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.

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.

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. 

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.