When you wish to rely on an external institutional review board, 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.
Use of an external IRB to for IRB review and oversight must be approved. Investigators who are approached by an outside investigator, sponsor, or central IRB to participate in a multi-site research study, and use their designated IRB for review, must complete a request form.
Please click here to access form
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).
- When 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.
- The external IRB may require you to complete a local context form. The IRB office can help you with this process.
- You will have to provide reliance agreement from the reviewing IRB. UAMS prefers to document reliance through the SMART IRB system, when possible.
- If you are not using a pre-approved IRB agreement, (i.e., reviewing IRB is providing their own) UAMS legal will likely have to review the agreement before it can be finalized.
- 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.
- 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.