IRB/IEC: Responsibilities,
Composition, and Functions
Understanding the Role of Ethical Oversight in Clinical Research
• IRB (Institutional Review Board) or IEC (Independent Ethics
Committee):
• - Established to protect the rights, safety, and well-being of research
participants.
• - Ensures ethical standards in clinical research.
• - Operates according to regulations (e.g., FDA, ICH-GCP, local health
authorities).
ICH-GCP (International Conference on Harmonization– Good Clinical
Practice) is an internationally recognized standard of regulations that
covers all scientific and ethical aspects of a clinical trial before, during
and after a clinical trial.
Key Responsibilities of IRB/IEC
• 1. **Ethical Review of Research**:
• - Review proposed research protocols for ethical standards.
• - Ensure the research has scientific merit and is socially valuable.
•
• 2. **Risk-Benefit Assessment**:
• - Evaluate potential risks to participants against expected benefits.
• - Minimize risks and ensure informed consent.
•
Key Responsibilities of IRB/IEC
• 3. Informed Consent Monitoring:
• - Review and approve the consent forms.
• - Ensure that participants fully understand their role, risks, and
rights.
• 4. Ongoing Oversight:
• - Monitor research progress through continuing reviews.
• - Assess whether the research complies with approved protocols.
Composition of IRB/IEC
• Multidisciplinary Membership:
• - **Scientists/Researchers**: Experts in the field of study.
• - **Non-scientists**: Laypersons representing the general population.
• - **Legal Experts**: Professionals who ensure compliance with laws and
regulations.
• - **Healthcare Professionals**: Clinicians or practitioners with medical expertise.
• - **Community Representatives**: Individuals representing participant interests.
• A broad range of expertise ensures comprehensive review of different aspects of
research, including ethical, scientific, and social considerations.
Basic Functions of IRB/IEC
• 1. **Initial Protocol Review**:
• - Review new research proposals to assess their ethical and scientific integrity.
• 2. **Ongoing Review**:
• - Conduct regular reviews of ongoing research to ensure continued compliance.
• 3. **Adverse Event Monitoring**:
• - Monitor and assess reports of adverse events to ensure participant safety.
Basic Functions of IRB/IEC
• 4. **Protocol Amendments**:
• - Review and approve any proposed changes to research protocols.
• 5. **Handling Non-compliance**:
• - Investigate and address cases of protocol deviations or non-compliance.
• 6. **Termination of Studies**:
• - Have the authority to terminate research if participants' rights or well-
being are at risk.
Informed Consent Process
• - IRB/IEC ensures:
• - **Clarity**: Consent forms must be written in plain language.
• - **Voluntariness**: Participants are not coerced and have the right to
withdraw.
• - **Comprehension**: Participants understand the research and any
potential risks or benefits.
Legal and Regulatory Framework**
• - IRB/IEC operates under:
• - **Good Clinical Practice (GCP)** guidelines.
• - **The Declaration of Helsinki** (World Medical Association).
• - **National laws and regulations (e.g., FDA, EMA).
Conclusion**
• - IRB/IEC plays a critical role in ensuring that research is conducted ethically
and that the rights and safety of participants are protected.
• - The oversight provided by IRB/IEC helps maintain public trust in clinical
research.
