This course was designed to provide a context for the historical evolution of current Human Subjects Protection Programs and the mechanisms developed to guide researchers and protect the rights of research subjects. An in-depth examination of the ethical issues encountered in conducting clinical research was provided, including research with vulnerable populations, conflict of interest, and scientific misconduct. The intent was to provide a foundational understanding of the researcher’s role in ensuring the ethical and responsible conduct of research.
- Analyze global trends in human subject research using historical and ethical frameworks.
- Compare and contrast codes, declarations and ethical guidance as they relate to national and international ethical frameworks.
- Justify the unique context, purpose and value of clinical research within the medical domain.
- Explain the challenges and ethical considerations in recruiting subjects for national and international clinical trials.
- Summarize the concept of autonomy as it relates to impaired decision-making, recruitment of vulnerable populations, and informed consent.
- Differentiate the roles, responsibilities and interactions of the various members of the clinical research team in protecting and overseeing the safety of human subjects.
- Critique the concepts of research conflict of interest, scientific integrity, and scientific misconduct as they relate to responsible conduct of research.