Conducting Research with External Institutions

It is the responsibility of the IRB to ensure that the research conducted at external institutions or entities receives appropriate approval and oversight. This includes national multi-center trials as well as local studies involving sites external to the University of Utah or its affiliate institutions. This guidance is based on the following regulations and policy:

Definitions

What is a "Lead Site" and "Lead Investigator"?

  • A lead site is one that initiates or manages a research study involving multiple sites that conduct research procedures for the study. A lead investigator is one who oversees the operations of the study at the lead site and is ultimately responsible for coordination, management, reporting, and regulatory requirements between the multiple sites.

What is an "External Institution"?

  • The University of Utah definition of an External Institution is an institution, site, etc. that:
    • Is engaged in research according to federal guidance; and
    • Does not have a Memorandum of Understanding (MOU) with the University of Utah; and,
    • Is not part of the University of Utah or the University of Utah Health Sciences Center, including Associated Regional & University Pathologists (ARUP), Eccles Institute of Human Genetics, Huntsman Cancer Institute, Moran Eye Center, and all other centers and clinics managed by University Health Care and all main campus departments.

What does it mean to be "affiliated" with the University of Utah?

  • Affiliated institutions have a Memorandum of Understanding (MOU) with the University of Utah designating the University of Utah IRB as the IRB of record.
  • The University of Utah IRB has the authority to review and approve studies:
    • That are conducted at the University of Utah or any affiliated institution; or
    • Where the Principal Investigator is an employee or student at the University of Utah or any affiliated institution.

When is a site "Engaged in Research?"

  • Engaged in research means a site is conducting an activity that satisfies the federal definition of “Human Subject Research” or a “Clinical Investigation”. Human subject research is defined by the Office of Human Research Protections (OHRP) (45 CFR 46.102). A clinical investigation is defined by the Food and Drug Administration (FDA) (21 CFR 50.3(c)).
    • If the study is DHHS funded, all participating sites are considered “engaged in research” regardless of their activities.
    • If an external site does not have an IRB of record, the University of Utah IRB can determine whether the research activities to be conducted at the external site meet these definitions.

Lead Site

The application of this guidance largely depends on whether the University of Utah is serving as the lead site for the study. The IRB will need different information based whether we are responsible for all sites, or just our own.

When the University of Utah is the Lead Site:

  • What is the lead investigator responsible for?
  • Do external sites need IRB review?
  • When will the University of Utah IRB be the IRB of record for other external institutions?
  • What are the Sponsor-Investigator requirements (for investigator-initiated drug and device trials)?
  • What information does the investigator need to provide to the IRB regarding the external sites?

When the University of Utah is not the Lead Site

  • What is the local investigator responsible for?
  • What information does the investigator need to provide to the IRB regarding the external sites?

What is the Lead Investigator Responsible for?

  • The lead investigator has ultimate responsibility for the following actions and activities at the University of Utah and all participating external sites:
    1. the conduct of the study
    2. the ethical performance of the project
    3. the protection of the rights and welfare of human participants
    4. strict adherence to the study protocol and any stipulations imposed by the University of Utah Institutional Review Board
    A lead investigator fulfills these responsible by adhering to the requirements outlined in the Investigator's Statement of Assurance. The lead investigator must have a management and communication plan in place between all of the participating external sites to ensure that the lead investigator is always aware of information that may be relevant to the protection of research participants, such as:
    • Unanticipated problems involving risks to participants or others
    • Interim results
    • Protocol modifications and amendments
    A lead investigator must also ensure each site is adequately equipped to handle safety concerns.

Do External Sites need IRB Review?

  • The University of Utah IRB must ensure that all participating external sites provide documentation of the following, as appropriate for the activities conducted at each site:
    • Review and determination from an IRB
    • If necessary, research project support from the appropriate institutional officials/collaborators
    Only an IRB can determine the level of review that is needed for the activities conducted at each site. Many external sites have their own IRB of record and can obtain review and determination. Other sites, such as local clinics or schools, may not have their own IRB and may need to obtain review and determination from a private IRB or another IRB that will agree to act as the IRB of record for their site. Research at an external site cannot begin until the appropriate documentation is obtained.

Sponsor-Investigator Requirements

A sponsor-investigator is someone who both initiates and actually conducts a clinical investigation. The sponsor-investigator may conduct the research alone or with other investigators and external sites.

Investigators who conduct studies involving an FDA test article and for which they hold the IND or IDE must abide by the same regulatory requirements as any other sponsor. For example, the FDA will hold the investigator to the same regulatory requirements as if they were an industry sponsor, regardless of whether the investigator has the same resources.

For all requirements, please reference the following IRB guidance and templates:

What information does the investigator need to provide to the IRB about external sites?

  • The following information must be provided with each new study application for studies with multiple sites, where the University of Utah is the lead site:
    • Contact information for the sponsor and CRO, if applicable
    • Contact information for each participating external site
    • A description of the activities to be conducted at each site
    • If the lead investigator is a Sponsor-Investigator, all required documents as stipulated by the requirements above
    • An IRB approval letter or a letter of support for each participating external site, as stipulated by the requirements above
    • If the University of Utah is to act as the IRB of record, all required documents as stipulated by the requirements above

What is the local investigator responsible for?

  • The local investigator has ultimate responsibility for the following actions and activities at the University of Utah:
    1. the conduct of the study
    2. the ethical performance of the project
    3. the protection of the rights and welfare of human participants
    4. strict adherence to the study protocol and any stipulations imposed by the University of Utah Institutional Review Board
    A local investigator fulfills these responsibilities by adhering to the requirements outlined in the Investigator Statement of Assurance. The local investigator should ensure that there is a management and communication plan in place with the lead site or sponsor for the reporting of important information, such as
    1. Unanticipated problems involving risks to participants or others
    2. Interim results
    3. Protocol modifications and amendments

What information does the investigator need to provide to the IRB about external sites?

  • The following information must be provided with each new study application for studies with multiple sites, where the University of Utah is not the lead site:
    • Contact information for the sponsor and CRO if applicable
    • Contact information for the lead site (this may be the sponsor)

Documentation of IRB Determination

If the External Site is "Engaged in Research"

  • All participating external sites which are engaged in research must seek review and approval or exemption from an IRB. An IRB will then determine the level of review that is needed based on the activities and risk level of the study.
  • The University of Utah investigator must retain the IRB approval or exemption letter for the external site in the research record.  In rare cases, the University of Utah IRB may ask for this documentation to be attached in ERICA.

The External Site is Not "Engaged in Research"

  • If an external site is not engaged in research, the University of Utah investigator must obtain the following:
    1. If the external site has its own IRB of record, a letter from the external site's IRB indicating that the site's activities do not meet the definition of human subject research or a clinical investigation.
    2. If the external site does not have its own IRB, a letter of support from the appropriate official(s)/collaborator(s) at the external site, indicating that the research will be permitted at the site.

Investigators are responsible for retaining documentation of permission that has been obtained in the research record.

University of Utah IRB as the IRB of Record for an External Site

The UUIRB may serve as the IRB of record in the following situations:

  • The UUIRB may review and issue approval or exemption of research conducted at an external institution if there is no other IRB of record for the external site.  
  • The UUIRB may act as a Central IRB (CIRB) to review and issue approval or exemption of research conducted at external institutions in order to avoid duplication of effort across multiple institutions.  

The UUIRB may serve as the IRB of record for a single project or multiple projects at an external institution. Those interested in having the UUIRB serve as the IRB of record must contact the UUIRB to initiate the process. 

Visit Alternative IRB Review Arrangements for the procedure to designate the UUIRB as the IRB of record.