Informed Consent in People with Multiple Sclerosis

多发性硬化症患者的知情同意书

• 批准号: 6925644
• 负责人: MICHAEL R BASSO
• 金额: $ 31.22万
• 依托单位: UNIVERSITY OF TULSA
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-01 至 2008-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6925644
• 关键词: attention; behavioral /social science research tag; choice; clinical research; decision making; ethics; executive function; functional ability; human subject; informed consent; language; memory; multiple sclerosis; neuropsychological tests; questionnaires; statistics /biometry

DESCRIPTION (provided by applicant): Ethical standards for obtaining competent informed consent require that a potential participant is able to express a choice concerning research participation. Standards further require that the individual is capable of appreciating, understanding, and reasoning through information pertaining to the research protocol. These capacities may be impaired in individuals with neurologic illness. In particular, owing to the presence of neuropsychological impairment, some patients with multiple sclerosis (M.S.) may have difficulty making competent decisions concerning research participation. Yet, this issue has heretofore not been addressed. Accordingly, the proposed project will evaluate performance of people with M.S. on a measure that is used to assess decision-making ability regarding research participation. It will also evaluate what aspects of neuropsychological function predict decision making with regard to research participation. Finally, it will examine whether cueing and repetition of research-related information improves decisional capacity regarding research participation. Individuals with M.S. and control participants will be administered a battery of standard neuropsychological tests that will emphasize executive function, memory, attention, and expressive and receptive language. Participants will then be presented with a standardized fictional research protocol that has previously been used to examine competency to provide informed consent, namely the MacArthur Competence Assessment Tool - Clinical Research (MacCAT-CR). The MacCAT-CR will assess ability to express a choice concerning research participation as well as ability to appreciate, understand, and reason through informed consent disclosures. Subsequently, information concerning the fictional research protocol will be repeated and cued, and participants' ability to appreciate, understand, and reason through the material will be re-assessed as will their capacity to express a choice. Performance on the neuropsychological test battery will be used to stratify participants according to severity of neurobehavioral deficit (participant groups: control group, M.S. unimpaired, M.S. mildly impaired, M.S. moderately-severely impaired). A one-way MANOVA (participant groups) will be used to compare MacCAT-CR performance across groups, specifically choice expression, understanding, appreciation, and reasoning about informed consent disclosures. Regression analyses will be employed to examine what aspects of neuropsychological function predict these same MacCAT-CR scores. To evaluate the effects of repetition and cueing on MacCAT-CR choice expression, understanding, appreciation, and reasoning scores, a mixed factor MANOVA will be conducted, and the resulting design will be a 4 (participant group: control group, M.S. unimpaired, M.S. mildly impaired, M.S. moderately-severely impaired) X 2 (time: pre-recognition cueing, post-recognition cueing) with time being a repeated factor. In addressing these issues, the proposed research will imply which M.S. patients are at greatest risk of making incompetent decisions to participate in research, and it may provide an effective method of remediating this difficulty. Overall, the long-term goal of this research is to ensure that research participants with M.S. are treated in an ethical manner.

描述（由申请人提供）：获得有能力的知情同意书的道德标准要求潜在参与者能够表达有关研究参与的选择。标准进一步要求个人能够通过与研究协议有关的信息来欣赏，理解和推理。这些能力可能会在神经系统疾病的个体中受到损害。特别是，由于存在神经心理学障碍，一些多发性硬化症患者（M.S.）可能难以做出有关研究参与的胜任决定。然而，迄今为止尚未解决这个问题。因此，拟议的项目将评估M.S.用于评估有关研究参与的决策能力的措施。它还将评估神经心理学功能的哪些方面可以预测有关研究参与的决策。最后，它将检查与研究相关信息的提示和重复是否提高有关研究参与的决策能力。患有硕士控制参与者将被管理一系列标准的神经心理学测试，这些测试将强调执行功能，记忆，注意力以及表现力和接受语言。然后，将向参与者提供标准化的虚构研究方案，该方案以前已用于检查能力以提供知情同意，即MacArthur能力评估工具 - 临床研究（MACCAT -CR）。 MACCAT-CR将评估表达有关研究参与的选择的能力，以及通过知情同意披露来欣赏，理解和推理的能力。随后，有关虚构研究协议的信息将被重复和提示，并且参与者通过材料的欣赏，理解和推理的能力将被重新评估，以表达选择的能力。神经心理测试电池的性能将根据神经行为缺陷的严重程度（参与者组：对照组，M.S。未损坏，M.S.轻度受损，M.S。中度较差的障碍）对参与者进行分层。单向MANOVA（参与者组）将用于比较跨小组的MacCat-CR表现，特别是选择表达，理解，欣赏和有关知情同意披露的推理。回归分析将用于检查神经心理学功能的哪些方面预测这些相同的MACCAT-CR分数。 To evaluate the effects of repetition and cueing on MacCAT-CR choice expression, understanding, appreciation, and reasoning scores, a mixed factor MANOVA will be conducted, and the resulting design will be a 4 (participant group: control group, M.S. unimpaired, M.S. mildly impaired, M.S. moderately-severely impaired) X 2 (time: pre-recognition cueing, post-recognition cueing) with time being a repeated 因素。在解决这些问题时，拟议的研究将暗示哪些M.S.患者有做出无能参加研究的最大风险，它可能会提供一种修复这一难度的有效方法。总体而言，这项研究的长期目标是确保M.S.的研究参与者以道德方式对待。