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Ethics of Implants

This bibliography cites current literature incorporating the technical background and the ethical issues regarding the implantation of electrodes into the visual cortex of the brain to facilitate use of a prosthesis which can help improve sight. Included are citations regarding cochlear/ear implants which similarly utilize cortical implants to for a prosthesis to improve hearing loss, and so the discussion about issues regarding the cochlear implant can help frame the ethical concerns of the newer experimentation into visual prostheses. Other projects attempting to improve sight using a retinal implant are included as well, for these can be a useful comparative tool. Where possible, articles have been hyperlinked to their source.

Aughan, H. G., Jr. “Some Reflections on Stimulation of the Human Brain.” American Psychopathological Association. Proceedings of the Annual Meeting 58 (1969): 66-77.

Beard, Marion. “Signs of the Times: Cochlear Implants May Not Be the Best Way to Help Deaf Children.” New Scientist 162.2183 (24 Apr 1999): 52.

Berg, Abby. Alice Herb, and Marsha Hurst. “Cochlear Implants in Children: Ethics, Informed Consent, and Parental Decision Making.” Journal of Clinical Ethics 16.3 (Fall 2005): 239-250.

Blume, Stuart S. “The Rhetoric and Counter-rhetoric of a ‘Bionic’ Technology.” Science, Technology, and Human Values 22.1 (Winter 1997): 31-56.

Bramstedt, Katrina A. “When Microchip Implants Do More Than Drug Delivery: Blending, Blurring, and Bundling of Protected Health Information and Patient Monitoring.” Technology and Health Care 13.3 (2005): 193-198.

Branwyn, Gareth. "The Desire to Be Wired.” Wired 1.4 (Sept./Oct. 1993). Online. 46 pars. 12 October 2001.

Brown, Chappell. “Medical Implants Edge Toward 'Bionic Man'.” Electronic Engineering Times Issue 1388 (September 12, 2005): 1-24.

Bruck, S. D. "Implant Retrieval, Analysis, and Database: A Challenge For the Medical Devices Industry.” Journal of Long Term Effects of Medical Implants 2.2-3 (1992): 93-7.
Burton, M. J. “The Biological Safety and Efficacy of Cochlear Implantation in Young Children. An Evaluation in an Animal Model.” Diss. Oxford U., 1994.

Christiansen, John B and Irene Leigh. Cochlear Implants in Children: Ethics and Choices. Washington, D.C.: Gallaudet University Press, 2002.

Clark, Graeme M. and Robert S. Cowan, eds. International Cochlear Implant, Speech and Hearing Symposium--Melbourne 1994. St. Louis, MO: Annals Publishing Co., 1995.

Clark, Graeme M., Robert S. Cowan, and Richard C. Dowell. “Ethical Issues.” Cochlear Implantation for Infants and Children: Advances. San Diego, CA: Singular Publishing Group, 1997. 241-249.

Clinical Research Resources. Selected Regulations and Guidance for Medical Device Studies as of April 1, 2004. Philadelphia, PA: Clinical Research Resources, 2004.

Cohen, N. L. “Cochlear Implants in Young Children: Ethical Considerations.” Annals of Otology, Rhinology and Laryngology Suppl. 166 (Sept. 1995): 17-19.

Cole-Turner, Ronald. “Do Means Matter? Evaluating Technologies of Human Enhancement.” Philosophy and Public Policy 18.4 (Fall 1998): 8-12.

Crisp S. "The Medical Device Directives and Their Impact on the Development and Manufacturing of Medical Implants.” Proc Institution of Mechanical Engineers Proceedings [H]: Journal of Engineering in Medicine 210.4 (1996): 233-9.

Davis, D. S. “Cochlear implants and the claims of culture? A response to Lane and Grodin.” Kennedy Institute of Ethics Journal 7.3 (1997, September): 253-258.

Drum, Bruce. "Federal Regulation of Vision Enhancement Devices for Normal and Abnormal Vision." Journal of Modern Optics 53.9 (2006): 1215-28.

European Commission. "The Ethical Aspects of ICT Implants in the Human Body: Proceedings of the Roundtable Debate." European Group on Ethics in Science and New Technologies Amsterdam, December 2004.

Farah, Martha J and Paul Root Wolpe. “Monitoring and Manipulating Brain Function: New Neuroscience Technologies and their Ethical Implications.” Hastings Center Report 34.3 (May-June 2004): 35-45.

“F. D. A. Establishes Performance Standard for Electrode Lead Wires and Patient Cables.” Health Devices 27.1 (Jan. 1998): 34-6.

Fielder, John. “Defects and Deceptions – The Bjork-Shiley Heart Valve” IEEE Technology and Society Magazine (Fall 1995), pp. 17-22.

