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“headline”: “SOP for Ethics Committee Quorum and Conflict of Interest Handling”,
“description”: “This SOP describes regulatory-compliant procedures for managing Ethics Committee (EC)/IRB quorum requirements and handling conflicts of interest, in alignment with ICH GCP, WHO, FDA, EMA, and CDSCO standards.”,
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Published on 22/12/2025
Standard Operating Procedure for EC Quorum and Conflict of Interest Handling
| Department | Clinical Research |
| SOP No. | CR/ETH/009/2025 |
| Supersedes | NA |
| Page No. | 1 of 20 |
| Issue Date | 26/08/2025 |
| Effective Date | 01/09/2025 |
| Review Date | 01/09/2026 |
Purpose
The purpose of this SOP is to define the procedures for ensuring that Ethics Committee (EC)/Institutional Review Board (IRB) meetings meet quorum requirements and
Scope
This SOP applies to all EC/IRB members, secretariat staff, investigators, and sponsors involved in clinical trials reviewed by the EC/IRB. It covers quorum establishment, conflict of interest disclosure, member recusal, documentation, and record-keeping.
Responsibilities
- EC/IRB Chairperson: Ensures quorum is met before review or approval of any protocol and manages COI declarations.
- EC/IRB Secretariat: Maintains attendance logs, COI declarations, and meeting minutes.
- EC/IRB Members: Disclose any conflict of interest prior to participation in protocol review.
- Quality Assurance Officer: Verifies compliance with quorum and COI handling requirements.
- Head of Clinical Research: Oversees adherence to SOP at institutional level.
Accountability
The EC/IRB Chairperson is accountable for ensuring that all meetings adhere to quorum and COI handling requirements. Any deviation may render decisions invalid and result in regulatory non-compliance.
Procedure
1. Quorum Requirements
A quorum is defined as at least 5 voting members, including at least one lay person, one member with medical/scientific expertise, and one member independent of the institution (as per ICH GCP and national guidelines).
Meetings without quorum shall be rescheduled; decisions made without quorum are invalid.
2. Attendance Recording
EC/IRB Secretariat records attendance at each meeting.
Attendance log must include name, designation, role (voting/non-voting), and signature.
3. Conflict of Interest (COI) Disclosure
All members must declare COI before discussion of any protocol where they have financial, academic, or personal interest.
Declarations must be documented in the COI Register (Annexure-2).
4. COI Management
Members with COI shall leave the meeting room during discussion and decision-making.
Their absence and recusal must be recorded in meeting minutes.
5. Documentation and Record Keeping
Secretariat files attendance logs, COI declarations, and minutes in EC/IRB records.
Records are archived in compliance with ICH GCP and local requirements.
Abbreviations
- SOP: Standard Operating Procedure
- EC: Ethics Committee
- IRB: Institutional Review Board
- COI: Conflict of Interest
- ICH: International Council for Harmonisation
- GCP: Good Clinical Practice
- QA: Quality Assurance
Documents
- EC/IRB Attendance Log (Annexure-1)
- Conflict of Interest Declaration Register (Annexure-2)
- EC/IRB Meeting Minutes Template (Annexure-3)
References
- ICH E6(R2) Good Clinical Practice
- US FDA 21 CFR Part 56 – IRB Requirements
- EMA Clinical Trial Regulation (EU No. 536/2014)
- WHO Operational Guidelines for Ethics Committees
- CDSCO Clinical Trial Rules, India (2019)
Version: 1.0
Approval Section
| Prepared By | Rajesh Kumar, EC/IRB Secretariat Officer |
| Checked By | Sunita Reddy, QA Officer |
| Approved By | Dr. Anil Sharma, EC/IRB Chairperson |
Annexures
Annexure-1: EC/IRB Attendance Log
| Date | Member Name | Designation | Role | Signature |
|---|---|---|---|---|
| 05/09/2025 | Dr. Meera Joshi | Clinician | Voting | Signed |
| 05/09/2025 | Mr. Ravi Kumar | Lay Member | Voting | Signed |
Annexure-2: Conflict of Interest Declaration Register
| Date | Member Name | Protocol No. | Declared Interest | Action Taken |
|---|---|---|---|---|
| 05/09/2025 | Dr. Anil Sharma | CTP-2025-05 | Consultant for sponsor | Recused |
Annexure-3: EC/IRB Meeting Minutes Template
| Date | Protocol No. | Discussion Summary | Decision | Remarks |
|---|---|---|---|---|
| 05/09/2025 | CTP-2025-05 | Protocol reviewed, quorum achieved | Approved | With condition: SAE reporting within 24 hrs |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 26/08/2025 | 00 | Initial version | New SOP creation | Head, Clinical Research |
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