Does my institution need to be AAHRPP accredited in order to join SMART IRB?

No. If an institution has an IRB or is an independent IRB organization, then within the 5 years prior to joining SMART IRB, the institution must have undergone or have initiated an assessment of the quality of its human research protection program (“HRPP”). However, SMART IRB does not proscribe the nature of the assessment. There are many ways an institution might fulfill this criterion. It can fulfilled via a third-party assessment or a self-assessment; accreditation through an external organization, use of OHRP’s QA Self-Assessment Tool or FDA’s Self-Evaluation Checklist for IRBs, use of the AAHRPP Evaluation Instrument for Accreditation with self-documentation of satisfaction of requirements, or another approach with a comparable, comprehensive scope of review of the HRPP that includes assessment of the IRB are sufficient to meet this criterion. Depending on the scope of audit, an audit of the institution’s IRB by a federal agency, with no major issues identified and any minor issues corrected/resolved, may also be sufficient.

The Agreement provides that Participating Institutions may obtain information about how any other Participating Institution satisfied SMART IRB’s HRPP quality assessment requirement prior to determining whether to participate in a ceded review with that institution. Note: While OHRP no longer offers QA consultations as part of a Quality Assessment Program, completion of the OHRP QA Self-Assessment Tool (which is still available for use) is considered sufficient to satisfy this requirement.

If you have questions about fulfilling the eligibility criterion for assessing the quality of the HRPP and IRB, please connect with an ambassador or contact us.