Fielder, J. H. and J. Black. “But Doctor, It's My Hip!: The Fate of Failed Medical Devices.” Kennedy Institute of Ethics Journal 5.2 (June 1995): 113-31.

Ford, Paul J. “Neurosurgical Implants: Clinical Protocol Considerations.” Cambridge Quarterly of Healthcare Ethics 16.3 (July 2007): 308-311.

Ford, Paul et al. “A Patient Revoking Consent During Awake Craniotomy: An Ethical Challenge.” Neuromodulation 10.4 (October 2007): 329-332.

Foster, Kenneth R., Paul R. Wolpe and Arthur L. Caplan. “Bioethics and the Brain.” IEEE Spectrum 40.6 (June 2003): 34-39

Fraysse, Bernard G. and O. Deguine. Cochlear Implants New Perspectives: International Symposium, Toulouse, June 2-3, 1992. Basel; New York: Karger, 1993.

Gillet, G. “Cyborgs and Moral Identity.” Journal of Medical Ethics 32.2 (2006): 79-83.

Grodin, Michael and Harlan L. Lane. “Ethical Issues in Cochlear Implant Surgery: An Exploration into Disease, Disability and the Best Interests of the Child.” Kennedy Institute of Ethics Journal 7.3 (September 1997): 231-251.

Gusseck, H. “Retinaimplantate. Erwartungen aus Patientensicht. [Retinal Implants. Patients’ Expectations].” Der Ophthalmologe : Zeitschrift der Deutschen Ophthalmologischen Gesellschaft 102.10 (2005): 950-6

Haggar, B. "How Do Regulatory Agencies Ensure the Release of a Safe Medical Device?" Clinical Performance and Quality

Health Care 7.2 (Apr.-Jun. 1999): 100-3.Handbook of Biomaterials Evaluation: Scientific, Technical, and Clinical Testing of Implant Materials Ed. Andreas Con Recum. 2nd ed. Philadelphia, PA: Taylor & Francis, 1999.

Hansson, Sven-Ove. “Implant Ethics.” Journal of Medical Ethics 31.9 (Summer, 2005): 519-525.

Harris, John. Wonderwoman and Superman: The Ethics of Human Biotechnology. Oxford: Oxford University Press, 1992.

Hyde, M. “Some Ethical Dimensions of Cochlear Implantation of Deaf Children.” Annals of Otology, Rhinology and Laryngology Suppl. 166 (Sept. 1995): 19-20.

Kay, L. "Electronic Aids for Blind Persons: An Interdisciplinary Subject''. IEE Proceedings Pt. A, 131 (Sept. 1984): 559-576.

Keiper, Adam “The Age of Neuroelectonics.” New Atlantis No. 11 (Winter 2006): 4-41

Komesaroff, Linda R. Surgical Consent: Bioethics and Cochlear Implantation. Washington D.C.: Gallaudet University Press, 2007.

Kubu, Cynthia. S. and Paul J. Ford. “Ethics in the Clinical Application of Neural Implants.” Cambridge Quarterly of Healthcare Ethics 16.3 (July 2007): 317-321.

Macklin, R. “Ethical Implications of Surgical Experiments.” Bulletin of the American College of Surgeons 70.6 (June 1985): 2-5.

Maguire, G. Q., Jr., and Ellen M. McGee. “Ethical Assessment of Implantable Brain Chips.” Twentieth World Congress of Philosophy. Boston University. Boston, MA, 10-15 August, 1998. 19 pars. 15 October 2001.

---. “Implantable Brain Chips? Time for Debate.” The Hastings Center Report 29. 1 (Jan.-Feb. 1999): 7-13.

---. “Implantable Brain Chips: Ethical and Policy Issues.” Medical Ethics (Newsletter of the Lahey Clinic, in collaboration with Dartmouth-Hitchcock Medical Center). Winter 2001. 3 pgs. 11 October 2001.

McCaughey, J. D. “Cochlear Implants: Some Considerations of a More or Less Ethical Character.” Annals of Otology, Rhinology and Laryngology Suppl. 166 (Sept. 1995): 16-17.

McGee, Ellen M. and Gerald Q. Maguire. “Becoming a Borg to Become Immortal: Regulating Brain Implant Technologies.” Cambridge Quarterly of Healthcare Ethics 16.3 (July 2007): 291-302.

Meir, Barry. “Implants with Flaws: Disclosure and Delay.” New York Times (June 14, 2005): C1, C3

Morgan, R. W. “Tracking and Surveillance of Patients with Medical Devices and Implants.” Medical Device Technology 4.1 (Jan.-Feb. 1993): 38-43.

