Informed consent is an important part of a clinical trial that is often overlooked. To avoid potential liability, sponsors need to recognize that obtaining informed consent is about much more than getting a signature on a page. In order to ensure legally-effective informed consent from participants, the informed consent process must be focused on education, comprehension, and voluntariness. This presentation discusses the role of the FDA and Institutional Review Boards (IRBs) in the informed consent process, pitfalls to avoid when drafting and executing informed consent documents, and best practice tips for obtaining and maintaining legally-effective informed consent.

Daniel S. Wittenburg, J.D., is a partner in the law firm of Snell & Wilmer, LLP. His practice is focused on representing medical device, pharmaceutical, biotechnology, consumer product, and heavy equipment manufacturers in products liability litigation as well as counseling these companies on risk management and product recalls and in responding to regulatory agency inquiries. Dan has attained certification as a Global Regulatory Affairs Compliance Professional (GRACP) and has also served as national counsel for major medical device manufacturing concerns and regional counsel in mass tort cases. He also represents companies in commercial litigation and consumer class actions and works with entities in technology transfer and intellectual property matters. Dan is a recipient of Medmarc's Attorney of the Year award.

In connection with defending medical technology and life science companies, Dan has served as national coordinating counsel defending a manufacturer of excimer lasers and participated on the regional team defending a global pharmaceutical and biotechnology company in mass tort litigation involving diet drugs as well as mass tort litigation involving phenylpropanolamine. He also serves as local counsel in various jurisdictions throughout the western United States, defending pharmaceutical and medical device companies in numerous national “pattern” litigation cases. In addition to counseling life science and medical technology companies in regulatory matters, product recall strategies, and risk management issues, Dan supports the industry through participation on the Board of Directors of the Colorado BioScience Association.