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The UNT IRB defines its scope of oversight jurisdiction to include studies falling in the following categories:

  • Human subjects research conducted at UNT
  • Human subjects research conducted by, collaborating with, or initiated by UNT faculty, staff, or students.
  • Human subjects research conducted with the use of UNT resources, including recruitment of UNT faculty, staff, or students.

All projects that fall within the categories noted above must be submitted to the UNT IRB for review and approval.

Collaborative/multi-institutional research is research conducted in conjunction with an institution or with personnel not affiliated with UNT.

When UNT researchers plan to participate in a collaborative or multi-institutional study, there are a few options for IRB oversight of the project. Determining the best strategy depends on several factors, including:

  • Funding agency requirements;
  • Potential risk to participants;
  • The nature of the research activities;
  • The location of research activities; which other institution(s) are involved;
  • The internal processes and policies required at each collaborating institution. 

Due to the variable nature of human subjects research activity, studies and situations are reviewed on a case-by-case basis.

Before you begin the process of seeking IRB approval for multi-institutional or collaborative research, contact the IRB office to discuss your situation and to find the best solution for your research study.

The guidance below applies to domestic human subjects research studies. If you are performing international collaborative or multi-institutional research, please contact the IRB office. Alternative guidance, including the International Compilation of Human Research Standards, will apply.

Definitions

Collaborative Research

When non-UNT researchers work with UNT researchers to conduct an aspect of a single human subjects research study (for example- data collection or data analysis).

Institutions with an IRB

If you are performing research with a group that is affiliated with an Institution that has an IRB, the following are options for approval:

Separate/Multiple IRBs Review

In some cases, it is most efficient for researchers from each participating institution to obtain IRB approval from their own institution's IRB, covering any regulated human participant activities that will occur at their site. This will almost always be the case when research is reviewed and issued an Exempt category of review from the IRB.

One IRB Reviews

In some situations, to avoid duplicative reviews and increase efficiencies, the UNT IRB will consider acting as the IRB of record or will cede IRB review to another institution's IRB. The IRB at each participating site will need to formally cede their IRB review to the reviewing IRB using a fully-executed IAA.

When UNT IRB is acting as the reviewing IRB, UNT training requirements apply. Likewise, if another institution is reviewing your project, you will need to comply with that institution's training requirements. When UNT cedes IRB review to another institution's IRB, the UNT Principal Investigator is responsible for ensuring compliance with any ancillary reviews (for example-Biosafety or Radiation Safety review).

Single IRB- SMART IRB

  • The Streamlined, Multisite, Accelerated Resources for Trials IRB Reliance platform (SMART IRB), is designed to harmonize and streamline the IRB review process for multisite studies while ensuring a high level of protection for research participants. SMART IRB is not an IRB, but a master reliance agreement with many participating institutions.  The SMART IRB master reliance agreement replaces the need to have an individual Institutional Authorization Agreement (IAA).
  • The University of North Texas is a participating institution of SMART IRB and this method can be utilized to complete the reliance process for a study being conducted with another SMART IRB participating institution. Please review the list of Participating Institutions to see if your collaborator is a member of SMART IRB. Additional resources are available on the SMART IRB Learning Center webpage.
  • If you would like to use SMART IRB to enter an agreement for a multisite study, please email untirb@unt.edu.

Institutions without an IRB

If you are performing research with a group that is affiliated with an Institution that does not have an IRB:

Unaffiliated Investigator Agreement

UNT IRB is supportive of human subjects research conducted with Unaffiliated Investigators, while at the same time being mindful of risk/liability concerns and the impact on UNT resources. All Unaffiliated Investigators listed on a UNT IRB application must sign an Unaffiliated Investigator Agreement. This agreement must also be signed by the Principal Investigator.

Unaffiliated Investigators may not serve as Principal Investigator or Co-Principal Investigator on any UNT IRB approved human subjects research study. Unaffiliated Investigators are subject to the same education, training, and human subjects research requirements as UNT affiliated Researchers.

To obtain an Unaffiliated Investigator Agreement, the Principal Investigator must contact Research Integrity and Compliance by emailing untirb@unt.edu. Once complete, the Unaffiliated Investigator Agreement must be uploaded to the IRB submission portal for review with the research study submission.

Take Action

Please reach out to the IRB at untirb@unt.edu if your research qualifies as a collaborative or multi-institutional study. The UNT IRB staff will provide guidance on how to proceed with identifying the best course of action. Studies and situations will be reviewed on a case-by-case basis.