Human Subjects Issues and IRB Review in Practice-based Research

Purpose: This article explores the challenges that practice-based research networks (PBRNs) face with respect to the regulatory requirements for institutional review board (IRB) review and the protection of human subjects in research.

Methods: We used a regulatory and literature review, our previous research involving PBRN researchers, and our experience to identify issues in regulatory compliance and human subjects protections that present challenges to PBRNs and to suggest possible responses.

Results: We identified 3 challenges that PBRNs face with respect to regulatory compliance and human subjects protections. First, ensuring compliance with federal regulations governing human subjects research across all participating practices may be difficult. Clinicians may be unfamiliar with the regulatory requirements and may not have access to an IRB that can provide the required protocol review; moreover, different IRBs may impose inconsistent requirements. Second, conducting research in the practice setting presents unique issues regarding identification of human subjects, consent, and confidentiality. Finally, the use of electronic databases across practices for research raises concerns about how to respect the wishes of participants when combining data and how to maintain confidentiality of data.

Conclusions: PBRN research makes unique contributions to the clinical evidence base by collecting data in community settings where most clinical care is provided. Such research, however, also presents unique challenges to human subject protections and regulatory compliance. Addressing these challenges is necessary to maintain public trust in and support for PBRN research. With careful planning, these ethical and regulatory challenges can be overcome.