Resnik David B
National Institute of Environmental Health Science, US.
National Institutes of Health, US.
Citiz Sci. 2019;4(1). doi: 10.5334/cstp.150. Epub 2019 Mar 8.
An increasing number of human studies are asking participants to have substantial involvement in research. Citizens in human studies may contribute to various research activities, including study design, recruitment, data interpretation, and data and sample collection. Citizen involvement in research raises novel ethical issues for human studies, because individuals have traditionally occupied the role of researcher or subject, but not both at the same time. The confluence of these two different roles in the same person poses challenges for investigators and oversight committees because legal rules and ethical guidelines focus on protecting the rights and welfare of human subjects and do not address issues that fall outside this domain, such as study design, data quality and integrity, reporting misconduct, authorship, or publication. This article examines some of these issues and makes recommendations for investigators and oversight committees.
越来越多的人体研究要求参与者深度参与研究。人体研究中的公民可能会参与各种研究活动，包括研究设计、招募、数据解读以及数据和样本收集。公民参与研究给人体研究带来了新的伦理问题，因为传统上个人要么扮演研究者的角色，要么扮演受试者的角色，不会同时兼具这两种角色。同一个人兼具这两种不同角色给研究者和监督委员会带来了挑战，因为法律规则和伦理准则侧重于保护人类受试者的权利和福祉，并未涉及该领域之外的问题，如研究设计、数据质量与完整性、报告不当行为、署名权或发表问题。本文探讨了其中一些问题，并为研究者和监督委员会提出了建议。
