Skip to main content
Log in

Ethical Considerations for Volunteer Recruitment of Visual Prosthesis Trials

  • Published:
Science and Engineering Ethics Aims and scope Submit manuscript

Abstract

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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Similar content being viewed by others

References

  • Berson, E. L. (1996). Retinitis Pigmentosa: unfolding its mystery. Proceedings of the National academy of Sciences of the United States of America, 93(10), 4526–4528.

    Article  Google Scholar 

  • Brindley, G. S., & Lewin, W. S. (1968). The sensations produced by electrical stimulation of the visual cortex. The Journal of Physiology, 196(2), 479–493.

    Google Scholar 

  • Chow, A. Y., & Chow, V. Y. (1997). Subretinal electrical stimulation of the rabbit retina. Neuroscience Letters, 225(1), 13–16.

    Article  Google Scholar 

  • Chow, A. Y., Chow, V. Y., Packo, K. H., et al. (2004). The artificial silicon retina microchip for the treatment of vision loss from retinitis pigmentosa. Archives of Ophthalmology, 122, 460–469.

    Article  Google Scholar 

  • Cohen, E. D. (2007). Safety and effectiveness considerations for clinical studies of visual prosthetic devices. Journal of Neural Engineering, 4(1), S124–S129.

    Article  Google Scholar 

  • Dagnelie, G. (2008). Psychophysical evaluation for visual prosthesis. Annual Review of Biomedical Engineering, 10, 339–368.

    Article  Google Scholar 

  • Delbeke, J., Pins, D., Michaux, G., et al. (2001). Electrical stimulation of anterior visual pathways in retinitis pigmentosa. Investigative Ophthalmology & Visual Science, 42(1), 291–297.

    Google Scholar 

  • Delbeke, J., Wanet-Defalque, M. C., Gerard, B., et al. (2002). The microsystems based visual prosthesis for optic nerve stimulation. Artificial Organs, 26, 232–234.

    Article  Google Scholar 

  • Dobelle, W. H., Mladejovsky, M. G., & Girvin, J. P. (1974). Artificial vision for the blind: electrical stimulation of visual cortex offers hope for a functional prosthesis. Science, 183(123), 440–444.

    Article  Google Scholar 

  • Eckmiller, R. (1997). Learning retina implants with epiretinal contacts. Ophthalmic Research, 29(5), 281–289.

    Article  Google Scholar 

  • Edwards, S. J. L., Lilford, R. J., Thornton, J., & Hewison, J. (1998). Informed consent for clinical trials: in search of the “best” method. Social Science and Medicine, 47(11), 1825–1840.

    Article  Google Scholar 

  • Emanuel, E. J., Wendler, D., & Grady, C. (2000). What makes clinical research ethical? JAMA, 283(20), 2701–2711.

    Article  Google Scholar 

  • Humayun, M. S., de Juan, E., Jr., Dagnelie, G., Greenberg, R. J., Propst, R. H., & Phillips, D. H. (1996). Visual perception elicited by electrical stimulation of retina in blind humans. Archives of Ophthalmology, 114(1), 40–46.

    Article  Google Scholar 

  • Humayun, M. S., de Juan, E., Jr., Weiland, J. D., Dagnelie, G., Katona, S., Greenberg, R. J., et al. (1999). Pattern electrical stimulation of the human retina. Vision Research, 39, 2569–2576.

    Article  Google Scholar 

  • Humayun, M. S., Weiland, J. D., Fujii, G. Y., et al. (2003). Visual perception in a blind subject with a chronic microelectronic retinal prosthesis. Vision Research, 43(24), 2573–2581.

    Article  Google Scholar 

  • Joffe, L. (1996). The medical and surgical management of ARMD. International Ophthalmology Clinics, 36(2), 99–116.

    Article  Google Scholar 

  • Levine, R. J. (1988). Ethics and regulation of clinical research (pp. 37–93). New Haven (CT): Yale University Press.

    Google Scholar 

  • Lidz, C. W., Appelbaum, P. S., Grisso, T., & Renaud, M. (2004). Therapeutic misconception and the appreciation of risks in clinical trials. Social Science Medicine, 58(9), 1689–1697.

    Article  Google Scholar 

  • Marco, C. A. (2008). Impact of detailed informed consent on research subjects’ participation: a prospective randomized trial. The Journal of Emergency Medicine, 34(3), 269–275.

