The need for local Institutional Review Board (IRB) approval appears to impede participation in research conducted by primary care practice-based research networks (PBRNs). IRB involvement discourages the inclusion of minority patients, delays data collection and results in little significant change to research protocols.
PBRNs conduct multi-site studies addressing community-based practice aimed at improving the effectiveness of primary care. Local IRBs review research protocols for compliance with federal rules regarding research with human subjects. Local IRB applications can vary considerably, even when assessing identical clinical protocols.
This study reports the process and outcomes of local IRB review for two large, federally-funded studies conducted by Pediatric Research in Office Settings (PROS), the PBRN of the American Academy of Pediatrics (AAP). It focuses on determining local IRB prevalence, level of staff assistance required to apply to local IRBs, local IRB process, and the impact on study participation, data collection completion and protocol modifications. Two studies were included in the assessment: Child Abuse Recognition Experience Study (CARES), an observational study of physician decision-making; and Safety Check, a violence prevention intervention trial.
- For both studies, the requirement of additional local IRB approval reduced study participation.
- Local IRB approval took an average of 81 days for CARES and 109 days for Safety Check.
- Practices requiring local IRB approval were more likely to be located in an urban setting.
These findings indicate that to facilitate large-scale PBRN studies and ensure the validity of results, IRB processes need to be streamlined, particularly for minimal-risk studies.