590. Using an External IRB

Under specific conditions and only following IRB acknowledgement of a written request to use an external IRB, University or affiliate investigators may use an external IRB as the Reviewing IRB for research when >50% of research activities will take place at the external facility.

The principal investigator and all other University researchers involved in the research at the external site must have a formal association with the external institution (e.g., hospital privileges, contract or statement of work).

Requests to use an external IRB will be considered on a case-by-case basis. When research activities take place at both a University site (including UNSOM clinics) and the external institution, investigators may be required to submit an application for review by a University IRB and the external IRB, even if this results in multiple IRB reviews.

NOTE: See the next policy section for information about using WIRB as the reviewing IRB.

IRB Authorization Agreements

Federal regulations require a written agreement to allow one IRB to use (i.e., "rely on") another IRB as the Reviewing IRB for non-exempt human subject research. To streamline the process for University investigators to use an external IRB, the University has entered into non-specific IRB Authorization Agreements (IAAs) with IRBs at institutions where University or affiliate investigators commonly conduct research as follows: Mountain View Hospital (under the Sunrise Health IRB) (biomedical research only)

  • Renown Regional Medical Center in Reno, Nevada (biomedical research only)
  • Sunrise Health (biomedical research only)
  • University Medical Center of Southern Nevada (UMC) (biomedical research only)
  • University of Nevada, Las Vegas (UNLV) (social behavioral and biomedical research; agreement is reciprocal)

 

NOTE: These pre-existing IAAs do NOT preclude the need for University and affiliate investigators to obtain written acknowledgment from a University IRB to use an external IRB for a given research project.

A PI who wishes to use an external IRB that does not have an existing IAA with a University IRB may contact the Research Integrity Office to discuss the possibility of establishing an IRB Authorization Agreement.

Requesting Acknowledgement from a University IRB to Use an External IRB

1.      PIs must complete a request to use an external IRB, provide a copy of the proposed consent form, and electronically sign the request; obtain the signature of a University Responsible Official; and submit the request.

2.      If no IAA exists, RIO staff will work with a contact at the external institution to establish an agreement or confirm that an agreement will not be established. In the latter case, IRB review by both institutions will be required.

3.      PIs must specify in the request form and the consent materials, which research activities will take place at the external site and which will occur at a University site (e.g., UNSOM clinic).

4.      Following administrative review, the University IRB will notify the PI in writing of one of the following IRB decisions:

  • Acknowledge the request to use an external IRB; the PI may submit for review by the external IRB.
  • Request information or revisions to the consent materials before acknowledging the request.
  • Require the PI to submit to the University IRB for exempt determination, or review by expedited procedures or at a convened meeting, in addition review by the external IRB.

5.      If the request is acknowledged, the PI must submit the University IRB's acknowledgement with the application for review by the external IRB.

University IRB Acknowledgement of Approval from an External IRB

1.      The PI must provide the University IRB with a copy of the external IRB approval letter and the approved consent form.

2.      The University will provide the PI with written acknowledgement of the external IRB as the Reviewing IRB. NOTE: The research may not be initiated until the PI receives this final acknowledgment.

Consent for Projects that Involve Research Activities at Both External and UNSOM Sites

For an external IRB to be the Reviewing IRB, >50% of the research must occur at the external site but some research activities may take place at a University site. This commonly occurs due to the unique structure of the UNSOM whereby University faculty provide care at a University clinic but have privileges at one or more local hospitals. When this occurs, PIs must inform participants of the involvement of the University site in the research.

Suggested section heading and language for consent when some research activities will take place at a University site:

Additional Information about the Study Doctor:

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 the hospital which were described earlier (omit if all procedures are standard of care) and activities that will take place at the [insert name of clinic]. Researchers will use [information from your clinic records related to your follow-up visits and (describe additional activities that will occur at the UNSOM site if applicable)].

Examples of Projects that Involve Research Activities at Both External and UNSOM Sites

Example 1

A physician who is University faculty with privileges at a local hospital performs an experimental procedure at the hospital and obtains biological specimens from the procedure that would normally be discarded. The procedure requires follow-up visits that take place at a UNSOM clinic. The PI may add activities to the follow-up visit that are specific to the research (e.g., administration of a survey; additional blood draw; further analysis of tissue or blood obtained during the research procedure). In this example, the research would include the following components, all of which must be described in the appropriate sections in the request to an external IRB:

  1. experimental procedure at the hospital (which must be distinguished from standard of care);
  2. collection of information from the hospital records related to the procedure;
  3. collection of biological specimens from the procedure;
  4. collection of information from UNSOM clinic records for the related follow-up visits;
  5. administration, at the UNSOM clinic, of the research questionnaire; and
  6. addition, at the UNSOM clinic, of routine clinical procedures that will be conducted solely for the research (e.g., additional blood draw).

All six elements of the research would be described in the consent form, with clarification about which procedures will take place at the hospital and which, at the UNSOM clinic or lab. The consent form would address the following risks:

·        risks of the experimental procedure,

·        risks of confidentiality related to the collection of the hospital and clinic records, and the specimens, and

·        risks associated with the questionnaire and the additional (albeit routine) clinical procedure.

Example 2

A physician who is University faculty with privileges at a local hospital performs a procedure at the hospital which only involves standard of care. The procedure requires follow-up visits that take place at a UNSOM clinic that also represent standard of care. In this example, the research would include the following components, both of which must be described in the appropriate sections of the request to use an external IRB:

  1. collection of information from the hospital records related to the procedure; and
  2. collection of information from the UNSOM clinic records for the related follow-up visits.

The details about the procedure (including associated risks) would NOT be described in the consent form although an overview of the procedure may be included to provide some context for the research. The summary should specify that the procedure would be performed regardless of the research. The consent form would describe the processes and identify the sources for obtaining the research data. Risks associated with this research involve disclosure of the information from participants' medical and research records to unauthorized persons.

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