Ethical issues in Dementia Research involving Surrogates and Study Partners

涉及代孕者和研究合作伙伴的痴呆症研究中的伦理问题

• 批准号: 8520143
• 负责人: Betty E Black
• 金额: $ 34.46万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-15 至 2015-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8520143
• 关键词: Address; Adult; Affect; Altruism; Benefits and Risks; Caregivers; Cerebrospinal Fluid; Clinical Trials; Conflict (Psychology); Conflict of Interest; Consent; Dementia; Emotional; Enrollment; Ensure; Ethical Analysis; Ethical Issues; Ethics; Family member; Foundations; Health Care Costs; Individual; Informed Consent; Institutional Review Boards; Interview; Knowledge; Language; Light; Magnetic Resonance Imaging; Nature; Participant; Patients; Personal Satisfaction; Persons; Play; Policies; Procedures; Process; Prospective Studies; Proxy; Qualitative Research; Research; Research Methodology; Research Personnel; Risk; Role; Sampling; Social Welfare; Time; Trust; Visit; Work; base; caregiving; consent capacity; design; expectation; experience; improved; interest; minimal risk; psychologic; research study; surrogate decision maker

DESCRIPTION (provided by applicant): Research that includes dementia patients who lack capacity to give informed consent always requires surrogate decision makers to provide proxy consent. Surrogates also frequently serve as study partners for participants in dementia research to help them comply with study procedures and oversee patients' welfare. The involvement of surrogates and study partners in research raises unique ethical issues that should be addressed by researchers and institutional review boards, but little is known about the experiences of surrogates and their potential conflicts of interest in the research setting. Surrogates are usually family members and dementia patients' primary caregivers. While research has demonstrated that care giving to persons with dementia can be highly burdensome, the experience of caregivers who also participate in research is unexamined. Participation of caregivers in dementia research can involve a significant commitment of time and considerable effort to enable patients to undergo multiple study procedures and return for repeated study visits. Empirical studies to date that are often based on hypothetical scenarios have focused primarily on surrogates' decisions to enroll persons with dementia in research and show that their decisions are often motivated by altruism, trust in the investigators, hope for benefits to the patient, caregiver or the patient's descendents, or desperation to stop or slow the progression of dementia. Enrollment decisions can also reflect an expectation that there is an interdependence of the potential risks and benefits of research for both the patient and caregiver-what affects one can affect the other. How such hopes and expectations play out over the course of research participation is unknown. In addition, little is known about the conflicts of interest that may arise for surrogates in their multiple roles as family member, caregiver, proxy decision maker, and study partner. This prospective study has three specific aims: (1) describe the roles and responsibilities of surrogate decision makers and study partners for dementia research participants who lack consent capacity, (2) describe the experiences of and potential conflicts for caregivers, who are serving as surrogates and study partners, and how their conflicts of interest are managed over the course of their involvement in research, and (3) delineate and analyze the common ethical issues raised in dementia research involving surrogates and study partners in light of the ethical perspectives of the Principlist and Relational paradigms. Qualitative research methods will be used to achieve these aims by interviewing individuals who are actively involved in dementia studies, including investigators, dementia study coordinators, and caregivers who are serving as surrogates and study partners. At a time when research into the causes, cures, and treatment of dementia is crucial to help relieve suffering in millions of affected citizens and reduce health care costs, results of this project will inform the work of researchers and institutional review boards to ensure that the interests of dementia patients and their study partners are protected in research.

描述（由申请人提供）：涉及缺乏知情同意能力的痴呆症患者的研究始终需要代理决策者提供代理同意。代理人还经常充当痴呆症研究参与者的研究伙伴，帮助他们遵守研究程序并监督患者的福利。代理人和研究合作伙伴参与研究会引发独特的伦理问题，研究人员和机构审查委员会应解决这些问题，但人们对代理人的经历及其在研究环境中潜在的利益冲突知之甚少。代理人通常是家庭成员和痴呆症患者的主要照顾者。虽然研究表明，为痴呆症患者提供护理可能会带来很大的负担，但参与研究的护理人员的经验尚未得到检验。护理人员参与痴呆症研究可能需要投入大量的时间和大量的精力，以使患者能够接受多种研究程序并返回进行重复的研究访问。迄今为止的实证研究通常基于假设情景，主要关注代理人让痴呆症患者参与研究的决定，并表明他们的决定往往是出于利他主义、对研究人员的信任、希望患者、护理人员或其他人受益。患者的后代，或绝望地阻止或减缓痴呆症的进展。入组决定还可以反映出这样一种期望，即研究的潜在风险和益处对患者和护理人员来说是相互依赖的——影响其中一方的因素也会影响另一方。这些希望和期望在研究参与过程中如何发挥作用尚不清楚。此外，人们对代理人作为家庭成员、照顾者、代理决策者和研究伙伴等多重角色可能出现的利益冲突知之甚少。这项前瞻性研究有三个具体目标：(1) 描述缺乏同意能力的痴呆症研究参与者的代理决策者和研究合作伙伴的角色和责任，(2) 描述充当代理的护理人员的经历和潜在冲突和研究伙伴，以及他们在参与研究过程中如何管理他们的利益冲突，以及（3）从伦理角度描述和分析涉及代孕者和研究伙伴的痴呆症研究中提出的常见伦理问题原则论范式和关系范式。将使用定性研究方法通过采访积极参与痴呆症研究的个人来实现这些目标，包括调查人员、痴呆症研究协调员以及充当代理人和研究合作伙伴的护理人员。目前，对痴呆症的病因、治愈方法和治疗的研究对于帮助减轻数百万受影响公民的痛苦和降低医疗保健成本至关重要，该项目的结果将为研究人员和机构审查委员会的工作提供信息，以确保痴呆症患者及其研究伙伴的利益在研究中受到保护。