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: 8331463
• 负责人: Betty E Black
• 金额: $ 37.61万
• 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 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8331463
• 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)：包括缺乏给予知情同意能力的痴呆症患者的研究总是要求代理决策者提供代理同意。代理人还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。代孕者和研究伙伴参与研究提出了独特的伦理问题，研究人员和机构审查委员会应该解决这些问题，但对代孕者的经历及其在研究环境中的潜在利益冲突知之甚少。代孕者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，给痴呆症患者提供护理可能是非常繁重的，但也参与研究的照顾者的经历没有得到检验。照顾者参与痴呆症研究可能需要投入大量的时间和相当大的努力，使患者能够进行多项研究程序，并在反复进行研究访问后返回。到目前为止，通常基于假设情景的实证研究主要关注代理人将痴呆症患者纳入研究的决定，并表明他们的决定往往是出于利他主义、对调查人员的信任、希望让患者、照顾者或患者的后代受益，或者绝望地阻止或减缓痴呆症的进展。登记决定也反映了这样一种预期，即患者和照顾者的潜在风险和研究收益之间存在相互依存的关系--影响一方的东西也会影响另一方。在参与研究的过程中，这种希望和期望是如何实现的，目前尚不清楚。此外，对于代孕者作为家庭成员、照顾者、代理决策者和研究伙伴的多重角色可能出现的利益冲突，人们知之甚少。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伙伴的角色和责任；(2)描述作为代理和研究伙伴的照顾者的经历和潜在冲突，以及他们在参与研究的过程中如何管理他们的利益冲突；(3)根据原则主义和关系范式的伦理学观点，描绘和分析涉及代理和研究伙伴的痴呆症研究中提出的常见伦理问题。为了实现这些目标，将使用定性研究方法，采访积极参与痴呆症研究的个人，包括调查人员、痴呆症研究协调员和充当代理人和研究伙伴的照顾者。在痴呆症的病因、治疗和治疗研究对帮助缓解数百万受影响公民的痛苦和降低医疗成本至关重要的时候，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参考，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。