Welcome! All of the LA CaTS and LA CDRN institutions have joined IRBshare to help streamline IRB approval and study start up for multi-center studies.
IMPORTANT: IRBshare is an IRB reliance model allowing IRBs to utilize the reviews of another qualified IRB (per 45 CFR 46.114), while allowing the secondary/Local IRB (“Local Oversight IRB”) to maintain oversight for the study. This means each investigator will still submit and report to his or her LOCAL IRB, even when using IRBshare. Responsibilities and steps for using IRBshare are listed below.
1. Ensure at least TWO (2) eligible sites are participating study sites
- Baylor, Scott and White (LACDRN studies only)
- LSU A&M
- LSU Health Sciences Center New Orleans
- LSU Health Sciences Center Shreveport
- Oschner Health System (LACDRN studies only)
- Pennington Biomedical Research Center
- Tulane University Health Sciences Center
- Xavier University of New Orleans
2. Ensure the study meets the eligibility criteria below:
- Study requires IRB review (exempt studies do not qualify)
- Multi-site Study: when some or all of the research procedures occur at more than one site, clinic, hospital, etc.
- Multi-institutional Study (Research Collaboration): when components (patient recruitment, data analysis, etc.) of the research project are distributed across more than one institution with the research procedures occurring at one site only, but IRB review is required by multiple institutions.
STOP: If your study does not meet criteria 1 and 2, it does not qualify for IRBshare. Please submit the study to your local IRB as usual.
3. Identify a Lead IRB
If your study met criteria 1 and 2, the next step is to identify the “Lead IRB”, which is the IRB that uploads their approval to IRBshare for other IRBs to use to streamline the IRB review at their institutions.
How to identify the Lead IRB? The Lead IRB is typically the IRB of the overall study PI (if there is one) or the IRB of the institution at which all or the majority of the study procedures are occurring. Some consideration of turnaround time should be considered as well, given that other study site IRBs cannot grant approval until the Lead IRB uploads their approval to IRBshare.
4. Register your study with IRBshare!
Once criteria criteria 1, 2, and 3 have been met, you are ready to submit the IRBshare Registration Request Form. This should be submitted by the investigator or a designee at the identified Lead IRB site. The IRBshare Liaison at that institution will review the request and respond within 3-5 business days. If you have any questions about the IRBshare Registration Request process, please contact the IRBshare Administrator at: firstname.lastname@example.org
5. Confirm Use of IRBshare with Collaborating Investigators at Secondary Study Sites.
To optimize coordination among sites and efficiency, follow these steps after the Lead IRB is confirmed, but before IRB approval is received, if possible:
- Inform: The investigator at the Lead IRB site should contact all collaborating investigators/study teams to confirm that IRBshare will be used.
- Request submission instructions: The collaborating/secondary site investigators (or their coordinator) should contact their site’s IRBshare Liaison (listed here) or look on their local IRB’s website for submission instructions (we could link to HRPP/IRB website for each site or IRBshare page if available).
- Disseminate: Once approved by the Lead IRB, the study documents (e.g., protocol and approved consent template) should be disseminated to the other sites so they can submit according to their IRB’s submission policy when using IRBshare (see step 2). This dissemination should happen as it would have without IRBshare. For example, a coordinating center or sponsor or clinical research organization (CRO) may disseminate the documents. If none of these are part of the study, the investigator should create a mechanism to keep everyone informed of study updates.
6. Submission Tips
- Investigators at each site ONLY submit to their local IRB.
- The investigator at the Lead IRB should always submit in a timely manner to their IRB:
- Initial Review: the study should be submitted to the Lead IRB as soon as the protocol is finalized. All potential study sites do not have to be identified before the study is submitted for initial approval.
- Continuing Review: Lead investigators should submit at least 8 weeks prior to their expiration date to ensure the IRB has time to review, approve and upload it to IRBshare for other IRB’s to utilize to streamline their review.
- Study-wide Amendments: submit as soon as the change is finalized and disseminate documents to other sites as soon as approval is received.
- Local Amendments: Local amendments do not get uploaded to IRBshare as they are site-specific and do not require review by each IRB, only the local IRB.
Visit the Louisiana Consortiums FAQs page for additional information.