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505. Using an External IRB

The University considers an external IRB to be any IRB that is not the University IRB (i.e., the local IRB*) including:

  • Independent IRB: a review board that is not owned or operated by the research organization for which it provides review services; an independent IRB may or may not charge for these services.
  • Central IRB: an IRB that provides review services for multiple sites participating in a clinical trial.

*Local IRB: an IRB that provides review only for the researchers of its organization. (For the University, this includes researchers at its Affiliate sites.)

NOTE: An independent IRB may act as a central IRB for multisite trials. However, the role of a central IRB can be filled by an institutionally based IRB or by a regional IRB formed by a consortium of institutions.

Regardless of the type of external IRB, University/Affiliate principal investigators (PIs) and student co-investigators cannot initiate any human subject research until the University Research Integrity Office (RIO) or the University IRB provides the PI with written acknowledgement

  • of an exempt determination by the external institution or
  • of the external IRB as the IRB of Record (see Policy Manual Definitions) and approval from the IRB of Record.

Submission Requirements for University/Affiliate PIs to Conduct Exempt Research at an External Site

University/Affiliate PIs planning to conduct research that is exempt under 45 CFR 46.101 or 21 CFR 56.104 (for FDA-regulated research) at an external site must complete the steps outlined below.

  1. Obtain an exempt determination from the external institution.
  2. Create a New Project in IRBNet.
  3. Add a Part I Cover Sheet and documentation of exempt review from the external site to the New Project in IRBNet.
  4. Obtain PI signature electronically through IRBNet. (NOTE: Responsible Official signature is not required for exempt research.)
  5. Submit the project for Administrative Review.

NOTE: IRB Authorization Agreements are not required for exempt research.

Exclusion of Requirement for University IRB Acknowledgement for CIRB Trials

Affiliate investigators using the NCI Central IRB (CIRB) for CIRB-reviewed cancer trials under another signatory institution are not required to request acknowledgment from the University IRB for these projects.

Criteria for University/Affiliate PIs to Use an External IRB for Non-Exempt Research

One of the following statements must be true for University/Affiliate PIs to use an external IRB for non-exempt research.

  1. For clinical investigations, the sponsor requests use of a central/independent IRB as the IRB of Record.
  2. For non-exempt research that will occur at or on behalf of an external institution, the external institution requests its IRB serve as the IRB of Record, and the University/Affiliate PI or student co-investigator is employed by or has a formal association or agreement with the external institution (e.g., hospital privileges, contract, statement of work, or employment).

University/Affiliate investigators planning to use an external IRB must submit a request to use an external IRB with the proposed consent document (revised to include University requirements for consent forms) through IRBNet. (See "Submission Requirements for New Projects Using an External IRB" below). Ideally, the request and proposed consent form are submitted to and acknowledged by the University IRB before the project is submitted for review by the external IRB.

Initial Assessment for Designation of an IRB

As noted in the IRB policy for designation of IRBs and in compliance with accreditation standards, when University/Affiliate PIs are engaged in non-exempt human research, the University IRB is the preferred IRB of Record. However, the University recognizes there may be situations in which the University IRB may cede review, thereby allowing an external IRB to be the IRB of Record. The RIO considers requests from University/Affiliate PIs to use an external IRB on a case-by-case basis as follows:

  1. University/Affiliate PIs planning research that may involve review by an external IRB notify the RIO Director of their intentions (see the RIO website, Contact Us).
  2. The RIO Director or senior RIO staff will discuss the project with the PI and obtain information about the sponsor and the proposed IRB, as relevant.
  3. The RIO Director/staff will contact the sponsor or proposed IRB to determine if the University IRB could be the IRB of Record for the project.
  4. The RIO Director/staff will inform the PI as to whether a University or the external IRB, or both IRBs will review the research.

