91女神

Use of another institution鈥檚 IRB will require agreement from that institution and 91女神鈥檚 IRBs, so it is important to have a dialogue with both parties before completing the forms below.

Complete the IRB reliance agreement determination form and submit it 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) occur at one institution, investigators can complete the 91女神-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.

91女神 has joined SMART IRB and 91女神 investigators may use the SMART IRB Agreement to enable IRB reliance for their studies. To request the use of SMART IRB for a study, please contact the IRB Office at irb-reliance@slu.edu.

91女神 is also an IRB Reliance Exchange (IREx) member. IREx is a 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 reviews of selected NCI-sponsored trials. It is open only to NCI-sponsored trials and 91女神- and CIRB-approved principal investigators.

Use the NCI CIRB Application to gain authorization from 91女神 to submit to CIRB. Note that CIRB-91女神 boilerplate language must be incorporated into the locally developed consent/assent forms. The 91女神 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 91女神 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.

Please contact the IRB with questions about the NCI-CIRB submission process and 91女神 requirements at irb-reliance@slu.edu.

Questions regarding CIRB submission and reporting requirements are best handled by contacting CIRB directly or by visiting .

Use the following process if using one of our partner central IRBs [Advarra (formerly Schulman IRB, Chesapeake IRB and Quorum Review IRB) or WCG's Single Review Solution (SRS) process (WIRB, Aspire IRB, Copernicus Group, Midlands, New England IRB), or StrokeNet].

These are the only central IRBs that 91女神 researchers may use at this time. If you have a study that requires reliance on another central IRB, please contact the IRB Office at irb-reliance@slu.edu 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 91女神 has granted an exception to use.

Note: it is recommended that you identify whether the IRB serves 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 91女神 site.

• For Advarra: Contact Advarra at 513-878-2409 to determine whether they have the protocol (ask whether there is an Advarra protocol ID for that sponsor protocol).
• For WCH: if unsure, contact WCG Client Services at clientservices@wcg.com to ask whether there is a WCG protocol ID for that sponsor protocol). If WCG has the protocol, then review the 91女神 eligibility criteria above to ensure submission to WCG is allowable.

Once confirmed, you must request access to the Central IRB鈥檚 portal system via their website. You will need to submit their draft application as part of your package to 91女神 to get the required approval to use a Central IRB.

Step 2a: Investigator Begins Local Processes Necessary for All Clinical Trials at 91女神

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 clinical-trials-office@health.slu.edu). Note that the signed 1572 and signed SSM Health 91女神H application must be submitted with the CTA for the 91女神H 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 simultaneously. See the RSC website 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. A one-time 91女神 administrative review fee of $750 for industry-sponsored studies 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. 91女神 prefers that Central IRBs bill the sponsor directly. Research teams should request a sponsor/CRO billing contact, and include that contact information in the submission.

Step 2b: Prepare Forms for Required 91女神 Approval

The 91女神 IRB Office facilitates the 91女神 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 91女神 central IRB submission authorization form (91女神 form)
• Completed (but not yet submitted!) Central IRB application
• For Advarra: Research site submission form
• For WCG: Initial review submission form. Note: when asked if the research will be conducted through an organization that has a contract to use WCG for services, insert "91女神" and our WCG Institution Number: 74837
• Sponsor's protocol, recruitment material, investigator's brochure/package insert/device manual

Consent/Assent Documents

• For Advarra/WCG: Submit the central IRB-approved template without 91女神 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 91女神 site-specific language into the central IRB-approved template.
• For all studies, 91女神 uses a stand-alone HIPAA authorization form so this document should be customized as is normally done in a 91女神 IRB-reviewed study.

The 91女神 IRB office will route materials to other 91女神 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 91女神 Administrative Review, the PI or study contact will be contacted and revisions may be requested.

Step 3: Submission to Central IRB

Once 91女神 authorization (the signed central IRB submission authorization form) is received, the investigator can proceed with submission to the central IRB. Note: the signed 91女神 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 directly with the central IRB during the submission process. For partner central IRBs, 91女神 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, 91女神 will provide a stamped HIPAA authorization for use in the study. If using a partner central IRB, the 91女神 IRB gets notified and will initiate this promptly; if using StrokeNet or an exception was granted, forward your approval letter and approved consent to irb-reliance@slu.edu so that the stamped HIPAA authorization can be provided.

Step 5: Do Not Commence Research Until all Institutional Approvals are in Place

Ensure that all institutional approvals, hospital approvals, and the clinical-trial agreement are in place before beginning the study.

Post-Approval Submission Requirements

Central IRBs and 91女神 each have responsibilities for overseeing this research, thus there are reporting requirements for both organizations. Reporting requirements are summarized in the Central IRB Post-Approval Submission Requirements table.

Please contact the IRB Office with questions about the 91女神 process and requirements at irb-reliance@slu.edu.

Questions regarding central IRB forms, submission or reporting requirements are best handled by contacting the central IRB directly.