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

For example, Fost N. and Levine R. J. , “The Dysregulation of Human Subjects Research,” JAMA 298, no. 18 (2007): 2196–2198.

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.

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.

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.

Id. (ISSCR), Section 7.

Pollack A. , “Geron Is Shutting Down Its Stem Cell Clinical Trial,” New York Times, November 14, 2011.

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).

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).

45 United States Code of Federal Regulations 46.102.d.

See ISSCR, supra note 4, at Recommendation 34(h).

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.

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).

FDA, IDE Early/Expanded Access, available at <http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/ucm051345.htm#emergencyuse> (last visited December 7, 2012).]

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).

See ISSCR, supra note 4, at Section 7.

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.

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.

Id.

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.

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.

See ISSCR, supra note 4, Section 7.

See McKneally and Daar , supra note 16.

Lindvall O. and Hyun I. , “Medical Innovation versus Stem Cell Tourism,” Science 324, no. 5935 (2009): 1664–1665.

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.

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.

King N. M. P. , “The Line between Clinical Innovation and Human Experimentation,” Seton Hall Law Review 33, no. 2 (2011): 573–582, at 574.

Agich G. J. , “Ethics and Innovation in Medicine,” Journal of Medical Ethics 27, no. 5 (2001): 295–296.

See Sugarman and Sipp , supra note 24, at 131.

Jones J. W. , “The Surgeon's Autonomy: Defining Limits in Therapeutic Decision Making,” in Reitsma and Moreno , supra note 19, at 75–92.

Margo C. E. , “When Is Surgery Research? Towards an Operational Definition of Human Research,” Journal of Medical Ethics 27, no. 1 (2001): 40–43.

See Biffl , supra note 17; and Mastroianni , supra note 20.