Hostname: page-component-8448b6f56d-42gr6 Total loading time: 0 Render date: 2024-04-25T01:28:51.693Z Has data issue: false hasContentIssue false

Reflections on Governance Models for the Clinical Translation of Stem Cells

Published online by Cambridge University Press:  01 January 2021

Extract

Acentral promise of human embryonic stem cell research is the potential to develop viable therapeutic approaches to a range of devastating diseases and conditions. Despite excitement over such advances, there are scientific and medical reasons to be cautious as stem cells and their products are introduced into patients. In response to such concerns, the International Society for Stem Cell Research (ISSCR) as well as ad hoc groups and individuals have offered approaches to governance of this research. While there are similarities among these governance models and they are in principle easily endorsable, in this paper I raise a set of concerns related to their implementation, suggesting areas where gathering data may facilitate more appropriate oversight. Next, I suggest areas that seem to have been neglected as these governance models have been developed so that they may be on the agendas of those seeking to revise these models in the future. Finally, I describe how some of the concerns that have arisen in considering the appropriate governance of stem cell research may be useful in science and translational research more broadly.

Type
Symposium
Copyright
Copyright © American Society of Law, Medicine and Ethics 2010

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Lo, B., Kriegstein, A., and Grady, D., “Clinical Trials in Stem Cell Transplantation: Guidelines for Scientific and Ethical Review,” Clinical Trials 5, no. 5 (2008): 517522; Lo, B., “Case-Based Reasoning in Stem Cell Clinical Trials: The Case of Parkinson Disease,” Journal of Law, Medicine & Ethics 38, no. 2 (2010); Magnus, D., “Translating Stem Cell Research: Challenges at the Research Frontier,” Journal of Law, Medicine & Ethics 38, no. 2 (2010).CrossRefGoogle Scholar
National Academy of Sciences, Guidelines for Human Embryonic Stem Cell Research (Washington, D.C.: National Academies Press, 2005).Google Scholar
National Academy of Sciences, 2007 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research (Washington, D.C.: National Academies Press, 2007).Google Scholar
National Academy of Sciences, 2008 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research (Washington, D.C.: National Academies Press, 2008).Google Scholar
International Society for Stem Cell Research, Guidelines for the Conduct of Human Embryonic Stem Cell Research, 2006, available at <http://www.isscr.org/guidelines/ISS-CRhESCguidelines2006.pdf> (last visited April 7, 2010).+(last+visited+April+7,+2010).>Google Scholar
See International Society for Stem Cell Research, “Guidelines for the Conduct of Human Embryonic Stem Cell Research,” available at <http://www.isscr.org/guidelines/index.htm> (last visited April 7, 2010).+(last+visited+April+7,+2010).>Google Scholar
International Society for Stem Cell Research, Guidelines for the Clinical Translation of Stem Cells, 2008, available at <http://www.isscr.org/clinical_trans/pdfs/ISSCRGLClinicalTrans.pdf> (last visited April 7, 2010).+(last+visited+April+7,+2010).>Google Scholar
Hyun, I., Lindvall, O., Ahrlund-Richter, L., Cattaneo, E., Cavazzana-Calvo, M., Cossu, G., De Luca, M., Fox, I. J., Gerstle, C., Goldstein, R.A., Hermeren, G., High, K. A., Kim, H. O., Lee, H.P., 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., and Daley, G. Q., “New ISSCR Guidelines Underscore Major Principles for Responsible Translational Stem Cell Research,” Cell Stem Cell 3, no. 6 (2008): 607609.CrossRefGoogle Scholar
See Lo, et al., supra note 1.Google Scholar
Id., at 517.Google Scholar
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 71, no. 4 (2008): 16.CrossRefGoogle Scholar
Sugarman, J., McCrory, D. C., Powell, D., Krasny, A., Adams, B., Ball, E., and Cassell, C., “Empirical Research on Informed Consent,” Hastings Center Report 29, no. 1 (1999): S1S42.CrossRefGoogle Scholar
Sugarman, J., Kass, N. E., Goodman, S. N., Perentesis, P., Fernandes, P., and Faden, R. R., “What Patients Say About Medical Research,” IRB 20, no. 4 (1998): 17.Google Scholar
King, N. M. P., “Rewriting the ‘Points to Consider’: The Ethical Impact of Guidance Document Language,” Human Gene Therapy 10, no. 1 (1999): 133139.CrossRefGoogle Scholar
Sugarman, J., Lavori, P. W., Boeger, M., Cain, C., Edson, R., Morrison, V., and Yeh, S. S., “Evaluating the Quality of Informed Consent,” Clinical Trials 2, no. 1 (2005): 18.CrossRefGoogle Scholar
Taylor, H. A., Chaisson, L., and Sugarman, J., “Enhancing Communication Among Data Monitoring Committees and Institutional Review Boards,” Clinical Trials 5, no. 3 (2008): 277282.CrossRefGoogle Scholar
Zettler, P., Wolf, L., and Lo, B., “Establishing Procedures for Institutional Oversight of Stem Cell Research,” Academic Medicine 82, no. 1 (2007): 610; Sugarman, J. and Siegel, A., “How to Determine Whether Existing Human Embryonic Stem Cell Lines Can Be Used Ethically,” Cell Stem Cell 3, no. 3 (2008): 238239; Sugarman, J. and Siegel, A. W., “When Embryonic Stem Cell Lines Fail to Meet Consent Standards,” Science 322, no. 5900 (2008): 379.CrossRefGoogle Scholar
Levine, C., Faden, R., Grady, C., Hammerschmidt, D., Eckenwiler, L., and J. Sugarman, on behalf of the Consortium to Examine Clinical Research Ethics, “‘Special Scrutiny’: A Targeted Form of Research Protocol Review,” Annals of Internal Medicine 140, no. 3 (2004): 220223.CrossRefGoogle Scholar
See Lo, et al. supra note 1.Google Scholar
Office of Biological Activities, National Institutes of Health. Appendix L, available at <http://oba.od.nih.gov/oba/rac/guidelines_02/Appendix_L.htm> (last visited April 7, 2010).+(last+visited+April+7,+2010).>Google Scholar
National Institutes of Health (NIH), Gene Therapy Policy Conference: Prenatal Gene Transfer: Scientific, Medical, and Ethical Issues, January 7–8, 1999, available at <http://oba.od.nih.gov/oba/rac/gtpcconc.pdf> (last visited April 7, 2010); Sugarman, J., “Ethical Considerations in Leaping from Bench to Bedside,” Science 285, no. 5436 (1999): 20712072.CrossRefGoogle Scholar
Recombinant DNA Advisory Committee, RAC Statement, March 11, 1999, available at <http://oba.od.nih.gov/oba/rac/racinutero.pdf> (last visited April 7, 2010).+(last+visited+April+7,+2010).>Google Scholar
Lau, D., Ogbogu, U., Taylor, B., Stafinski, T., Menon, D., and Caulfield, T., “Stem Cell Clinics Online: The Direct-to-Consumer Portrayal of Stem Cell Medicine,” Cell Stem Cell 3, no. 6 (2008): 591594; Kiatpongsan, S. and Sipp, D., “Monitoring and Regulating Offshore Stem Cell Clinics,” Science 323, no. 5921 (2009): 15641565.CrossRefGoogle Scholar
See ISSCR, supra note 7.Google Scholar
Id.; see Lo, et al., supra note 1.Google Scholar
Id. (ISSCR).Google Scholar