RSPP & IRB ceded research
Ceded research means the research is deferred to an external IRB (institutional review board) for oversight. Many research studies require single IRB review. Ceding oversight allows review by one IRB.
Aurora Health Care’s IRB is part of our Research Subject Protection Program (RSPP), which protects human research participants. We can defer oversight to external IRBs for many research studies. At Aurora, an external IRB (sometimes referred to as “IRB of record”) is any IRB that is not the Aurora IRB.
When your research study relies on an external IRB, you must follow that IRB’s policies and procedures. Note that certain changes and incidents must be submitted to the Aurora RSPP, even when your study is ceded to an external IRB. These changes and incidents are outlined in SOP 3 – Post-approval responsibilities submissions [PDF].
Policies & forms for ceded research
Ceded research requires specific standard operating procedures (SOPs) and forms. The guidance and forms below will help you determine whether your study will use an external IRB. They will also assist you in providing the external IRB with the information it needs to make a decision about your research proposal.
External IRB guidance
- Guidance on deferral/ceding of Aurora IRB oversight to an external IRB [PDF]
- Conducting investigator-initiated multisite collaborative research activities [PDF]
- Advocate Aurora Health (AAH) IRB as the IRB of Record for external sites [PDF]
Submission policies & procedures
- SOP 1 – Initial submission requirements & processes [PDF]
- SOP 2 – Review of initial submission [PDF]
- SOP 4 – Review of post-approval submissions [PDF]
Forms
- External IRB Boilerplate [DOC]
- External IRB Boilerplate: NCI CIRB [DOCX]
- External IRB Boilerplate: NCI CIRB - Spanish [DOCX]
- External IRB Boilerplate: WCG (WIRB) [DOC]
- External IRB Boilerplate: Advarra [DOCX]
- SMART IRB Indemnity and Insurance Agreement: Aurora DOCX]
- SMART IRB Indemnity and Insurance Agreement: Advocate [DOCX]
- Representation for reviews preparatory to research [DOCX]
- Instructions for registering for CITI [PDF]
- Renewal instructions for CITI training [PDF]
Contact the RSPP/IRB office
We’re here to answer your research documentation questions. Contact us
Starting a research application
Learn how to get started with research training and approval. Get started
Resources
Download templates for IRB application, informed consent and more. IRB forms and templates
Policies
Want to know about our research policies and procedures? Learn about our policies