Governing stem cell research in California and the USA: towards a social infrastructure

Trends in Biotechnology

Volumn 24, Issue 9, 2006, Pages 390-394

  Winickoff, David E ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ENGINEERING RESEARCH; GENETIC ENGINEERING; LAWS AND LEGISLATION; PROBLEM SOLVING; PUBLIC POLICY; SOCIAL ASPECTS;

HUMAN EMBRYONIC STEM CELL (HESC); SOCIAL INFRASTRUCTURE;

CELLS;

ARTICLE; BIOETHICS; BIOTECHNOLOGY; BONE MARROW TRANSPLANTATION; CELL DIFFERENTIATION; EMBRYONIC STEM CELL; ETHICS; FERTILIZATION IN VITRO; FINANCIAL MANAGEMENT; GOVERNMENT; HEALTH CARE POLICY; HEALTH CARE SYSTEM; HUMAN; MEDICAL RESEARCH; MEDICAL TECHNOLOGY; OOCYTE DONATION; PATENT; POLITICS; PRACTICE GUIDELINE; PRIORITY JOURNAL; PUBLIC HEALTH; SOCIAL ATTITUDE; STEM CELL; UNITED STATES;

CALIFORNIA; EMBRYO RESEARCH; FINANCING, GOVERNMENT; HUMANS; INTELLECTUAL PROPERTY; OOCYTE DONATION; PUBLIC POLICY; RESEARCH SUPPORT; STATE GOVERNMENT; STEM CELLS; TISSUE BANKS; UNITED STATES;

EID: 33747085806     PISSN: 01677799     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.tibtech.2006.06.010     Document Type: Article

References (42)

1. Bush, G.W. (2001) Remarks by the President on Stem Cell Research. (http://www.whitehouse.gov/news/releases/2001/08/20010809-2.html)
2. Reagan, R., Jr. (2004) Speech delivered at the (Democratic National Convention. (http://www.pbs.org/newshour/vote2004/demconvention/speeches/reagan.htm)
3. Herrera S. Leaders and laggards in the stem cell enterprise. Nat. Biotechnol. 23 (2005) 775-777
4. Wagner J. Maryland approves fund to support medical stem cell research. The Washington Post (2006) A1
5. Lo B., et al. A new era in the ethics of human embryonic stem cell research. Stem Cells 23 (2005) 1454-1459
6. Magnus D. Stem cell research: the California experience. Hastings Cent. Rep. 36 (2006) 26-28
7. California Stem Cell Research and Cures Act. (2004) California Health and Safety Codes, §§ 125290.10-125290.70
8. Negrin, R.S. (2005) Hematopoietic stem cell transplantation: where we have come and where we are going. Talk delivered at Stem Cell Research: Charting New Directions in California, San Francisco, CA, October 1-2, 2005. web cast available at http://www.thesciencenetwork.org/Events/CIRM_meeting_10.1-2.05/
9. Institute of Medicine (US). Scientific Opportunities and Public Needs: Improving Priority Setting and Public Input at the National Institutes of Health (1998), National Academies Press. http://fermat.nap.edu/catalog/6225.html
10. Callahan D. What Price Better Health? (2003), University of California Press
11. Scott C.T. Chimeras in the crosshairs. Nat. Biotechnol. 24 (2006) 487-490
12. Bayh-Dole Act (1980) 35 United States Code, §§ 200-212
13. Rai A.K., and Eisenberg R.S. Bayh-Dole reform and the progress of biomedicine. Law Contemp. Probl. 68 (2003) 289-314
14. Schofield A.R. The demise of Bayh-Dole protections against the pharmaceutical industry's abuses of government-funded inventions. J. Law Med. Ethics 32 (2004) 777-780
15. Walsh J.P., et al. The view from the bench: patents, material transfers and biomedical research. Science 309 (2005) 2002-2003
16. Wadman, M. (2005) Licensing fees slow advance of stem cells. News@Nature.com, 272-273. (http://www.nature.com/news/2005/050516/full/435272a.html)
17. Rabin S. The gatekeepers of hES cell products. Nat. Biotechnol. 23 (2005) 817-819
18. Loring J.F., and Campbell C. Intellectual property and human embryonic stem cell research. Science 311 (2006) 1716-1717
19. California Institute for Regenerative Medicine (2006) Intellectual Property Policy for Non-profit Organizations. (http://www.cirm.ca.gov/policies/pdf/IPPNPO.pdf)
20. Organisation for Economic Co-operation and Development (2006). Guidelines for the Licensing of Genetic Inventions. Adopted by the OECD Council on February 23, 2006 (C(2005)149/Rev1) (http://www.oecd.org/dataoecd/39/38/36198812.pdf)
21. Steinbrook R. Egg donation and human embryonic stem-cell research. N. Engl. J. Med. 354 (2006) 324-326
22. Regalado A. Stem-cell rift shows difficulty obtaining eggs. Wall Street Journal (2005) B1
23. Magnus D., and Cho M.K. Issues in oocyte donation for stem cell research. Science 308 (2005) 1747-1748
24. Kalfoglou A.L., and Gittelsohn J. A qualitative follow-up study of women's experiences with oocyte donation. Hum. Reprod. 15 (2000) 798-805
25. American Society for Reproductive Medicine. Ovarian hyperstimulation syndrome. Fertil. Steril. 82 (2004) S81-S86
26. Golan A., et al. Ovarian hyperstimulation syndrome: an update review. Obstet. Gynecol. Surv. 44 (1989) 430-440
27. The Common Rule, U.S. Code of Federal Regulations, 45 C.F.R. 46 (1991) (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm)
28. US Office for Human Research Protections (10 August 2004) Guidance on Research Involving Coded Private Information of Biological Specimens. (http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf)
29. National Research Council, Institute of Medicine. Guidelines for Human Embryonic Stem Cell Research (2005), The National Academies Press. http://www.nap.edu/catalog/11278.html
30. Lo B., et al. Consent from donors for embryo and stem cell research. Science 301 (2003) 921
31. Baum K. Golden eggs: towards the rational regulation of oocyte donation. Brigh. Young Univ. Law Rev. 1 (2001) 107-166
32. California Institute for Regenerative Medicine (2006) Proposed medical and ethical standard regulations. (March 3 edn) (http://www.cirm.ca.gov/prop71/pdf/prop71.pdf)
33. Sherwin S. No Longer Patient: Feminist Ethics and Health Care (1992), Temple University Press
34. Stacey, G. (2004) First report from the UK Stem Cell Bank. (http://www.mrc.ac.uk/pdf-stemcell_steer_comm_annrep.pdf)
35. Associated Press (2005) Wisconsin group to run stem cell bank: federal program will store and distribute cells for research. October 4
36. Brivanlou A.H., et al. Setting standards for human embryonic stem cells. Science 300 (2003) 913-916
37. Faden R., et al. Public stem cell banks: considerations of justice in stem cell therapy. Hastings Cent. Rep. 33 (2003) 13-27
38. UK Stem Cell Bank (2005) Code of Practice for the Use of Human Stem Cell Lines (http://www.mrc.ac.uk/pdf-public-stem_cell_code_of_practice_june2005.pdf)
39. US Department of Health and Human Services (2005) Best practices for the licensing of genomic inventions. 70 Federal Regulations 18413
40. Rothstein M. The role of IRBs in research involving commercial biobanks. J. Law Med. Ethics 30 (2002) 105-108
41. O'Neill O. Autonomy and Trust in Bioethics (2002), Cambridge University Press
42. Winickoff D. Governing population genomics: law, bioethics, and biopolitics in three case studies. Jurimetrics 43 (2003) 187-228