Department of Ophthalmology, PLA Navy General Hospital, Beijing, China.
Sci Eng Ethics. 2013 Sep;19(3):1099-106. doi: 10.1007/s11948-012-9375-6. Epub 2012 Jun 23.
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.
随着视觉假体研究从工程阶段向临床试验的发展，早期视觉假体试验的志愿者招募需要仔细考虑。本文主要讨论了一些与志愿者招募相关的问题，这些问题对视觉假体试验构成了严重挑战，例如参与者比例低、对参与视觉假体试验的高期望和潜在动机，以及知情同意的重要性。在招募接受视觉假体植入的志愿者时，视觉假体研究人员不仅要考虑患者的期望和动机，还要让患者充分了解参与可能涉及的利弊，并帮助患者对视觉假体植入的早期阶段建立现实的期望。基于对这些挑战的考虑，可能会在视觉假体试验的初步阶段招募到合格的志愿者。
