What are the eligibility criteria that an institution must meet in order to participate in SMART IRB?
An institution must meet the following criteria in order to become a Participating Institution in SMART IRB:
1) If it conducts any human subjects research, regardless of funding source, the institution must maintain an Office for Human Research Protections (“OHRP”)-approved Federalwide Assurance (“FWA”). SMART IRB views maintenance of an FWA as a baseline indicator of an institution’s agreement to be accountable for the compliance of its human subjects research program with federal and ethical norms and standards. Additionally, the institution, by policy or otherwise, must require IRB review and provide institutional oversight of its human subjects research regardless of funding source or the scope of its FWA. Even when IRB review is not required, other institutional policies and oversight mechanisms should still exist and apply such that the exempt project is still under the “jurisdiction” of the institution and subject to its generally applicable standards. For example, many institutions provide in their policies that exempt research must still be in compliance with basic ethical standards, is subject to institutional/investigator conflict of interest policies, must be conducted in accordance with the institution’s HIPAA privacy/patient confidentiality policies, etc. These are just examples; the SMART IRB Agreement does not prescribe exactly what institutional oversight is required, just that there is some level of jurisdiction of the institution over the conduct of the project.
2) If it 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”). SMART IRB does not proscribe the nature of the assessment; it can be 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 Association for the Accreditation of Human Research Protection Programs (“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.
3) The institution must designate at least one individual (“Point of Contact”) who will serve as the contact person for the institution with respect to matters concerning the initial and ongoing implementation of the Agreement, including decisions about ceding particular research studies.
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