Denver Health Medical Center Website
Denver Health has an internal approval process that is required prior to all projects being submitted to COMIRB.
This new approval process is as follows:
- For all new protocols that involve Denver Health, a copy of the COMIRB packet will be required to be submitted to SPARO prior to submission to COMIRB.
- SPARO will then review the packet and provide an Acknowledgement to Submit Protocol for COMIRB Review. The Acknowledgement will be faxed directly to COMIRB. COMIRB will withhold IRB approval pending receipt of the Denver Health Acknowledgement form. It is anticipated that this review step will take approximately 5 business days, if DOS approval has previously been obtained. This new, streamlined review process will consist of the following:
- Ensure protocol is in accordance with DHHA mission
- Identify if DHHA is listed as a site of performance on the IRB application
- Review the Routing Form for completeness including; DOS Approval/Signature (if not previously obtained)
- Confirm the source of payment of the IRB fee
- Confirm DH investigator and research personnel have completed DH Research Compliance Training
SPARO does not review COMIRB/WIRB applications and related documentation for completeness and compliance with human subjects protection rules or HIPAA rules. With COMIRB as Denver Health's IRB of record and Denver Health's HIPAA Privacy Board for research, compliance with these rules/regulations falls under COMIRB's purview.
SPARO is required to ensure that the contractual requirements and the consent form document are in alignment. If the COMIRB/WIRB application is submitted prior to the contact being finalized and language discrepancies are discovered between contract and consent, SPARO will first work with the sponsor to modify contract language to align with consent. In the event that the sponsor does not agree to modify contract language a modification of consent will be required to be submitted to COMIRB/WIRB for approval.
An Acknowledgement or Approval Letter is not required for alterations/updates/modifications or Continuing Reviews. Please note the exception to this is if the alteration/update is to add Denver Health as a site, in which case it would be treated as a new protocol from Denver Health's perspective and the process outlined above would apply.
If you have questions on this process, please contact Laurie Blumberg-Romero, Director of SPARO or Amanda Breeden, Research Compliance Analyst.