Ethics and Safeguards in Psychiatric Research

精神病学研究的伦理和保障措施

• 批准号: 7871081
• 负责人: LAURA W ROBERTS
• 金额: $ 13.49万
• 依托单位: MEDICAL COLLEGE OF WISCONSIN
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-08-01 至 2010-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7871081
• 关键词: Address; Area; Attitude; Basic Science; Belief; Child; Classification; Communities; Community Consents; Computer Retrieval of Information on Scientific Projects Database; Confidentiality; Conflict of Interest; Consent; Counseling; Country; Data; Development; Discrimination; Disease; Drug abuse; Educational Intervention; Effectiveness; Employment; Ethical Issues; Ethics; Face; Failure; Family; Family member; First Degree Relative; Focus Groups; Fright; Funding; Future; Genetic; Genetic Counseling; Genetic Research; Goals; Grant; Guidelines; Health; Human; Human Resources; Individual; Information Dissemination; Informed Consent; Intervention; Intervention Studies; Interview; Knowledge; Left; Link; Literature; Manuscripts; Marriage; Measures; Mediating; Mental disorders; Mentally Ill Persons; Methods; New Mexico; Online Systems; Outcomes Research; Participant; Perception; Persons; Phase; Policies; Policy Maker; Property; Protocols documentation; Psyche structure; Public Health; Public Policy; Publications; Publishing; Randomized; Randomized Controlled Trials; Recommendation; Relative (related person); Reporting; Research; Research Ethics; Research Ethics Committees; Research Personnel; Resources; Schizophrenia; Science; Science of genetics; Shapes; Site; Source; Stigmata; Structure; Surveys; Testing; Time; Tissue Sample; Translations; United States National Institutes of Health; Wisconsin; Work; Writing; addiction; base; beneficiary; burden of illness; comparison group; cost; design; evidence base; improved; informant; innovation; insight; investigator training; member; neuropsychiatry; physical conditioning; prevent; programs; psychogenetics; reproductive; research study; skills; social; social stigma; sound; tool

DESCRIPTION (provided by applicant): Psychiatric genetic research (PGR) holds great promise for preventing, understanding, and treating neuropsychiatric disorders - a source of immense societal burden and personal suffering. Such research poses many ethical challenges, and failure to perform systematic study of the ethical issues surrounding PGR may threaten societal acceptance of this important scientific work. To date, NIH has not funded any work on PGR that focuses on collecting empirical data about ethical issues. To remedy this gap, we will involve well-established, transdisciplinary collaborative researchers at two sites with a national Scientific Advisory Board and a national Stakeholder Advisory Board to achieve 2 Aims: (1) to understand how 6 key stakeholder groups view important ethical considerations and safeguards in psychiatric genetic research, and (2) to develop and test a specific method for enhancing the research ethics skills of psychiatric genetic researchers and institutional reviewers of research. In the Developmental Phase, we will conduct focus groups with 100 lay stakeholders at Med Coll of Wisconsin & U of New Mexico SOM, and we will conduct key informant interviews with 20 professional stakeholders nationwide. To achieve Aim 1, we will conduct 2 hypothesis-driven mainly quantitative surveys. Project 1 will used structured interviews to collect survey data at both sites from 120 mentally ill people, 120 family members of people with mental illness, and 120 healthy people. Project 2 will be a national Web-based survey of 120 psychiatric genetic investigators, 120 IRB leaders, and 120 IRB members. Both empirical survey projects will assess ethical issues in psychiatric genetic research, emphasizing participant-oriented safeguards (i.e., consent, confidentiality, & genetic counseling) & investigator- and institutional-oriented safeguards (i.e., institutional review, conflict of interest management, tissue/sample retention, & community consent). To achieve Aim 2, we will perform a randomized controlled trial to evaluate a Web-based ethics educational module to enhance 80 researchers' and 160 research reviewers' abilities to identify, analyze, and manage PGR ethics issues. We suggest that evidence-based ethics inquiry for PGR will displace bias and fear in shaping scientific practices and public policy. Our proposed endeavor will generate new knowledge for wide dissemination and publication that can inform future evidence-based PGR ethics guidelines and generate further empirical ethics research on PGR.

描述（由申请人提供）：精神病遗传研究（PGR）对预防，理解和治疗神经精神疾病具有巨大的希望 - 这是巨大的社会负担和个人痛苦的来源。这样的研究提出了许多道德挑战，并且未能对PGR围绕的道德问题进行系统的研究可能威胁到社会接受这项重要的科学工作。迄今为止，NIH尚未资助PGR上的任何工作，该工作着重于收集有关道德问题的经验数据。为了解决这一差距，我们将涉及两个网站上建立良好的，跨学科的合作研究人员，其中包括国家科学顾问委员会和国家利益相关者咨询委员会，以实现2个目标：（1）6个关键的利益相关者如何了解重要的道德考虑因素和在精神遗传学方面的特定方法，以发展和测试精神遗传学的方法（2），并（2）研究机构（2）机构研究审稿人。在发展阶段，我们将在新墨西哥州的威斯康星州和U的Med Coll与100个外行利益相关者一起举办焦点小组，我们将对全国20位专业利益相关者进行关键的线人访谈。为了达到目标1，我们将进行2个假设驱动的主要定量调查。项目1将使用结构化的访谈来收集来自120名精神病患者，120名精神病患者和120名健康人的家庭成员的调查数据。项目2将是一项基于国家网络的国家调查，对120名精神病遗传研究者，120名IRB领导者和120名IRB成员进行调查。这两个经验调查项目均应评估精神病遗传研究中的道德问题，强调以参与者为导向的保障措施（即同意，保密性和遗传咨询），以及研究人员以及研究人员和面向机构的保障措施（即，机构审查，利益管理，组织/样本保留和社区的冲突，组织/样本保留和社区同意）。为了实现目标2，我们将执行一项随机对照试验，以评估一个基于Web的道德教育模块，以增强80位研究人员和160位研究审稿人的能力来识别，分析和管理PGR伦理问题。我们建议，基于证据的PGR伦理探究将在塑造科学实践和公共政策时取代偏见和恐惧。我们提出的努力将为广泛的传播和出版提供新知识，这些知识可以为未来的证据PGR伦理准则提供信息，并在PGR上产生进一步的经验伦理研究。