Research Article: Responsible Oversight of Human Stem Cell Research: The California Institute for Regenerative Medicine’s Medical and Ethical Standards

Date Published: May 8, 2007

Publisher: Public Library of Science

Author(s): Geoffrey P Lomax, Zach W Hall, Bernard Lo

Abstract: California voters recently approved $3 billion over 10 years for public funding of stem cell research through the California Institute for Regenerative Medicine (CIRM). Geoffrey Lomax and colleagues discuss the principles that guided the CIRM regulations.

Partial Text: Restrictions on United States federal funding have thrust state governments into a leadership role in funding and establishing standards for human embryonic stem cell (hESC) research. In 2004, California voters approved $3 billion over 10 years for public funding of stem cell research through the California Institute for Regenerative Medicine (CIRM), making CIRM one of the world’s largest supporters of this pioneering new field. CIRM recently adopted strong, comprehensive, and legally binding regulations for the human stem cell (hSC) research that it funds. Box 1 describes the historical background of CIRM regulations. Because other states and jurisdictions may also be developing standards for hESC research, consideration of the principles that guided the CIRM efforts and the innovative measures that it enacted may be useful to others.

Several overall objectives, in addition to the goal of setting high ethical standards, guided formulation of the CIRM regulations.

Informed and voluntary consent. Because human embryonic stem cell research is controversial, prospective donors need to be informed as completely as possible 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. Because it is difficult to foresee all future uses, however, researchers are free to utilize only materials whose donors have consented to all future research uses that are approved by scientific and ethical review bodies. This provision strikes a balance between respecting the informed preferences of donors and maximizing the scientific benefit from research funding.

Source:

http://doi.org/10.1371/journal.pmed.0040114

 

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