Determination that Dual or Joint Review by an External and the University IRB Is Required

Review by both an external and the University IRB may be required when

  • research activities take place at both an external institution and a University/Affiliate site;
  • University/Affiliate faculty, students, or staff will be enrolled as participants in multi-site research;
  • the sponsor requests use of a central/independent IRB for multi-site research, but the University IRB determines local oversight is warranted (e.g., participant risk is extreme, the research involves highly regulated or toxic substances, local context issues are significant); or
  • limited review by the University IRB is necessary to assess/monitor local context issues or concerns directly affecting the local community.

Submitting for Review by the University IRB or Dual Review

See the IRB policy for submission requirements for full committee or for expedited review when review by the University IRB or dual review is required. See below for submission requirements when review by an external IRB is acceptable.

Submission Requirements when RIO Determines Review by an External IRB Is Acceptable

After RIO confirms review by an external IRB is acceptable the PI must complete the following steps.

  1. Determine if an existing IAA applies or if a new IAA is required (see policy for IRB agreements).
  2. Use the Consent Form Checklist and revise the sponsor/external IRB-prepared consent templates to include University/AAHRPP-required elements for informed consent.
  3. Comply with University training requirements.
  4. Comply with University or the Affiliate institution's conflict of interest disclosure requirements.
  5. Comply with applicable University/Affiliate-site requirements for review by local, ancillary committees (e.g., biosafety, radiation safety, pharmacy). Documentation of ancillary committee approval should be added to the project in IRBNet.
  6. Create a New Project in IRBNet.
  7. Add Part I, Cover Sheet.
  8. Add the Consent Form Checklist and the proposed consent document
  9. Obtain the PI's signature electronically through IRBNet.
  10. Submit the project to IRBNet for Administrative Review. (NOTE: The RIO Director may determine a request to use an external IRB requires Expedited or Full Committee Review.)

Submission of External IRB Approval Correspondence and Study Consent form
PI should submit the external IRB approval correspondence and approved informed consent form within sixty days of the initial submission, Request to Use External IRB, in IRBNet.

  1. Open the existing project in IRBNet.
  2. Create a New Package for the existing project, selecting Submission Type "Other."
  3. Add the external IRB of Record approval letter and approved consent document.
  4. Obtain the PI's signature electronically through IRBNet.
  5. Submit the project to IRBNet for Administrative Review.

As noted previously, the preferred sequence of events is for the University IRB to (1) confirm the proposed consent document complies with University requirements and acknowledge the external IRB as the IRB of Record BEFORE the project is submitted for review by the external IRB; and (2) after the external IRB approves the project, acknowledge the external approval, again by administrative review. If this order is reversed, the PI should attach the external IRB of Record approval letter and approved consent form when submitting the request to use an external IRB. Under these circumstances, the University IRB may require changes to consent documents approved by the external IRB if the documents don't comply with University requirements.

Requirements for Post-Approval Notifications to the University IRB

To enable the University IRB to ensure requirements for post-approval monitoring are met, University/Affiliate PIs conducting research reviewed by an external IRB promptly notify the University IRB of

  • the IRB of Record's approval for continuing reviews, including the regulatory requirement to assess interim findings that may affect the research;
  • the IRB of Record's determinations of noncompliance, unanticipated problems, and suspension of termination of the IRB approval or investigators involvement in the research; and
  • local, unexpected and related serious adverse events (SAEs) and study closures.

Notifying the University IRB of the External IRB's Approvals for Continuing Review

For the duration of the research, University/Affiliate PIs must promptly provide the University IRB with documentation of each continuing review approval from the external IRB of Record.

  1. Open the existing project in IRBNet.
  2. Create a New Package for the existing project, selecting Submission Type "Other"
  3. Add documentation of IRB approval for each continuing review.

Notifying the University IRB of the External IRB's Determinations of Noncompliance, Unanticipated Problems, or Suspension/Termination of IRB Approval or Investigator's Involvement in the Research

For the duration of the research, University/Affiliate PIs must promptly provide the University IRB with documentation of each determinations of Noncompliance, Unanticipated Problems, or Suspension/Termination of IRB Approval from the external IRB of Record.

