PM&R
Volume 2, Issue 7 , Pages 664-670 , July 2010

Informed Consent and Phase 1 Research in Spinal Cord Injury

  • Kristi L. Kirschner, MD (Feature Editor)

      Affiliations

    • Medical Humanities and Bioethics, and PM&R, Northwestern University Feinberg School of Medicine, 750 N. Lake Shore Drive, Room 623, Chicago, IL 60611; and Schwab Rehabilitation Hospital, 1401 S California Blvd., Chicago, IL 60608∥
    • Corresponding Author InformationAddress correspondence to K.L.K.
    • ,
  • Katherine Stenson, MD (Contributor)

      Affiliations

    • Department of PM&R, Northwestern University Feinberg School of Medicine and the Rehabilitation Institute of Chicago, Chicago, IL⁎
    • ,
  • David Chen, MD (Contributor)

      Affiliations

    • Department of PM&R, Northwestern University Feinberg School of Medicine and the Rehabilitation Institute of Chicago, Chicago, IL⁎
    • ,
  • Keith Tansey, MD, PhD (Contributor)

      Affiliations

    • Spinal Cord Injury Research, Shepherd Center and Departments of Neurology and Physiology, Emory University School of Medicine, Atlanta, GA†
    • ,
  • Thomas R. Kerkhoff, PhD, ABPP/RP (Contributor)

      Affiliations

    • University of Florida, Gainesville, FL‡
    • ,
  • Lester Butt, PhD, ABPP/RP (Contributor)

      Affiliations

    • Craig Hospital, Englewood, CO
    • ,
  • Andrés J. Gallegos, Esq (Contributor)

      Affiliations

    • Robbins, Salomon and Patt, Ltd., Chicago, IL§

References 

  1. GERON Regenerative Medicine: hESC-Derived Oligodendrocytes—GRNOPC1. http://www.geron.com/products/productinformation/spinalcordinjury.aspxAccessed May 28, 2010
  2. FAQ ClinicalTrials.gov—Clinical Trial Phases: NIH National Library of Medicine. http://www.nlm.nih.gov/services/ctphases.htmlAccessed May 28, 2010
  3. NIH Clinical Center Department of Bioethics: Research: the ethics of clinical design. http://www.bioethics.nih.gov/research/design.shtmlAccessed May 28, 2010
  4. Applebaum PS, Roth LH, Lidz CW, Benson P, Winslade W. False hopes and best data: Consent to research and the therapeutic misconception. The Hastings Center Report. 1987;17:20–24
  5. Gilbert F. Geron's hESC Trial for Spinal Cord Injury: The Risk of Therapeutic Misconception (Bioethics Forum). Posted 4/17/09 http://www.thehastingscenter.org/Bioethicsforum/Post.aspx?id=3370&blogid=140&terms=geron+stem+cells+and+%23filename+*.html#ixzz0jln2y9olAccessed May 28, 2010
    Commentary from Katherine W. Stenson, MD, and David Chen, MD
  1. Tuszynski MH, Steeves JD, Fawcett JW, et al. Guidelines for the conduct of clinical trials for spinal cord injury as developed by the ICCP Pane: Clinical trial inclusion/exclusion criteria and ethics. Spinal Cord. 2007;45:222–231
  2. Alper J. Geron gets green light for human trial of ES cell-derived product. Nat Biotechnol. 2009;27:213–214
    Commentary from Keith Tansey, MD, PhD
  1. Jones LA, Lammertse DP, Charlifue SB, et al. A phase 2 autologous cellular therapy trial in patients with acute, complete spinal cord injury: Pragmatics, recruitment and demographics. Spinal Cord, [Epub ahead of print, 2010 April 13].
  2. Deforge D, Nymark J, Lemaire E, et al. Effect of 4-aminopyridine on gait in ambulatory spinal cord injuries: A double-blind, placebo-controlled crossover trial. Spinal Cord. 2004;42:674–685
  3. Sherwood AM, Dimitrijevic MR, McKay WB. Evidence of subclinical brain influence in clinically complete spinal cord injury: Discomplete SCI. J Neurol Sci. 1992;110:90–98
  4. McKay WB, Lim HK, Priebe MM, Stokic DS, Sherwood AM. Clinical neurophysiological assessment of residual motor control in post-spinal cord injury paralysis. Neurorehabil Neural Repair. 2004;18:144–153
  5. Steeves JD, Fawcett JW, Tuszynski MH, et al. ICCP Clinical Trials Information (Experimental treatments for spinal cord injury: What you should know if you are considering participation in a clinical trial). http://icord.org/documents/iccp-clinical-trials-information/Accessed April 23, 2010
  6. Demarquay G, Derex L, Nighoghossian N, et al. Ethical issues of informed consent in acute stroke (Analysis of the modalities of consent in 56 patients enrolled in urgent therapeutic trials). Cerebrovas Dis. 2005;19:65–68
  7. Dobkin BH, Curt A, Guest J. Cellular transplants in China: Observational study from the largest human experiment in chronic spinal cord injury. Neurorehabil Neural Repair. 2006;20:5–13
  8. Blight A, Curt A, Ditunno JF, et al. Position statement on the sale of unproven cellular therapies for spinal cord injury: The international campaign for cures of spinal cord injury paralysis. Spinal Cord. 2009;47:713–714
    Commentary from Thomas R. Kerkhoff, PhD, ABPP/RP, and Lester Butt, PhD, ABPP/RP
  1. Schwab A. Formal and effective autonomy in healthcare. J Med Ethics. 2006;32:575–579
  2. Appelbaum P, Roth L. Clinical issues in the assessment of competency. Am J Psychiatry. 1981;138:1461–1467
  3. Smithline H, Mader T, Crenshaw B. Do patients with acute medical conditions have the capacity to give informed consent for emergency medicine research?. Acad Emerg Med. 2008;6:776–780
  4. Mangset M, Forde R, Nessa J, Berge E, Bruun-Wyller T. “I don't like that, it's tricking people too much …”: Acute informed consent to participation in a trial of thrombolysis for stroke. J Med Ethics. 2008;34:751–756
  5. Thompson F, Reier P, Uthman B, et al. Neurophysiological assessment of the feasibility and safety of neural tissue transplantation in patients with syringomyelia. J Neurotrauma. 2001;18:931–945
  6. Knifed E, Lipsman N, Mason W, Bernstein M. Patients' perceptions of the informed consent process for neuro-oncology clinical trials. Neuro-Oncology. 2008;10:348–354
    Commentary from Andrés J. Gallegos, Esq
  1. National Spinal Cord Injury Statistical Center, Spinal Cord Injury Facts and Figures at a Glance, February 2010. https://www.nscisc.uab.edu/public_content/pdf/Facts%20and%20Figures%20at%20a%20Glance%202010.pdfAccessed April 30, 2010

 Disclosure Key can be found on the Table of Contents and at www.pmrjournal.org

PII: S1934-1482(10)00449-1

doi: 10.1016/j.pmrj.2010.05.014

PM&R
Volume 2, Issue 7 , Pages 664-670 , July 2010

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