Alternative IRB Review Arrangements
The University of Utah IRB (UUIRB) may enter into joint review arrangements, rely upon the review of another qualified IRB, or make similar arrangements for review of research. Such arrangements may allow for the UUIRB to provide IRB review for research conducted outside the University of Utah and its affiliates. Additionally, such arrangements may be allowed in order to avoid duplication of effort across multiple institutions.
All alternative IRB review arrangements must be set forth in a written agreement between the IRB providing the review and the institution conducting the research (i.e., the IRB agrees to provide review and the research institution agrees to rely on the IRB for review).
Consideration and decisions for entering into alternative IRB review arrangements are made by the University of Utah IRB directors, General Counsel (when appropriate), and the Vice President for Research.
Designating the UUIRB as the IRB of Record
The UUIRB may serve as the IRB of record in the following situations:
- The UUIRB may review and issue approval or exemption of research conducted at an external institution if there is no other IRB of record for the external site.
- The UUIRB may act as a Central IRB (CIRB) to review and issue approval or exemption of research conducted at external institutions in order to avoid duplication of effort across multiple institutions.
The UUIRB may serve as the IRB of record for a single project or multiple projects at an external institution. Those interested in having the UUIRB serve as the IRB of record must contact the UUIRB to initiate the process.
Procedure for Designating the UUIRB as the IRB of Record
Once the UUIRB has agreed to serve as the IRB of Record, the following documentation is required.
1. Federal-wide Assurance (FWA)
For federally funded human subject research, all participating research sites must be in compliance with the policies and regulations established by the Office for Human Research Protections (OHRP). A Federal-wide Assurance (FWA) is an assurance of compliance accepted and approved by OHRP. The external institution must complete an FWA to conduct such research. The external institution's FWA number must be provided to the UUIRB via the written agreement (see below).
The external institution may need to complete a new FWA. For more information about FWAs or to submit an FWA, please visit the OHRP website. For research that is NOT federally funded, an FWA does not need to be completed.
If the external institution does not already have an IRB listed on its FWA, then the
UUIRB must be listed on the external institution's FWA. To do this, the external institution
must provide the following information in its FWA:
University of Utah Assurance Information
|Assurance:||FWA00003745 - U Utah|
|Panel 1 ID:||IRB00000104 - U of Utah IRB #1|
|Panel 2 ID:||IRB00000105 - U of Utah IRB #2|
|Panel 3 ID:||IRB00000106 - U of Utah IRB #3|
|Panel 4 ID:||IRB00000107 - U of Utah IRB #4|
|Panel 5 ID:||IRB00006644 - U of Utah IRB #5|
|Panel 6 ID:||IRB 00007857 - U of Utah IRB #6|
|Panel 7 ID:||IRB 00008865 - U of Utah IRB #7|
2. Written Agreement
When a request is made for the UUIRB to be the IRB of record for an external investigator or external institution, there are two types of agreements that are used; 1) the IRB Authorization Agreement (IAA), or 2) the Reliance Agreement (RA). Both agreements have the same purpose; to designate the UUIRB as the IRB of record. Contact the IRB office for assistance in determining which agreement should be used for your situation. Please note that the final determination of which agreement will be used is left to the IRB staff in consultation with the external institution.
- IRB Authorization Agreement (IAA): This agreement is typically used in situations when both parties have an FWA. It is used for a single project when the research is no more than minimal risk and there is no IRB of record for the external site. An IRB Authorization Agreement (IAA) must be completed for each center. The document must be signed by the Signatory Official (under “Institution B”) of the external institution(s) in order to be considered valid. When the document is attached, the IRB Staff will obtain the signature of the Signatory Official (under “Institution A”) of the University of Utah and re-attach the completed document in ERICA on your behalf. The IAA templates may be found on the IRB Forms Menus under "External Sites and Agreements Documents".
- Reliance Agreement (RA): This agreement is typically used in situations that require more specification in regard to what is being reviewed by UUIRB (e.g., all studies from a particular department, all studies by a particular investigator, UUIRB acting as the CIRB, etc.) or the research activities are greater than minimal risk. The RA template may be found on the IRB Forms Menus under "External Sites and Agreements Documents".
3. Other Documents
- Consent and Authorization Document: The UUIRB will approve consent forms unless a waiver is granted. The UUIRB will make available the University of Utah Consent Template for use. Modifications will be expected as to customize the form for the external site. Modifications will be subject to approval by the UIRB. If authorization will be obtained from the patients through the External Institution, the consent and authorization document must be attached to the application in ERICA for review and approval by the IRB.
