The Challenge of Informed Consent in Times of Controversy

Friday, November 13, 2015
9:00 a.m. to 4:30 p.m.
Sue & Bill Gross Stem Cell Research Center (map)

Video >

Does informed consent convey different meanings depending on who invokes the term? When do we know that consent is informed? What are human research subjects entitled to know before, during, and after agreeing to participate in clinical trials? These questions gain further urgency In the wake of recent controversy over the use of fetal tissue in human research. Federal legislation has long supported such research, but now there are calls to halt such studies. What impacts might pushback on fetal tissue research have on scientific development of vaccines, research on Alzheimer's Disease, or other medical advancements?

The 2015 Stem Cell Symposium considers these important questions and many others. The symposium tackles issues concerning the roles of law, science, technology, ethics, and society in the production and promotion of scientific knowledge through human research. Hosted by the Sue & Bill Gross Stem Cell Research Center and the School of Law at the University of California Irvine, this meeting queries whether the FDA and other government agencies should intensify the regulation of human subject research and establish enforcement standards. These issues deserve urgent address, particularly in the wake of patients forum shopping for stem cell therapies and being injured in the process. However, does this signify that the federal government is obligated to step in or should the market self-regulate this trend?

This symposium is a culmination of an ongoing project investigating human subject research protections in stem cell clinical trials. The investigation arises from concerns about the informed consent process used in these types of studies and the adequacy of information sharing between pharmaceutical companies, research trial sites, principal investigators, human research subjects, and the public in general. Speakers are organized along three themes: law, ethics, and science. Full Event Schedule (PDF) here >

Sponsored by: California Institute for Regenerative Medicine, UCI Office of Research, UCI Institute for Clinical and Translational Research, UCI Medical Humanities Initiative, UC Humanities Research Institute, UCI Sue & Bill Gross Stem Cell Research Center, Center for Biotechnology & Global Health Policy, UCI School of Law

Register online >



Featured Speakers

Patricia J. Williams

Patricia J. Williams

Keynote Speaker

Columbia Law School
James L. Dohr Professor of Law

Michele Goodwin

Michele Goodwin

UC Irvine School of Law
Chancellor’s Professor of Law and Director, Center for Biotechnology and Global Health Policy

Sidney H. Golub

Sidney H. Golub

UC Irvine School of Medicine
Research Professor, Microbiology & Molecular Genetics, School of Medicine
Director, Sue & Bill Gross Stem Cell Research Center

Aileen Anderson

Aileen Anderson Ph.D.

UC Irvine School of Medicine
Professor of Physical Medicine & Rehabilitation; Associate Director, Sue and Bill Gross Stem Cell Center; Director, Christopher Reeve Foundation Spinal Cord Injury Core Facility

Brian Cummings

Brian Cummings, Ph.D.

UC Irvine School of Medicine
Associate Professor of Physical Medicine & Rehabilitation, Anatomy & Neurobiology

Image of Jeffrey Kahn

Jeffrey Kahn, Ph.D., M.P.H.

Johns Hopkins University
Robert Henry Levi and Ryda Hecht Levi Professor of Bioethics and Public Policy, Deputy Director for Policy and Administration at the Johns Hopkins Berman Institute of Bioethics

Image of Deborah Zoe Laufer

Deborah Zoe Laufer

Playwright, author of Informed Consent

Laurie Zoloth

Laurie Zoloth, Ph.D.

Northwestern University
Professor of Religious Studies, Professor of Bioethics and Medical Humanities, Feinberg School of Medicine; Director of Graduate Studies


Marcy Darnofsky

Marcy Darnovsky, Ph.D.

Center for Genetics and Society
Executive Director

Geoff Lomax

Geoff Lomax, Ph.D.

California Institute for Regenerative Medicine
Senior Officer for Medical Standards

Larry Couture

Larry A. Couture, Ph.D.

City of Hope
Sr. Vice President, Center for Applied Technology, Beckman Research Institute

Radhika Rao

Radhika Rao, J.D.

UC Hastings College of the Law
Professor of Law

Maxwell Gregg Bloche

Maxwell Gregg Bloche, M.D., J.D.

Georgetown University Law Center
Professor of Law
Co-Director, Georgetown-Johns Hopkins Joint Program in Law and Public Health