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Ethical Issues in Health Care

Level:
Foundation
Area:
Drug Development
Code:
DDF17b
Duration:
03:30:00
Workshop profile:
This workshop is intended for medical writers (and others) who are interested in research and development of new medicines, and how decisions are made about how these are provided to patients. Global ethical aspects that are taken into consideration for studies will be reviewed. In addition, case examples of situational clinical research, healthcare, and medical ethics will be provided for interactive discussion.
Objective:
To give an overview of the various ethical considerations associated with conducting clinical trials, and associated policies and processes, including institutional oversight, pre-approval access, regulatory authority clearance, subject informed consent, investigatory conflict of interest, issues of fraud, and ensuring subject safety and well-being.
Content:
This workshop will consist of a combination of presentations on the evolution of ethical principles associated with human subject participation, relevant ethical issues, with respect to clinical research and development, clinical trials, and group discussions on challenging ethical considerations of some “real-world” case studies. The presentations will focus on the importance of ethics in GCP, the informed consent process, and the dynamic tension between the individual and societal needs. Practical experience will be shared with the participants.