, and Primary Contact. 
  • To meet the IRB CITI requirements, the following courses must be completed: 
    • CITI Health Information Privacy and Security (HIPS) for Clinical Investigators 
    • One of the following courses: 
      • Group 1: Biomedical Investigators 
      • GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) 
      • Group 4: ICH/GCP (Meets NIH requirements)
4

External IRB Team will input billing information (when applicable)

  • For UCD-teams provide a SpeedType and Department Billing Contact Name. 
  • For UCD-affiliates a billing contact nameand email address is acceptable. 
    • Children's Hospital Colorado, Denver Health and Hospital Authority, Veterans Association, and UCHealth North & South. 
5

In the absence of a standing reliance agreement (such as with the WCG or Advarra) we will reach out and obtain a reliance agreement from the reviewing IRB

  • Institutional officials must sign the reliance agreement. 
  • The External IRB Team will work with the research study team to complete local context documents (when applicable). 
7

Once all requirements are verified, we will issue your Clearance to Submit Letter

As a reminder, the Clearance to Submit Letter is your green light submit to your external IRB of choice (your reviewing IRB) NOT IRB Approval.

 

See next tab "What do I do after receiving Outside IRB approval" for UCD Sign-off details for IRB Approval.

UCD Sign-off

1

Once you receive IRB approval from the reviewing IRB, email us the following documents as they become available:

  • Initial IRB Approval Letter (specific to our site) 
  • IRB Approved Protocol 
  • Final Approved Consent Form (and Assent, if applicable) 
  • Fully Executed Contract/ CTA (if applicable) 
2

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 consent injury language and contract have been confirmed as consistent, we will issue a “UCD sign off”.
3

The Outside IRB Approval Letter and HIPAA Certificate will be automatically generated and sent to the PI and Primary Contact via InfoEd

Pease note:You may have additional approvals to attain prior to enrollment. 

For the duration of the study, please notify the External IRB Team of the following: 

  • Changes in key study team members: PI, Co-Investigators, and Primary Contact or site locations 
  • Continuing review approvals 
  • Amendment approvals 
  • Revised protocols or consent forms; e.g.: consent forms that alter cost, injury, compensation or HIPAA language must be submitted for review prior to outside IRB submission 
  • Determinations from the reviewing IRB regarding reportable events 
  • Study closure notice 

Office of the Vice Chancellor for Research

CU Anschutz

Fitzsimons Building

13001 East 17th Place

WG109

Mail Stop F520

Aurora, CO 80045

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