505. Using an External IRB
External IRBs include central and commercial IRBs, and IRBs at external institutions where some or all of a research project will take place.
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 a 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).
Submission Requirements for University/Affiliate PIs to Conduct Exempt Research at an External Site
- Obtain an exempt determination from the external institution.
- Create a New Project in IRBNet.
- Add a Part I Cover Sheet, documentation of exempt review from the external site, and federal grant proposal and notice of award (when applicable) to the New Project in IRBNet.
- Obtain PI signature electronically through IRBNet. (NOTE: Responsible Official signature is not required for exempt research.)
- 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.
- For clinical investigations, the sponsor requests use of a central or commercial IRB as the IRB of Record.
- 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, or statement of work).
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, a University IRB is the preferred IRB of Record. However, the University recognizes there may be situations in which a University IRB must 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.
- University/Affiliate PIs planning research that may involve review by an external IRB must send an email to notify the RIO Director of their intentions (see the RIO website, Contact Us).
- The RIO Director or senior RIO staff will contact the PI to discuss the project and obtain information about the sponsor and the proposed IRB, as relevant.
- The RIO Director/staff will contact the sponsor or proposed IRB to determine if a University IRB could be the IRB of Record for the project.
- The RIO Director/staff will immediately 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 a University IRB Is Required
Review by both an external and a 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 the research;
- the sponsor requests use of a central or commercial IRB for multi-site research, but a University IRB determines local oversight is warranted (e.g., participant risk is extreme, the research involves highly regulated or toxic substances); or
- limited review by a University IRB is necessary to assess local context issues or concerns directly affecting the local community.
Submitting for Review by a University IRB or Dual Review
See the IRB policy for submission requirements for full committee or for expedited review when review by a 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
- Determine if an existing IAA applies or if a new IAA is required (see policy for IRB agreements).
- Use the Consent Form Checklist and adapt the sponsor/external IRB-prepared consent templates to include University/AAHRPP-required elements for informed consent.
- Comply with University training requirements.
- Comply with University or the Affiliate institution's conflict of interest disclosure requirements.
- Create a New Project in IRBNet.
- Add Part I, Cover Sheet.
- Add Request to Use External IRB form or WIRB cover sheet (only for clinical trials to be overseen by WIRB).
- Add the Consent Form Checklist and the adapted consent documents (or the consent documents approved by the IRB of Record).
- For federally-funded research, Add grant proposal and notification of award.
- Add the approval letter from the external IRB of Record if available at the time of submission. If not available until after University acknowledgement of the external IRB of Record, submit the external IRB approval in an Amendment package with a completed Amendment form.
- Obtain the PI's signature electronically through IRBNet.
- 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.)
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 must be stated in the external IRB's application (or protocol), the request to use an external IRB form, and the consent materials.
Consider the following example project and suggestion for an additional heading and language for consent materials 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. 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, and administration of a survey and an additional blood draw that are both 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 Materials 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].