For some multisite studies, investigators may, or must, have a single IRB act as the overseeing IRB. Keep reading for an introduction to the steps required for either a UAMS investigator to rely on an external IRB, or for the UAMS IRB to act as the IRB 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 IRB
  • 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 IRB to delegate its review of research to either another institution’s IRB or to an independent IRB. 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 IRB (see also SMART IRB).
  • Single/Central IRB: A single IRB overseeing all sites involved in a multisite study. Also referred to as “xIRB,” “reviewing IRB,” or “IRB of record.”
  • SMART IRB agreement: A prenegotiated reliance agreement that institutions can use to rely on each other for IRB 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 IRBs, including the NCI’s IRB for oncology studies, and commercial IRBs including Advarra and Western Copernicus Group.
  • The UAMS Reliance Agreement, which can be sent to sites wishing to rely on the UAMS IRB if the SMART IRB agreement is not used.* Contact the UAMS IRB office for information about this form.
  • Other sites’ reliance agreements, which we can sign when we rely on another institution’s IRB. * Contact the UAMS IRB 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 xIRB Review by a non-UAMS IRB

Whether you wish to rely on an external IRB or use the UAMS IRB as the IRB of record, please let the UAMS IRB 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 xIRB 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 IRBs upon which UAMS investigators rely be AAHRPP-accredited. 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 xIRB processes require the study team to submit a regular new submission in CLARA.
  • If you’re relying on an external IRB, you’ll indicate that on the form, and add the name of the reviewing IRB.
  • If the UAMS IRB will be the IRB of record for a multisite study, you’ll indicate that as well. See below for more information on having the UAMS IRB be the overseeing IRB.
  • Why do I need to complete a CLARA new submission form if I’m using someone else’s IRB? Remember, CLARA is the system used by multiple research offices, and not just the IRB. Even if IRB 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 IRB must include the study protocol, the signed reliance agreement, and the xIRB’s most recent approval letter, plus anything required by other UAMS oversight offices. The IRB 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 IRB changes only the IRB 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 IRB as the IRB of record for a multisite study

Two different scenarios are possible when UAMS acts as the IRB of record for a multisite study.

The first is when UAMS is the IRB 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 IRB is the IRB 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 IRB 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 IRB of record and also a participating site. Things can get a little confusing here — you’ll actually complete two full new submissions in CLARA. One will be for the IRB 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 IRB of record. Then, once that’s approved, you can start creating the site addition modifications, EXCEPT for the UAMS site. The UAMS site will 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 do you need two submissions when UAMS is both the IRB 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.

Remember — while the original CLARA submission process is going on, study teams, with the assistance of the UAMS IRB’s xIRB 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 IRB blog item 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