Reflections on governance models for the clinical translation of stem cells

Journal of Law, Medicine and Ethics

Volumn 38, Issue 2, 2010, Pages 251-256

  Sugarman, Jeremy ^a  

^a UNIVERSITY OF BALTIMORE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADVISORY COMMITTEE; CONFERENCE PAPER; EMBRYO RESEARCH; EMBRYONIC STEM CELL; ETHICS; GOVERNMENT; GOVERNMENT REGULATION; HEALTH CARE ORGANIZATION; HEALTH CARE QUALITY; HUMAN; INFORMED CONSENT; INTERPERSONAL COMMUNICATION; LEGAL ASPECT; MASS COMMUNICATION; NONBIOLOGICAL MODEL; ORGANIZATION; ORGANIZATION AND MANAGEMENT; PRACTICE GUIDELINE; SCIENCE; SOCIAL JUSTICE; TRANSLATIONAL RESEARCH; UNITED STATES;

ADVISORY COMMITTEES; CLINICAL GOVERNANCE; DECISION MAKING, ORGANIZATIONAL; DIFFUSION OF INNOVATION; EMBRYO RESEARCH; EMBRYONIC STEM CELLS; FEDERAL GOVERNMENT; GOVERNMENT REGULATION; GUIDELINES AS TOPIC; HUMANS; INFORMED CONSENT; MODELS, ORGANIZATIONAL; NATIONAL ACADEMY OF SCIENCES (U.S.); SCIENCE; SOCIAL JUSTICE; SOCIETIES, SCIENTIFIC; TRANSLATIONAL MEDICAL RESEARCH; TRUTH DISCLOSURE; UNITED STATES;

EID: 77954893603     PISSN: 10731105     EISSN: 1748720X     Source Type: Journal    
DOI: 10.1111/j.1748-720X.2010.00485.x     Document Type: Conference Paper

References (24)

