A New Era in the Ethics of Human Embryonic Stem Cell Research

¹ Program in Medical Ethics and the Division of General Internal Medicine in the Department of Medicine at the University of California San Francisco, San Francisco, California
² Department of Obstetrics, Gynecology, and Reproductive Sciences at the University of California San Francisco, San Francisco, California
³ Program in Development and Stem Cell Biology and the Department of Neurology at the University of California San Francisco, San Francisco, California
⁴ School of Law at Santa Clara University, Santa Clara, California
⁵ Department of Obstetrics, Gynecology, and Reproductive Sciences, and the Program in Human Embryonic Stem Cell Biology at the University of California San Francisco, San Francisco, California
⁶ Human Subjects Protection Program at the University of California San Francisco, San Francisco, California
⁷ Department of Cellular and Molecular Pharmacology at the University of California San Francisco, San Francisco, California

^* To whom correspondence should be addressed. E-mail: bernie{at}medicine.ucsf.edu.

	Abstract

Scientific progress in human embryonic stem cell (hESC) research and increased funding make it imperative to look ahead to the ethical issues generated by the expected use of hESC for transplantation. Several issues should be addressed now, even though Phase I clinical trials of hESC transplantation are still in the future. To minimize the risk of hESC transplantation, donors of materials used to derive hESC lines will need to be recontacted to update their medical history and screening. Because of privacy concerns, such recontact needs to be discussed and agreed to at the time of donation, before new hESC lines are derived. Informed consent for Phase I clinical trials of hESC transplantation also raises ethical concerns. In previous Phase I trials of highly innovative interventions, allegations that trial participants had not really understood the risk and benefits caused delays in subsequent trials. Thus researchers should consider what information needs to be discussed during the consent process for hESC clinical trials and how to verify that participants have a realistic understanding of the study. Lack of attention to the special ethical concerns raised by clinical trials of hESC transplantation and their implications for the derivation of new hESC lines may undermine or delay progress towards stem cell therapies.