    Article  Google Scholar 

  • Merabet, L. B., Rizzo, J. F., I. I. I., Pascual-Leone, A., & Fernandez, E. (2007). ‘Who is the ideal candidate?’: Decisions and issues relating to visual neuroprosthesis development, patient testing and neuroplasticity. Journal of Neural Engineering, 4(1), S130–S135.

    Article  Google Scholar 

  • Meslin, E. M., Sutherland, H. J., Lavery, J. V., & Till, J. E. (1995). Principlism and the ethical appraisal of clinical trials. Bioethics, 9, 399–418.

    Article  Google Scholar 

  • National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont report: Ethical principals and guidelines for the protection of human subjects of research. OPRR [Office for Protection from Research Risks] Reports, pp. 1–8.

  • Normann, R. A., Maynard, E. M., Guillory, K. S., & Warren, D. J. (1996). Cortical implants for the blind. IEEE Spectrum, 112, 54–59.

    Article  Google Scholar 

  • Richard, C., & Leslie, W. (2006). Artificial vision technology: An early step towards an ethics of cybernetic repair and augmentation. Columbia University Journal of Bioethics, Fall, 59–64.

  • Rizzo, J., & Wyatt, J. (1997). Prospects for a visual prosthesis. Neuroscientist, 3, 251–262.

    Article  Google Scholar 

  • Saha, P., & Saha, S. (1986). Ethical responsibilities of the clinical engineer. Journal of Clinical Engineering, 11(1), 17–25.

    Article  Google Scholar 

  • Schmidt, E. M., Bak, M. J., Hambrecht, F. T., Kufta, C. V., O’Rourke, D. K., & Vallabhanath, P. (1996). Feasibility of a visual prosthesis for the blind based on intracortical microstimulation of the visual cortex. Brain, 119, 507–522.

    Article  Google Scholar 

  • Thompson, R. W., Barnett, G. D., Humayun, M. S., & Dagnelie, G. (2003). Facial recognition using stimulated prostheric pixelized vision. Investigative Ophthalmology & Visual Science, 44, 5035–5042.

    Article  Google Scholar 

  • Veraart, C., Duret, F., Brelen, M., et al. (2004). Vision rehabilitation in the case of blindness. Expert Review of Medical Devices, 1, 139–153.

    Article  Google Scholar 

  • Veraart, C., Raftopoulos, C., Mortimer, J. T., Delbeke, J., Pins, D., Michaux, G., et al. (1998). Visual sensations produced by optic nerve stimulation using an implanted self-sizing spiral cuff electrode. Brain Research, 813(1), 181–186.

    Article  Google Scholar 

  • Veraart, C., Wanet-Defalque, M. C., Gérard, B., Vanlierde, A., & Delbeke, J. (2003). Pattern recognition with the optic nerve visual prosthesis. Artificial Organs, 27(11), 996–1004.

    Article  Google Scholar 

  • Weijer, C. (1996). Evolving ethical issues in selection of subjects for clinical research. Cambridge Quarterly of Healthcare Ethics, 5, 334–345.

    Article  Google Scholar 

  • Yanai, D., Lakhanpal, R. R., Weiland, J. D., et al. (2003). The value of preoperative tests in the selection of blind patients for a permanent microelectronic implant. Transactions of the American Ophthalmological Society, 101, 223–230.

    Google Scholar 

  • Yu, X., & Qiushi, R. (2010). Preoperative candidate evaluations for retinal prosthesis trials. International Journal of Artificial Organs, 33, 844–850.

    Google Scholar 

  • Yu, X., Xiujun, P., & Qiushi, R. (2012). Retinitis pigmentosa patients’ attitudes toward participation in retinal prosthesis trials. Contemporary Clinical Trials, 33, 628–632.

    Google Scholar 

  • Zrenner, E., Miliczek, K. D., Gabel, V. P., Graf, H. G., Guenther, E., Haemmerle, H., et al. (1997). The development of subretinal microphotodiodes for replacement of degenerated photoreceptors. Ophthalmic Research, 29(5), 269–280.

    Article  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Yu Xia.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Xia, Y., Ren, Q. Ethical Considerations for Volunteer Recruitment of Visual Prosthesis Trials. Sci Eng Ethics 19, 1099–1106 (2013). https://doi.org/10.1007/s11948-012-9375-6

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11948-012-9375-6

Keywords

Navigation