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基于废水检测的结构化伦理审查

Structured Ethical Review for Wastewater-Based Testing.

作者信息

Bowes Devin A, Darling Amanda, Driver Erin M, Kaya Devrim, Maal-Bared Rasha, Lee Lisa M, Goodman Kenneth, Adhikari Sangeet, Aggarwal Srijan, Bivins Aaron, Bohrerova Zuzana, Cohen Alasdair, Duvallet Claire, Elnimeiry Rasha A, Hutchison Justin M, Kapoor Vikram, Keenum Ishi, Ling Fangqiong, Sills Deborah, Tiwari Ananda, Vikesland Peter, Ziels Ryan, Mansfeldt Cresten

机构信息

Biodesign Center for Environmental Health Engineering, The Biodesign Institute, Arizona State University, 1001 S. McAllister Ave, Tempe, AZ, 85287.

Center on Forced Displacement, Boston University, 111 Cummington Mall, Boston, MA, 02215.

出版信息

medRxiv. 2023 Jun 14:2023.06.12.23291231. doi: 10.1101/2023.06.12.23291231.

Abstract

UNLABELLED

Wastewater-based testing (WBT) for SARS-CoV-2 has rapidly expanded over the past three years due to its ability to provide a comprehensive measurement of disease prevalence independent of clinical testing. The development and simultaneous application of the field blurred the boundary between measuring biomarkers for research activities and for pursuit of public health goals, both areas with well-established ethical frameworks. Currently, WBT practitioners do not employ a standardized ethical review process (or associated data management safeguards), introducing the potential for adverse outcomes for WBT professionals and community members. To address this deficiency, an interdisciplinary group developed a framework for a structured ethical review of WBT. The workshop employed a consensus approach to create this framework as a set of 11-questions derived from primarily public health guidance because of the common exemption of wastewater samples to human subject research considerations. This study retrospectively applied the set of questions to peer- reviewed published reports on SARS-CoV-2 monitoring campaigns covering the emergent phase of the pandemic from March 2020 to February 2022 (n=53). Overall, 43% of the responses to the questions were unable to be assessed because of lack of reported information. It is therefore hypothesized that a systematic framework would at a minimum improve the communication of key ethical considerations for the application of WBT. Consistent application of a standardized ethical review will also assist in developing an engaged practice of critically applying and updating approaches and techniques to reflect the concerns held by both those practicing and being monitored by WBT supported campaigns.

SYNOPSIS

Development of a structured ethical review facilitates retrospective analysis of published studies and drafted scenarios in the context of wastewater-based testing.

摘要

未标注

在过去三年中,基于废水的新冠病毒检测(WBT)迅速发展,因为它能够独立于临床检测,全面测量疾病流行情况。该领域的发展与同时应用模糊了为研究活动和为追求公共卫生目标测量生物标志物之间的界限,这两个领域都有成熟的伦理框架。目前,WBT从业者并未采用标准化的伦理审查程序(或相关的数据管理保障措施),这给WBT专业人员和社区成员带来了产生不良后果的可能性。为解决这一缺陷,一个跨学科小组制定了一个对WBT进行结构化伦理审查的框架。该研讨会采用共识方法创建了这个框架,该框架是一组主要源自公共卫生指南提出的11个问题,因为废水样本通常被豁免于人体研究考量。本研究将这组问题回顾性地应用于2020年3月至2022年2月大流行初期涵盖新冠病毒监测活动的同行评审发表报告(n = 53)。总体而言,由于缺乏报告信息,43%的问题回复无法评估。因此推测,一个系统框架至少会改善WBT应用中关键伦理考量的沟通。一致应用标准化伦理审查也将有助于形成一种积极实践,即批判性地应用和更新方法与技术,以反映WBT支持的监测活动的从业者和被监测者所关注的问题。

摘要

结构化伦理审查的发展有助于在基于废水检测的背景下对已发表研究和拟定方案进行回顾性分析。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/af7a/10312843/abf80b13c7a5/nihpp-2023.06.12.23291231v1-f0001.jpg

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