Reliance Agreement: A formal, written document that provides a mechanism for an institution engaged in research to delegate institutional review board (IRB) review to an independent IRB or an IRB of another institution. Institutions that are engaged in human subjects research, where one institution will rely on the other institution’s IRB, must agree to the terms of the Reliance Agreement before research can begin.

Single IRB [sIRB]: An Institutional Review Board that oversees all sites participating in a multisite study.

Multisite: Under the NIH Single IRB Review policy, “multisite” is defined as two or more sites participating in non-exempt research.

SMART IRB: The SMART IRB master reliance agreement was created to harmonize and streamline the IRB review process for multisite studies. It enables reliance on a study-by-study basis, clearly defines roles and responsibilities of relying institutions and reviewing IRBs, and eliminates the need to sign reliance agreements for each study [e.g., a non-SMART IRB agreement].

Reliance Agreements

For cooperative research projects, a single institution is often able to serve as the designated “Reviewing IRB” for all (or some) of the study sites engaged in the research project. The Reviewing IRB assumes the primary responsibility for the IRB review and approval of all human subject research procedures for the study, including those at the IRB’s home institution as well as those taking place at the external relying institutions. When two or more institutions enter into an agreement to allow one institution’s IRB to serve as the Reviewing IRB for a collaborative study, this is called “reliance.”

UTA may serve as the Reviewing IRB or may serve as the Relying IRB depending upon the procedures and circumstances of each specific study and the funding source(s) involved. For NIH funded projects, the Final NIH Policy on the Use of a Single IRB for Multi-Site Research requires that all NIH-funded studies must select one institution to serve as the Single/Reviewing IRB, unless an exception is met under the Policy. For projects that are subject to the Common Rule, cooperative research projects must rely on a single IRB.

Reliance agreements may be required any time more than one institution is “engaged” in human subject research. The following scenarios require consideration of reliance:

1. Multi-Site Studies. If multiple sites will be engaged in the research, it will need to be determined in advance which IRB(s) will serve as the Reviewing IRB, and which institutions will Rely on the Reviewing IRB. Other IRBs can typically choose to Rely on the Reviewing IRB’s approval, or conduct their own IRB review. However, non-exempt research subject to the Common Rule or NIH-Policy is required to be reviewed by a single IRB unless an exception was approved under the grant, and research regulated by FDA is required to document any reliance in writing. For studies not subject to any of these requirements, institutions have discretion to use reliance or conduct their own IRB review for either a portion of the project (for example, the portion of work at their own site) or the full scope of the project. A protocol at UTA might include multiple reliance agreements from different sites. IRB Staff will help facilitate coordination with the other IRB Offices involved, but researchers should consider these options and requirements in advance of submission to ensure a smooth review process.
2. UTA Researcher as Protocol Personnel in a Non-UTA Study. When a UTA researcher will be engaged in research reviewed by an external IRB, their participation effectively “engages” UTA in the research as well. UTA researchers that will be engaged in any human subject research reviewed by an external IRB must submit a reliance request to UTA’s IRB. In this scenario, UTA is the Relying IRB.
3. Non-UTA Collaborator as Protocol Personnel in a UTA Study. When a non-UTA collaborator will be engaged in research reviewed by UTA’s IRB, their participation effectively “engages” their own institution in the research as well. If the research is subject to the Common Rule and/or is FDA regulated, inclusion of any non-UTA collaborators as protocol personnel would require documentation of reliance between UTA and the other institution. For research not subject to those requirements, institutional policies for reliance vary widely, therefore it is the responsibility of the non-UTA collaborator to contact their own IRB office to determine their institution’s requirements. IRB Staff will help facilitate reliance agreements when required. In this scenario, UTA is the Reviewing IRB while the non-UTA collaborator’s institution is the Relying IRB.

For Scenarios 1 or 2.

All reliance requests must be submitted as a new protocol (or as a Modification to an existing protocol) in the Mentis IRB System. Submissions must include the following items for each site/reliance request:

• Copy of approved protocol from the external IRB
• Copy of external IRB’s approval letter
• Documentation of UTA as an approved research site and/or documentation of the UTA researcher’s role in the study
• Other approved study documents including the consent form should also be made available to the IRB upon request
• For multi-site studies, an explanation of other institutions/IRBs involved and their status as a Reviewing or Relying IRB (or both) in the project

Once all information is received and reviewed, the UTA IRB office will reach out to the external IRB to establish reliance if required by regulation or the other institution’s policies.

