Multi-Institutional or Collaborative Research

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).

Multi-Institutional Research

When UNT is one of the participating sites on a research study, with each site recruiting participants, consenting, and collecting data at their local institution, to combine for aggregate data analysis.

IRB Authorization Agreement (IAA)

A document, signed by institution officials, permitting one institution's IRB to cede review (institution B) to another institution's IRB (institution A) for a particular study involving human participants. In this way, only one IRB reviews and approves human subject research activities for both institutions, avoiding duplicative review and regulatory oversight. This is sometimes referred to as a “reliance agreement.”

Single IRB (sIRB)

A Single IRB ("sIRB) is the IRB of record, selected on a study-by-study basis, which provides the ethical review and related administrative coordination for all sites participating in a multi-institutional study and assumes responsibility for all human participant research compliance. Under the revised (2018) Common Rule, federally-funded multi-institution studies, with few exceptions, are required to use an sIRB for review and approval of cooperative studies conducted in the United States. This applies to all cooperative study application and contract proposals submitted on or after January 20, 2020. For NIH studies, a version of the sIRB requirement has been in effect since January 2018. For applications submitted on or after January 25, 2018, NIH-funded multi-institutional studies involving non-exempt research must use an sIRB, when the same protocol is used at multiple domestic study sites.

Unaffiliated Investigator

Any individual proposing to conduct research using any UNT property, facility, population, non-public information, or in collaboration with a UNT faculty, staff or student, who is not employed or affiliated with an institution that has an IRB covered under a Federal Wide Assurance (FWA). A researcher from another institution that has an IRB would not qualify under this definition.

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).

(If you are seeking an sIRB review for a federally-funded multi-institution studies, please reach out to untirb@unt.edu to discuss the process for identification of the appropriate sIRB.)

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.