title: A new era in the ethics of human embryonic stem cell research.
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 hESCs 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 toward stem cell therapies.
authors.affiliation: Program in Medical Ethics and Division of General Internal Medicine, University of California San Francisco, San Francisco, California, USA. bernie@medicine.ucsf.edu
authors.forename: Bernard
authors.initials: B
authors.lastname: Lo
authors.forename: Patricia
authors.initials: P
authors.lastname: Zettler
authors.forename: Marcelle I
authors.initials: MI
authors.lastname: Cedars
authors.forename: Elena
authors.initials: E
authors.lastname: Gates
authors.forename: Arnold R
authors.initials: AR
authors.lastname: Kriegstein
authors.forename: Michelle
authors.initials: M
authors.lastname: Oberman
authors.forename: Renee
authors.initials: R
authors.lastname: Reijo Pera
authors.forename: Richard M
authors.initials: RM
authors.lastname: Wagner
authors.forename: Mary T
authors.initials: MT
authors.lastname: Wuerth
authors.forename: Leslie E
authors.initials: LE
authors.lastname: Wolf
authors.forename: Keith R
authors.initials: KR
authors.lastname: Yamamoto
mesh_terms: D002460:Cell Line; D017321:Clinical Trials, Phase I as Topic / Q000941:ethics; D033041:Embryo Research / Q000941:ethics*; D017408:Guidelines as Topic; D006291:Health Policy / Q000639:trends; D006801:Humans; D007258:Informed Consent / Q000941:ethics; D033581:Stem Cell Transplantation / Q000208:ethnology / Q000639:trends; D014019:Tissue Donors / Q000941:ethics