For Scenario 3.

Researchers at UTA may add external collaborators who are engaged in the research as study personnel (i.e., when the non-UTA collaborator will be interacting or intervening with the human subject participants, or when they will be granted access to identifiable human subject data collected under the UTA IRB protocol). All Non-UTA personnel must be listed in a new protocol submissions or added to an existing protocol via a Modification in the Mentis IRB System. The following items must be provided in the submission for each non-UTA personnel:  

• A revised IRB protocol application form with Non-UTA Personnel listed (Section 1: Non-UTA Personnel).
• Upload the completed and signed Non-UTA Collaborator Form for each individual.
• Attach a copy of the non-UTA collaborator’s certificate of completion for Human Subjects Protection (HSP) Training taken within the past 3 years. The certificate may be obtained through the collaborator’s home institution, CITI, the NIH HSP training course, or OHRP HSP training course(free of charge).
• For clinical trials or FDA-regulated studies only, upload a copy of the non-UTA collaborator’s certificate of completion for Good Clinical Practice training taken within the past 3 years.
• For NSF-funded studies only, upload a copy of the non-UTA collaborator’s certificate of completion for Responsible Conduct of Research (RCR) Training taken within the past 4 years. The certificate may be obtained through the collaborator’s home institution, CITI, or UTA’s free version of RCR Training.
• For Greater than Minimal Risk or Full Board protocols only, non-UTA collaborators must review all of the information on the Conflict of Interest Process for PHS Subrecipients and Collaborators webpage and submit an email to Regulatory Services according to the webpage’s instructions. Upload a copy of this completion email to the request in Mentis. If the non-UTA collaborator has a Significant Financial Interest (SFI) to report, upload the non-UTA collaborator’s completed Subrecipient/Collaborator Disclosure Form.
• For protocols involving Protected Health Information (PHI), upload a copy of the non-UTA collaborator’s certificate of completion for HIPAA Training.
• For PHS Funded (or PHS-Compliant Agency) protocols only, upload a copy of the non-UTA collaborator’s certificate of completion for NIH’s Free Financial Conflict of Interest Training or equivalent taken within the past 4 years.
• For foreign collaborators only, upload a copy of the clearance email from Office of Research Security (they must be provided with the name(s) and institutions(s) of any foreign collaborators in order for them to perform a restricted party screening).

If a reliance agreement is required to cover the Non-UTA personnel’s engagement in UTA research, IRB Staff will facilitate the process with the collaborator’s institution.

For Non-UTA researchers listed on a UTA IRB protocol who are affiliated with an institution holding a Federalwide Assurance (FWA), the UTA IRB Office will reach out to the IRB Office at the non-UTA researcher’s home institution to initiate the reliance / reciprocity process if applicable. However, it is ultimately the responsibility of the Non-UTA researcher to comply with the policies and procedures of his/her home institution regarding the engagement of researchers in collaborative projects that have received IRB approval at an external institution. 

For non-UTA researchers listed on a UTA IRB protocol who are not affiliated with an institution that holds a Federalwide Assurance (FWA) for the Protection of Human Subjects with OHRP, UT Arlington is willing to extend the coverage of our FWA to cover the individual investigator provided that the non-UTA researcher has read, completed, and signed the Non-UTA Collaborator Form; has provided documentation of current Human Subjects Protection Training; and he/she understands and accepts the responsibility to comply with the standards and requirements stipulated in (a) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research; (b) the HHS regulations for the protection of human subjects at 45 CFR part 46; (c) the terms listed on the second page of the Non-UTA Collaborator Form; and (d) the UT Arlington IRB Standard Operating Procedures posted on the Regulatory Services website. 

When the UTA IRB will serve as the Reviewing IRB, reliance through an IAA is required when the study meets the definition of human subject research at all sites and is non-exempt research subject to the Common Rule, NIH-Policy, or FDA Regulations. When considering whether to rely on another institution, if the other IRB (domestic or international) does not have an active Federal Wide Assurance UTA’s IRB will not rely on the IRB and will conduct its own review. Search for the FWA status of an institution here. 

