How is California regulating its $3 billion stem cell research initiative?
Regulations governing human stem cell research must strive to assure strict oversight while simultaneously fostering scientific innovation through collaboration, says a group of scientists from the California Institute for Regenerative Medicine (CIRM), one of the world's largest supporters of such research.
In November 2004, California voters approved $3 billion over 10 years for public funding of stem cell research through the CIRM. In their policy paper in PLoS Medicine, Geoffrey Lomax, Zach Hall, and Bernard Lo discuss how CIRM came to adopt its legally binding regulations for the stem cell research it funds.
In addition to the goal of "setting high ethical standards," say the authors, there were five other crucial objectives that guided the regulations:
- Encourage research institutions and researchers to develop best practices for ethical conduct of human stem cell research
- Avoid unnecessary regulatory burdens
- Involve the public in developing regulations
- Be consistent with existing laws, regulations, and ethical guidelines
- Facilitate collaboration to accelerate scientific progress.
Dr Lomax and colleagues describe two innovative features of the regulations: the informed consent process and the protection of egg (oocyte) donors.
"Because human embryonic stem cell research is controversial," they say, "prospective donors need complete information about possible research uses of embryos, gametes, and tissue that they might donate. If donors have stated restrictions on the future uses of donated materials, CIRM-funded researchers must respect these."
And for oocyte donors, in addition to obtaining consent, researchers must ascertain that such donors fully comprehend eight essential features of the research. "In other research settings," say Dr Lomax and colleagues, "research participants often fail to understand the information in detailed consent forms." The CIRM regulations require that CIRM researchers evaluate whether women have fully understood the benefits and risks of oocyte donation.
The regulations, they say, were developed with extensive public input and are a "critical first step in increasing public trust and support for human stem cell research."
Citation: Lomax GP, Hall ZW, Lo B (2007) Responsible oversight of human stem cell research: The California Institute for Regenerative Medicine's medical and ethical standards. PLoS Med 4(5): e114.
PLEASE ADD THE LINK TO THE PUBLISHED ARTICLE IN ONLINE VERSIONS OF YOUR REPORT: http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0040114
PRESS-ONLY PREVIEW OF THE ARTICLE: http://www.plos.org/press/plme-04-05-lomax.pdf
Related image for press use: http://www.plos.org/press/plme-04-05-lomax.jpg
- Caption: CIRM developed comprehensive medical and ethical standards for stem cell research through a process involving extensive expert and public consultation. (Credit: The Burnham Institute & CIRM)
CONTACT:
Geoffrey Lomax
California Institute for Regenerative Medicine (CIRM)
210 King Street 3rd Floor
San Francisco, CA 94107
United States of America
+1 415-396-9134
glomax@cirm.ca.gov
www.cirm.ca.gov
Reduced T cell interferon signaling in melanoma
Prompted by altered expression patterns of interferon-responsive genes in T and B cells, Peter Lee and colleagues find that lymphocytes from patients with melanoma have defects in interferon signaling.
Citation: Critchley-Thorne RJ, Yan N, Nacu S, Weber J, Holmes SP, et al. (2007) Down-regulation of the interferon signaling pathway in T lymphocytes from patients with metastatic melanoma. PLoS Med 4(5): e176.
PLEASE ADD THE LINK TO THE PUBLISHED ARTICLE IN ONLINE VERSIONS OF YOUR REPORT: http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0040176
PRESS-ONLY PREVIEW OF THE ARTICLE: http://www.plos.org/press/plme-04-05-lee.pdf
CONTACT:
Peter Lee
Stanford University
School Medicine
Stanford, CA 94305
United States of America
+1 650-498-7942
+1 650-498-7943 (First Alternate Telephone)
+1 650-736-0974 (fax)
About PLoS Medicine
PLoS Medicine is an open access, freely available international medical journal. It publishes original research that enhances our understanding of human health and disease, together with commentary and analysis of important global health issues. For more information, visit http://www.plosmedicine.org
About the Public Library of Science
The Public Library of Science (PLoS) is a non-profit organization of scientists and physicians committed to making the world's scientific and medical literature a freely available public resource. For more information, visit http://www.plos.org
Journal
PLoS Medicine