Erica Online

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:

Please review the IRB guidance on conducting research with external institutions or entities according to the following topics:

Definitions

  • What is an external institution?
  • What does it mean to be affiliated with the University of Utah?
  • What is a lead site and lead investigator?
  • When is a site engaged in research?

When the University of Utah is the Lead Site

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

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Definitions

What is an External Institution?

The University of Utah definition of an External Institution is:

  • engaged in research
  • does not have a Memorandum of Understanding 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 with the University of Utah designating the University of Utah IRB as the IRB of record. Click here for a list of all institutions with a current MOU with the University of Utah.

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
  • the Principal Investigator is an employee or student at the University of Utah or any affiliated institution.

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.

When is a Site Engaged in Research?

Engaged in research means a site is conducting an activity that meets the definitions of Human Subject Research or a Clinical Investigation. Human subject research is defined by the Office of Human Research Protections (OHRP) in 45 CFR Part 46.102. A clinical investigation is defined by the Food and Drug Administration (FDA) in 21 CFR Part 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.

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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.

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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:

  1. Review and determination from an IRB
  2. 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.

Obtaining Documentation

The external site is engaged in research

All participating external sites which are engaged in research must have 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 attach the IRB approval or exemption letter for the external site to the application under "Other Documents.".

The external site is not engaged in research

If an external site is not engaged in research, the University of Utah investigator must attach the following documentation to the application under "Other Documents.":

  1. If the external site has an IRB, 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 an 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.

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When will the University of Utah be the IRB of record for external institutions?

The University of Utah IRB may review and approve a research project conducted at an external institution if the research is no more than minimal risk and there is no IRB of record for the external site.

In general, the University of Utah IRB does not function as the IRB of record for sites that have their own IRB.  The decision to act as the IRB of record in this situation will be made on a case-by-case basis by the University of Utah IRB in conjunction with the external institution.

The University of Utah may act as an IRB for an external institution where its activities are minimal risk. Under limited circumstances, the University of Utah will act as an IRB for an external institution where its activities are more than minimal risk; however, the University of Utah may require that the external institution obtain IRB review and approval from its IRB of record or an independent IRB.

If an External Institution does not have an IRB of record, the University of Utah IRB may determine that the research activities to be conducted at the external institution are eligible for exemption. The external institution would not need further IRB review for its activities. In this case, a letter supporting the study from the appropriate official/collaborator at the External Institution must be obtained and attached to the new study application under "Other Documents."

The IRB will make the final risk level determination for the study (i.e. more than minimal risk, minimal risk, exempt).

The following information is necessary if the University of Utah IRB agrees to act as the IRB or record for an external institution:

Is the study federally funded?

For Federally funded human subject research, all participating research sites must be in compliance with the policies and regulations established by the Office for Human Research Protections (OHRP). A Federal-wide Assurance (FWA) is an assurance of compliance accepted and approved by OHRP. The external institution must complete an FWA to conduct such research. For more information about FWAs or to submit an FWA, please visit the OHRP website.

In order for the University of Utah IRB to review and approve research for the external institution, the external institution must list our IRB on the FWA. To do this, the external institution must provide the following information in its FWA:

University of Utah Assurance Information

Assurance: FWA00003745 - U Utah
Panel 1 ID: IRB00000104 - U of Utah IRB #1
Panel 2 ID: IRB00000105 - U of Utah IRB #2
Panel 3 ID: IRB00000106 - U of Utah IRB #3
Panel 4 ID: IRB00000107 - U of Utah IRB #4
Panel 5 ID: IRB00006644 - U of Utah IRB #5

In conjunction with completing an FWA, the External Institution must sign an IRB Authorization Agreement to allow the University of Utah IRB to act as the IRB of record for the External Institution.

For research that is not federally funded, an FWA does not need to be completed. A Research Compliance Agreement must be signed to allow the University of Utah IRB to act as the IRB of record for an External Institution without an FWA. If the study is FDA regulated, the signatory officials of both institutions must sign. If the study is not FDA regulated, only the signatory official from the External Institution must sign.

Is the study subject to HIPAA regulations?

If the University of Utah IRB is to act as the IRB of record for an External Institution, where patients’ protected health information (PHI) will be disclosed from the External Institution to researchers at the University of Utah and/or its covered entity, the External Institution must sign a HIPAA Assurance Letter. This letter confirms that the External Institution will comply with the University of Utah IRB’s determinations regarding authorization for use of PHI. This letter must be signed by the External Institution’s HIPAA privacy officer (if applicable) or the signatory official.

Using a Waiver of Authorization

If a wavier of authorization is being requested to use patient records and data from the External Institution, a copy of the External Institution’s Notice of Privacy Practice must be attached to the application in ERICA under “Other Documents.” This will allow the IRB to verify that the External Institution has notified the patients that their PHI may be used for research purposes.

If the Notice of Privacy Practice does not inform the patients that PHI may be used for research purposes, a waiver of authorization may not be used unless the Notice of Privacy Practice is revised to include this stipulation and the patients sign the revised copy. Records and data cannot be used from patients who have not signed the revised copy.

If the Notice of Privacy Practice is not revised or the patients do not sign the revised copy, the Investigators obtain consent and authorization directly from each patient.

The External Institution must also complete an Information for Accounting of Disclosures Form signed by the External Institution’s signatory official or HIPAA privacy officer.

Using a Consent and Authorization Form

If authorization will be obtained from the patients through the External Institution, the consent and authorization document must be attached to the application in ERICA for review and approval by the IRB.

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What are the 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:

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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

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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

  • Unanticipated problems involving risks to participants or others
  • Interim results
  • Protocol modifications and amendments

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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)