OVERSIGHT OF COLLABORATIVE RESEARCH

For many years, multi-site research also entailed multiple site-specific IRB reviews.  However, the research community has long recognized the inefficiency of this model, and recent regulatory changes have sought to streamline the process of submitting and reconciling multiple, independent reviews. As of January 2020, the OHRP Common Rule has stipulated that multi-institutional studies shall be reviewed by a single IRB of record. 

 

The HCSRN has had a streamlined reciprocal IRB review process and Inter-Institutional Agreements in place since 2011.  In recognition of further administrative streamlining opportunities and mechanisms now available, the HCSRN has "retired" their reciprocal review agreement. Effective January 1, 2020, the HCSRN will be utilizing the SMART IRB Platform to manage and adhere to the oversight provisions for multisite research.

 

More information about our historic (i.e., retired process) is available below.  

 

 

RECIPROCAL / CEDED IRB REVIEW 

The Health Care Systems Research Network (formerly known as the HMO Research Network) developed an IRB ceding process in 2010-2011 to support streamlined review. A Standard Operating Procedure (SOP) documented policies and procedures for ceded IRB review of research between HCSRN sites.

The SOP covered research performed in the HCSRN, including data only, observational, and interventional research. The historic materials developed for this process are provided below as guidance and background.

  • 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