Cho Mildred K, Taylor Holly, McCormick Jennifer B, Anderson Nick, Barnard David, Boyle Mary B, Capron Alexander M, Dorfman Elizabeth, Havard Kathryn, Reider Carson, Sadler John, Schwartz Peter, Sharp Richard R, Danis Marion, Wilfond Benjamin S
Stanford University, Stanford, California, USA.
Johns Hopkins University, Baltimore, Maryland, USA.
Clin Transl Sci. 2015 Aug;8(4):376-87. doi: 10.1111/cts.12268. Epub 2015 Mar 10.
Clinical research ethics consultation services have been established across academic health centers over the past decade. This paper presents the results of collaboration within the CTSA consortium to develop a standard approach to the collection of research ethics consultation information to serve as a foundation for quality improvement, education, and research efforts. This approach includes categorizing and documenting descriptive information about the requestor, research project, the ethical question, the consult process, and describing the basic structure for a consult note. This paper also explores challenges in determining how to share some of this information between collaborating institutions related to concerns about confidentially, data quality, and informatics. While there is much still to be learned to improve the process of clinical research ethics consultation, these tools can advance these efforts, which, in turn, can facilitate the ethical conduct of research.
在过去十年中，学术健康中心已建立了临床研究伦理咨询服务。本文介绍了临床与转化科学奖（CTSA）联盟内部合作的成果，以开发一种收集研究伦理咨询信息的标准方法，作为质量改进、教育和研究工作的基础。这种方法包括对请求者、研究项目、伦理问题、咨询过程的描述性信息进行分类和记录，并描述咨询记录的基本结构。本文还探讨了在确定如何在合作机构之间共享部分此类信息时所面临的挑战，这些挑战涉及保密性、数据质量和信息学方面的问题。虽然在改进临床研究伦理咨询过程方面仍有许多需要学习的地方，但这些工具可以推动这些工作，进而促进研究的伦理开展。
