DIA 48th Annual Meeting
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Applying Longstanding Ethical Principles in a Period of Dynamic Change
Track : Track 01: Clinical Operations
Program Code: 327
Date: Wednesday, June 27, 2012
Time: 10:00 AM to 11:30 AM  EST
CHAIR :
 Bonnie Brescia, BBK Worldwide, United States
PRESENTER (S):
 Bonnie Brescia, BBK Worldwide, United States
 Jon Holmlund, Aspire IRB, United States
Description
Review boards and regulatory committees are increasingly challenged by new technologies that impact patient protections and ethical considerations in clinical study planning. This symposium will explore how IRBs and ethics committees can apply basic principles of research ethics in the context of evolving value considerations in clinical research. The speakers will address issues such as: new definitions of autonomous action in a digitally enabled information age; applying the height of efficacy bar in the review process; the ongoing struggle to obtain true informed consent; and the cultural and generational differences in the definition of privacy.

Learning Objectives:
Discuss the ethical implications of efficacy goals, particularly in drug intervention trials
Identify the changes digital media have brought to patient recruitment and retention
Apply existing protection guidelines to evolving definitions of ethical standards and evolving means of communication.