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Boston Convention and Exhibition Center

Jun 23, 2013 8:30 AM - Jun 27, 2013 12:45 PM

415 Summer Street, , Boston, MA 02210 , USA

DIA 2013 49th Annual Meeting: Advancing Therapeutic Innovation and Regulatory Science

Ethical Issues in Clinical Trials

Session Chair(s)

Art  Gertel, MSc

Art Gertel, MSc

President and Principal Consultant

MedSciCom, LLC, United States

This workshop 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.

This workshop will also be offered on Tuesday, June 25, at 8:00 am (#214).

**Due to workshop format, seating will be limited and will be available on a first come, first served basis.

The Boston Convention and Exhibition Center (BCEC) has stringent regulations on maximum room capacities, and they are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no more participants will be admitted. Interested attendees are encouraged to arrive at workshops early in order to ensure seating. Please note, as a workshop with interactivity, this event will not be recorded.

Learning Objective : 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.

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