All investigators on a study team who are “engaged” in human subjects research must be covered by an IRB approval regardless of their affiliation with UTRGV. An entity becomes “engaged” in human subjects research when its employees or agents:

1. intervene or interact with living individuals for research purposes, or
2. obtain individually identifiable private information for research purposes.

Note: An entity is automatically considered to be “engaged” in human subjects research whenever it receives a direct DHHS award to support such research.

Federal regulations from DHHS and FDA [45 CFR 46.114 and   21 CFR 56.114] allow one IRB to defer oversight to another. This reduces the need for multiple review efforts by IRBs on a single study. The name for this process is ‘IRB reliance’ or ‘Single IRB’.

UTRGV is a SMART IRB participating institution. SMART IRB is a platform designed to ease common challenges associated with initiating multisite research and to provide a roadmap for institutions to implement the NIH Single IRB Review policy (effective date: January 25, 2018). Freely available for institutions and investigators, SMART IRB is an integrated, comprehensive platform that allows flexibility in the size and scope of collaboration to enable IRB reliance for multisite studies across the nation, regardless of funding status.

There are two instances whereby a reliance agreement would not be used:

1. Collaboration with an international entity – which typically use either International IRBs or Ethics Review Committees (ERCs).
2. Collaborative research projects that have been determined or qualify for exempt level review.

NOTE: When an IRB decides to provide the oversight for a project, they become the IRB of record. When an IRB decides to defer oversight for a project, they become the relying IRB.

UTRGV IRB may defer oversight to an external institution:

1. To meet a sponsor requirement – e.g., complying with NIH Single IRB requirement.
2. When an outside investigator is serving as the Principal Investigator.
3. When an outside investigator is conducting most of the research.
4. When the research site is located at another institution (non-multisite research).

UTRGV IRB may serve as the IRB of record:

1. To meet a sponsor requirement.
2. When UTRGV is the award recipient (required).
3. When the Principal Investigator is an employee or agent of UTRGV.
4. When UTRGV is identified as the only research site.

If an external institution wants to defer oversight to UTRGV, the following steps should be followed (this is most commonly used for UTRGV initiated research projects):

1. A UTRGV IRB application must be submitted to the UTRGV IRB for review. As part of the application collaborative efforts should be explained and a request for the external institution(s) to rely on UTRGV IRB should marked on the application.
2. The Office of Research Compliance staff will make the determination about whether or not the external entity is “engaged” in human subjects research upon conducting their administrative review of the project application.
3. If the determination is made that the external institution is “engaged” in human subjects research, an agreement is formalized through the use of an IRB Authorization Agreement (IAA).

If an external institution will serve as the IRB of record, the following steps should be followed (this is most commonly used for externally initiated research projects):

1. Send an email to the UTRGV IRB (IRB@utrgv.edu) with a brief description of the project and how UTRGV will be involved. This description should include what our agents or employees will do as part of the research.
2. The email should also provide a copy of the approved IRB application and approval letter from the external institution. In some cases, the external PI may have already discussed this reliance process with his/her IRB and a drafted agreement may be ready to be sent to UTRGV for execution. If this applies, the drafted agreement should also be attached to the email.
3. The Office of Research Compliance staff will evaluate whether an agreement can be used for the project.
4. The agreement is formalized using an IAA or other equivalent agreement. The external IRB is then added to the UTRGV’s Federal Wide Assurance (FWA).

Collaborative Research on Exempt Level Projects

If the project you are collaborating on is determined to be exempt by an external institution, we would be not able to set up a reliance agreement. Instead, our agents or employees will need to submit an IRB application to the UTRGV IRB for exemption determination. Upon receipt of this determination, our agents or employees may begin their involvement.

If your project at UTRGV is determined to be exempt, the external researchers whom you have chosen to collaborate with will need to obtain their own exempt determination from their IRB.

Collaborative Research with Non-affiliated Individuals

When a non-affiliated individual investigator (whether an independent investigator or an institutional investigator) is engaged in human participant research, the UTRGV IRB may choose to extend its FWA to cover that individual’s activities. In such cases, an Individual Investigator Agreement (IIA) outlining the terms and conditions of this arrangement must be executed by individual instigator and later the intuitional official (IO) at UTRGV which an IRB Coordinator will facilitate. The executed IIAs are maintained by the Office of Research Compliance.