55 - Audit of Multi-Site Research (MSR) Studies Subject to a Single IRB (sIRB) Mandate

Background: : There are federal mandates and policies that require sIRB review of federally funded MSR studies. The HRPP QA/QI unit at University A created an auditing framework to audit MSR studies where University A is the sIRB, and a federal sIRB mandate applies.

Program

Description: : The audit is designed to determine compliance with the NIH sIRB Policy and the Revised Common Rule Cooperative Research sIRB Mandate. The scope of the audits is limited to research where University A is the sIRB and a federal sIRB mandate applies.

The audit includes a remote audit of University A investigator’s compliance with additional responsibilities when serving as the sIRB and an audit of the participating site(s) compliance with regulatory requirements, the IRB approved protocol, and local context, as applicable. The audit includes a regulatory audit, an interview with the PIs and key study team members, and an audit of research records at each site. The interviews and audit of research records are conducted remotely.

Since the implementation of this auditing framework, the QA/QI unit has audited seven sIRB studies. These audits represent an audit of compliance across 17 total sites, including University A.

Program

Assessment: : The audit framework has been successful in establishing a mechanism for University A to conduct remote audits of multiple participating sites and to report audit findings with stakeholders at each participating institution. Audit reports are shared with HRPP Leadership for awareness and input. Presentations on audit findings and process are also shared with the QA/QI program’s Advisory Committee for feedback and input. In addition, PI feedback is solicited using surveys.

The audits have identified areas for improvement in the sIRB review process at University A and in compliance for investigators at University A with the unique requirements of sIRB. For example, audits have led to the implementation of improved or additional guidance regarding navigation of the multi-site and participating site IRB applications, the process for correctly amending consent documents at the study and site level, and PI reporting obligations to the sIRB. In addition, based on audit findings, the QA/QI unit started offering a study start up consult service to investigators with newly approved MSR studies to assist them in implementing their sIRB responsibilities.

Limitations:: sIRB audits are complex, time consuming, and require more resources than an audit of just University A. Scheduling interviews and audit of research records proved challenging with multiple participating sites because scheduling conflicts led to delays between site interviews, requiring the responsible QA/QI staff person to reorient themselves with the study at each interview. Additionally, local context considerations and different institutional requirements and access to systems made auditing of records challenging.

Discussion: : Currently, audits of sIRB studies represent a small percentage of the QA/QI unit’s audit portfolio, but there are plans to increase the number of sIRB audits conducted due to increasing requests to function as the sIRB. The QA/QI unit is also modifying the sIRB audit framework to apply to the audit of studies ceded to an external IRB. As research becomes more collaborative and regulations and policy requirements increase around sIRB, QA/QI programs need to modify their single site audit processes to an audit of multiple sites, develop communication mechanisms with external institutions, and maintain compliance oversight of institutional policies.