Institutional review board (IRB) and independent ethics committee (IEC)

An institutional review board (IRB)also known as an Independent Ethics Committee(IEC),is committee responsible for reviewing and approving the ethical aspects of research involving human subjects. IRBs/IECs play a crucial role in protecting the rights, welfare, and safety of research participants.

1. CHHATRAPATI SAHUJI MAHARAJ UNIVERSITY,KANPUR SCHOOL OF PHARMACEUTICAL SCIENCES UTKARSH DWIVEDI M.Pharm (1 st semester) session 2024-25 Regulatory Affairs(MPH 104T) M.Pharm (Pharmaceutics) Topic- Institutional review board /Independent ethics committee(IRB/IEC)

2. Table of content Introduction Definition and purpose History and regulation Structure and composition Investigational product safety Audit and maintenance Conclusion

3. Introduction   An Institutional Review Board(IRB)or Independent Ethics Committee (IEC) is a group of experts who review research projects to ensure the safety and well-being of human research subjects. Reviewing, approving , and monitoring research protocols , amendments, and methods.

4. Purpose. The primary purpose of the IRB is to protect the rights and welfare of human subjects involved in research activities being conducted under its authority. There are adequate provisions to protect the privacy of human research and to maintain the confidentiality of research data. IRB/IEC REVIEW RIGHT SAFETY AND WELL-BEING BENEFITS AND RSKS DECISION APPROVES

5. History and Regulation IRB/IEC are rooted in several landmark events and documents, including: The Nuremberg code of 1945. This code focused on the responsibility of the individual scientist and was only applied to non-therapeutic clinical research. Helsinki Declaration(1964). This document introduced the concept of an independent committee, which evolved into the IRB system. Belmont Report (1979). This report established three ethical principles that guide research involving human subjects: Beneficence, Respect and Justice. FDA (21 CFR 56 ) . IRB role in the review and approval of research involving human subjects.

6. Structure and Composition. IRB consists of members, who collectively have the qualifications and experience to review and evaluate the science, medical aspects and ethics of the proposed trials . IRB includes at least 5 members. At least one members whose primary area of interest is non scientific discipline and at least one member who is independent of the institutional site.

7. Members of IRB/IEC

8. Investigational Product Safety Adverse event monitoring Serious adverse event monitoring Ensuring ethical conduct. Reviewing protocols. Safeguard the rights and well-being of human subjects. Implement quality systems. Conducts continuing review of each ongoing trials at least once per year.

9. Audit and Maintenance To ensure compliance with regulations and guidelines. Types: -Internal audit ( self – assessment) -External audit ( third party review) -Regulatory audit ( by – FDA ,EMA) Maintenance- Continuing education and training. SOP updates and revisions. Quality assurance and Quality control. Document management.

10. Conclusion IRC/IEC plays a critical role in ensuring ethical research practices. Effective IRB/IEC review is a crucial for the integrity of research and protecting human subjects.

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