- External Institution’s Notice of Privacy Practice: If applicable, a copy of the External Institution’s Notice of Privacy Practice must be attached to the application in ERICA under “Other Documents.” This will allow the IRB to verify that the External Institution has notified the patients that their PHI may be used for research purposes. If the Notice of Privacy Practice does not inform the patients that PHI may be used for research purposes, a waiver of authorization may not be used unless the Notice of Privacy Practice is revised to include this stipulation.
- Information for Accounting of Disclosures: If applicable, the External Institution must also complete an Information for Accounting of Disclosures Form [DOC] signed by the External Institution’s signatory official or HIPAA privacy officer.
Terms and Conditions of the UUIRB Reliance Agreement
Full terms and conditions will be negotiated with each Reliance Agreement executed by the University of Utah. External institutions and investigators must review the full agreement to ensure that all terms and conditions can be met.
An overview of the UUIRB Reliance Agreement includes the following terms and conditions:
- Following Regulations and Policies: All institutions conducting and reviewing research are responsible for adhering to all applicable regulations, state laws, University of Utah policies, External Institution policies, and Federalwide Assurance terms. External institutions are responsible for informing the UUIRB of state laws and local policies that must be followed; this may be accomplished through the facilitated review.
- Facilitated Review: External institutions may choose to conduct a facilitated review (sometimes this is called a local context review), to ensure all state laws and local policies are met. This includes the External Institution's ancillary committee reviews, such as radiation safety reviews, pharmacy reviews, scientific committee reviews, data use reviews, etc.
- Financial Conflicts of Interest: The External Institution is responsible for evaluating their investigators' financial conflicts of interest and reporting conflicts and management plans to the UUIRB; this may be accomplished through the facilitated review. If the External Institution does not have a mechanism for reviewing their investigators' financial conflicts of interest, the Reliance Agreement can be modified to allow for the University of Utah Conflict of Interest policy and review process to be applied to the External Institution.
- Research-Specific Training and Qualifications: The External Institution is responsible for ensuring that their investigators and research staff are appropriately trained and credentialed to conduct the proposed research; this may be accomplished through the facilitated review.
- Informed Consent and HIPAA Authorization: The UUIRB will be responsible for approving all consent and authorization forms that are used for the specific research at the External Institution. Additionally, the UUIRB will be responsible for making determinations for waivers of consent, waivers of authorization, use and disclosure of limited datasets, and use and disclosure of de-identified datasets. This means that the UUIRB is also acting as the HIPAA Privacy Board for the research being reviewed. The External Institution is responsible for providing any institution-specific language for the consent and authorization forms, which generally includes local contact information, local research-related injury language, and local HIPAA Authorization language.
- Continuing Reviews and Amendments: The UUIRB will be responsible for reviewing and approving all continuing reviews and amendments proposed for the project.
- Unanticipated Problems and Non-Compliance: The UUIRB will be responsible for reviewing all reports of problems and non-compliance, making determinations on such reports, and further reporting of such determinations to the External Institution and other necessary entities. The UUIRB may choose to involve the External Institution in this review, determination, and reporting process. The External Institution retains the authority to review local problems and non-compliance using a separate process than the UUIRB.
- Authority to Audit: Both the UUIRB and the External Institution have the authority to audit the research activities conducted at the External Institution.
Deferring IRB Review to an External IRB
The University of Utah may choose to rely on an external IRB. In this case, the UUIRB review is deferred to another IRB, such as a Central IRB (CIRB). Though IRB review may be conducted by an external IRB, the University of Utah uses a facilitated review process to ensure that Utah State laws and University of Utah-specific requirements are met. The facilitated review process is conducted by the UUIRB.
The UUIRB may defer review to another IRB for a single project or multiple projects. Those interested in having the UUIRB defer review to another IRB must contact the UUIRB to initiate the process.
Although external IRBs may propose the use of Reliance Agreements that differ from the UUIRB Reliance Agreement, the UUIRB will attempt to negotiate similar terms and conditions as the UUIRB Reliance Agreement. Legal review of all Reliance Agreements is required prior to acceptance of the agreement.
Important Note: The VA Salt Lake City Medical Center (VA) and Primary Children's Hospital (PCH) are not part of the University of Utah, even though the UUIRB acts as their IRB of record in usual circumstances. If an external IRB other than the UUIRB wishes to act as the IRB of record for research conducted at the VA or PCH, a Reliance Agreement with the VA or PCH is required. If the VA or PCH research involves University faculty or staff, a Reliance Agreement with the University of Utah is also required.