  1. Open the existing project in IRBNet.
  2. Create a New Package for the existing project, selecting Submission Type "Other."
  3. Add documentation of the IRB of Record's determination.

Notifying the University IRB of Local, Unexpected and Related SAEs

  1. Open the existing project in IRBNet.
  2. Create a New Package for the existing project, selecting Submission Type "Other."
  3. Add problem report form or other document describing the local, unexpected and related SAE.

Notifying the University IRB of Closure of Projects Overseen by External IRB of Record

University/Affiliate PIs must promptly notify the University IRB of closures of research projects that are overseen by an external IRB of Record.

  1. Open the existing project in IRBNet.
  2. Create a New Package for the existing project, selecting Submission Type "Other."
  3. Add notification of closure.

Submission Requirements for University/Affiliate PIs to Conduct Research using Western Institutional Review Board (WIRB) as the External Site

University/Affiliate PIs planning to conduct research that is under 21 CFR 56.104 (for FDA-regulated research) at WIRB must complete the steps outlined below. PI will have all WIRB submissions in IRBNet archive.

  1. Create a New Project in IRBNet; go to Select Library, click on Western Institutional Review Board (WIRB) Puyallup WA-documents for Researchers
  2. Add a Part I Cover Sheet
  3. Obtain PI signature electronically through IRBNet.
  4. Submit the project for Administrative Review.
  5. RIO staff will forward to WIRB.  WIRB accepts the transmission via IRBNet as local policy review and approval.

When a Project Involves Research Activities at Both External and University/Affiliate Sites

A single research project may involve activities that occur at an external site with its own IRB and other activities that occur at a University/Affiliate site, or vice versa. Such research may be overseen by a single IRB as long as the PI describes all of the research activities and specifies which activities will take place at the external site and which, at the University/Affiliate site. This information should be provided to the external IRB, and must be specified in the request to use an external IRB form and consent and HIPAA documents (as relevant).

Consider the following example project and suggestion for an additional heading and language for consent documents for research that involves activities at both an external and University/Affiliate site.

Example Project Involving Research Activities at Both External and University/Affiliate Sites

A physician is University faculty with privileges at a local hospital and a practice at a University/Affiliate clinic. As the PI for a research project, the physician performs an experimental procedure at the hospital. The physician-PI obtains biological specimens from the procedure which would normally be discarded, for further analysis at her/his clinic for research purposes. The experimental procedure requires follow-up visits that take place at the physician-PI's clinic. The follow-up visits include standard-of-care for the procedure with the outcome data used for the research; and administration of a survey and an additional blood draw which are specific to the research. The following research activities must be summarized in the request to use an external IRB, and described in the consent and HIPAA documents:

  • experimental procedure at the hospital (which must be distinguished from standard-of-care);
  • collection of information related to the procedure from participants' hospital records;
  • collection and analysis of biological specimens from the procedure;
  • collection of information from clinic records for the related follow-up visits;
  • administration at the clinic of the research questionnaire; and
  • additional blood draw at the clinic for the research.

Additionally, the consent form must describe the risks related to

  • the experimental procedure and standard-of-care;
  • privacy and confidentiality due to the collection and use of information from hospital and clinic records, and the specimens; and
  • the questionnaire and additional blood draw.

Suggested Heading and Content for Consent Documents for Project Involving Research Activities at both External and University/Affiliate Sites

Additional Information about the Study Doctor and Study Locations
The physician performing [insert name of procedure] has hospital privileges at [insert name of hospital] and is a faculty member at the [specify: University of Nevada, Reno or University of Nevada School of Medicine]. This research includes activities that will take place at both the hospital and the [insert name of clinic]. Activities that will take place at the hospital include the [summarize or list] and activities that will take place at the clinic include [summarize or list].

[When applicable, add: The study doctor will also use information from your clinic records for the research, including [specify the information to be obtained from clinic records].

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