Ethics, IRB & Patient Safety in Clinical Trials

This session emphasizes the ethical considerations essential for conducting safe and responsible clinical trials. Topics include the role of Institutional Review Boards (IRBs) and Ethics Committees in overseeing trial protocols, ensuring informed consent, and protecting vulnerable populations. Subtopics cover ethical principles such as autonomy, beneficence, non-maleficence, and justice, and how they apply to clinical research. Participants will learn about strategies for assessing risk versus benefit, monitoring adverse events, and maintaining participant confidentiality. Case studies will demonstrate ethical dilemmas in clinical trials, including placebo use, early trial termination, and inclusion of special populations such as pediatrics, pregnant women, and patients with rare diseases. The session will also explore global ethical frameworks, regulatory expectations, and strategies for aligning local practices with international standards. Discussions will address the importance of transparency, reporting, and documentation in maintaining trust and compliance. By the end of this session, attendees will understand how to implement robust ethical oversight, ensure patient safety, and navigate complex ethical challenges in clinical trials effectively.

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