The process for obtaining SIRB approval for multisite research includes several steps. The UU IRB has an established process for engaging with site investigators and HRPP representatives to secure IRB reliance and approval for each participating site.
The single IRB (SIRB) is the institution serving as the IRB for the multisite research. The relying Human Research Protection Program (HRPP) is the institution relying on a SIRB. This page focuses on the process from the perspective of the HRPP. To learn more about the process from the SIRB’s perspective, please visit our SIRB Review Process Page.
Step 1: Invitation
An invitation to rely on a SIRB is sent to participating sites. We call this a Reliance Invitation Letter. Sometimes the SIRB sends the invitation directly to site Human Research Protection Programs (HRPP), and sometimes the study teams receive instructions to connect with their HRPP.
At the University of Utah: We typically wait for a reliance invitation either from the SIRB or the study team before initiating reliance activities. Study teams may initiate reliance by submitting a Reliance Consultation Request Form.
At the University of Utah: We typically wait for a reliance invitation either from the SIRB or the study team before initiating reliance activities. Study teams may initiate reliance by submitting a Reliance Consultation Request Form.
Step 2: Consultation
A consultation between the HRPP and their local investigator will help them to discuss the relevant terms/requirements of the proposed reliance relationship.
At the University of Utah: Begin the consultation process by submitting a Reliance Consultation Request Form. Even if you aren't sure about your funding or only want to get a better feel for our local process, this meeting will get you connected with a member of our SIRB Reliance Team.
We prefer to use the SMART IRB Reliance Agreement to execute reliance with SIRBs. You can find out more about it at: https://smartirb.org/agreement/. If for some reason your SIRB cannot use the SMART IRB Reliance Agreement, we can also negotiate a study-specific agreement.
Step 3: Reliance Decision
The relying HRPP responds to the SIRB by either: a) agreeing to rely by sending a Reliance Decision Letter or a signed Reliance Agreement to the SIRB so they can proceed with their review, or b) declining to rely by notifying the SIRB and the local investigator of the determination.
(If reliance is declined, the investigator proceeds with usual local IRB review, and the SIRB process stops here.)
While the relying HRPP and SIRB complete reliance negotiations according to their local policies and procedures, the relying HRPP submits their Local Considerations Package to the lead site investigator and SIRB so site-specific materials (e.g. consent documents, recruitment materials, etc.) can be prepared.
Step 4: SIRB and Local HRPP Review
While the lead site investigator pursues SIRB approval to add the relying site to the application, the investigator submits an application to the relying HRPP to initiate HRP Review. At a minimum, the HRP review application should include:
- A copy of the protocol.
- A copy of the consent document template. Note: It is not necessary to include site-specific consent language in the document at this point, since the relying HRPP can assume their required language will be inserted into the final, SIRB-approved version of the document, as outlined in the steps following.
- Recruitment materials that will be distributed in the relying HRPP’s local community.
- A copy of the SIRB approval for the overall study.
The relying HRPP conducts their Local HRP Review according to their own policies and procedures. When Local HRP Review has progressed as far as it can without the final, SIRB-approved documents for their local site, the relying HRPP sends a notification to the study team requesting the final, SIRB-approved documents, which must include:
- The SIRB-approved version of the site-specific consent document which includes required information from the Local Considerations Package, if any.
- The SIRB approval to add the local site to the study.
When the SIRB-approved documents are submitted to the relying HRPP, the HRPP completes their Local HRP Review, and notifies the investigator that the study has been activated at the relying site. The investigator should forward the HRPP activation letter to the SIRB and retain a copy for their own research records.
At the University of Utah: Submit a New Study Application in the ERICA online application system to begin local HRPP review.
Step 5: Ongoing Review
After initial study startup, the SIRB provides ongoing review services to ensure that research can be updated and renewed in a timely manner. Only a small part of ongoing information needs to be submitted to the HRPP during this stage. Consult your SIRB Reliance Team contact for more information.
Step 6: Site and Study Closures
When each participating site and the overall study are ready to close, the SIRB helps the study team close the application. Each site PI should also work with their HRPP to ensure a Final Project Report is submitted so the HRPP file can be closed.
