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症患者的研究总是需要代理决策者提供代理同意。代理人也经常作为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。代理人和研究伙伴参与研究提出了独特的伦理问题，应该由研究人员和机构审查委员会解决，但很少有人知道代理人的经验和他们在研究环境中的潜在利益冲突。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是非常繁重的，但也参与研究的护理人员的经验尚未得到审查。护理人员参与痴呆症研究可能需要投入大量时间和相当大的努力，以使患者能够接受多个研究程序并返回进行重复的研究访视。迄今为止的实证研究通常基于假设场景，主要集中在代理人决定将痴呆症患者纳入研究，并表明他们的决定通常是出于利他主义，对调查人员的信任，希望为患者，照顾者或患者的后代带来好处，或者绝望地阻止或减缓痴呆症的进展。入组决策也可以反映出这样一种预期，即研究的潜在风险和益处对患者和患者都是相互依赖的，影响一方的因素也会影响另一方。在参与研究的过程中，这种希望和期望是如何发挥作用的，我们不得而知。此外，很少有人知道的利益冲突，可能会出现代理人在他们的多重角色作为家庭成员，照顾者，代理决策者，研究伙伴。这项前瞻性研究有三个具体目标：（1）描述代理决策者和研究伙伴对缺乏同意能力的痴呆症研究参与者的作用和责任，（2）描述作为代理人和研究伙伴的照顾者的经历和潜在冲突，以及如何在他们参与研究的过程中管理他们的利益冲突，以及（3）根据原则主义和关系主义范式的伦理观点，描述和分析涉及代理人和研究伙伴的痴呆症研究中常见的伦理问题。定性研究方法将用于实现这些目标，通过采访积极参与痴呆症研究的个人，包括研究人员，痴呆症研究协调员和作为代理人和研究伙伴的照顾者。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费用至关重要的时候，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得到保护。 公共卫生相关性：本研究探讨了照顾者谁是代理决策者和研究伙伴的个人参与研究，缺乏能力，给自己的知情同意的痴呆症患者的经验。照顾者作为家庭成员、代理决策者和研究伙伴的多方面角色和利益可能会在他们参与研究的过程中引起伦理问题和利益冲突。该项目将使用定性研究方法，以确定常见的伦理问题提出的照顾者在他们的角色作为代理决策者和/或研究伙伴，并进行这些问题的伦理分析，以帮助通知研究人员和机构审查委员会谁是关心保护痴呆症患者和他们的研究伙伴的研究。

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. PUBLIC HEALTH RELEVANCE: This study examines the experiences of caregivers who are serving as surrogate decision makers and study partners for individuals with dementia who are participating in research and lack the capacity to give their own informed consent. The multifaceted roles and interests that caregivers have as family members, proxy decision makers, and study partners may pose ethical concerns and conflicts of interest for them over the course of their involvement in research. This project will use qualitative research methods to identify common ethical issues raised for caregivers in their role as surrogate decision maker and/or study partner and conduct an ethical analysis of these issues to help inform investigators and institutional review boards who are concerned with the protection of dementia patients and their study partners in research.