MEDICINE:
Consent from Donors for Embryo and Stem Cell Research

Research on human embryos and embryonic stem cells holds great promise for understanding human reproduction and development and for regenerative medicine. The need for informed consent from research participants is well established (1). Under U.S. federal regulations, persons who provide biological materials for research are research subjects who need to provide consent (1-3). In research involving human embryos, informed consent is particularly important because of the diverse opinions and strong emotions that surround these issues (4, 5). Some potential donors consider all such research to be unacceptable; others only support some forms of research (6-8). A donor might consider infertility research acceptable but object to research that could lead to stem cell lines, patenting, or commercial products (9, 10). Governmental bodies in several countries have considered the issue of consent for embryo and stem cell research (5, 11-13).

In the United States, federal regulations permit a waiver of informed consent for the research use of anonymous biological materials that cannot be linked to donors even through a code (2, 14). However, people commonly place great emotional and moral significance on their reproductive materials (15, 16). Using gametes or embryos for certain kinds of research without consent, even after identifiers have been removed, could be regarded as a wrong or offensive (17, 18).

The consent of the woman or couple in the assisted reproductive technology (ART) program is clearly required for research with frozen embryos remaining after completion of infertility treatment (19, 20-22). Frozen embryos may be created with sperm or oocytes from donors who do not participate any further in assisted reproduction or child-rearing. Guidelines in the United Kingdom and Canada require consent from gamete donors, as well as infertility patients, for research with frozen embryos (12, 23). However, current U.S. guidelines do not consider whether these gamete donors also have an autonomy-based interest in the use of such embryos for research (20, 21). The argument against requiring such consent is that in donating to ART patients, gamete donors have ceded their right to direct further usage of their gametes, particularly when they received financial compensation. However, gamete donors who are willing to help women and couples bear children may object to the use of their genetic materials for research. In one study, 25% of women who donated oocytes for infertility treatment did not want the embryos created to be used for research (18). Little is known about the wishes of sperm donors concerning research. Moreover, if stem cell lines are created, it is the donor's genetic material that will be propagated indefinitely.

We suggest that gamete donors' wishes should be determined and respected; informed consent from both oocyte and sperm donors should be obtained for an embryo to be used in research (19). Our position does not depend on ascribing personhood to embryos or on classifying gametes or embryos per se as research subjects. There are logistical and practical differences in obtaining consent to embryo research from oocyte and sperm donors. ART clinics can readily discuss donation for research with oocyte donors during visits for oocyte stimulation and retrieval. However, most ART clinics obtain donor sperm from sperm banks and typically have no direct contact with the donors. Commercial agencies and nonacademic ART centers may be reluctant to include research in their consent discussions with sperm donors. The current consent form used by one of the largest sperm banks in the United States makes no provisions for use of sperm other than for "the primary purpose of causing pregnancy" (24). Furthermore, sperm is often donated anonymously, with strict confidentiality provisions, and frozen sperm must be quarantined for 6 months (25). Thus, recontacting sperm donors may be difficult or impossible and may violate donor privacy. Sperm banks and researchers need to collaborate to change the consent process for future sperm donation to include consideration of donation for research.

Basic and clinical scientists, ART clinicians, and leaders of research institutions should together stimulate broad public discussion to create guidelines for informed consent that protect donors while allowing important research to proceed.

References and Notes

1. 45 Code of Federal Regulations (C.F.R.) ¡ì46 (1991).
2. National Bioethics Advisory Commission, "Research involving human biological materials: Ethical issues and policy guidance" (National Bioethics Advisory Commission, Rockville, MD, 1999).
3. 45 C.F.R. 46.102 (1991).
4. ABCNews.com, "Public backs stem cell research," 26 June 2001.
5. Commission of the European Communities, "Report on human embryonic stem cell research" (Office of Publications for the EU, Luxembourg, 2003).
6. Center for Public Policy, Virginia Commonwealth University, VCU Life Sciences Survey (2002).
7. C. A. McMahon et al., Hum. Reprod. 18, 871 (2003).
8. House of Lords, Report from the Select Committee on Stem Cell Research (27 February 2002); available at www.publications.parliament.uk/pa/ld200102/ldselect/ldstem/83/8301.htm.
9. M. J. Radin, Contested Commodities (Harvard Univ. Press, Cambridge, MA, 1996).
10. A. Kimbrell, The Human Body Shop: The Cloning, Engineering, and Marketing of Life (Regnery Publishing, Washington, DC, 1997).
11. Department of Health and Human Services, National Institutes of Health guidelines for research using human, pluripotent stem cells. Fed. Regist. 65, 51975 (2000).
12. Ad Hoc Working Group on Stem Cell Research, Canadian Institutes for Health Research (CIHR), "Human pluripotent stem cell research: Recommendations for CIHR-funded research (2002); available at www.cihr-irsc.gc.ca/publications/ethics/stem_cell/stem_cell_guidelines_e.shtml.
13. CIHR, "Human stem cell research: Opportunities for health and ethical perspectives"; available at www.cihr-irsc.gc.ca/publications/ethics/stem_cell/index_e.shtml; updated 13 May 2003; accessed 30 June 2003.
14. 45 C.F.R. 46.101(b)(4) (1991).
15. J. Robertson, Children of Choice: Freedom and the New Reproductive Technologies (Princeton Univ. Press, Princeton, NJ, 1994).
16. New York State Task Force on Life and the Law, "Assisted reproductive technologies: Recommendations for public policy" (New York State Task Force on Life and the Law, New York, 1998).
17. J. Feinberg, Harmless Wrongdoing (Oxford Univ. Press, New York, 1988).
18. A. Kalfoglou, G. Geller, Fertil. Steril. 74, 660 (2000).
19. National Institutes of Health, "Report of the Human Embryo Research Panel" (National Institutes of Health, Bethesda, MD, 1994).
20. National Bioethics Advisory Commission, "Ethical issues in stem cell research" (National Bioethics Advisory Commission, Rockville, MD, 1999).
21. Ethics Committee of the American Society for Reproductive Medicine, Fertil. Steril. 78, 957 (2002).
22. Calif. Health and Safety Code, prec. ¡ì125115 (2003).
23. Human Fertilisation and Embryology Authority (HFEA), Code of Practice (Human Fertilisation and Embryology Authority, London, 5th ed., 2001).
24. California Cryobank, Donor consent agreement (1997), private communication, 1 February 2003.
25. American Society for Reproductive Medicine, Fertil. Steril. 77, S2 (2002).
26. B. Lo, L. Wolf, and V. Chou are supported by the Greenwall Foundation.

*To whom correspondence should be addressed. E-mail: bernie@medicine.ucsf.edu Volume 301, Number 5635, Issue of 15 Aug 2003, p. 921.
Copyright © 2003 by The American Association for the Advancement of Science. All rights reserved.