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If your research involves collaboration with any sites and/or personnel outside the University of Kentucky, then it is considered multisite research and IRB reliance issues will need to be addressed. This may include national multi-center trials as well local studies involving sites/personnel external to UK. If you would like to request that the University of Kentucky IRB (UK IRB) serve as the lead IRB for your study, or if you would like the UK IRB to defer review to another IRB, please complete the forms below and submit them to IRBReliance@uky.edu.

This policy applies to non-exempt human subjects research for which Indiana University or its affiliates are relying on an external IRB for oversight and human subjects research for which IU Institutional Review Boards (IRBs) are serving as IRB of record pursuant to a reliance agreement.

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IU may enter into reliance agreements, under which IU or IU-affiliated research personnel utilize the services of and rely on an external IRB for review and oversight. Alternatively, IU IRBs may agree to provide IRB review and oversight for external sites and non-affiliated personnel.

When reliance on an external IRB is requested for research which is greater than minimal risk, the reviewing IRB must be qualified by the IU HRPP and Office of Research Compliance (ORC) leadership in accordance with 3.1 below.

When the IU IRB provides approval for non-affiliated research personnel who are not conducting research on behalf on an institution, a reliance agreement is not required. Instead, the research personnel must provide written attestation of knowledge of and agreement to follow the IU HRPP Policies. For federally-funded research, IU must extend its Federalwide Assurance to cover non-affiliated research personnel. For these studies, the written attestation must also be signed by the IU Institutional Official or his/her designee.

Study teams may request reliance on an external IRB by submitting a Request to Rely on a non-IU IRB to the IU HRPP via Kuali Protocols. IU HRPP staff will conduct a review of the Request to Rely to determine whether reliance is appropriate and ensure all institutional responsibilities are met. Specifically, IU HRPP review will include:

Study teams may request that the IU IRB provide IRB approval for non-affiliated research personnel and/or external sites by submitting an Amendment. An IRB reviewer, or the convened committee, evaluate the request and determine on a case-by-case basis whether reliance is acceptable.

In order to help facilitate human research by allowing investigators to avoid duplicative IRB review while at the same time protecting the rights and welfare of human research participants, UCLA is willing to establish IRB reliance agreements for research involving collaborations between two or more institutions. IRB reliance agreements allow for only one IRB review for research procedures completed by all collaborating personnel.

The UCLA OHRPP will ensure that any required IRB reliance agreement is appropriately signed by the lOs/Delegates for both or all institutions involved and is kept on file for reference and review.

All relying UCLA investigators must complete a reliance registration in the IRB electronic submission systems for each study. The use of the IRB application provides the mechanism for the OHRPP to collect and track administrative and compliance requirements.

For each model, the Rutgers IRB enters into a reliance agreement with the Reviewing IRB. A reliance agreement is a formal, written document that provides a mechanism for institutions partnering in research to rely on one IRB to be responsible for multi-site IRB review. Funded and unfunded multi-site studies may enter into reliance agreements.

A CIA is an agreement between Rutgers University (RU) and an institution/organization that does not have an FWA. This agreement is only applicable to research that is non-federally funded involving non-profit community organizations in the local tristate area. This agreement outlines the responsibilities of RU and the community organization for the protection of human subjects. The CIA is signed by a representative who has the authority to make commitments on behalf of the organization and by the RU Institutional Official. For further information regarding this agreement, please contact the IRB Reliance Team at IRBrelianceteam@research.rutgers.edu.

Contrary to what the title implies, the Streamlined, Multi-Site, Accelerated Resources for Trials, or SMART IRB, is NOT an IRB, but rather an online system to facilitate reliance agreements, which are arrangements between institutions allowing the IRB of one or more institutions to rely on the IRB of another institution for the review of human subjects research in which they jointly seek to be engaged.

Rutgers is a member of SMART IRB and our researchers are welcome to review the resources found at its website to begin thinking through the framework for reliance it offers. Rutgers Human Subjects Protection Program is currently crafting policies to harmonize with SMART IRB to best serve the needs of our research community and will post guidance documents soon. Until that time, contact Rutgers HSPP Unit with questions about the SMART IRB Portal.

