Ask us if COMIRB can serve as sIRB for your research. Send a copy of the protocol or funding proposal and a list of the potential sites to: COMIRB@ucdenver.edu.
We may schedule a meeting with the PI and study team to go over their additional responsibilities and the COMIRB review process. We may also discuss strategies to involve institutions in the research without formally "engaging" them in human subjects research.
If COMIRB agrees we can serve as sIRB, submit your IRB application as usual for our university and our affiliates.
After COMIRB has issued initial approval, share the IRB-approved protocol and relevant study documents with the PIs at the relying sites. The relying site PIs will need to contact their IRB office to ask to rely on COMIRB. Let COMIRB know that this step has been taken and COMIRB will contact the relying IRB offices to formalize reliance documents and obtain local context information. If site-specific documents will be needed, (e.g., site-specific consent form with locally-required injury and HIPAA statements), obtain those from your relying site PIs, using the COMIRB-approved versions as templates.
COMIRB will notify you when the IRB authorization has been signed by both parties. At this point, submit an amendment to COMIRB to finalize full approval of the relying site. Include all site-specific documents requiring approval.
If there are multiple sites, it is usually best to submit amendments site-by-site due to differences in how quickly the relying sites complete their tasks.
When COMIRB assumes oversight for relying sites, continuing review will be required. Our PI assumes responsibility for reporting events, changes to the research, and continuing review on behalf of the relying sites.
Any unanticipated problems or non-compliance at relying sites which meet COMIRB’s 5-day reporting requirements must be submitted to COMIRB by our PI and study team.
Any changes to approved research at relying sites must be submitted to COMIRB for prior approval. Personnel changes at relying sites do not need to be reported to COMIRB, unless the PI changes. If the relying PI changes, COMIRB must be notified, and a new IRB reliance agreement will be executed with the new PI listed.
When preparing a continuing review submission, include a report for each relying site.
The NIH sIRB policy applies to the domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research. It does not apply to career development, research training or fellowship awards. Applicants must identify the single IRB during the Just-in-time submission before an award is issued.
Since January 2020, the common rule has required single IRB review for most federally funded research involving more than one institution. Exceptions include situations where additional IRB review is required by law, including American Indian or Alaska Native tribal law, and research where the federal funder determines that a single IRB is not necessary.
Regardless of IRB review, in the conduct of the research each institution remains responsible for safeguarding the rights and welfare of human subjects. Contact COMIRB if you are seeking an exception from sIRB requirements.
If the non-affiliated site is a participating institution in the Smart IRB network, COMIRB will serve as lead IRB under the terms of the Smart IRB Agreement. Depending on the risk and complexity of the research, COMIRB may require the use of IREx to ensure clear communications between relying sites.
This agreement will be used for institutions that are not part of the Smart IRB network. It lists responsibilities for both the reviewing institution and the relying institution and requires the non-affiliated site to take responsibility for ensuring their personnel have completed required human subjects training and conflict of interest disclosures, and to report any conflicts of interest to COMIRB.
Memorandum of Understanding (MOU) or other Agreements: The University has MOUs or similar agreements for IRB review with some of the institutions and networks with which our researchers regularly collaborate. IRB Reliance Agreements may not be necessary in these cases.
A: No. Relying sites are responsible for oversight of their employees, including training and COI disclosures.
A: Yes. However, if the relying institution will be interacting with subjects, COMIRB will not initiate a reliance agreement before the relying institution has reviewed the COMIRB-approved protocol and has completed a local context survey.
A: Sometimes. COMIRB is more restrictive in these cases where sIRB review is not required by federal regulation or NIH policy.
A: No, COMIRB is not required to serve as sIRB. If COMIRB cannot serve as sIRB, other options include using a commercial IRB, or relying on an IRB from one of the sub-recipients of the award.
A: No, unless the research is federally funded.
A: Yes, you should budget for additional PRA time for coordinating relying site approvals. You cannot direct additional funding to COMIRB. However, you can budget for a private IRB.
A: No, an IRB authorization signed by appropriate officials at both institutions is required, and COMIRB must formally approve the addition of the site. Without both of those, the PI at the other institution does not have IRB approval to begin research activities.
A: No, all site PIs are always required to contact their local IRB offices about relying on COMIRB. Each local IRB office will have their own process to review the research before deciding to rely on COMIRB.
A: To help ensure adequate oversight of the research at relying sites, COMIRB requires at least annual continuing review when providing IRB oversight for a non-affiliated institution where investigators are interacting with subjects.
A: SMART IRB is an administrative organization supported by NCATS to help IRBs rely upon one another. SMART IRB is not an IRB. More information is available at smartirb.org.
A: No. The relying site must apply for their own FWA. The application process is on-line, and instructions are posted on the OHRP website. They will need to identify one IRB on the FWA application form, and they can name the COMIRB panel that has reviewed and approved the research.
A: COMIRB can only serve as the IRB of record for a non-affiliated site when that site is directly collaborating with our university or one of our affiliates.
A: If COMIRB is being considered as the single IRB for your proposal, email a copy of your proposal to COMIRB@ucdenver.edu. If the Director agrees COMIRB can serve as the single IRB, the Director will send you a letter of support. If the university is being asked to cede to another IRB, email a copy of your proposal to ExternalIRB@ucdenver.edu for a letter of support.