Lea Schläpfer, "Protecting Human Subjects in Research: Legal Principles and Responsibility in Clinical Trial Sponsorship"
Nov 18, 2014
from 12:10 PM to 01:30 PM
|Contact Name||Andrew Ventimiglia|
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Lunch provided. Please RSVP if you plan to attend.
Concerning research involving human subjects, numerous recommendations, declarations, guidelines and treaties have been developed at the international level. In spite of many different motives and interests behind these international rules and standards, some legal principles regarding the protection of the human subject and the quality and transparency of research can be found in most or even all of them. These internationally recognized legal principles have been implemented and specified in the new Swiss Federal Act on Research involving Human Beings (HRA, in force since January 2014). One of the particularities of the Swiss interpretation of the international legal principles is the concept of the clinical trial sponsor: Being a sponsor, legally defined as a “person or organization which takes the responsibility for the initiation, management, and financing of a clinical trial”, means having the duty to supervise the clinical trial as well as being liable for damages that research subjects may suffer. After a short introduction to the topic, Lea Schläpfer will discuss with the participants the role of the clinical trial sponsor against the background of the internationally recognized legal principles of biomedical law, with a focus on the differences between the sponsor’s responsibilities to the human research subjects under Swiss law and under US law.
Lea Schläpfer is a PhD candidate in biomedical ethics and law at the Universities of Lucerne and Zurich, Switzerland. She holds Master's degrees in both sociology and law. For her master thesis in sociology she conducted an empirical research project on the topic of HIV/AIDS at the National University of Lesotho. From 2009 until 2011, she was a research associate for the General Secretary of the Swiss Medical Association (FMH). Since 2012, Lea is a research fellow at the University of Lucerne working on the Project “New legal questions concerning drug development”, funded by the Swiss National Science Foundation (SNSF). Concurrently, she is a visiting scholar at UC Davis focusing on her doctoral dissertation on the “Role of the Sponsor in Clinical Research”.
Note this is our Food for Thought format where everyone is asked to read a paper ahead of time. After you RSVP, you will be emailed with the paper to be discussed.