MULTIPLE INDEPENDENT  IRB REVIEWS

If a site reviews locally all IRB approval memos should be submitted to the prime site for their records. Anytime multiple IRBs will be reviewing a protocol independently allow an extra 1-6 months. The number of sites, level of risk, divergent modifications, variations in local laws, and differing interpretations can all add time.

 

 

CEDED IRB REVIEW

The Health Care Systems Research Network (formerly known as the HMO Research Network) has an IRB ceding process to support streamlined review. A Standard Operating Procedure (SOP) documents policies and procedures for ceded IRB review of research between HCSRN sites.

The SOP covers data-only, epidemiologic, and health services research performed in the HCSRN for which participant informed consent and HIPAA authorization may or may not be required.

The HCSRN’s IRB ceding process cannot be used for prospective biomedical research studies of human participants involving drugs, devices or biologics.

  • Standard Operating Procedure (SOP) - includes purpose and scope, responsibilities of primary investigators and IRBs involved, policies and procedures, as well as document history and approvals and Appendices A-D (definitions, application cover sheet, process flowchart and FAQs, respectively).

  • Application Cover Sheet – to be completed and submitted by the PI at the Lead IRB site when using the HCSRN IRB ceding process. This cover sheet accompanies the lead site’s IRB form. See the SOP for details.(Appendix B)

  • Process Flowchart - schematic illustrating the HCSRN’s IRB ceding process. (Appendix C) 

  • FAQs – answers to frequently asked questions about using the ceding process. (Appendix D)

 

 

OTHER IRB RESOURCES