Newswise — IRVINE, Calif. — The 2015 stem cell symposium, “The Challenge of Informed Consent in Times of Controversy,” will take place from 9 a.m. to 4:30 p.m. Friday, Nov. 13, at University of California, Irvine. The symposium will be livestreamed, and a video recording will be available on www.law.uci.edu following the event. The symposium will explore whether the Food and Drug Administration and other government agencies should intensify the regulation of human subject research and establish enforcement standards.

WHAT: The 2015 stem cell symposium is a culmination of an ongoing project investigating human subject research protections in stem cell clinical trials by UCI researchers. The investigation arises from concerns about the informed consent process used in these types of studies and the adequacy of information-sharing among pharmaceutical companies, research trial sites, principal investigators, human research subjects and the public. This symposium features the nation’s most highly sought-after thought leaders to discuss these concerns, along three themes: law, ethics and science. Questions to be addressed include:

• 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? • How might the pushback on fetal tissue research impact the scientific development of vaccines, research on Alzheimer’s disease or other medical advancements?

WHERE: Sue & Bill Gross Stem Cell Research Center, 845 Health Sciences Road, Irvine, CA 92697 (map and directions)

WHEN: 9 a.m. – 4:30 p.m. Friday, Nov. 13, 2015

Symposium Schedule

9 a.m. Welcome: Dr. Sidney Golub, Research Professor of Microbiology & Molecular Genetics; Director, Sue & Bill Gross Stem Cell Research Center, UCI

9:15 a.m. Keynote Lecture: Professor Patricia J. Williams, James L. Dohr Professor of Law, Columbia University; Columnist, The Nation

10:25 a.m. Money, Mischief, and Science: What Have We Learned About Doing Stem Cell Research?

Dr. Aileen Anderson, Professor of Physical Medicine & Rehabilitation; Associate Director, Sue & Bill Gross Stem Cell Center, UCI Dr. Geoffrey Lomax, Senior Officer, Medical Standards, California Institute for Regenerative Medicine, San Francisco Dr. Larry Couture, Senior Vice President, Center for Applied Technology, Beckman Research Institute, City of Hope, Duarte, Calif.

1:00 p.m. The Ethical Boundaries of Human Research

Dr. Jeffrey Kahn, Robert Henry Levi and Ryda Hecht Levi Professor of Bioethics and Public Policy, Johns Hopkins University, Baltimore, Md. Dr. Laurie Zoloth, Professor of Religious Studies, Bioethics and Medical Humanities, Feinberg School of Medicine, Northwestern University, ChicagoMarcy Darnovsky, Ph.D., Executive Director, Center for Genetics and Society, Berkeley, Calif.Deborah Zoe Laufer, Playwright; Author of “Informed Consent”

2:40 p.m. Human Research and the Role of Law

Prof. Michele Goodwin, J.D., Chancellor’s Professor of Law; Director, Center for Biotechnology & Global Health Policy, UCI School of LawProf. Maxwell Gregg Bloche, M.D., J.D., Co-Director, Georgetown-Johns Hopkins Joint Program in Law and Public Health, Washington, D.C.Prof. Radhika Rao, J.D., UC Hastings College of Law, San Francisco

4:10 p.m. Closing Remarks

WHO: The following speakers are available for media interviews: • Dr. Sidney Golub, Director, Sue & Bill Gross Stem Cell Research Center, UCI • Dr. Aileen Anderson, Professor of Physical Medicine & Rehabilitation; Associate Director, Sue & Bill Gross Stem Cell Center, UCI• Dr. Brian Cummings, Associate Professor of Physical Medicine & Rehabilitation, Anatomy & Neurobiology, UCI• Prof. Michele Goodwin, Chancellor’s Professor of Law & Director, Center for Biotechnology & Global Health Policy, UCI School of Law• Professor Patricia J. Williams, James L. Dohr Professor of Law, Columbia University and Featured Columnist, The Nation

MEDIA CONTACT: Media planning to attend the event should contact Tom Vasich at [email protected] or 949-824-6455.

REGISTER: The symposium is free to UCI student, staff and faculty. There is a $20 registration fee for non-UCI attendees. Visit the event page to register.

ABOUT THE SUE & BILL GROSS STEM CELL RESEARCH CENTERStem cell research is in the early stages of transforming the treatment of human disease. The potential of stem cell treatment are just becoming realized. Researchers at the University of California, Irvine are leading in the application of stem cells to treat neurological disorders and injuries such as Alzheimer’s Disease, Huntington’s Disease and spinal cord injury. Our scientists have developed stem cell-based treatments that reduce the effects of Alzheimer’s in animal models, have enabled rats with spinal cord injuries to walk again, are developing cell therapies to treat Huntington’s Disease, and are about to begin a clinical trial to use bone marrow stem cells to treat stroke. We have also pioneered a new stem cell therapy for Retinitis Pigmentosa, a blinding disease of young adult, and this treatment is now in an FDA-approved clinical trial. The University of California, Irvine has received over $105 million in funding from the California Institute of Regenerative Medicine (CIRM), some of which was matched with private funding to create the Sue & Bill Gross Stem Cell Research Center — a place where stem cell investigators across campus can come together to accelerate research towards treatments for these debilitating diseases. For more information, visit stemcell.uci.edu.

ABOUT THE CENTER FOR BIOTECHNOLOGY AND GLOBAL HEALTH POLICYThe Center for Biotechnology and Global Health Policy serves as a reference point for research, policy development and advocacy concerning science, biotechnology, bioethics and health care in the United States and abroad. The CBGHP engages multiple stakeholder communities: scholars, policy makers, civil society, healthcare providers, the judiciary and the general public, highlighting the collaborative role and function of law in responding to state, federal and international health care concerns.

ABOUT UC IRVINE SCHOOL OF LAWUCI Law is a visionary law school focused on training talented and passionate lawyers and driven by professional excellence, intellectual rigor, and a commitment to enrich our communities through public service. UCI Law is a collegial environment, and our faculty comprises accomplished, nationally ranked thought leaders from around the country with a broad range of expertise. More about the Law School is available at law.uci.edu.