Governance and Organizational Structure
Governance and Organizational Structure
The Ethics Committee operates as an independent and multidisciplinary body, functioning in accordance with national regulations and international ethical guidelines. Its governance is designed to ensure impartiality, transparency, and accountability in the ethical review of research involving human participants.
- Oversight Authority
The committee reports to the Chairman and functions within a defined regulatory and policy framework.
- Composition
The committee is composed of a diverse group of members to ensure a balanced and holistic review process. Membership typically includes:
- Chairperson (independent of the institution)
- Member Secretary
- Medical scientists (clinicians and researchers)
- Legal expert
- Social scientist or community representative
- Ethicist or bioethics expert
- Layperson (to represent public interest)
- Pharmacologist (if clinical trials are involved)
- Statistician (optional)
- Roles and Responsibilities
- Chairperson: Leads the meetings, ensures independent decision-making, and signatory to the final decisions.
- Member Secretary: Manages documentation, coordinates meetings, and facilitates communication.
- Scientific Members: Assess scientific validity and methodological soundness.
- Legal/Ethics Experts: Evaluate compliance with ethical norms and regulatory requirements.
- Lay person and Community Representatives: Provide perspectives on participant rights and societal impact.
- Decision-Making Process
- Decisions are made through quorum-based meetings.
- A minimum quorum includes representatives from medical, legal, ethics, and community backgrounds.
- Decisions are based on consensus or majority voting.
- Tenure and Appointment
- Members are appointed for a fixed term and may be renewed based on institutional policy.
- Independence and conflict-of-interest declarations are required from all members.