Morreim. E.H. “Surgically Implanted Devices: Ethical Challenges in a Very Different Kind of Research.” Thoracic Surgery Clinics 15(4) (2005): 555-63.

National Institutes of Health. “Cochlear Implants in Adults and Children.” Consensus Statements. NIH Consensus Development Program. NIH Consensus Development Conference Statement, May 15-17, 1995. 13 sects. 7 Sept. 2007.
http://consensus.nih.gov/1995/1995CochlearImplants100html.htm

Nsanze, Fabienne. Ethical Aspects of ICT Implants in the Human Body. Opinion Number 20. Brussels, Belgium: European Group on Ethics in Science and New Technologies, European Commission, 2005 March 16.

Owens, Elmer and Dorcas K. Kessler. Cochlear Implants in Young Deaf Children. Boston: Little, Brown, 1989.

Parens, Erik. “The Enhancement Project: Is Better Always Good?” Hastings Center Report (Special Supplement) 28.1 (Jan.-Feb. 1998): S1-S17.

---, ed. Enhancing Human Traits: Ethical and Social Implications. Hastings Center Studies in Ethics series. Washington, D. C.: Georgetown University Press, 1998.

Posner, K. “Implantable Medical Devices and Products Liability.” Medical Trial Technique Quarterly 28.3 (Winter 1982): 255-78.

Roco, Mihail and William Sims (eds). Converging Technologies for Improving Human Performance: Nanotechnology, Biotechnology, Information Technology and Cognitive Science. World Technology Evaluation Center (WTEC): Arlington, VA, 2002. URL Available: http://www.wtec.org/ConvergingTechnologies/Report/NBIC_report.pdf

Rosahl, Steffen. “Vanishing Senses- Restoration of Sensory Functions by Electronic Implants.” Poiesis & Praxis 2.4 (May 2004): 285-295.

Saha, Pamela S. and Subrata Saha. “Clinical Trials of Medical Devices and Implants: Ethical Concerns.” IEEE Engineering in Medicine and Biology Magazine 7.2 (June 1988): 85-87.

Saha, Subrata. “Ethical Questions in Biomedical Engineering Research.” Annual International Conference of the IEEE Engineering in Medicine and Biology Society 12.5 (1990): 1981-82.

Saha, Subrata and Pamela S. Saha. “Introduction of New Medical Technologies: An International and Ethical Perspective.” Proceedings of the 20th Annual International Conference of the IEEE Engineering in Medicine and Biology Society 20.6 (1998): 3357-58.

Saviola, James. “The FDA’s Role in Medical Device Clinical Studies of Human Subjects.” Journal of Neural Engineering (March 2005): 2: S1-S4.

Sauberman, H. R. “Approval Process for Implants in Otolaryngology.” Otolaryngologic Clinics of North America 28.2 (April 1995): 235-44.

Scott, L. “Liability Concerns about Implanted Material May Hurt Device Availability.” Modern Healthcare 23.26 (28 June 1993): 90.

Sparrow, Robert. “Defending Deaf Culture: The Case of Cochlear Implants.” Journal of Political Philosophy. 13.2 (June 2005): 135-152.

Sterling, T. D. et al, eds. Visual Prosthesis: The Interdisciplinary Dialogue: Proceedings of the Second Conference on Visual Prosthesis. University of Chicago. 1969. New York; London: Academic Press, 1971.

Thoma, H. “Some Aspects of Medical Ethics from the Perspective of Bioengineering.” Theoretical Medicine 7 (1986): 305-317.

Van der Wilt, Gert Jan, Rob Reuzal and David H. Banta. “The Ethics of Assessing Health Technologies.” Theoretical Medicine and Bioethics 21.1 (Jan. 2000): 103-115.

Walter, P., K. Heimann, and M. Vobig. “Retinal Implants: The Ophthalmologist's Viewpoint.” Human Communication and Cybernetics. Proceedings of the IEEE International Conference on Systems, Man and Cybernetics. 12-15 Oct. 1999. Vol. 4. Tokyo, Japan: IEEE, 1999. IV-400 --IV 403.

Weinstein, Allan, United States, and National Bureau of Standards. Implant Retrieval
Material and Biological Analysis: Proceedings of a Conference Held at the National Bureau of Standards, Gaithersburg, MD 20234, May 1-3, 1980. Washington, D.C: U.S. Dept. of Commerce, National Bureau of Standards, 1981.

Williams, D. “Objectivity in the Evaluation of Biological Safety of Medical Devices and Biomaterials.” Medical Device Technology 2.1 (Jan.-Feb. 1991): 44-8.

---. "Where Have All the Implants Gone? The Need for Surveillance and Tracking.” Medical Device Technology 5.6 (Jul.-Aug. 1994): 8, 10.