Reimagining Human Research Protections for 21st Century Science
Reimagining Human Research Protections for 21st Century Science
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DOI：
10.2196/jmir.6634
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发表时间：
2016-12-01
影响因子：
7.4
通讯作者：
Melichar, Lori
中科院分区：
文献类型：
--
作者：
Bloss, Cinnamon;Nebeker, Camille;Melichar, Lori
背景：不断发展的研究实践和技术进步带来的新的研究形式需要重新设计的研究监督制度，尊重和保护人类研究参与者。目标：我们的目标是为重新设计我们当前的人类研究监督制度产生创造性的想法。方法：11名研究人员和机构评审委员会(IRB)专业人员参加了2015年1月的设计思维研讨会，以提出重新设计IRB系统的想法。结果：在5个主要领域产生了想法。重点关注的领域是(1)改进同意书和程序，(2)授权研究人员保护他们的参与者，(3)创建一个从错误中学习的系统，(4)提高IRB的效率，以及(5)促进对利用技术进步的研究的审查。结论：我们描述了设计思维研讨会的动机和结果，以重新设想一个响应21世纪科学的人类研究保护体系。
Background: Evolving research practices and new forms of research enabled by technological advances require a redesigned research oversight system that respects and protects human research participants.Objective: Our objective was to generate creative ideas for redesigning our current human research oversight system. Methods: A total of 11 researchers and institutional review board (IRB) professionals participated in a January 2015 design thinking workshop to develop ideas for redesigning the IRB system.Results: Ideas in 5 major domains were generated. The areas of focus were (1) improving the consent form and process, (2) empowering researchers to protect their participants, (3) creating a system to learn from mistakes, (4) improving IRB efficiency, and (5) facilitating review of research that leverages technological advances.Conclusions: We describe the impetus for and results of a design thinking workshop to reimagine a human research protections system that is responsive to 21st century science.