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Science 19 February 2010:
Vol. 327 no. 5968 pp. 962-963
DOI: 10.1126/science.1180725
  • Policy Forum
Research Ethics

NIH Guidelines for Stem Cell Research and Gamete Donors

  1. Bernard Lo1,2,3,*,
  2. Lindsay Parham1,
  3. Marcelle Cedars4,
  4. Susan Fisher3,5,
  5. Elena Gates3,4,
  6. Linda Giudice3,4,
  7. Dina Gould Halme6,
  8. William Hershon7,
  9. Arnold Kriegstein3,8,
  10. Radhika Rao9,
  11. Clifford Roberts10 and
  12. Richard Wagner11
  1. 1Program in Medical Ethics, University of California, San Francisco (UCSF), San Francisco, CA 94143, USA.
  2. 2Department of Medicine, UCSF, San Francisco, CA 94143, USA.
  3. 3The Eli and Edythe Broad Center for Regeneration Medicine and Stem Cell Research, UCSF, San Francisco, CA 94143, USA.
  4. 4Department of Obstetrics, Gynecology, and Reproductive Sciences, UCSF, San Francisco, CA 94143, USA.
  5. 5Department of Anatomy, UCSF, San Francisco, CA 94143, USA.
  6. 6Office of the Dean of the School of Medicine, UCSF, San Francisco, CA 94143, USA.
  7. 7Disability Rights California, Oakland, CA 94612, USA.
  8. 8Program in Developmental and Stem Cell Biology, UCSF, San Francisco, CA 94143, USA.
  9. 9University of California, Hastings College of the Law, San Francisco, CA 94102, USA.
  10. 10Office of the Vice Chancellor for Research, UCSF, San Francisco, CA 94143, USA.
  11. 11Human Research Protection Program, UCSF, San Francisco, CA 94143, USA.
  1. *Author for correspondence. E-mail: bernie{at}medicine.ucsf.edu

Summary

Recent National Institutes of Health (NIH) guidelines regarding human embryonic stem cell (hESC) lines created from embryos remaining after infertility treatment (1) are expected to increase substantially the number of hESC lines eligible for U.S. federal funding. Although the guidelines require informed consent from embryo donors for derivation of hESC lines, such consent is not required from third-party donors (not an intended parent) whose gametes were used to create the embryos.This is in contrast to many state, national, and international recommendations (2–8). We argue that dispositional authorization after disclosure regarding hESC research should be obtained from third-party gamete donors, but that the requirements may be more flexible and less complex than for informed consent.

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