Ethical issues in Dementia Research involving Surrogates and Study Partners

描述（由申请人提供）：包括缺乏知情同意能力的痴呆患者的研究总是需要代理决策者提供代理同意。代理也经常作为痴呆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。代孕母亲和研究伙伴参与研究引发了独特的伦理问题，研究人员和机构审查委员会应该解决这些问题，但对代孕母亲的经历及其在研究环境中的潜在利益冲突知之甚少。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，对痴呆症患者的护理可能非常繁重，但参与研究的护理人员的经历却未经审查。护理人员参与痴呆症研究可能需要投入大量时间和精力，使患者能够接受多个研究程序并反复进行研究访问。迄今为止，通常基于假设情景的实证研究主要集中在代理将痴呆症患者纳入研究的决定上，并表明他们的决定通常是出于利他主义，对研究人员的信任，对患者，护理人员或患者后代的利益的希望，或绝望地阻止或减缓痴呆症的进展。入组决定也可以反映出一种预期，即对患者和护理人员来说，研究的潜在风险和收益是相互依赖的——影响一方会影响另一方。这些希望和期望在参与研究的过程中如何发挥作用尚不得而知。此外，我们对作为家庭成员、照顾者、代理决策者和研究伙伴的代理人的多重角色可能产生的利益冲突知之甚少。这项前瞻性研究有三个具体目的：(1)描述缺乏同意能力的痴呆研究参与者的代理决策者和研究伙伴的角色和责任；(2)描述作为代理和研究伙伴的护理人员的经历和潜在冲突，以及他们在参与研究过程中的利益冲突如何管理；(3)从原则范式和关系范式的伦理观点出发，描述和分析痴呆研究中涉及代理和研究伙伴的常见伦理问题。定性研究方法将通过采访积极参与痴呆症研究的个人来实现这些目标，包括调查者、痴呆症研究协调员和作为代理人和研究伙伴的护理人员。在研究痴呆症的原因、治疗和治疗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的时候，本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得到保护。

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.