Below you will find resources to help you prepare and submit an IRB application to an approved external/central IRB. Using an external or central IRB for IRB review still requires an abbreviated submission to the Saint Louis University IRB Office for local administrative review and pre-authorization.
You will also find include forms and helpful tools to guide you through this process, as well as information on IRB expectations for conducting IRB-approved research and the forms and guidance you may need along the way.
Permission from the Saint Louis University Institutional Review Board is required to use an external/central IRB. See the "Determine Which IRB to Use" section on the Getting Started page for guidance on knowing when an external or central IRB can be used.
Use of another institution’s IRB will require agreement from that institution and
SLU’s IRBs, so it is important to have a dialogue with both parties prior to completion
of forms, below.
Complete the IRB Reliance Agreement Determination Form and submit to the IRB to initiate an IRB Authorization Agreement (IAA, also referred to as a Reliance Agreement). If the study involves collaboration with Washington University, and all research activities (except data analysis) take place at one institution, investigators can complete the SLU-Washington University Umbrella Agreement Determination Form instead.
Researchers with studies that fall under the NIH Single IRB Use Policy will need to identify their IRB plan and associated costs as part of the application to the NIH. See the NIH Single IRB Use Guidance for more information. Researchers should work with the IRB and Go Center/Research Strategy teams in advance to develop their plans.
SLU has joined SMART IRB and SLU investigators may potentially use the SMART IRB Agreement to enable IRB reliance for their studies. To use SMART IRB for a study, please contact Maureen Bresnahan at firstname.lastname@example.org or 314-977-7734 to discuss a reliance request.
SLU is also an IRB Reliance Exchange (IREx) member. IREx is a freely available web-based portal that supports single IRB (sIRB) documentation and communication for multi-center clinical trials.
NCI CIRB (CIRB) is a central IRB that conducts IRB review of selected NCI-sponsored trials. It is open only to NCI-sponsored trials and SLU- and CIRB-approved Principal Investigators.
Use the NCI CIRB Application to gain authorization from SLU to submit to CIRB. Note that CIRB-SLU Boilerplate language must be incorporated into the locally-developed consent/assent forms. The SLU site is also responsible for developing a HIPAA Authorization form for local use. Refer to the Guidelines for using NCI CIRB and the Quick Sheet for Submitting to the NCI CIRB for additional guidance.
Note, once approved and conducting the study, CIRB and Saint Louis University each have responsibilities for overseeing this research, thus there are reporting requirements to both organizations. See the Central IRB Post-Approval Submission Requirements for further instruction.
Questions about the CIRB process and SLU requirements should go to Maureen Bresnahan
at email@example.com or 314-977-7734.
Questions regarding CIRB submission and reporting requirements are best handled by contacting CIRB directly or by visiting ncicirb.org.
If using one of our partner central IRBs [Advarra (formerly Schulman IRB, Chesapeake IRB and Quorum Review IRB), Western IRB (WIRB) directly or WCG's Single Review Solution (SRS) process (Aspire IRB, Copernicus Group, Midlands, New England IRB), or StrokeNet], use the following forms/process.
These are the only central IRBs that SLU researchers may use at this time. If you have a study that requires reliance on another central IRB, please contact Maureen Bresnahan at firstname.lastname@example.org or 314-977-7734 to discuss the possibility of an exception.
Step 1: Confirm that a study is eligible for Central IRB review
Ensure the study has been reviewed and/or approved by one of the central IRB partners, or by an IRB that SLU has granted an exception to use.
Note: it is recommended that you identify whether the IRB is serving as a "local IRB" or true central for the study. If acting as a central IRB, it is more probable that the sponsor/CRO will be willing to submit post-approval materials (such as protocol amendments) on behalf of the SLU site.
- For Advarra: Contact Kathleen Rankin at 513-878-2409 to determine whether they have the protocol (ask whether there is an Advarra protocol ID for that sponsor protocol).
- For WIRB: if unsure, contact WIRB Client Services at email@example.com to ask whether there is a WIRB protocol ID for that sponsor protocol). If WIRB or WIRB Single Review Service has the protocol, then review SLU eligibility criteria, above, to ensure submission to WIRB is allowable.
Once confirmed, you must request access to the Central IRB’s portal system via their website. You will need to submit their draft application as part of your package to SLU in order to get the required approval to use a Central IRB.
