A new era in the ethics of human embryonic stem cell research. Lo, B., Zettler, P., Cedars, M. I, Gates, E., Kriegstein, A. R, Oberman, M., Reijo Pera, R., Wagner, R. M, Wuerth, M. T, Wolf, L. E, & Yamamoto, K. R Stem Cells, 23(10):1454–1459, England, November, 2005.
abstract   bibtex   
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.
@ARTICLE{Lo2005-oe,
  title    = "A new era in the ethics of human embryonic stem cell research",
  author   = "Lo, Bernard and Zettler, Patricia and Cedars, Marcelle I and
              Gates, Elena and Kriegstein, Arnold R and Oberman, Michelle and
              Reijo Pera, Renee and Wagner, Richard M and Wuerth, Mary T and
              Wolf, Leslie E and Yamamoto, Keith R",
  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.",
  journal  = "Stem Cells",
  volume   =  23,
  number   =  10,
  pages    = "1454--1459",
  month    =  nov,
  year     =  2005,
  address  = "England",
  language = "en"
}

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