For some multisite studies, investigators may, or must, have a single institutional review board act as the overseeing institutional review board. Keep reading for an introduction to the steps required for either a UAMS investigator to rely on an external institutional review board, or for the UAMS Institutional Review Board to act as the institutional review board of record for multisite research. Scroll to the bottom of this page to see some checklists and resources.
Definitions
- Local context form: The form relying research sites complete to provide site-specific information to the reviewing institutional review board
- Multisite study: A single human subject research project taking place at two or more distinct sites.
- Participating site: A site engaged in a multisite study.
- Reliance Agreement: A written agreement allowing an institution’s institutional review board to delegate its review of research to either another institution’s institutional review board or to an independent Institutional Review Board. The reliance agreement spells out each institution’s responsibilities. The reliance agreement must be finalized and signed before the research can begin. UAMS has a reliance agreement it can provide to sites relying on the UAMS Institutional Review Board (see also SMART IRB).
- Single / Central Institutional Review Board: A single institutional review board overseeing all sites involved in a multisite study. Also referred to as “xIRB,” “reviewing institutional review board,” or “institutional review board of record.”
- SMART IRB agreement: A prenegotiated reliance agreement that institutions can use to rely on each other for institutional review board review on a study-by-study basis. Hundreds of institutions, including UAMS, have signed on to the SMART IRB agreement. Participating institutions can use the SMART IRB agreement instead of site-specific reliance agreements.
Available Reliance Agreements
Reliance agreements, no matter which one you use, can be signed only by the institutional official or their designee.
- The SMART IRB agreement. This agreement is preferred when all study sites are SMART IRB signatories.
- Prenegotiated reliance agreements with certain institutional review boards, including the NCI’s institutional review board for oncology studies, and commercial institutional review boards including Advarra and Western Copernicus Group.
- The UAMS Reliance Agreement, which can be sent to sites wishing to rely on the UAMS Institutional Review Board if the SMART IRB agreement is not used.* Contact the UAMS Institutional Review Board office for information about this form.
- Other sites’ reliance agreements, which we can sign when we rely on another institution’s institutional review board.* Contact the UAMS Institutional Review Board office to arrange to use another site’s reliance agreement.
* Note that participating sites, including UAMS, may wish to have their legal offices review reliance agreements that have not been previously approved, which can lengthen the approval process.
Requesting external institutional review board review by a non-UAMS institutional review board
Whether you wish to rely on an external institutional review board or use the UAMS Institutional Review Board as the institutional review board of record, please let the UAMS Institutional Review Board office know as soon as you can. Giving us plenty of advance notice will allow us to write any needed letters of support for the external institutional review board project, and work with the study team to make sure all the procedural requirements are met.
A few process highlights:
- We strongly prefer that the institutional review boards upon which UAMS investigators rely be accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Why? Because AAHRPP, our accrediting agency, strongly prefers that too. Accreditation is also an indicator of the quality of an institution’s human research protection program.
- All external institutional review board processes require the study team to submit a regular new submission in Clinical Research Administration (CLARA).
- If you’re relying on an external institutional review board, you’ll indicate that on the form, and add the name of the reviewing institutional review board.
- If the UAMS Institutional Review Board will be the institutional review board of record for a multisite study, you’ll indicate that as well. See below for more information on having the UAMS Institutional Review Board be the overseeing institutional review board.
- Why do I need to complete a CLARA new submission form if I’m using someone else’s institutional review board? Remember, CLARA is the system used by multiple research offices, and not just the UAMS Institutional Review Board. Even if institutional review board review is delegated to another institution, the CLARA new submission form ensures the study done at UAMS undergoes all required institutional reviews, such as legal review, pharmacy, budget and coverage, etc. The documents to be included with a submission that is to be reviewed by an external institutional review board must include the study protocol, the signed reliance agreement, and the external institutional review board’s most recent approval letter, plus anything required by other UAMS oversight offices. The UAMS Institutional Review Board office will use CLARA to do what’s called a “local context review.” To complete the local context review, the following documents must be uploaded as well: the approved informed consent template, a copy of the local informed consent form and HIPAA authorization form, recruitment materials, and any questionnaires or other items the subjects will see.