1. Lo B, Kriegstein A, Grady D. " Clinical Trials in Stem Cell Transplantation: Guidelines for Scientific and Ethical Review," Clinical Trials 2008, 5(no. 5):517-522. B. Lo, " Case-Based Reasoning in Stem Cell Clinical Trials: The Case of Parkinson Disease," 38, no. 2 (2010); D. Magnus, " Translating Stem Cell Research: Challenges at the Research Frontier," 38, no. 2 (2010)
2. Guidelines for Human Embryonic Stem Cell Research 2005, National Academy of Sciences, Washington, D.C., National Academies Press
3. 2007 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research 2007, National Academy of Sciences, Washington, D.C., National Academies Press
4. 2008 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research 2008, National Academy of Sciences, Washington, D.C., National Academies Press
5. Guidelines for the Conduct of Human Embryonic Stem Cell Research. 2006, http://www.isscr.org/guidelines/ISS-CRhESCguidelines2006.pdf, International Society for Stem Cell Research, , last visited April 7, 2010
6. " Guidelines for the Conduct of Human Embryonic Stem Cell Research," http://www.isscr.org/guidelines/index.htm, See, International Society for Stem Cell Research, , last visited April 7, 2010
7. Guidelines for the Clinical Translation of Stem Cells. 2008, http://www.isscr.org/clinical_trans/pdfs/ISSCRGLClinicalTrans.pdf, International Society for Stem Cell Research, , last visited April 7, 2010
8. Hyun I, Lindvall O, Ahrlund-Richter L, Cattaneo E, Cavazzana-Calvo M, Cossu G, De Luca M, Fox I J, Gerstle C, Goldstein RA, Hermeren G, High K A, Kim H O, Lee HP, Levy-Lahad E, Li L, Lo B, Marshak D R, McNab A, Munsie M, Nakauchi H, Rao M, Rooke H M, Valles C S, Srivastava A, Sugarman J, Taylor P L, Veiga A, Wong A L, Zoloth L, Daley G Q. " New ISSCR Guidelines Underscore Major Principles for Responsible Translational Stem Cell Research," Cell Stem Cell 2008, 3(no. 6):607-609.
9. See Lo et al., note 1.
10. Mathews D J, Sugarman J, Bok H, Blass D M, Coyle J T, Duggan P, Finkle J, Greely H T, Hillis A, Hoke A, Johnson R, Johnston M, Kahn J, Kerr D, Kurtzberg J, Liao S M, McDonald J W, McKhann G, Nelson K B, Rao M, Regenberg A, Siegel A W, Smith K, Solter D, Song H, Vescovi A, Young W, Gearhart J D, Faden R. " Cell-Based Interventions for Neurologic Conditions: Ethical Challenges for Early Human Trials," Neurology 2008, 71(no. 4):1-6.
11. Sugarman J, McCrory D C, Powell D, Krasny A, Adams B, Ball E, Cassell C. " Empirical Research on Informed Consent," Hastings Center Report 1999, 29(no. 1):S1-S42.
12. Sugarman J, Kass N E, Goodman S N, Perentesis P, Fernandes P, Faden R R. " What Patients Say About Medical Research," IRB 1998, 20(no. 4):1-7.
13. King N M P. " Rewriting the 'Points to Consider': The Ethical Impact of Guidance Document Language," Human Gene Therapy 1999, 10(no. 1):133-139.
14. Sugarman J, Lavori P W, Boeger M, Cain C, Edson R, Morrison V, Yeh S S. " Evaluating the Quality of Informed Consent," Clinical Trials 2005, 2(no. 1):1-8.
15. Taylor H A, Chaisson L, Sugarman J. " Enhancing Communication Among Data Monitoring Committees and Institutional Review Boards," Clinical Trials 2008, 5(no. 3):277-282.
16. Zettler P, Wolf L, Lo B. " Establishing Procedures for Institutional Oversight of Stem Cell Research," Academic Medicine 2007, 82(no. 1):6-10. J. Sugarman and A. Siegel, " How to Determine Whether Existing Human Embryonic Stem Cell Lines Can Be Used Ethically," 3, no. 3 (2008): 238-239; J. Sugarman and A. W. Siegel, " When Embryonic Stem Cell Lines Fail to Meet Consent Standards," 322, no. 5900 (2008): 379.
17. Levine C, Faden R, Grady C, Hammerschmidt D, Eckenwiler L, Sugarman J. " 'Special Scrutiny': A Targeted Form of Research Protocol Review," Annals of Internal Medicine 2004, 140(no. 3):220-223. on behalf of the Consortium to Examine Clinical Research Ethics
18. See Lo, et al. note 1.
19. http://oba.od.nih.gov/oba/rac/guidelines_02/Appendix_L.htm, Office of Biological Activities, National Institutes of Health. Appendix L, , last visited April 7, 2010
20. http://oba.od.nih.gov/oba/rac/gtpcconc.pdf, National Institutes of Health (NIH), Gene Therapy Policy Conference: Prenatal Gene Transfer: Scientific, Medical, and Ethical Issues, January 7-8, 1999,, last visited April 7, 2010); J. Sugarman, " Ethical Considerations in Leaping from Bench to Bedside," 285, no. 5436 (1999): 2071-2072
21. RAC Statement. March 11, 1999, http://oba.od.nih.gov/oba/rac/racinutero.pdf, Recombinant DNA Advisory Committee, , last visited April 7, 2010
22. Lau D, Ogbogu U, Taylor B, Stafinski T, Menon D, Caulfield T. " Stem Cell Clinics Online: The Direct-to-Consumer Portrayal of Stem Cell Medicine," Cell Stem Cell 2008, 3(no. 6):591-594. S. Kiatpongsan and D. Sipp, " Monitoring and Regulating Offshore Stem Cell Clinics," 323, no. 5921 (2009): 1564-1565.
23. See ISSCR, note 7.
24. see Lo, et al., note 1