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Questions Concerning the Clinical Translation of Cell-Based Interventions under an Innovation Pathway

Published online by Cambridge University Press:  01 January 2021

Jeremy Sugarman
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Extract

Criticisms of the traditional clinical research pathway and its extensive oversight often focus on proposals for deregulation or assert that as in clinical treatment, clinical research should always offer benefit to patient-subjects. Proponents of medical innovation take a different, middle path, arguing that innovation is distinguishable from both research and treatment. This article considers this third pathway by examining stem cell-based innovation.

Stem cell-based medical innovation is one pathway toward clinical translation. In fact, such an approach was taken in developing umbilical cord blood transplantation, which is now widely viewed as a safe and effective means for treating a range of malignant and non-malignant conditions. While the Guidelines for the Clinical Translation of Stem Cells created by the International Society for Clinical Research (ISSCR) provide an approach to clinical translation that involves “responsible innovation” as an alternative to clinical research, there are at least four sets of unanswered questions regarding the use of an innovation pathway in this context that warrant careful attention.

Type
Symposium
Information
Journal of Law, Medicine & Ethics , Volume 40 , Issue 4 , Winter 2012 , pp. 945 - 950
Copyright
Copyright © American Society of Law, Medicine and Ethics 2012

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References

For example, Fost, N. and Levine, R. J., “The Dysregulation of Human Subjects Research,” JAMA 298, no. 18 (2007): 2196–2198.CrossRefGoogle Scholar
For example, Jansen, L. A., “A Closer Look at the Bad Deal Trial: Beyond Clinical Equipoise,” Hastings Center Report 35, no. 5 (2005): 29–36.CrossRefGoogle Scholar
Kurtzberg, J. Lyerly, A. D., and Sugarman, J., “Untying the Gordian Knot: Policies, Practices, and Ethical Issues Related to Banking of Umbilical Cord Blood,” Journal of Clinical Investigation 115, no. 10 (2005): 2592–2597.CrossRefGoogle Scholar
International Society for Stem Cell Research (ISSCR), Guidelines for the Clinical Translation of Stem Cells, 2008, available at <http://www.isscr.org/GuidelinesforClinicalTranslation/2480.htm> (last visited December 7, 2012); 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): 607–609.CrossRefGoogle Scholar
Id. (ISSCR), Section 7.Google Scholar
Pollack, A., “Geron Is Shutting Down Its Stem Cell Clinical Trial,” New York Times, November 14, 2011.Google Scholar
Rettig, R. A. Jacobson, P. D. Farquhar, C. M., and Aubry, W. M., False Hope: Bone Marrow Transplantation for Breast Cancer (New York: Oxford University Press, 2007).Google Scholar
United States Department of Health and Human Services, Federalwide Assurance(FWA) for the Protection of Human Subjects, June 17, 2011, available at <http://www.hhs.gov/ohrp/assurances/assurances/filasurt.html> (last visited December 7, 2012).+(last+visited+December+7,+2012).>Google Scholar
45 United States Code of Federal Regulations 46.102.d.Google Scholar
See ISSCR, supra note 4, at Recommendation 34(h).Google Scholar
Casarett, D. Karlawish, J. H. T., and Sugarman, J., “Determining When Quality Improvement Initiatives Should be Considered Research: Proposed Criteria and Potential Implications,” JAMA 283, no. 17 (2000): 2275–2280.CrossRefGoogle Scholar
FDA, Access to Investigational Drugs Outside of a Clinical Trial, available at <http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/AccesstoInvestigationalDrugs/ucm176098.htm> (last visited December 7, 2012).+(last+visited+December+7,+2012).>Google Scholar
FDA, IDE Early/Expanded Access, available at <http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/ucm051345.htm#emergencyuse> (last visited December 7, 2012).]+(last+visited+December+7,+2012).]>Google Scholar
National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, April 18, 1979, available at <http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html> (last visited December 8, 2012).+(last+visited+December+8,+2012).>Google Scholar
See ISSCR, supra note 4, at Section 7.Google Scholar
McKneally, M. F. and Daar, A. S., “Introducing New Technologies: Protecting Subjects of Surgical Innovation and Research,” World Journal of Surgery 27, no. 8 (2003): 930–935.CrossRefGoogle Scholar
Biffl, W. L. Spain, D. A. Reitsma, A. M. Minter, R. M. Upperman, J. Wilson, M. Adams, R. Goldman, E. B. Angelos, P. Krummel, T., L. J. Greenfield, and the Society of University Surgeons Surgical Innovations Project Team, “Responsible Development and Application of Surgical Innovations: A Position Statement of the Society of University Surgeons,” Journal of the American College of Surgeons 206, no. 3 (2008): 1204–1209.CrossRefGoogle Scholar
Id.Google Scholar
Reitsma, A. M., “Ethical Guidelines for Innovative Surgery: Obstacles for Policy Change,” in Reitsma, A. M. and Moreno, J. D., eds., Ethical Guidelines for Innovative Surgery (Hagerstown, Maryland: University Publishing Group, 2006): 117–149.Google Scholar
Mastroianni, A. C., “Liability, Regulation and Policy in Surgical Innovation: The Cutting Edge of Research and Therapy,” Health Matrix Cleveland 16, no. 2 (Summer 2006): 351–442.Google Scholar
See ISSCR, supra note 4, Section 7.Google Scholar
See McKneally, and Daar, , supra note 16.Google Scholar
Lindvall, O. and Hyun, I., “Medical Innovation versus Stem Cell Tourism,” Science 324, no. 5935 (2009): 1664–1665.CrossRefGoogle Scholar
Sugarman, J. and Sipp, D., “Ethical Aspects of Stem Cell-based Clinical Translation: Research, Innovation, and Delivering Unproven Interventions,” in Hug, K. and Hermeren, G., eds., Translational Stem Cell Research: Issues Beyond the Debate on the Moral Status of the Human Embryo (New York: Springer, 2011): At 125–135.Google Scholar
London, A. J., “Cutting Surgical Practice at the Joints: Individualizing and Assessing Surgical Procedures,” in Reitsma, and Moreno, , supra note 19, 19–52, at 41.Google Scholar
King, N. M. P., “The Line between Clinical Innovation and Human Experimentation,” Seton Hall Law Review 33, no. 2 (2011): 573–582, at 574.Google Scholar
Agich, G. J., “Ethics and Innovation in Medicine,” Journal of Medical Ethics 27, no. 5 (2001): 295–296.Google Scholar
See Sugarman, and Sipp, , supra note 24, at 131.Google Scholar
Jones, J. W., “The Surgeon's Autonomy: Defining Limits in Therapeutic Decision Making,” in Reitsma, and Moreno, , supra note 19, at 75–92.Google Scholar
Margo, C. E., “When Is Surgery Research? Towards an Operational Definition of Human Research,” Journal of Medical Ethics 27, no. 1 (2001): 40–43.CrossRefGoogle Scholar
See Biffl, et al., supra note 17; and Mastroianni, , supra note 20.Google Scholar