Kasherman Lawrence, Madariaga Ainhoa, Liu Qin, Bonilla Luisa, McMullen Michelle, Liu Shiru Lucy, Wang Lisa, Fazelzad Rouhi, Karakasis Katherine, Heesters Ann M, Oza Amit M
Division of Medical Oncology and Hematology, Princess Margaret Hospital Cancer Centre, Toronto, Ontario, Canada.
Department of Medical Oncology, St George Hospital, Kogarah, New South Wales, Australia.
BMJ Open. 2021 Jul 23;11(7):e047076. doi: 10.1136/bmjopen-2020-047076.
In response to the COVID-19 pandemic there have been significant developments in research, its conduct and the supporting ethical framework. While many protocols have been delayed, halted or modified, other research efforts have been accelerated, generating controversy. The goal of this paper is to determine the rates of references surrounding the ethical oversight of research as reported in current COVID-19-related research publications.
Scoping review.
Population-based observational or interventional studies from December 2019 to May 2020 with sample size of two or more. Studies were searched through electronic databases including Medline, EMBASE, and Cochrane CENTRAL Register of Controlled Trials.
Eligibility criteria included participants within published studies who tested positive for COVID-19.
Data were extracted and charting methods included taking note of references to ethical frameworks, institutional review board (IRB), ethics committee (EC) or research ethics board (REB) involvement, consent processes, and other variables.
11 556 articles were screened, with 656 included in the final analysis. References to ethics were present in 530 (80.8%) studies, with 491 (74.8%) involving IRB/ECs/REBs and 126 (19.2%) not referencing ethics. Consent processes were outlined in 201 (30.6%) studies, with 198 (30.2%) reporting that they obtained consent waivers, however, 257 (39.2%) did not mention consent at all. Differences (p<0.001) in ethics-related references were apparent when analysed by continent, publication type, sample size and IF.
The majority of published articles pertaining to COVID-19 research made mention of ethical considerations, however, national and regional variations in research ethics review requirements introduce heterogeneity between studies and raise important questions about the conduct of scientific research during global public emergencies.
Open Science Framework: https://osfio/z67wb.
为应对新冠疫情，研究、研究开展方式及相关伦理框架均有重大进展。虽然许多研究方案被推迟、暂停或修改，但其他研究工作加速推进，引发了争议。本文旨在确定当前新冠相关研究出版物中有关研究伦理监督的参考文献比例。
范围综述。
2019年12月至2020年5月基于人群的观察性或干预性研究，样本量为两个或更多。通过电子数据库检索研究，包括Medline、EMBASE和Cochrane对照试验中央注册库。
纳入标准包括新冠检测呈阳性的已发表研究中的参与者。
提取数据，图表绘制方法包括记录对伦理框架、机构审查委员会（IRB）、伦理委员会（EC）或研究伦理委员会（REB）参与情况、同意程序及其他变量的参考文献。
筛选了11556篇文章，最终纳入分析656篇。530项（80.8%）研究提及伦理，491项（74.8%）涉及IRB/ECs/REBs，126项（19.2%）未提及伦理。201项（30.6%）研究概述了同意程序，198项（30.2%）报告获得了同意豁免，但257项（39.2%）根本未提及同意。按洲、出版物类型、样本量和影响因子分析时，伦理相关参考文献存在差异（p<0.001）。
大多数已发表的新冠研究文章提及了伦理考量，然而，研究伦理审查要求的国家和地区差异导致研究之间存在异质性，并引发了关于全球公共卫生紧急事件期间科学研究开展的重要问题。
开放科学框架：https://osfio/z67wb 。
