Ethics of Control and Consent in Brain Stimulation for Parkinson Disease

描述(由申请人提供)：本申请涉及广泛的挑战领域(02)：生物伦理和具体挑战主题02-OD(OSP)-101：新兴技术提出的独特伦理问题。目前的研究考察了参与者在考虑使用脑深部刺激(DBS)治疗帕金森病(PD)作为范例进行控制时所固有的伦理挑战。许多历史和虚构的故事都揭示了人们的恐惧，即大脑刺激器必然会阻碍一个人的自由和自主，特别是在控制方面。然而，这些故事只提供了简单的富有想象力的探索，未能涉及当代医学现实中面临的更重要的伦理挑战。医学的一个基本伦理原则是最大化和尊重个人对身体主权的保留，其中固有的是控制的概念。有三种控制特别重要：症状控制、设备控制和个人控制。症状控制指的是一个人改变疾病症状的能力，比如震颤。设备控制指的是一个人调整实际刺激器设置的能力。个人控制指的是一个人为实现个人目标而自主和意志地采取行动的能力。个人控制是高度个人化和充满价值的，这使得它在伦理上很有趣，并且是知情同意的核心。症状控制或刺激器控制的改进可能不能与个人控制的改进相提并论。为了提供更好的知情同意，重要的是认识到在DBS治疗前后发生的个人控制的变化性质所固有的挑战。我们假设患者对DBS的目标包括症状、设备和个人控制元素，总体目标与增加个人对特定个人功能的控制有关。这项研究采用了重复测量设计，其中50名帕金森病患者接受DBS治疗，他们将与手术前和手术后两个时间点(手术后3个月和6个月)进行比较，对症状管理和个人控制方面的具体个人定制行为进行评级和排名。我们还将研究潜在的认知和心理变量在调节手术后控制力变化方面的作用。除了量化措施外，从半结构化访谈中收集的定性数据还将评估参与者关于特定目标的控制观的主题。脑深部刺激可能会影响人们的自由和自主，特别是他们对身体运动、思想和感觉的控制。拟议的研究将提供数据，以改进知情同意程序，其中包括考虑参与者价值观的流动性。这项研究还将提供数据，以确定哪些参与者需要更多的教育努力，以确保知情同意。目前的研究考察了在同意深部脑刺激(DBS)的背景下，参与者对控制的考虑所固有的伦理挑战。这些数据将通过仔细考虑参与者与个人控制相关的价值观的不稳定性质来改进知情同意程序。这项研究还将提供数据，以确定哪些参与者需要更多的教育努力，以确保知情同意。

DESCRIPTION (provided by applicant): This application addresses broad Challenge Area (02): Bioethics and specific Challenge Topic 02- OD(OSP)-101: Unique Ethical Issues Posed by Emerging Technologies. The current study examines the ethical challenges inherent in participants' considerations of control using Deep Brain Stimulation (DBS) for the treatment of Parkinson disease (PD) as a paradigm. Many historical and fictional stories have promulgated fears that brain stimulators necessarily impede a person's liberty and autonomy, particularly with respect to control. However, these stories offer only simple imaginative explorations that fail to engage the more important ethical challenges faced in the realities of contemporary medicine. A fundamental ethical tenet in medicine is to maximize and respect an individual's retention of bodily sovereignty, inherent in which is the concept of control. Three types of control are particularly important: symptom control, device control, and personal control. Symptom control refers to one's ability to alter disease symptoms, such as tremor. Device control refers to one's ability to adjust the actual stimulator settings. Personal control refers to one's ability to autonomously and volitionally act to achieve personal goals. Personal control is highly individualized and value laden which makes it ethically interesting and central to informed consent. Improvements in symptom control or stimulator control may not match improvements in personal control. In order to provide better informed consent it is important to recognize the challenges inherent in the shifting nature of personal control that occur before and after DBS therapy. We hypothesize that patients' goals for DBS include symptom, device and personal control elements with overarching goals related to increases in personal control over specific personal functions. The study employs a repeated measures design in which 50 participants with Parkinson Disease who are undergoing DBS will rate and rank symptom management and personal control with respect to specific individually tailored behaviors compared prior to surgery and at two time points following surgery (3 months and 6 months post-operative). We will also examine the role of potential cognitive and psychological variables in moderating changes in considerations of control following surgery. In addition to the quantitative measures, qualitative data gleaned from semi-structured interviews will assess themes in participants' values of control with respect to specific objectives. Deep Brain Stimulation may affect people's liberty and autonomy, particularly their control over bodily movements, thoughts, and feelings. The proposed study will provide data to improve the informed consent process that includes consideration of the fluid nature of participants' values. This study will also provide data to identify participants who require increased educational efforts in order to ensure informed consent. The current study examines the ethical challenges inherent in participants' considerations of control in the context of consent for Deep Brain Stimulation (DBS). These data will improve the informed consent process through careful deliberation of the fluid nature of participants' values related to personal control. This study will also provide data to identify participants who require increased educational efforts in order to ensure informed consent.