Keenoy Katie E, Lenze Eric J, Nicol Ginger E
Washington University School of Medicine, St. Louis, MO, USA.
happyMedium | healthyMedium, LLC, St. Louis, MO, USA.
J Clin Transl Sci. 2021 Oct 6;5(1):e189. doi: 10.1017/cts.2021.865. eCollection 2021.
COVID-19 has forced medical research institutions to conduct clinical research remotely. Here, we describe how a university's mHealth Research Core helped facilitate the shift to remote research during the COVID-19 pandemic. In 2019 (pre-pandemic), we conducted stakeholder interviews and leadership group sessions to identify, create, and implement resources and core functions to support investigator-initiated mHealth research. Between April 2019 and February 2020, we identified four investigator needs: 1) a on trends in mHealth research, 2) mHealth services, 3) with institutional regulatory compliance groups, and 4) for implementation of mHealth methods (e.g., eConsent) and for building partnerships with technology vendors. To date, the mHealth Research Core has held seven seminars, completed 71 case consultations, assisted four COVID-related clinical studies, advised the IRB on shifting to remote research, and widely disseminated eConsent navigation tools. Although pre-pandemic stakeholder and investigator needs led to the creation of the mHealth Research Core, this institutional resource played a critical role in continuing clinical research during the pandemic by assisting investigators in rapidly shifting to remote study methodology.
新冠疫情迫使医学研究机构开展远程临床研究。在此，我们描述一所大学的移动健康研究核心如何在新冠疫情期间助力向远程研究的转变。2019年（疫情前），我们开展了利益相关者访谈和领导小组会议，以确定、创建并实施支持研究者发起的移动健康研究的资源和核心功能。在2019年4月至2020年2月期间，我们确定了研究者的四项需求：1）移动健康研究趋势的最新信息，2）移动健康服务，3）与机构监管合规小组的协调，4）移动健康方法（如电子同意书）实施以及与技术供应商建立合作关系的支持。迄今为止，移动健康研究核心已举办了七场研讨会，完成了71次案例咨询，协助了四项与新冠相关的临床研究，就转向远程研究向机构审查委员会提供建议，并广泛传播电子同意书导航工具。尽管疫情前利益相关者和研究者的需求促使了移动健康研究核心的创建，但这一机构资源在疫情期间通过协助研究者迅速转向远程研究方法，在持续开展临床研究中发挥了关键作用。
