External IRB

Ceding Review to an Institutional Review Board Other than COMIRB

The External IRB is a team that 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 Cenral 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.

  1. Log into InfoEd and select “Human Protocol”.
  2. Select “Create new” and then add the study’s title, our local P.I., any study team members.
  3. Click “Save” and “Done”. DO NOT hit “Submit”.
  4. Open the HSR Portal website and click “Submit to the HSR Portal”.
  5. 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.
  6. Upload any study documents you have to the Protocol Assessment Form.
  7. Click “Submit”.
  8. The study will then be triaged to the necessary reviewers including the External IRB team.
  9. 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.
  10. We will check on CITI training and advise on any need to update.
  11. 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.
  12. 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 UCD Consent Reference Template for standard language.
  13.  Once everything is in place:
    1. if a commercial IRB, we will issue you a clearance to submit memo
    2. if another IRB type, we will work with you to understand expectations
  14. 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.
  15. For the rest of the study, any and all IRB approvals and approved documents should be forwarded to externalirb@ucdenver.edu.

 

Note: When studies are industry initiated and industry funded – the UCD Research Administration will charge a one time fee of $5000 for the study.

Classes

Join us at CTSA30: External IRB Oversight - UCD Requirements and Processes, where we discuss this process in depth.

 

Resources

We are currently working remotely. Please contact us by email with any questions.”


Email: ExternalIRB@ucdenver.edu