Responsible researchers and reviewers: Ethics of Good Clinical Practice silver jubilee workshop report.

D Savitha, Mathangi Krishnakumar, Prem Pais, Jagdish Chinnappa, Johnson Pradeep, Jyothi Idiculla, Manjulika Vaz, C K Nisha, Kavitha Rajarathna, Nancy Angeline, Mary Joseph, Jayanthi Savio, Karuna Ramesh Kumar
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Abstract

Ethics education in biomedical research in India is frequently limited to regulatory compliance, with inadequate emphasis on ethical reasoning, contextual vulnerability, and deliberative review processes. As part of the Silver Jubilee of the Institutional Ethics Committee of St John's Medical College Hospital, a one-day preconference workshop titled "Responsible Researchers and Reviewers: Ethics of Good Clinical Practice" was conducted during the 13th International Conference of Ethics Education. The workshop employed case-based, interdisciplinary discussions focusing on vulnerability, ethics committee accreditation, and ethical review of diverse study designs. Key gaps identified included difficulties in operationalising vulnerability, managing surrogate consent in critical care research, inconsistent ethics committee monitoring practices, and limited faculty preparedness for ethics pedagogy. The discussions revealed a need to move beyond knowledge transmission towards reflective, skills-based ethics education.

负责任的研究人员和审稿人:良好临床实践伦理银禧研讨会报告。
印度生物医学研究中的伦理教育常常局限于遵守法规,对伦理推理、环境脆弱性和审议审查过程的重视不够。作为圣约翰医学院附属医院机构伦理委员会银禧纪念活动的一部分,在第十三届国际伦理教育会议期间,举办了为期一天的会前研讨会,题为“负责任的研究人员和审稿人:良好临床实践的伦理”。研讨会采用基于案例的跨学科讨论,重点关注脆弱性、伦理委员会认证和不同研究设计的伦理审查。确定的主要差距包括在脆弱性操作方面的困难,在重症监护研究中管理替代同意,伦理委员会监督实践不一致,以及教师对伦理教学法的准备有限。讨论表明,有必要从知识传播转向反思的、以技能为基础的道德教育。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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