This guide is intended for use by Washington University researchers. If you are a non-WU Researcher, please see the Guidance for External Researchers and IRB Staff section below.
sIRB Research Guide (Flipbook) (PDF) (Table of Contents)
To request that HRPO defer IRB oversight to an external IRB/ rely on another IRB, a Request to Rely (RTR) application must be submitted in myIRB. The process for this varies depending on the type of IRB you are requesting we defer to. Please see the section Relying on an External IRB in the sIRB Research Guide linked above for specific guidance.
Washington University has Reliance agreements with 2 Independent IRBs- WCG IRB and Advarra. As a part of these agreements, these independents IRBs are responsible for inserting institutionally required consent form language into a limited number of sections in the consent document. This language is available for review in the sIRB Independent IRB Language Memo.
Reporting Requirements
When the WU IRB has deferred oversight to another IRB, WU PI’s must follow the reviewing IRBs reporting requirements. Ask the reviewing IRB for information about their reporting policy.
While WU IRB is not the IRB, there are a few circumstance where you are required to report events to the WU IRB. As described in the sIRB policy document, these events include any unexpected deaths related to the research or unexpected events that are at least possibly related to the research that may result in permanent or long-term disability.
The decision about acting as the single IRB will be made on a case-by-case basis depending on the costs of sIRB review, number, type and location of sites, complexity of the protocol, current capacity of the WU IRB and ability to meet study review timelines.
Washington University has the right of first refusal for the role of sIRB for all studies where WU is the prime awardee of the grant. Should you receive a request to complete or sign any agreements related to single IRB, please contact HRPO for assistance.
The sIRB costs must be included in your grant budget at the time of grant submission. You must contact HRPO to request the WU IRB act as the single IRB and to obtain an estimated budget for these services. Complete the Single IRB Grant Intake Form to request WU act as the sIRB and obtain a budget. See the section WU as Reviewing IRB/ Single IRB (sIRB) in the sIRB Research Guide linked above for additional information.
This section is reserved for external researchers and IRB staff. If you are a WU researcher, please go to the WU IRB is Reviewing IRB/ Single IRB tab for guidance.
These documents offer guidance to external researchers and IRB staff about how to use myIRB and the WU IRB sIRB review process.
Unless directed to do so by the WU IRB, external researchers should not submit to the WU IRB for review.
Site PI and Study Teams
The site PI responsible for the conduct of the Research at only his/her site. The Site PI will be responsible for managing the sIRB Site application for their site in myIRB.
The Site PI and Study Team Single IRB Reference Manual contains information for use by the site PIs and study team when WU IRB will be acting as the sIRB.
Lead PI and Study Team
In some circumstances, the Lead PI (the initiating principal investigator or funding principal investigator) is not from WU.
The Lead PI and Study Team Single IRB Reference Manual contains information for use by the Lead PI and study team when they are from WU.
REPORTING REQUIRMENTS
If you are relying on the WU IRB as your IRB for a study, you are required to follow the WU IRB Policy on reporting requirements for non-compliance, unanticipated problems, new information and certain other events. NOTE: You may also be subject to local reporting requirements.
Reportable Events – How to Report in myIRB When the IRB of Record is the WU IRB or the NCI CIRB
Content current as of 02/12/2024