What are the challenges of the Institutional Review Board (IRB) process?

Key Challenges of the Institutional Review Board (IRB) Process

The IRB process faces significant challenges including lengthy review times, protocol complexity, inconsistent interpretations of regulations, and difficulties obtaining informed consent, which collectively impede research progress and increase costs while creating barriers to advancing medical knowledge.

Procedural and Administrative Challenges

Time and Efficiency Issues

• IRB approval processes are often extremely time-consuming, with studies showing approval can take up to 404 days (median 108 days) and require up to 7 submissions (median 2 submissions) 1
• These delays significantly impact research timelines and can delay potentially life-saving interventions from reaching patients
• The lengthy review process contributes to high costs and poor return on investment, particularly for complex studies like hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) trials 1

Inconsistency in Regulatory Interpretation

• There are significant variations in how local IRBs interpret federal requirements, particularly regarding community consultation and public disclosure 1
• This inconsistency creates unpredictability for researchers, who face "an evolving set of criteria" for both initial and continuing approval 1
• The lack of standardization across IRBs leads to different requirements at different institutions, making multi-center research particularly challenging

Multiple IRB Review Challenges

• Multi-site studies face the burden of obtaining approval from numerous IRBs, each with potentially different requirements and interpretations 2
• This creates redundancy, delays, and sometimes contradictory demands on researchers
• While centralized IRB models are emerging as a solution, implementation remains challenging 1

Ethical and Consent Challenges

Informed Consent Complexities

• Obtaining appropriate informed consent is particularly challenging in certain research contexts:
  • Emergency research where patients cannot provide consent 1
  • Studies involving vulnerable populations or those with diminished capacity 1
  • Disaster research where normal consent processes may be impractical 1
• The informed consent process has become increasingly complex with "extremely lengthy and complex IC documents" 1

Balancing Risk and Benefit Assessment

• IRBs struggle with assessing risk-benefit ratios, particularly for studies involving experimental treatments or vulnerable populations 1
• Some IRBs express "great reluctance to approve studies because of fear of liability," especially for studies using exception from informed consent 1
• This caution can prevent potentially beneficial research from proceeding, even when the potential benefits are substantial

Special Population Considerations

• Research involving special populations (children, pregnant women, prisoners) faces additional regulatory hurdles 1
• Newborn screening research, disaster research, and emergency research all present unique ethical challenges that standard IRB processes may not adequately address 1

Structural and Systemic Issues

Resource Limitations

• Many IRBs lack adequate staffing, expertise, or resources to efficiently review complex protocols
• Training requirements for IRB members and research staff create additional burdens 1
• Smaller institutions or community-based research sites may lack access to IRB resources entirely 2

Adapting to New Research Contexts

• IRBs struggle to apply traditional human subjects protection frameworks to emerging research contexts:
  • Practice-based research networks 2
  • Disaster research 1
  • Population-based screening studies 1
• Standard review criteria may not adequately address unique issues in these specialized research contexts

Potential Solutions and Innovations

Streamlining IRB Processes

• The "Real-Time IRB" model has shown promise in reducing review times by up to 40% by having investigators present during IRB meetings to make immediate protocol changes 3
• Standardizing community consultation and public disclosure requirements could reduce uncertainty and delays 1
• Developing specialized review criteria for specific research contexts (like disaster research) can improve efficiency 1

Centralized and Cooperative Review

• Using central IRBs for multi-site studies can reduce redundancy and inconsistency 1
• The Clinical Trials Transformation Initiative (CTTI) recommends central IRB use for complex trials like HABP/VABP studies 1
• Cooperative review agreements between institutions can streamline the process while maintaining appropriate oversight

Improved Training and Education

• Better training for IRB members on specialized research contexts can improve review quality and efficiency
• Educating researchers about IRB requirements and processes helps them prepare better submissions 4
• Developing appropriate human subjects protection training for community-based researchers and clinicians 2

The IRB process, while essential for protecting human subjects, continues to face significant challenges that can impede valuable research. Addressing these challenges requires innovative approaches, standardization of processes, and better resources while maintaining the core ethical principles that protect research participants.