While individual reliance agreements may differ, relying on a single institutional review board changes only the institutional review board part of the study approval process. Each site will remain responsible for ensuring the other requirements of its human research protection program are addressed.
The UAMS Institutional Review Board as the institutional review board of record for a multisite study
Two different scenarios are possible when UAMS acts as the institutional review board of record for a multisite study.
The first is when UAMS is the institutional review board of record and acting as a coordinating center, but will not be a study site itself, in that no UAMS investigators will enroll subjects, collect data, etc. In this scenario, you will submit a regular new submission in CLARA to describe the UAMS site’s role in the study. You’ll indicate that the project is a multisite study for which the UAMS Institutional Review Board is the institutional review board of record. You’ll describe the entire study in the form, e.g. the overall accrual goal, recruitment plans, where data will be sent, etc. Include all of the documents related to the study. Your new submission must include generic templates for the consent form, HIPAA authorization, and any other documents the participating sites will be allowed to amend for use at their site. You can list the sites you know will be participating in the appropriate section of the new submission form, but remember that you will still need to create a site addition form for each participating site after main study approval. Also, you will also need to get a signed reliance agreement from each participating site. The UAMS Institutional Review Board office staff can help you get the reliance agreements. Then, once the study goes through the full review process, and you have your IRB approval in hand, you can start adding site addition forms for each site. Remember, which each new site that’s added, you’ll include the signed reliance agreement, a copy of any completed local context form, and any site-specific documents, including the approved template documents that have been adapted for that site’s use.
The second is when UAMS is the institutional review board of record and also a participating site. Things can get a little confusing here — you may need to complete two full new submissions in CLARA. One will be for the institutional review board of record aspect, just like in the scenario above. Describe the overall study here, and include all of the generic study documents. Indicate that this is a multisite study for which UAMS will be the institutional review board of record. Then, once that’s approved, you can start creating the site addition modifications, except for the UAMS site. The UAMS site may require its own full new submission form, with all the site-specific documents, i.e., the template documents revised to fit the UAMS site. On this UAMS new submission form, please reference the IRB number of the overall study’s submission, so the reviewers can link up the two.
Why might you need two submissions when UAMS is both the institutional review board of record and a participating site? The second full submission for the UAMS site will ensure all of the ancillary reviews required for the UAMS site get completed and will list the study correctly in UAMS systems. Keeping the UAMS site on a separate submission will also keep the UAMS-specific documents separated from the study-wide documents, and will simplify making studywide modifications later. However, there may be other ways to achieve the same ends. Contact the IRB office for more information when you’re planning a study with UAMS being the IRB of record.
Remember — while the original CLARA submission process is going on, study teams, with the assistance of the UAMS Institutional Review Board’s external institutional review board coordinator, should start collecting the necessary information from the participating sites. This information can include sorting out which reliance agreement will be used and getting the reliance agreement approved and signed. Then, after main study approval, and after you receive the required paperwork from each site, you’ll submit a separate site addition modification form in CLARA to add each site. This UAMS Institutional Review Board blog post describes the process for getting a site added. Once the site is on the list, you’ll complete the site addition modification, unloading the site-specific consent form and HIPAA authorization, a copy of the signed reliance agreement, and a copy of the local site questionnaire, as applicable.
Resources
- UAMS Institutional Review Board Policy 2.3, Use of central institutional review boards, provides an overview of the external institutional review board process.
- Local site context questionnaire for sites that rely on the UAMS Institutional Review Board. You can ask sites to complete and return this form to you. You will submit each site’s completed form with the site addition modification adding that site.
- The Checklist for UAMS investigators relying on an external institutional review board was prepared to help UAMS investigators work their way through the external institutional review board process when they rely on an outside institutional review board.
- The Checklist for UAMS investigators leading a multisite study for which the UAMS Institutional Review Board is the institutional review board of record
- Information to help study teams complete local site information forms for external institutional review boards and sponsors This document contains the information typically requested on other institution’s local site context forms.
- Communication plan when the UAMS IRB is the reviewing IRB. This document shows how the reviewing IRB, the UAMS IRB, intends to communicate with relying sites. Note that while other arrangements may be made when negotiating a reliance agreement, this is our default plan.
Contact the UAMS Institutional Review Board office for more information and forms at irb@uams.edu.