Composition, Responsibilities, Procedures Of IRB/IEC

🧬 Composition, Responsibilities, and Procedures of IRB / IEC

🔷 Introduction

An IRB (Institutional Review Board) or IEC (Independent Ethics Committee) is an independent regulatory body responsible for the ethical review, approval, and monitoring of research involving human subjects.

🎯 Main Objective

To ensure that all research involving humans is conducted in accordance with ethical principles, and that the rights, safety, and well-being of participants are protected.

🔷 Composition of IRB / IEC

An IRB/IEC should consist of a reasonable number of members who collectively have the scientific, medical, and ethical expertise to review clinical research.

Recommended composition (ICH-GCP & ICMR aligned):

• Minimum 5 members
• Multidisciplinary and multisectoral
• Scientific members (medicine, pharmacy, research background)
• At least one non-scientific member (ethicist, lawyer, social worker, lay person)
• At least one independent member (not affiliated with the institution/trial site)
• Gender representation
• Lay person to represent community perspective

➡️ A quorum is mandatory for decision-making.

🔷 Core Responsibilities of IRB / IEC

✅ 1. Protection of Human Subjects

• Safeguard the rights, safety, and well-being of all trial subjects
• Give special attention to vulnerable populations, such as:
• Children
• Pregnant women
• Elderly
• Economically or socially disadvantaged groups
• Prisoners

✅ 2. Review of Essential Documents

Before approving a trial, the IRB/IEC must review:

1.     Trial protocol(s)

2.     Written informed consent form(s)

3.     Subject recruitment procedures and materials

4.     Written information to be provided to subjects

5.     Investigator’s Brochure (IB)

6.     Information on payment and compensation

7.     Available safety information

8.     Investigator’s current CV or proof of qualifications

✅ 3. Review and Decision-Making

The IRB/IEC must review clinical trial proposals within a reasonable time and document its decisions in writing, clearly identifying:

• Trial details
• Documents reviewed
• Date of review
• Decision taken

Possible decisions include:

• ✔ Approval / favorable opinion
• 🔄 Modifications required before approval
• ❌ Disapproval / negative opinion
• ⛔ Suspension or termination of prior approval

✅ 4. Assessment of Investigator Qualifications

• Review investigator’s education, training, and experience
• Based on curriculum vitae and supporting documents
• Ensure the investigator is qualified to conduct the study safely

✅ 5. Continuing Review of Ongoing Trials

• Conduct continuing review of all approved trials
• Frequency depends on risk level
• At least once per year
• More frequent review for high-risk studies

✅ 6. Review of Subject Information

• The IRB/IEC may request additional information to be provided to subjects
• When it improves:
• Understanding
• Safety
• Protection of rights
• Decision-making capacity

✅ 7. Review of Payment and Compensation

• Ensure payments are:
• Not coercive
• Free from undue influence
• Verify that payment details are clearly mentioned in the informed consent form
• Payment should be fair and preferably pro-rated

🔷 Procedures of IRB / IEC

The IRB/IEC must function according to written Standard Operating Procedures (SOPs).

Key procedures include:

• Defining IRB/IEC composition and authority
• Scheduling and conducting formal meetings
• Ensuring quorum before decisions
• Performing initial and continuing review
• Allowing expedited review for minor changes
• Ensuring no subject is enrolled without written approval
• Requiring prior approval for protocol changes, except to eliminate immediate hazards
• Ensuring investigators promptly report:
• Protocol deviations
• Serious and unexpected adverse drug reactions
• Risk-increasing changes
• New safety information

The IRB/IEC must inform investigators in writing about:

• Decisions and opinions
• Reasons for decisions
• Appeal procedures

🔷 Conclusion

The IRB/IEC plays a central role in ethical clinical research. Through independent review, continuous monitoring, and strict adherence to ethical and regulatory standards, it ensures that human dignity, safety, and rights remain the highest priority in clinical trials.