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.

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

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:

  • All xIRB processes require the study team to submit a regular new submission in CLARA.
  • If the UAMS IRB is the IRB of record, your new submission should include templates for the consent form, HIPAA authorization, and any other documents the participating sites will be allowed to amend for use at their site. Also include copies of the forms to be used at the UAMS site. The IRB will review and approve the study as usual. Then, after 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. With that form, you’ll submit 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.
  • If UAMS will rely on an external IRB, the CLARA new submission form will ensure the study done at UAMS undergoes all required institutional reviews, such as legal review, pharmacy, budget and coverage, etc.

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.

 

Resources