The three main methods of facilitating institutional reliance include reliance through standing reciprocity agreements, situational requests for reliance through IRB Authorization Agreements (IAA), or Smart IRB.  IRB Staff will determine the appropriate method for reliance:

1. Reliance through Standing Reciprocity Agreements:  UT Arlington is a participating institution in the UT System Statewide Master IRB Reciprocity Agreement. Per the terms of this executed agreement, reliance upon any of the participating institutions for IRB review is acceptable. IRB Staff will document use of the Standing Reciprocity Agreement during review of the submission.
2. Situational Requests for Reliance through IRB Authorization Agreements (IAA): In most cases where an executed IRB Reciprocity Agreement is not already in place between UTA and another institution, it is possible to manage reliance through an IRB Authorization Agreement (IAA) between IRBs when researchers from both institutions are engaged in a collaborative research project.
3. Situational Requests for Reliance through Smart IRB: If collaborating researchers belong to participating institutions, the Smart IRB Reliance Agreement can be used to establish reliance on a single IRB through the Smart IRB Online Reliance System.

IRB Staff will determine the appropriate reliance mechanism and facilitate the process with collaborating institutions/researchers. IRB Staff will document any reliance agreements during review of the submission. Reliance agreements must be executed before the collaborative research project can begin at the relying sites, and before Non-UTA personnel engage in the project.

It is important to note that institutions can choose not to participate in reliance arrangements, so it is essential that the UTA researcher reach out to Regulatory Services early in the collaborative process to determine whether it will be possible to request reliance upon another Reviewing IRB. Even if your collaborating researcher at another institution thinks that it will be possible, that does not mean that the IRB Office will necessarily agree with that determination.

UTA IRB Federalwide Assurance and Registration Information

• Federalwide Assurance (FWA)- FWA00001762
• IRB Registration (OHRP)- IRB00005768, IORG0001464

 

NIH Policy

Effective January 25, 2018, the NIH requires use of a Single IRB [sIRB] for the review of NIH-funded multisite studies where each site will conduct the same protocol involving non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program. This Policy applies to domestic sites only.

For more information: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-094.html

Revised Common Rule

Under the revised Final Rule governing human subjects protections approved by the DHHS in January 2017, most U.S. government funded cooperative studies that meet the criteria for non-exempt “human subjects research” and involve more than one site will also require sIRB review. 

For more information: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/finalized-revisions-common-rule/index.html

My human subjects research study is taking place at multiple sites or will involve collaborators from other institutions. How do I obtain IRB approval for this project?

Determining how to obtain IRB approval for these projects can get tricky, especially with other sponsor-specific rules such as the Final NIH Policy on the Use of a Single IRB for Multi-Site Research. Contact us at RegulatoryServices@uta.edu or by phone at 817-272-3723 to discuss the needs of your specific research project.

Tell me more about how the process for obtaining IRB approval for collaborative projects works.

For collaborative research projects, a single institution is often able to serve as the designated “IRB of Record” for all (or some) of the study sites engaged in the research project. The IRB of record assumes the primary responsibility for the IRB review and approval of all human subject research procedures for the study, including those at the IRB’s home institution as well as those taking place at the external relying institutions. When two or more institutions enter into an agreement to allow one institution’s IRB to serve as the IRB of Record for a collaborative study, this is called “reliance.”

UTA is often willing to serve as the IRB of Record for projects and may also serve as a Relying IRB depending upon the procedures and circumstances of each specific study and the funding source(s) involved. 

The two main methods of facilitating institutional reliance upon a single IRB of Record include standing reliance through reciprocity agreements, and situational requests for reliance through IRB Authorization Agreements (IAA).