Glossary of SIRB Terms Used on this Page
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Human Research Protection Program. The HRPP is usually comprised of multiple offices tasked with the ethical and compliant conduct of human subject research at an institution. The IRB is often one of the groups within the HRPP, which may also include other groups, e.g. Conflict of Interest, Radiation Safety, HIPAA Privacy Boards, Biosafety, etc.
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While a relying HRPP may not be responsible for the IRB review portion of the HRP Review for a study where a reliance relationship exists with a SIRB, there are many other HRP requirements that must be completed before a study can begin at a given site. When IRB review and the rest of HRP Review are conducted altogether within an institution, the IRB approval and study activation are typically granted together. When the IRB piece of the HRP Review is delegated to an external SIRB, the study activation piece remains with the rest of the HRP Review.
It is critical that institutions educate their investigators about this part of the reliance process. Local sites are under no obligation to activate the study at their site, even if SIRB approval is granted, which means the investigator may NOT begin research procedures until both SIRB approval AND HRPP activation have been received and documented.
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The process by which a research site relying on a single IRB (SIRB) completes their required Human Research Protection Program (HRPP) review and communicates local concerns to the SIRB, if needed. This process is sometimes referred to as “local review”. Every institution/relying site has different processes for collaborating with a SIRB and ensuring the additional, non-IRB requirements are met at their site before the research begins. It is the responsibility of the site investigator in collaboration with the site HRPP Administrator to ensure local HRP review is completed according to local policies.
Non-IRB requirements include, but are not limited to the following:
- Financial conflict of interest (COI) review and management plans for any investigators or study staff at your site.
- Institutional conflict of interest management plans for your site.
- Ensuring sufficient resources, training, or compliance measures relevant to this study being conducted at your site.
- Ancillary committee reviews that are performed at your site.
- Ensuring compliance with local laws or policies.
Local sites are under no obligation to activate the study at their site, even if SIRB approval is granted.
Note: SIRB approval may be issued before HRP Review is completed. If SIRB approval is issued before local review is completed, the reviewing SIRB must require amended materials if a study is not compliant with a site’s local requirements.
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A detailed profile of a research site’s local community. This report is a tool to assist a reviewing IRB in understanding social, economic, and legal aspects of the research site that are relevant to protecting human subjects and should include a detailed description of applicable institutional policies, site-specific template consent language, and state laws. (e.g. circumstances that affect the age of consent, institutional policies related to record-keeping, and state-mandated public health reporting). Information included in this profile should be relatively static, should require infrequent updating, and should not be significantly affected by individual research studies.
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It is recommended that a Local Considerations Package include:
- The Institutional/Community Profile for the relying institution
- Any consent document language required by the relying institution, with legal citations, policy references, and/or other justifications for why the language is required at the particular institution.
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A formal, written document that allows an institution, entity, or individual engaged in human subjects research to delegate Institutional Review Board (IRB) review to a specific IRB. This agreement allows one or more institution(s) to cede review to another IRB.
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Sometimes referred to as the “reliance handshake letter”, the Reliance Decision Letter is the first step in a reliance relationship between two institutions. The letter is the means by which each institution documents that the HRPP is amenable to relying on the SIRB. It also assures the SIRB that it is worth devoting resources to conducting the IRB review on behalf of the relying institution, and provides the HRPP with a starting point for reliance negotiations.
The format of the Reliance Decision Letter should follow local policies, keeping in mind that due to the nature of the reliance relationship with an entity external to themselves, each institution should be flexible with regard to the format, style and verbiage of the letter itself. In some cases, a simple email from an authorized individual may be sufficient documentation, while in others, a form letter signed by a designated signatory may be appropriate. However, this letter is not intended to replace the formal Reliance Agreement that will follow this step; it is merely a simple statement of intent to initiate the process.
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This letter is composed and sent by the lead study team (with the assistance of the single IRB (SIRB)) to a site or institution that may need/would like to rely on an IRB other than their usual IRB of record. The reliance invitation should identify the study/studies proposed for reliance, the investigator requesting the single IRB model, the name/affiliation of the SIRB, and in most cases, a copy of the draft protocol and draft consent.