Procedure HRP-893 establishes the process when Rutgers University IRB serves as the IRB of Record for an External IRB. In addition, the Human Research Protection Program Toolkit contains documents required to establish a reliance agreement when an External IRB is relying on Rutgers University to serve as the IRB of Record.

For Rutgers to cede review to an external IRB serving as the IRB of Record, a designated Rutgers Principal Investigator is required to submit an Administrative Review application for IRB review and execution of a reliance agreement.

If an IAA is used, forward the agreement to Minna Pak (minna.pak@duke.edu) for review by Duke. If acceptable, the DUHS IRB will sign the reliance agreement and return it to the Duke study team to facilitate the full execution by the external IRB. If unacceptable, the DUHS IRB will red-line revisions to the draft agreement and return to the Duke study team to facilitate the review by the external IRB.*

Important to note: Before the reliance agreement (IAA or SMART IRB) can be signed by the DUHS IRB, the Duke study team must complete and submit a New Study Application in iRIS and choose the external IRB pathway in the "Protocol Application Type" section of iRIS. List all normally required institutional reviews in the submission form and submit. This ensures that the DUHS IRB has enough information to assess whether to cede or not, and to begin the process of obtaining ancillary reviews (for example, CRU and applicable specialty committees).

As knowledge of cell metabolism has advanced, glutamine has been considered an important amino acid that supplies carbon and nitrogen to fuel biosynthesis. A recent study provided a new perspective on mitochondrial glutamine metabolism, offering mechanistic insights into metabolic adaptation during tumor hypoxia, the emergence of drug resistance, and glutaminolysis-induced metabolic reprogramming and presenting metabolic strategies to target glutamine metabolism in cancer cells. In this review, we introduce the various biosynthetic and bioenergetic roles of glutamine based on the compartmentalization of glutamine metabolism to explain why cells exhibit metabolic reliance on glutamine. Additionally, we examined whether glutamine derivatives contribute to epigenetic regulation associated with tumorigenesis. In addition, in discussing glutamine transporters, we propose a metabolic target for therapeutic intervention in cancer.

A reliance agreement may be required when you are collaborating with researchers external to UNC who are engaged in non-exempt human subjects research. This document, How to Request a Reliance Agreement, describes how to complete the IRBIS application to request one of the following:

The UNC Institutional Profile contains basic information about the UNC IRB and institutional processes and requirements when reliance agreements are being considered or negotiated with collaborating sites.

These are samples of the forms the IRB uses to document reliance arrangements. The UNC Reliance Team will be responsible for preparing these forms when specific reliance requests are made. They are provided here for informational purposes, and should not be completed by the study team unless during consultation with the Reliance Team.

IRB reliance is when an IRB agrees to rely on an external IRB for the review and approval of a study. For example, the VCU IRB typically relies on independent IRBs such as Advarra or WCG IRB for industry-sponsored research, and on the NCI Central IRB for cooperative group oncology studies.

As part of the IRB transformation process, VCU HRPP has expanded the types of studies that can utilize the IRB reliance process. Review the IRB review and reliance matrix that outlines which studies should be reviewed by an external IRB versus which should be reviewed by the VCU IRB.

To establish a reliance arrangement, the two IRBs must enter into a reliance agreement to document the arrangement. This agreement may be called a reliance agreement or an institutional authorization agreement (IAA). These agreements can be study-specific or a master agreement (i.e., an agreement that covers more than one study within VCU). Reliance agreements must be signed by an authorized institutional official (IO) or designee because the agreement is between institutions and not between investigators.

It is preferred that your reliance application is reviewed by the VCU reliance analyst before the study is approved by the external IRB, to ensure the consent form includes all the required VCU language. Some researchers find it time efficient to start the VCU and external applications simultaneously, but delay submitting to the external until after the initial VCU review. The reliance analyst will ensure the final consent includes all the required VCU language. 17dc91bb1f