WESTERN NY CHAPTER: ETHICS IN CLINICAL TRIALS, PAST AND PRESENT: WHEN WILL WE EVER LEARN?
Event Description:
As a clinical trial professional, have you ever wondered what all the fuss is about ethics? You and your team do everything ‘ethically,’ right? There are all kinds of regulations about how to conduct ‘good’ clinical trials with human subjects – haven’t those eliminated unethical human studies? In a word -NO! This session will look at some of those regulations and the history of ‘bad’ conduct in human research that brought them about. The speaker will reveal examples of egregious human experimentation beyond those well-known examples of WW II German medical experiments and Tuskegee, including horrific research conducted on unwitting subjects by the US government- some of them carried out at the University of Rochester Medical Center! We will discuss some of the more recent, even on-going, breaches in human research subject ethics and what is being done to remedy these violations.
Speaker:
Noreen L Connolly, MS, JD, GC-Bioethics, CCRC
Learning Objectives:
1.Understand the causal relationship between unethical studies and the growth of governmental and institutional regulations directed to human subject protection.
2.Identify at least two key paradigms that are historically at the basis of unethical human research.
3.Evaluate whether the clinical trials they are/will be conducting meet the most up-to-date standards for the protection of human subjects.
Registration Information:
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The educational portion of this event may be self-reported as 1 point toward an attendee’s Maintenance of Certification. These points are subject to review and acceptance by the Academy of Clinical Research Professionals in accordance with the criteria established. Attendees should keep a record of event participation in case they are randomly selected to participate in the maintenance verification process. The Chapter can provide a certificate of attendance upon request.
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