Facilitated Review Process for the University of Utah
Step 1: Initiate Facilitated Review with the UUIRB
- The UUtah investigator submits the protocol and a UUtah-version of the informed consent to the UUIRB via the new study application in the ERICA system.
- Applicable ancillary review of the new study application occurs at UUtah via ERICA. See the Ancillary Requirements webpage for a full list. The ancillary committees may request revisions or clarifications through the ERICA system.
- The UUIRB staff review the new study application to ensure that Utah State laws and University of Utah policies are met. The UUIRB staff may request revisions or clarifications through the ERICA system. The UUIRB staff may request that specific revisions or concerns be addressed by the External IRB during their review.
- The UUtah investigator provides the revised UUtah-version of the informed consent and any other comments or concerns expressed during the facilitated review to the External IRB.
Step 2: External IRB Review and Approval
The External IRB reviews the protocol and the UUtah versions of the informed consent according to the External IRB's policy and process.
The External IRB uses the University of Utah Institutional Profile and Local Context Information to conduct their review.
Approval of the study, as well as inclusion of UUtah as a site, must be issued in a documented letter. It is noted that the External IRB may choose to approve UUtah's participation via a new study review or via an amendment review if the study is already approved at the lead site.
Step 3: Finalize Facilitated Review with the UUIRB
- The UUtah investigator submits the final, approved version of the protocol, UUtah
informed consent, and other supporting documents (consistent with the ERICA new study
application) to the UUIRB via the open new study application in ERICA. The UUtah investigator
also provides a copy of the External IRB approval letter, which must include documentation
of the following:
- The approval date
- The current expiration date for the study
- A statement that the UUtah is an approved site through the External IRB
- The UUIRB staff confirm the UUtah informed consent is appropriate for use at the UUtah.
- The UUIRB staff completes the facilitated review and sends a facilitated review acknowledgement letter via the ERICA system. The UUtah investigator and study team may begin the research at the UUtah.
Step 4: Ongoing review, monitoring, and reporting at the UUtah
The following components may vary according to the Reliance Agreement that has been executed for the research. In the facilitated review acknowledgement letter, the UUIRB will specifically note how the following components should be accomplished by the UUtah investigator. However, the components are generally negotiated with the following terms and conditions:
- Continuing review is performed by the External IRB. The UUtah investigator must provide all relevant documentation to the External IRB to ensure continuing review. The External IRB's policy and process are followed.
- The UUtah may require facilitated review of a continuing review application if local ancillary committees need to performs such a review. Thus, a continuing review application may be required via the ERICA system.
- Study-wide and local site amendments are reviewed by the External IRB. The UUtah investigator must provide all relevant documentation to the External IRB to ensure approval of such amendments. The External IRB's policy and process are followed.
- The UUtah may require facilitated review of an amendment if local ancillary committees need to perform such reviews. Thus, an amendment application may be required via the ERICA system. Important note: All changes to UUtah study personnel must be reported via an amendment application in ERICA to ensure Conflict of Interest review.
Problems, Events, and Non-Compliance
- The External IRB reviews problems, events, and non-compliance. The UUtah investigator must appropriately report problems, events, and non-compliance according to the External IRB's policy and the requirements of the individual protocol. Important note: Reporting policies for IRBs can differ substantially and may not be consistent with the reporting policy of the UUIRB.
- The UUIRB requires that the following problems, events, and non-compliance be reported
using the ERICA Report Form:
- Local non-compliance meeting the reporting requirements of the UUIRB policy.
- Local problems/events that may be considered unanticipated problems according to the UUIRB policy. This includes, but is not limited to, adverse events, participant complaints, and breaches of privacy and confidentiality.
- Both the External IRB and the UUIRB have the authority and may require for-cause and routine audits according to each IRB's policy.
- The External IRB is responsible for ensuring that the study has an adequate plan for safety monioring in place. The UUtah investigator is responsible for adhering to the approved safety monitoring plan.
Study Suspension and Termination
- The External IRB may suspend or terminate the study at all sites or at specific sites. The UUtah investigator is responsible for reporting such suspension or termination to the UUIRB via the ERICA Report Form.
- The UUIRB may suspend or terminate UUtah participation in the study according to UU IRB SOP 904. Local suspensions or terminations are communicated by the UUIRB to the External IRB.
- The UUtah investigator is responsible for closing the study application in ERICA after the closure has been processed by the External IRB. A final project report must be submitted in ERICA.