结构信息缺失，包括知情同意、数据处理和共享、伦理审批，以及开放科学原则在 COVID-19 研究中作为研究质量行为的替代指标：系统范围审查。

Structural under-reporting of informed consent, data handling and sharing, ethical approval, and application of Open Science principles as proxies for study quality conduct in COVID-19 research: a systematic scoping review.

机构信息

Deparment of Intensive Care Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands.

Cardiovascular research institute Maastricht (CARIM), Maastricht University, Maastricht, The Netherlands.

出版信息

BMJ Glob Health. 2023 May;8(5). doi: 10.1136/bmjgh-2023-012007.

DOI:10.1136/bmjgh-2023-012007

PMID:37257937

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10254958/

Abstract

BACKGROUND

The COVID-19 pandemic required science to provide answers rapidly to combat the outbreak. Hence, the reproducibility and quality of conducting research may have been threatened, particularly regarding privacy and data protection, in varying ways around the globe. The objective was to investigate aspects of reporting informed consent and data handling as proxies for study quality conduct.

METHODS

A systematic scoping review was performed by searching PubMed and Embase. The search was performed on November 8th, 2020. Studies with hospitalised patients diagnosed with COVID-19 over 18 years old were eligible for inclusion. With a focus on informed consent, data were extracted on the study design, prestudy protocol registration, ethical approval, data anonymisation, data sharing and data transfer as proxies for study quality. For reasons of comparison, data regarding country income level, study location and journal impact factor were also collected.

RESULTS

972 studies were included. 21.3% of studies reported informed consent, 42.6% reported waivers of consent, 31.4% did not report consent information and 4.7% mentioned other types of consent. Informed consent reporting was highest in clinical trials (94.6%) and lowest in retrospective cohort studies (15.0%). The reporting of consent versus no consent did not differ significantly by journal impact factor (p=0.159). 16.8% of studies reported a prestudy protocol registration or design. Ethical approval was described in 90.9% of studies. Information on anonymisation was provided in 17.0% of studies. In 257 multicentre studies, 1.2% reported on data sharing agreements, and none reported on Findable, Accessible, Interoperable and Reusable data principles. 1.2% reported on open data. Consent was most often reported in the Middle East (42.4%) and least often in North America (4.7%). Only one report originated from a low-income country.

DISCUSSION

Informed consent and aspects of data handling and sharing were under-reported in publications concerning COVID-19 and differed between countries, which strains study quality conduct when in dire need of answers.

摘要

背景

COVID-19 大流行要求科学界迅速提供答案，以应对疫情。因此，在全球范围内，研究的可重复性和质量可能受到了以各种方式的威胁，尤其是涉及隐私和数据保护。目的是调查报告知情同意和数据处理情况，以此作为研究质量行为的指标。

方法

通过搜索 PubMed 和 Embase 进行了系统的范围界定审查。搜索于 2020 年 11 月 8 日进行。符合条件的研究包括年龄在 18 岁以上、因 COVID-19 住院的患者。研究重点是知情同意，提取了关于研究设计、预研究方案注册、伦理批准、数据匿名化、数据共享和数据传输等方面的信息，这些都是研究质量的指标。出于比较的原因，还收集了有关国家收入水平、研究地点和期刊影响因子的数据。

结果

共纳入 972 项研究。21.3%的研究报告了知情同意，42.6%的研究报告了同意豁免，31.4%的研究未报告同意信息，4.7%的研究提到了其他类型的同意。临床试验中知情同意报告率最高（94.6%），回顾性队列研究中最低（15.0%）。期刊影响因子对同意与不同意的报告差异无统计学意义（p=0.159）。16.8%的研究报告了预研究方案注册或设计。90.9%的研究报告了伦理批准情况。17.0%的研究提供了关于匿名化的信息。在 257 项多中心研究中，1.2%的研究报告了数据共享协议，没有研究报告可查找、可访问、可互操作和可重用数据原则。1.2%的研究报告了开放数据。在中东，知情同意报告率最高（42.4%），而在北美，知情同意报告率最低（4.7%）。只有一份报告来自低收入国家。