Human subjects issues and IRB review in practice-based research.

Area of Science:

• Health Services Research
• Clinical Research Ethics
• Regulatory Science

Background:

• Practice-based research networks (PBRNs) are crucial for generating clinical evidence in real-world settings.
• Navigating regulatory requirements for Institutional Review Board (IRB) review poses significant challenges for PBRNs.
• Ensuring robust human subjects protections is paramount in community-based clinical research.

Purpose of the Study:

• To explore the specific challenges PBRNs encounter regarding IRB review and human subjects protection.
• To identify key issues in regulatory compliance within the context of PBRN research.
• To propose potential solutions for overcoming these ethical and regulatory obstacles.

Main Methods:

• A comprehensive review of relevant regulations and existing literature was conducted.
• Previous research involving PBRN investigators was utilized.
• Expertise derived from practical experience with PBRN operations informed the analysis.

Main Results:

• Difficulty in ensuring consistent federal regulatory compliance across multiple participating practices.
• Unique challenges in identifying human subjects, obtaining informed consent, and maintaining confidentiality in practice settings.
• Concerns regarding participant data confidentiality and respecting participant wishes when using electronic databases across practices.

Conclusions:

• PBRN research offers valuable contributions to the clinical evidence base by utilizing community settings.
• Unique ethical and regulatory challenges in human subjects protection must be addressed to sustain public trust in PBRN research.
• Strategic planning can effectively mitigate these ethical and regulatory challenges, enabling continued PBRN research.