NIH guidelines for stem cell research and gamete donors

Science

Volumn 327, Issue 5968, 2010, Pages 962-963

  Lo, Bernard ^a,b   Parham, Lindsay ^a   Cedars, Marcelle ^a   Fisher, Susan ^a,b   Gates, Elena ^a,b   Giudice, Linda ^a,b   Halme, Dina Gould ^a   Hershon, William ^c   Kriegstein, Arnold ^a,b   Rao, Radhika ^a   Roberts, Clifford ^a   Wagner, Richard ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c Disability Rights California   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CYTOLOGY; EMBRYO; GAMETE; MEDICINE; REGULATORY FRAMEWORK; RESEARCH WORK;

EMBRYONIC STEM CELL; FERTILIZATION IN VITRO; GAMETE; HEALTH CARE POLICY; HUMAN; INFERTILITY THERAPY; INFORMED CONSENT; MEDICAL ETHICS; MEDICAL INFORMATION; MEDICAL RESEARCH; NATIONAL HEALTH ORGANIZATION; PRACTICE GUIDELINE; PRIORITY JOURNAL; SHORT SURVEY; STEM CELL; ARTICLE; CELL LINE; DONOR; EMBRYO DISPOSITION; EMBRYO RESEARCH; ETHICS; FEMALE; INTERPERSONAL COMMUNICATION; OOCYTE DONATION; STANDARD; UNITED STATES;

CELL LINE; DISCLOSURE; EMBRYO DISPOSITION; EMBRYO RESEARCH; EMBRYONIC STEM CELLS; FEMALE; FERTILIZATION IN VITRO; GUIDELINES AS TOPIC; HUMANS; INFORMED CONSENT; NATIONAL INSTITUTES OF HEALTH (U.S.); OOCYTE DONATION; TISSUE DONORS; UNITED STATES;

EID: 77149173779     PISSN: 00368075     EISSN: 10959203     Source Type: Journal    
DOI: 10.1126/science.1180725     Document Type: Short Survey

References (25)

1. NIH, National Institutes of Health Guidelines on Human Stem Cell Research (NIH, Bethesda, MD, 2009); http://stemcells.nih.gov/policy/2009guidelines.htm.
2. National Research Council and Institute of Medicine, 2007 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research (Nattaional Academies Press, Washington, DC, 2007); www.nap.edu/catalog.php? record-id=11871.
3. California Institute for Regenerative Medicine, CIRM MES Regulations Title 17, California Code of Regulations Section 100010-100110 (CIRM, San Francisco, CA, 2009); www.cirm.ca.gov/reg/pdf/Reg100100-SM-Acct-Stan-dards.pdf
4. International Society for Stem Cell Research (ISSCR), Guidelines for the Conduct of Human Embryonic Stem Cell Research (ISSCR, Deerfield, IL, 2006); www.isscr.org/guidelines/index.htm.
5. Human Fertilisation and Embryo Authority (HFEA), Guidance: Consent to use and storage of gametes and embryos; Note 5A, Interpretation of mandatory requirements (HFEA, London, 1991); www.hfea.gov.uk/336 html#guidanceSection3718.
6. Australian Government National Health and Medical Research Council, Prohibition of Human Cloning for Reproduction Act of 2002 (Attorney General's Department, Australian Government, Canberra, 2002); www. nhmrc.gov.au/ publications/synopses/prohibitsyn.htm
7. Parliament of Canada, Assisted Human Reproduction Act, SC 2004, chap. 2; http://laws.justice.gc.ca/PDF/Statute/A/A-13.4.pdf.
8. European Group on Ethics in Science and New Technologies to the European Commission, The Ethics Review of hESCFP7 Research Projects (European Communities, 2007); http://ec.europa.eu/european-group-ethics/avis/index-en.htm.
9. About 25% of women who provided oocytes to patients in infertility clinics said they would not want their oocytes to be used for research (22). In an IVF program, 13% of oocyte donors would not be willing to donate embryos created from their eggs for research, and 5% were unsure (23). Among prospective (not actual) oocyte donors, 10% would not be comfortable if embryos made using their oocytes were donated for research (24).
10. National Bioethics Advisory Commission (NEBAC), Ethical Issues in Human Stem Cell Research (NEBAC, Rockville, MD, 1999).
11. B. Lo et al., Science 301, 921 (2003).
12. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Biomedical and Behavioral Research (Office of Human Subjects Research, NIH, Bethesda, MD, 1979).
13. For research, informed consent forms must be approved by an Institutional Review Board and should contain specific required elements, including the risks and benefits of research participation and its alternatives (25). U.S. regulations on human subjects research do not apply to research with existing biological materials that investigators cannot link to the donors. The ethical justification for this exception is that few patients would object if a leftover tube of blood or surgical specimen were deidentified and used for research. Nonetheless, because hESC research is sensitive, NIH requires consent from embryo donors even if the materials are de-identified, a policy consistent with other standards (21).
14. G. P. Lomax, Z. W. Hall, B. Lo, PLoS Med. 4, e114 (2007).
15. The primary concerns of IVF physicians and oocyte donor agencies are (i) that donors appreciate that the medical procedures present risks (requiring donor consent), and (ii) that they will have no parental rights regarding children produced from their oocytes, and that the IVF patient may choose to donate frozen embryos to another IVF patient or destroy them (requiring donor dispositional authority). These issues may be more thoroughly discussed and documented than potential downstream hESC research, which some IVF physicians and donor agencies may regard as a secondary issue.
16. J. W. Berg, C. W. Lidz, P. S. Appelbaum, Informed Consent: Legal Theory and Clinical Practice (Oxford Univ. Press, New York, ed. 2, 2001).
17. R. Korobkin, S. R. Munzer, Stem Cell Century: Law and Policy for a Breakthrough Technology (Yale Univ. Press, New Haven, CT, 2007).
18. J. Sugarman, A. W. Siegel, Science 322, 379 (2008).
19. B. Lo et al., Cell Stem Cell 4, 115 (2009).
20. Exceptions may also be permitted for frozen embryos already in existence when the guidelines are revised if it is uncertain whether third-party gamete donors were told that hESC research was a dispositional option. Because it is not known before hESC lines are derived whether they will have significant scientific advantages over other lines, stricter standards should be applied for such exceptions than in the case of h ESC lines already in existence.
21. R. Streiffer, Hastings Cent. Rep. 38, 40 (2008).
22. A. L. Kalfoglou, G. Geller, Fertil. Steril. 74, 660 (2000).
23. R. Klitzman, M. V. Sauer, Reprod. Biomed. Online 18, 603 (2009).
24. N. Adsuar et al., Fértil. Steril. 84, 1513 (2005).
25. Department of Health and Human Services, Protection of Human Subjects, 45 Code of Federal Regulations, part46 (2005); www.dhhs.gov/ohrp/humansubjects/ guidance/45cfr46.htm.