Institutional Ethics Committee (IEC), EDPA

Introduction

The Institutional Ethics Committee (IEC) of the East Delhi Physicians Association (EDPA) is an independent body established to uphold ethical principles in biomedical and clinical research. Its primary purpose is to safeguard the rights, dignity, and well-being of human participants, ensuring that research is conducted responsibly and ethically.

The committee plays a critical role in reviewing, evaluating, and monitoring research proposals for adherence to national and international ethical guidelines, including the Declaration of Helsinki, the Indian Council of Medical Research (ICMR) Guidelines and the New Drugs and Clinical Trial Rules, 2019. By providing consistent oversight, from initial evaluation to final reporting, the IEC fosters the integrity of research activities while prioritizing participant safety.

The Institutional Ethics Committee (IEC) of EDPA serves as an ethical and scientific guardian in research involving human subjects. It ensures that research proposals are evaluated rigorously for ethical compliance, scientific validity, and social relevance. The IEC acts as a platform for researchers to uphold ethical standards and aligns with both local and global guidelines to address cultural sensitivities and societal needs.

Contact email: iecedpa@gmail.com

Composition - Members

The IEC-EDPA is multidisciplinary, comprising experts from varied fields to ensure comprehensive reviews. Key members include:

• Chairperson (independent, external professional)
• Member Secretary (responsible for day-to-day operations)
• Clinical experts from medical and healthcare domains
• Legal advisor (guiding on ethical and regulatory compliance)
• Social scientist or representative for societal perspectives
• Layperson (to represent the community's interests)

This diverse composition ensures independence, balanced judgments, and robust ethical oversight of research proposals.

Aims and Objectives of the IEC EDPA

1. Protecting the dignity, rights, and welfare of research participants.
2. Ensuring adherence to universal ethical principles and scientific standards tailored to community values and local customs.
3. Promoting ethical education and fostering a responsive research community attuned to local healthcare needs.

Responsibilities of the IEC EDPA

• Conducting initial reviews of ethical and scientific aspects of research proposals.
• Monitoring ongoing research for compliance with approved ethical standards.
• Facilitating the education and capacity-building of researchers.
• Ensuring participants' rights are protected, including informed consent and risk minimization.
• Addressing challenges in emerging areas of research, such as genetics and AI in healthcare.

Ethical Considerations

Informed Consent

Participants must provide fully informed, voluntary consent, with special measures for vulnerable populations (e.g., children, elderly, disabled, or economically disadvantaged individuals).

Confidentiality and Data Protection

Strict confidentiality protocols are enforced to ensure data privacy, including anonymization or de-identification of sensitive participant information.

Equity and Justice

Fair participant recruitment practices are mandatory to prevent exploitation and ensure diverse representation. Researchers must strive for equitable sharing of research benefits.

Risk-Benefit Analysis

Comprehensive assessments of risks (physical, psychological, or social) and benefits are undertaken to minimize harm and prioritize participant welfare.

Cultural Sensitivity

Research methodologies are adapted to respect local traditions, cultural norms, and societal customs, with collaboration from community leaders.

Conflict of Interest

Policies are in place to identify and manage conflicts of interest among committee members and researchers to maintain transparency and unbiased decision-making.

Post-Trial Access

Ethical obligations to provide post-trial benefits, such as continued access to effective interventions, are emphasized.

Transparency in Decision-Making

The IEC ensures open and transparent decision-making processes and publishes key decisions to foster accountability.

Community and Stakeholder Engagement

Community involvement is encouraged to align research objectives with local priorities and build trust among stakeholders.

Monitoring and Adverse Event Reporting

Procedures for continuous monitoring and reporting of adverse events ensure ongoing ethical compliance and participant safety during the study.

Regulations

The committee adheres to recognized ethical frameworks, including:

• ICMR Guidelines for Biomedical Research
• Declaration of Helsinki
• Good Clinical Practice (GCP)

These regulations ensure consistency and credibility in the ethical review process.

Review Procedures

Initial Review

A thorough evaluation of research proposals is conducted to assess scientific validity and ethical compliance before the commencement of any study.

Ongoing Review

Periodic monitoring ensures that research remains aligned with approved standards, with necessary amendments reviewed promptly.

Final Reporting

Post-study evaluations assess outcomes, ethical adherence, and learning points for future studies.