CLRA 6130 – Ethical, Legal, and Regulatory Considerations in Clinical Investigations♦
The nature of human clinical research and clinical investigation facilitates a host of ethical, legal, and regulatory issues related to the treatment of subjects, personal privacy, and institutional compliance, among others. Students in this course examine ethical codes of conduct, regulatory requirements, and existing laws that govern clinical research in the context of historical events that contributed to their development. They also explore recruitment and protection of human subjects; diversity and vulnerable populations in research; informed consent; privacy and confidentiality; the role of independent review committees; and the importance of reporting serious adverse events (SAEs). Students also discuss social and ethical implications of genetic technologies and research. Applying course concepts, students complete an FDA form for a clinical trial in their region, deepening their understanding of legal protocol.
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