1. Standing Reliance through Reciprocity Agreements:  UT Arlington is a participating institution in the UT System Statewide Master IRB Reciprocity Agreement. Per the terms of this executed agreement, reliance upon any of the participating institutions for IRB review is acceptable; however, before the collaborative project can begin, both the Reviewing IRB and the Relying Institution(s) must agree in writing that the Reviewing IRB will serve as IRB of record for each project and IRB protocol where reciprocity is requested. This agreement may be documented via email or another equivalent method, such as by the PI’s submission of the UT Centralized IRB Review form to the IRB of Record along with the initial IRB application.  
2. Situational Requests for Reliance through IRB Authorization Agreements (IAA): In most cases where an executed IRB Reciprocity Agreement is not already in place between UTA and another institution, it is possible to request reliance through an IRB Authorization Agreement (IAA) between IRBs when researchers from both institutions are engaged in a collaborative research project. Each individual study will be considered for reliance on a case by case basis; UTA can serve as either the IRB of Record for a collaborative study, or may rely on another institution to serve as the IRB of Record. When considering whether to rely on another institution, if the other IRB (domestic or international) does not have an active Federal Wide Assurance or AAHRPP accreditation the UTA IRB will not rely on the IRB and will conduct its own review. When the UTA IRB will serve as the IRB of Record, reliance through an IAA is required when the study meets the definition of human subject research at all sites and is non-exempt research subject to the Common Rule, NIH-Policy, or FDA Regulations. In either case, in order for the reliance to be effective, both the Reviewing IRB and the Relying Institution(s) must agree in writing that the Reviewing IRB will serve as IRB of record for the research procedures at all sites as described in the approved IRB protocol. This agreement may be documented via an executed IRB Authorization Agreement (IAA) or another equivalent effective method, such as via email between participating IRB Offices. Note that the IRB Authorization Agreement (IAA) must be executed before the collaborative research project can begin at the relying sites. 

It is important to note that institutions can choose not to participate in reliance arrangements, so it is essential that the UTA researcher reach out to Regulatory Services very early in the collaborative process to determine whether or not it will be possible to request reliance upon a single IRB of Record.  Even if your collaborating researcher at another institution thinks that it will be possible, that doesn’t mean that the IRB Office will necessarily agree with that determination.

What do I need to do to obtain UTA’s official approval for my research project that was approved at another University / Institution?

All UTA researchers who are engaged in research which has received IRB approval from an institution other than UT Arlington must submit the approval letter from the other IRB for each externally approved study in the electronic submission system as a new IRB protocol for official acknowledgement.  Other approved study documents such as the IRB protocol and consent form must also be provided to Regulatory Services upon request. 

What do I need to do to add a collaborator who is not from UTA to my approved UTA IRB protocol?

UT Arlington researchers may add researchers who are not affiliated with UTA as study personnel on their IRB protocols when necessary (i.e., when the non-UTA researcher will be interacting or intervening with the human subject participants for the purposes of the research study, or when they will be granted access to identifiable human subjects data collected under the UTA IRB protocol).  All non-UTA researchers must be clearly listed on the IRB protocol application forms and must complete and sign the Non-UTA Letter of Collaboration Form, which should be attached as part of the IRB protocol application. 

Additionally, the UTA investigator must attach a copy of the non-UTA collaborator’s certificate of completion for Human Subjects Protection Training taken within the past 3 years. The certificate may be obtained through the collaborator’s home institution, CITI, the NIH HSP training course, or OHRP HSP training course (free of charge).

For non-UTA researchers listed on a UTA IRB protocol who are not affiliated with an institution that holds a Federalwide Assurance (FWA) for the Protection of Human Subjects with OHRP, UT Arlington is willing to extend the coverage of our FWA to cover the individual investigator provided that the non-UTA researcher has read, completed, and signed the Non-UTA Letter of Collaboration Form; has provided documentation of current Human Subjects Protection Training; and he/she understands and accepts the responsibility to comply with the standards and requirements stipulated in (a) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research; (b) the HHS regulations for the protection of human subjects at 45 CFR part 46; (c) the terms listed on the second page of the Non-UTA Letter of Collaboration Form; and (d) the UT Arlington IRB Standard Operating Procedures posted on the Regulatory Services website. 

For non-UTA researchers listed on a UTA IRB protocol who are affiliated with an institution holding a Federalwide Assurance (FWA), the UT Arlington IRB Office will reach out to the IRB Office at the non-UTA researcher’s home institution in an attempt to initiate the reliance / reciprocity process.  However, it is ultimately the responsibility of the non-UTA researcher to comply with the policies and procedures of his/her home institution regarding the engagement of researchers in collaborative projects that have received IRB approval at an external institution.