DDF17a Ethical Issues in Clinical Trials

Description

Participant Profile
This workshop is intended for medical writers (and others) who are interested in clinical trials and would like to know more about the evolution of ethical principles associated with human subject participation. Global ethical aspects that are taken into consideration for studies will be reviewed. In addition, case examples of situational clinical trial 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 relevant ethical issues, with respect to 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 challenges that may arise in developing countries. Practical experience will be shared with the participants.