Empowerment of Terminally Ill Research Subjects. Uniformed Services University of the Health Sciences February 10, 2014. Lauren Solberg, JD, MTS Assistant Professor, Program in Bioethics, Law & Medical Professionalism Department of Community Health & Family Medicine;
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Uniformed Services University of the Health Sciences
February 10, 2014
Lauren Solberg, JD, MTS
Program in Bioethics, Law & Medical Professionalism
Department of Community Health & Family Medicine;
Departments of Aging and Geriatric Research & Psychiatry
Ronald Bayer et al., The Care of the Terminally Ill: Mortality and Economics, 309 NEJM 1490 (1983).
Some more so than others…
45 C.F.R. §46.111(a)(3); 21 C.F.R. §56.107(a); 32 C.F.R. §219.107(a)
45 C.F.R. §46.107(a)(3); 21 C.F.R. §56.111(a)(3); 32 C.F.R. §219.111(a)(3)
45 C.F.R. § 46.111(b); 21 C.F.R. §56.111(b); 32 C.F.R. §219.111(b)
Appelbaum, P. S.; Roth, L. H.; Lidz, C. (1982). "The therapeutic misconception: Informed consent in psychiatric research". International Journal of Law and Psychiatry 5 (3–4): 319–329.
Shira Bender et al. (2007). Access for the Terminally Ill to Experimental Medical Innovations: A Three-Pronged Threat. Am J Bioethics, 7(10): 3-6.
Paul S. Appelbaum, Charles W. Lidz, and Thomas Grisso, “Therapeutic Misconception in Clinical Research: Frequency and Risk Factors,” IRB: Ethics & Human Research 26 No. 2 (2004): 1-8.
Manish Agrawal & Mario Danis, End-of-life Care for Terminally Ill Participants in Clinical Research, 5 J. Palliative Med. 729, 732-33 (2002).
Emily Abdoler et al., The Ethics of Phase 0 Oncology Trials, 14 Clin. Cancer Res. 3692, 3694 (2008)
Therapeutic Doublethink: A Novel Concept to Ethically Justify Unrealistic Optimism in Patients with Advanced Cancer; Irene Ying, University of Toronto, as presented at ASBH meeting, Oct. 2013
David Casarett, Ethical Considerations in End-of-Life Care and Research, 8 J. Palliative Med. S-148,S-156 (2005).
Not because of course of disease, but…
UdoSchüklenk & Christopher Lowry. (2009). Terminal Illness and Access to Phase 1 Experimental Agents, Surgeries and Devices: Reviewing the Ethical Arguments. Brit Med Bulletin; 89: 7-22.
Emily Abdoler et al., The Ethics of Phase 0 Oncology Trials, 14 Clin. Cancer Res. 3692, 3694 (2008).
U.S. v. Rutherford, 442 U.S. 544 (1979)
“It cannot be disputed that the Due Process Clause protects an interest in life as well as an interest in refusing life-sustaining medical treatment.”
Cruzan v. MO Dep’t of Health, 497 U.S. 261 (1990)
*Competent people have Due Process right to refuse life-sustaining treatment
ASBH presentation, Legal update 2013: top 10 Legal Developments in Bioethics
Manish Agrawal & Mario Danis, End-of-life Care for Terminally Ill Participants in Clinical Research, 5 J. Palliative Med. 729, 732 (2002).
Lauren Solberg, JD, MTS
UF College of Medicine