Applies to: Agreement V3.0
No. Accreditation is one way to meet the HRPP quality-assessment criterion, not the only way. If your institution has an IRB or is an independent IRB organization, it needs to have completed or started an assessment of its human research protection program within the five years before joining. Any of these satisfies the criterion:
- AAHRPP accreditation, or a self-assessment using the AAHRPP Evaluation Instrument with documentation that the requirements are met
- OHRP's QA Self-Assessment Tool (still available even though OHRP no longer offers QA consultations)
- FDA's Self-Evaluation Checklist for IRBs
- A third-party assessment with a comparable, comprehensive scope that includes the IRB
- A federal agency audit of the IRB with no major findings and any minor findings resolved, depending on the audit's scope
The Agreement allows any Participating Institution to ask how another met this requirement before agreeing to a ceded review with it.
Questions about whether a particular assessment qualifies? Ask an Ambassador or email help@smartirb.org.
See also - What are the eligibility criteria?
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