TRAINING IN CLINICAL RESEARCH ETHICS

临床研究伦理培训

• 批准号: 6532603
• 负责人: MICHAEL W KALICHMAN
• 金额: $ 8.48万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-08-01 至 2006-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6532603
• 关键词: behavioral /social science research tag; biomedical facility; clinical research; decision making; education evaluation /planning; ethics; human subject; postdoctoral investigator; psychometrics; racial /ethnic difference; training; university

DESCRIPTION: Candidate: This career development award will allow the candidate to shift his focus as a biomedical scientist toward an independent career in the field of research ethics. The proposed research program provides an ideal framework for his career development goals to acquire expertise in ethical theory, human subject research ethics and policy, and survey methodology. Career development activities will consist of guided reading and discussion with the mentor, auditing of selected courses, and participation in national courses, meetings, and workshops. Environment: The career development and research goals are necessarily multi-disciplinary and multi-institutional. The candidate's mentor, Dr. Lawrence Schneiderman, can contribute approximately 25 years of experience in ethical theory, social research, and biomedical ethics. The candidate's home institution also provides a highly supportive administration as well as faculty and programs with expertise and interest in ethics, clinical research, and social research methods. This will be supplemented by consultants from the Universities of Minnesota, Pittsburgh, and Washington. Research: The need to address research ethics, and specifically clinical research ethics, is driven by several recent trends. The lines between clinical practice and research are increasingly unclear, new technologies are raising difficult questions not previously imagined, and reported violations of the ethical, legal, and social principles governing research with human subjects continue to increase. Formal instruction in research ethics seems an obvious solution and is increasingly required. Unfortunately, empirical data have provided little or no support for the presumed benefits of this training. Therefore, the central hypothesis to be tested is that: Research ethics training has a positive impact on ethical decisionmaking. Specific Aims: Aim #1: Define characteristics of existing training programs that might have an impact on the skills and knowledge necessary for ethical decisionmaking. Aim #2: Conduct pilot assessment of the roles of the different training methods in producing acute and long-term changes in ethical decisionmaking skills and knowledge. Aim #3: Assess acute and long-term effects of ethics training at a wide range of institutions representative of the following dimensions: large, medium, and small; public and private; and historically black and minority colleges and universities. Completion of the proposed aims will provide: valuable new information about the effectiveness of training in research ethics; a foundation for the candidate's independent career in applied research ethics; and the experience and knowledge necessary for the candidate to be a resource to his institution and the research community.

描述：候选人：该职业发展奖将使候选人 将他作为生物医学科学家的注意力转向独立的职业生涯 研究伦理领域。拟议的研究计划提供了一个理想的 他的职业发展目标的框架，以获取道德方面的专业知识 理论、人类受试者研究伦理和政策以及调查方法。 职业发展活动将包括引导阅读和讨论 与导师一起，审核选定的课程，并参与国家 课程、会议和研讨会。环境：职业发展和 研究目标必然是多学科和多机构的。这 候选人的导师 Lawrence Schneiderman 博士可以贡献大约 25 多年在伦理理论、社会研究和生物医学伦理学方面的经验。 候选人的母校也提供了高度支持 管理人员以及具有专业知识和兴趣的教师和项目 伦理学、临床研究和社会研究方法。这将是 由来自明尼苏达大学、匹兹堡大学和 华盛顿。研究：需要解决研究伦理问题，特别是 临床研究伦理是由最近的几个趋势驱动的。之间的线 临床实践和研究越来越不明确，新技术不断出现 提出了以前没有想象到的难题，并报告了违反规定的行为 管理人类研究的伦理、法律和社会原则 科目不断增加。研究伦理方面的正式指导似乎是 明显的解决方案并且越来越需要。不幸的是，经验数据 很少或根本没有对本次培训的预期好处提供支持。 因此，要检验的中心假设是： 研究伦理 培训对道德决策有积极影响。 具体目标： 目标 1：定义现有培训计划的特征 这可能会对道德所需的技能和知识产生影响 决策。目标#2：对不同角色的角色进行试点评估 产生急性和长期道德变化的培训方法 决策技能和知识。目标#3：评估急性和长期影响 在广泛的代表机构中开展道德培训 以下尺寸：大、中、小；公共和私人；和 历史上的黑人和少数族裔学院和大学。完成 拟议的目标将提供： 关于有效性的有价值的新信息 研究伦理培训；为候选人的独立性奠定基础 应用研究伦理学的职业生涯；以及必要的经验和知识 让候选人成为其所在机构和研究的资源 社区。