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#35: Ethical Issues in Clinical Trials

Tutorial name:
#35: Ethical Issues in Clinical Trials

Day & Time:
June 14, 1:00PM - 4:30PM

Room Number:

Maximize your learning while attending the DIA 2015 51st Annual Meeting! Receive $100 off of your DIA 2015 meeting registration by registering for two half-day tutorials or one full-day tutorial. Purchases must be made at the same time in order to receive the discount.

This tutorial will provide an overview of the various ethical considerations associated with conducting clinical trials, including the history of ethical principles - Nuremburg Conventions, Declaration of Helsinki, The Belmont Report, and ICH. Topics will include obtaining ethics committee and regulatory authority clearance, subject informed consent, investigator conflict-of-interest, issues of fraud, authorship, and ensuring subject safety and well-being. In addition, consideration will be given to conducting studies in emerging economy populations where fair distribution of risks and benefits come into play. It will become evident, through case examples, that these issues are not always black-and-white, and that the situation in which these issues are considered result in many shades of gray.

Learning Objective(s):
At the conclusion of this tutorial, participants should be able to:
• Discuss the foundations of ethics;
• Explain how ethical decisions may be influenced by context and experience;
• Discuss the viewpoint of the clinical study subject in educating clinical study site staff as to ethical considerations.

Target Audience:
This tutorial is designed for pharmaceutical company clinical operations staff, clinical trial site investigators and study coordinators, ethicists, regulators and regulatory affairs staff.