Hinga Alex, Jeena Lisha, Awuor Esther, Kahindi Jane, Munene Marianne, Kinyanjui Samson, Molyneux Sassy, Marsh Vicki, Kamuya Dorcas
Kenya Medical Research Institute (KEMRI) - Wellcome Trust Research Programme, Kilifi, P.O. Box 230-80108, Kenya.
Centre for Tropical Medicine, Nuffield Department of Medicine, Oxford University, Oxford, Old Road Campus, Headington, Oxford, OX3 7LF, UK.
Wellcome Open Res. 2022 Jun 21;7:75. doi: 10.12688/wellcomeopenres.17533.2. eCollection 2022.
: The scale of the COVID-19 pandemic and novelty of SARS-CoV-2 presented unprecedented challenges in the review of COVID-19 protocols. We investigated how research at the KEMRI Wellcome Trust Research Programme (KWTRP) was reviewed, including by institutional and national level committees. A document review and in-depth interviews with researchers, regulators and research reviewers were conducted. Documents reviewed included research logs of all protocols submitted between April-1-2020 and March-31-2021, feedback letters from review committees for 10 new COVID-19 protocols (n=42), and minutes from 35 COVID-19 research review meetings. Fifteen in-depth interviews were conducted with respondents purposively selected because of their experience of developing or reviewing COVID-19 protocols at the institution level (n=9 researchers, engagement officers and regulators) or their experience in reviewing proposals at a national-level (n=6 committee members). Data were managed and analyzed using MS Excel and NVivo12. : Between April-1-2020 and March-31-2021, 30 COVID-19-related submissions by KWTRP researchers were approved. Changes to the review system included strengthening the online system for protocol submission and review, recruiting more reviewers, and trialing a joint review process where one protocol was submitted to multiple review committees simultaneously . The turnaround time from submission to national approval/rejection over this period was faster than pre-pandemic, but slower than the national committee's target. COVID-19-specific ethics questions centred on: virtual informed consent and data collection; COVID-19 prevention, screening and testing procedures; and the challenges of study design and community engagement during the pandemic. : The unprecedented challenges of the pandemic and added bureaucratic requirements created a more complex review process and delayed final approval of research protocols. The feasibility of conducting joint review of research during public health emergencies in Kenya needs further investigation. Consideration of the unique COVID-19 ethics issues raised in this paper might aid expedience in current and future reviews.
新冠疫情的规模以及严重急性呼吸综合征冠状病毒2（SARS-CoV-2）的新颖性给新冠疫情相关研究方案的审查带来了前所未有的挑战。我们调查了肯尼亚医学研究协会-惠康信托基金研究项目（KWTRP）的研究是如何进行审查的，包括机构层面和国家层面委员会的审查情况。我们开展了文件审查，并对研究人员、监管人员和研究审查人员进行了深入访谈。审查的文件包括2020年4月1日至2021年3月31日期间提交的所有研究方案的研究日志、10项新的新冠疫情相关研究方案（n=42）的审查委员会反馈信，以及35次新冠疫情相关研究审查会议的会议记录。我们对15名受访者进行了深入访谈，这些受访者是因在机构层面有制定或审查新冠疫情相关研究方案的经验（n=9名研究人员、参与人员和监管人员）或在国家层面有审查提案的经验（n=6名委员会成员）而被有目的地挑选出来的。使用微软Excel和NVivo12对数据进行管理和分析。在2020年4月1日至2021年3月31日期间，KWTRP研究人员提交的30项与新冠疫情相关的申请获得批准。审查系统的变化包括加强研究方案提交和审查的在线系统、招募更多审查人员，以及试行联合审查流程，即一项研究方案同时提交给多个审查委员会。在此期间，从提交到获得国家批准/拒绝的周转时间比疫情前更快，但比国家委员会的目标要慢。新冠疫情特定的伦理问题集中在：虚拟知情同意和数据收集；新冠疫情预防、筛查和检测程序；以及疫情期间研究设计和社区参与的挑战。疫情带来的前所未有的挑战以及新增的官僚要求导致审查过程更加复杂，并延迟了研究方案的最终批准。在肯尼亚公共卫生紧急情况下对研究进行联合审查的可行性需要进一步调查。考虑本文中提出的新冠疫情独特伦理问题可能有助于加快当前和未来的审查。
