Cultural and Ethical Issues in Genetic Family Studies

遗传家庭研究中的文化和伦理问题

• 批准号: 6526870
• 负责人: NEDAL H. ARAR
• 金额: $ 7.23万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-01 至 2004-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6526870
• 关键词: attitude; behavioral /social science research tag; belief; clinical research; culture; diabetic nephropathy; ethics; family genetics; genetic susceptibility; health behavior; health education; health science research; human subject; informed consent; interview; longitudinal human study; medical complication; medical outreach /case finding; noninsulin dependent diabetes mellitus; questionnaires; racial /ethnic difference; statistics /biometry

DESCRIPTION (provided by applicant): Problem: There is a genetic susceptibility for the development of diabetic nephropathy (DN) in patients with a family history of type 2 diabetes mellitus (T2DM). Little is known about subjects' beliefs and attitudes towards genetic diseases (i.e., DN) and participation in genetic family studies (GFS). Understanding cultural and ethical issues associated with GFS will enhance the ascertainment process and establish strategies for genetic counseling of patients and relatives with a family history of T2DM and DN. Specific Aims: We have designed an anthropological study to: 1) determine whether subjects' beliefs about the hereditary aspects of DN influence participation in GFS, 2) explore subjects' opinions and awareness of ethical issues and risks related to their participation, and 3) analyze ethnic differences in attitudes toward participation in GFS. Methods: We will combine qualitative and quantitative methods to determine the generalizability of the qualitative findings and enhance the interpretability of the quantitative data. The study will be conducted in two phases: The Qualitative Phase I (24 months) will be based on an exploratory design using ethnographic methods of open-ended questions, probing, and participant observation. We will recruit subjects from the ongoing Family Investigation of Nephropathy and Diabetes (FIND) study at the University of Texas Health Science Center at San Antonio (UTHSCSA). Semi-structured interviews will be performed with 40 DN patients with a family history of T2DM and 40 of their relatives. An additional 20 DM patients with no family history of T2DM will be included. Most interviews will be conducted at UTHSCSA and last about 60 minutes. They will be tape-recorded, transcribed and content analyzed to identify themes across cases. Based on these themes, we plan to develop a quantitative questionnaire that will first be tested, validated, revised and applied to participants of different ethnic origins enrolled in our Center. In the Quantitative Phase II (36 months), we will mail this questionnaire to a larger population of participants (about 700) of different ethnic origins enrolled in other participating centers of FIND. Data analysis for this Phase will include both univariate and multivariate statistics. The statistical packages SAS and MINITAB will be utilized to perform these analyses. Outcomes: We expect to obtain data on: (1) subjects' beliefs about genetic diseases and participation in GFS. (2) recruiters' perspective on family enrollment. (3) association of participants' responses with demographic characteristics. (4) ethnic differences in attitudes towards participation in GFS.

描述（由申请人提供）：问题：存在遗传易感性 糖尿病肾病（DN）的发病原因有哪些 2型糖尿病（T2DM）病史。关于受试者的行为， 对遗传疾病的信念和态度（即，DN）和参与 遗传家族研究（GFS）理解文化和伦理问题 与GFS相关联的将增强确认过程，并建立 对有家族史的患者及其亲属的遗传咨询策略 T2DM和DN病史。 具体目标：我们设计了一项人类学研究，以：1）确定 受试者对DN遗传方面的信念是否影响 参与GFS，2）探讨受试者的意见和道德意识 问题和风险与他们的参与，和3）分析种族 对参与GFS的态度存在差异。 方法：采用联合收割机定性与定量相结合的方法， 定性结果的普遍性，并增强可解释性 的定量数据。研究将分两个阶段进行： 定性阶段I（24个月）将基于探索性设计， 开放式问题、探究和参与的民族志方法 观察.我们将从正在进行的家庭调查中招募受试者， 德克萨斯大学健康科学学院的肾病和糖尿病（FIND）研究 中心在圣安东尼奥（UTHSCSA）。将进行半结构化面试 有T2DM家族史的DN患者40例及其亲属40例。一个 将纳入另外20例无T2DM家族史的DM患者。最 面试将于岭大学生服务中心举行，约六十分钟。他们将 录音，转录和内容分析，以确定主题， 例基于这些主题，我们计划开发一个定量问卷 首先将进行测试、验证、修订并应用于 不同种族的人在我们的中心注册。在第二阶段的定量 (36月），我们将把这份问卷邮寄给更多的人， 参加者（约700人）来自不同种族，参加了其他 参与的中心。本阶段的数据分析将包括 单变量和多变量统计。统计软件包SAS和 将使用MINITAB进行这些分析。 结果：我们期望获得以下数据：（1）受试者对遗传的信念 疾病和参与GFS。(2)招聘人员对家庭的看法 招生(3)参与者的反应与人口统计学的关联 特色(4)对参与社会事务的态度的种族差异 GFS。