Ethical Considerations for Volunteer Recruitment of Visual Prosthesis Trials

With the development of visual prostheses research from the engineering phase to clinical trials, volunteer recruitment for the early visual prosthesis trials needs to be carefully considered. In this article, we mainly discuss several issues related to volunteer recruitment that had posed serious challenges to the visual prosthesis trials, such as low rates of participants, high expectations and underlying motivations to participate in the visual prosthesis trials as well as the importance of informed consent. When recruiting volunteers for visual prosthesis implants, it is critical that the visual prosthesis researchers should not only take into account the patient’s expectations and motivations, but also make the patients fully aware of the possible benefits and risks involved with their participation, and help patients establish realistic expectations for the early phase of visual prosthesis implantation. Based on these considerations to the challenges, eligible volunteers may be recruited in the preliminary stages of visual prosthesis trials.

[1]  Gislin Dagnelie,et al.  Facial recognition using simulated prosthetic pixelized vision. , 2003, Investigative ophthalmology & visual science.

[2]  Benoît Gérard,et al.  Pattern recognition with the optic nerve visual prosthesis. , 2003, Artificial organs.

[3]  Mark S Humayun,et al.  The value of preoperative tests in the selection of blind patients for a permanent microelectronic implant. , 2003, Transactions of the American Ophthalmological Society.

[4]  J. Wyatt,et al.  REVIEW ■ : Prospects for a Visual Prosthesis , 1997 .

[5]  Paul S Appelbaum,et al.  Therapeutic misconception and the appreciation of risks in clinical trials. , 2004, Social science & medicine.

[6]  R. Lilford,et al.  Informed consent for clinical trials: in search of the "best" method. , 1998, Social science & medicine.

[7]  L. Joffe.  The Medical and Surgical Management of Age-Related Macular Degeneration , 1996, International ophthalmology clinics.

[8]  B. Hoefflinger,et al.  The development of subretinal microphotodiodes for replacement of degenerated photoreceptors. , 1997, Ophthalmic research.

[9]  E. Berson,et al.  Retinitis pigmentosa: unfolding its mystery. , 1996, Proceedings of the National Academy of Sciences of the United States of America.

[10]  J. Mortimer,et al.  Visual sensations produced by optic nerve stimulation using an implanted self-sizing spiral cuff electrode , 1998, Brain Research.

[11]  Gislin Dagnelie,et al.  Psychophysical evaluation for visual prosthesis. , 2008, Annual review of biomedical engineering.

[12]  C. Grady,et al.  What makes clinical research ethical? , 2000, JAMA.

[13]  G. Brindley,et al.  The sensations produced by electrical stimulation of the visual cortex , 1968, The Journal of physiology.

[14]  P Saha,et al.  Ethical Responsibilities of the Clinical Engineer , 1986, Journal of clinical engineering.

[15]  R. Eckmiller.  Learning retina implants with epiretinal contacts. , 1997, Ophthalmic research.

[16]  David J. Warren,et al.  Cortical implants for the blind , 1996 .

[17]  C Veraart,et al.  The microsystems based visual prosthesis for optic nerve stimulation. , 2002, Artificial organs.

[18]  Ethan D Cohen,et al.  Safety and effectiveness considerations for clinical studies of visual prosthetic devices , 2007, Journal of neural engineering.

[19]  Q. Ren,et al.  Preoperative candidate evaluations for retinal prosthesis trials. , 2010, The International journal of artificial organs.

[20]  A. Y. Chow,et al.  Subretinal electrical stimulation of the rabbit retina , 1997, Neuroscience Letters.

[21]  J. Till,et al.  Principlism and the ethical appraisal of clinical trials. , 1995, Bioethics.

[22]  C. Marco.  Impact of detailed informed consent on research subjects' participation: a prospective, randomized trial. , 2008, The Journal of emergency medicine.

[23]  A. Y. Chow,et al.  The artificial silicon retina microchip for the treatment of vision loss from retinitis pigmentosa. , 2004, Archives of ophthalmology.

[24]  J. Weiland,et al.  Pattern electrical stimulation of the human retina , 1999, Vision Research.

[25]  R. H. Propst,et al.  Visual perception elicited by electrical stimulation of retina in blind humans. , 1996, Archives of ophthalmology.

[26]  Joseph F Rizzo,et al.  ‘Who is the ideal candidate?’: decisions and issues relating to visual neuroprosthesis development, patient testing and neuroplasticity , 2007, Journal of neural engineering.

[27]  C Veraart,et al.  Electrical stimulation of anterior visual pathways in retinitis pigmentosa. , 2001, Investigative ophthalmology & visual science.

[28]  Robert J. Levine,et al.  Ethics and Regulation Of Clinical Research , 1982 .

[29]  C. Veraart,et al.  Vision rehabilitation in the case of blindness , 2004, Expert review of medical devices.

[30]  M. Mladejovsky,et al.  Artificial Vision for the Blind: Electrical Stimulation of Visual Cortex Offers Hope for a Functional Prosthesis , 1974, Science.

[31]  Q. Ren,et al.  Retinitis pigmentosa patients' attitudes toward participation in retinal prosthesis trials. , 2012, Contemporary clinical trials.

[32]  C. Kufta,et al.  Feasibility of a visual prosthesis for the blind based on intracortical microstimulation of the visual cortex. , 1996, Brain : a journal of neurology.

[33]  Gislin Dagnelie,et al.  Visual perception in a blind subject with a chronic microelectronic retinal prosthesis , 2003, Vision Research.

[34]  C. Weijer.  Evolving Ethical Issues in Selection of Subjects for Clinical Research , 1996, Cambridge Quarterly of Healthcare Ethics.