Phang Kean Chang
University Malaya Medical Centre, Kuala Lumpur, Malaysia
Ensuring ethical integrity in clinical research is critical to safeguarding the rights and well-being of human participants. This presentation outlines the foundational principles of research ethics, the regulatory role of Institutional Review Boards (IRBs) like the UMMC-MREC, and the practicalities of ethics review and post-approval monitoring. Drawing on international frameworks, such as the Declaration of Helsinki and Malaysian Good Clinical Practice guidelines, we discuss key ethical challenges including informed consent, risk-benefit analysis, and justice in participant selection. Special attention is given to research in respiratory diseases, where emergencies like acute respiratory failure may necessitate urgent interventions such as intubation. In these scenarios, the ethical conduct of research is complicated by issues of impaired consent capacity, heightened patient vulnerability, and the need for rapid decision-making. Robust oversight by ethics committees, clear protocols for deviations in emergencies, and transparent communication channels are essential to maintain participant safety and trust. By fostering a culture of accountability and continuous education in research ethics, we can ensure that advances in respiratory medicine are achieved responsibly and equitably, even in the most urgent clinical contexts.