Step 2a: Investigator begins local processes necessary for all clinical trials at SLU
To get approval for submission to a Central IRB, the Clinical Trial Agreement (CTA) must be agreed upon and other necessary financial requirements must be met (for details, contact the Clinical Trials Office at 314-977-6335 or firstname.lastname@example.org). Note that the signed 1572 and signed SSM Health SLUH application must be submitted with the CTA for the SLUH review process, if applicable.
If the study involves non Standard of Care radioactive materials, the RSC will need to review the study. Submission to the RSC and the IRB can be done at the same time. See the RSC webpage for more instructions.
All investigators listed on the study must also have annual disclosures on file with the conflict of interest office and must have completed training in human subjects research protections.
When preparing study budgets, IRB fees should be included. There is a one-time SLU administrative review fee of $750 for industry-sponsored studies, which will be billed to the research department with the expectation that the sponsor ultimately provides payment. Additional central IRB review fees will apply and should be included in the study budget.
Central IRB fee schedules can be provided by that IRB. SLU prefers that Central IRBs bill the sponsor directly. Research teams should request a sponsor/CRO billing contact, and to include that contact information in the submission.
Step 2b: Prepare Forms for Required SLU Approval
The SLU IRB Office facilitates the SLU administrative review process; submission to
a Central IRB cannot occur until the Submission Authorization Form is approved. This
process may occur concurrently with work on the CTA and financial arrangements.
Prepare and submit the following:
- Completed SLU Central IRB Submission Authorization Form (SLU form)
- Completed (but not yet submitted!) Central IRB Application
- For Advarra: Research Site Submission Form
- For WIRB: Initial Review Submission Form. Note: when asked if the research will be conducted through an organization which has a contract to use WIRB for services, insert "Saint Louis University" and our WIRB Institution Number: 74837
- Sponsor's protocol, recruitment material, Investigator's Brochure/Package Insert/Device Manual
- For Advarra/WIRB: Submit the Central IRB-approved template without SLU customization, which will be done by the Central IRB staff. See the Site Specific Language or an example of what Central IRBs will include. You can proactively provide to the sponsor/CRO in advance if negotiations of language are likely to occur.
- For StrokeNet/Exception Central IRBs, please incorporate SLU Site Specific Language into the Central IRB-approved template.
- For all studies, SLU uses a stand-alone HIPAA Authorization Form so this document should be customized as is normally done in a SLU IRB reviewed study.
The SLU IRB office will route materials to other SLU offices as needed (Clinical Trials
Office, General Counsel, Biological Safety, Conflict of Interest, etc.) for review.
However, if investigators are aware that approvals will be necessary from other offices
or committees, they are encouraged to work with these groups directly as soon as possible
to expedite processes.
If issues arise during SLU Administrative Review, the PI or study contact will be contacted and revisions may be requested.
Step 3: Submission to Central IRB
Once SLU authorization (the signed Central IRB Submission Authorization Form) is received, the investigator can proceed with submission to the Central IRB. Note: the signed SLU Forms you receive from the IRB should be included with your submission, but the HIPAA Authorization may not.
Step 4: Central IRB Review
Investigators should work with the Central IRB directly during the submission process. For partner Central IRBs, SLU may be contacted to pre-approve the consent form for our site during the review process. If so, the IRB will include the research team on correspondence.
Once approval is obtained, SLU will provide a stamped HIPAA Authorization for use in the study. If using a partner Central IRB, the SLU IRB gets notified and will initiate this promptly; if using StrokeNet or an exception was granted, forward your approval letter and approved consent to email@example.com so that the stamped HIPAA Authorization can be provided.
Step 5: Do not commence research until all institutional approvals are in place
Make sure that all institutional approvals, hospital approvals, and the clinical trial agreement are in place prior to beginning the study.
Post-Approval Submission Requirements
Central IRBs and Saint Louis University each have responsibilities for overseeing this research, thus there are reporting requirements to both organizations. Reporting requirements are summarized in the Central IRB Post-Approval Submission Requirements table.
Questions about the SLU process and requirements should go to Maureen Bresnahan at
firstname.lastname@example.org or 314-977-7734.
Questions regarding Central IRB forms, submission or reporting requirements are best handled by contacting the Central IRB directly.