Informed Consent for Latinos with Schizophrenia

描述（由申请人提供）：拉丁美洲人是美国最大的少数民族，但在NIMH和fda相关的心理健康研究中仍然远远不足。对一些拉美裔人来说，入学的最大障碍之一可能是知情同意过程中的语言障碍。重要的是要避免将拉美裔人定型为单一的背景、偏好或技能；可能与知情同意过程相关的关键因素（如语言、文化适应、教育和健康素养）差异很大，但在拉丁裔亚群体中也往往交织在一起。尽管在过去的15年里，关于神经精神病人群的决策能力和知情同意过程的宝贵经验数据已经积累起来，但关于拉丁裔社区知情同意的研究却很少。这个项目将有助于填补这一重要的经验信息空白。具体目标包括确定语言、文化适应、教育、健康和研究素养对参与者最初理解和1个月信息保留的影响程度。此外，在强调研究方案在同意过程中的作用的概念模型的基础上，我们还将测试同意前教育干预（在讨论特定方案之前向参与者讲授临床研究和同意过程）对初始理解和1个月保留的影响。参与者将包括180名精神分裂症或分裂情感性障碍患者[60名偏爱西班牙语的拉丁裔，60名偏爱英语的拉丁裔和60名（说英语的）非拉丁裔白人]。参与者将被随机分配到一个假设的3期临床试验的常规或教育强化同意程序。措施将包括文化适应、卫生知识普及和对同意程序期间披露的信息的理解的标准评定量表。此外，将对30名参与者的子样本进行定性访谈，以确定他们对同意程序的印象，以及他们对参与研究的知情同意和决策的偏好。所有程序、访谈和评估将由双语双文化研究人员以每位参与者的首选语言（西班牙语或英语）进行。通过提供信息来促进有效的、在语言和文化上适当的同意程序，拟议的工作将促进NIMH战略计划目标3的实现，即“开发新的、更好的精神障碍干预措施，将精神疾病患者的不同需求和情况结合起来”。

DESCRIPTION (provided by applicant): Latinos are the largest ethnic minority group in the U.S., yet remain vastly underrepresented in NIMH and FDA-associated mental health research. One of the most salient barriers to enrollment for some Latinos may be language barriers in the informed consent process. It is important to avoid stereotyping Latinos as being characterized by a monolithic background, preferences, or skills; key factors likely relevant to the informed consent process (such as language, acculturation, education, and health literacy) vary widely, yet also tend to be intertwined among Latino subgroups. Although valuable empirical data on decisional capacity and the informed consent process in neuropsychiatric populations has amassed over the past 15 years, there has been a dearth of such research focused on informed consent in the Latino Community. This project will serve to fill this vital empirical information gap. Specific aims include identifying the degree to which language, acculturation, education, health, and research literacy affect participants' initial comprehension and 1-month retention of information. In addition, grounded in a conceptual model highlighting the role of a research schema in the consent process, we will also test the effects of a pre-consent educational intervention (teaching participants about clinical research and the consent process prior to discussing a specific protocol) on initial comprehension and 1-month retention. Participants will include 180 people with schizophrenia or schizoaffective disorder [60 Latinos with Spanish language preference, 60 Latinos with English preference, and 60 (English speaking) non-Latino whites]. Participants will be randomized to a routine or educationally enhanced consent procedure for a hypothetical phase 3 clinical trial. Measures will include standard rating scales of acculturation, health literacy, and comprehension of information disclosed during consent procedures. In addition, qualitative interviews will be conducted with a subsample of 30 participants to ascertain their impressions of the consent procedures, as well as their preferences regarding informed consent and decision making about research participation. All procedures, interviews, and assessments will be conducted in each participant's preferred language (Spanish or English) by bilingual- bicultural research staff. By providing information to foster effective and linguistically and culturally appropriate consent procedures, the work proposed will facilitate pursuit of Objective 3 in the NIMH Strategic Plan, i.e., to "Develop New and Better Interventions for Mental Disorders that Incorporate the Diverse Needs and Circumstances of People with Mental Illness." PUBLIC HEALTH RELEVANCE: Latinos are the largest ethnic minority group in the U.S., yet are vastly underrepresented in mental health research. The proposed study will provide data essential to ensuring that investigators are able to enroll a diverse range of Latinos with schizophrenia using linguistically, culturally appropriate, and effective procedures for obtaining informed consent for participation.