Developing and Implementing Electronic Consent Procedures in Response to Covid-19 Restrictions.
Developing and Implementing Electronic Consent Procedures in Response to Covid-19 Restrictions.
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DOI：
10.1002/eahr.500135
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发表时间：
2022-07-01
影响因子：
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通讯作者：
Mello, Michael J
中科院分区：
文献类型：
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作者：
Bromberg, Julie R;Nimaja, Evelyn;Mello, Michael J
新冠肺炎疫情导致美国和其他地方的许多公共、私人和工作场所活动受到前所未有的限制。当实施限制时，我们正在10个儿科创伤中心进行III型混合有效性-实施试验。为了应对几项基于大流行的限制，我们不得不制定程序，在限制非临床、面对面互动的同时，与潜在的研究参与者接触。这份手稿描述了在多点创伤中心的研究中获得电子知情同意和同意的程序和挑战。我们开发、测试和培训了工作人员，以实现获得知情同意的三种选择。在使用同意选项的前六个月，有25名参与者参加了有效性-实施多点试验，其中11人使用混合同意程序或电子同意程序进行登记。我们确定的涉及电子同意程序的挑战包括对谁将完成电子同意程序的困惑，以及与家人重新联系的困难。吸取的经验教训可以加强电子同意和今后研究的批准程序。需要进行更多的研究，以进一步加强这一进程并提高其利用率。
The Covid-19 pandemic resulted in unprecedented restrictions on many public, private, and workplace activities throughout the United States and elsewhere. When restrictions were imposed, we were conducting a type III hybrid effectiveness-implementation trial in 10 pediatric trauma centers. In response to several pandemic-based restrictions, we had to develop procedures for engaging with potential research participants while limiting nonclinical, in-person interactions. This manuscript describes the procedures and challenges of obtaining electronic informed consent and assent in a multisite trauma center-based research study. We developed, tested, and trained staff to implement three options for obtaining informed consent. Twenty-five participants were enrolled in the effectiveness-implementation multisite trial during the first six months of utilization of the consent options, with eleven of these individuals enrolled using hybrid or electronic consent procedures. The challenges we identified involving electronic consent procedures included confusion over who would complete the electronic consent process and difficulties reconnecting with families. Lessons learned can strengthen electronic consent and assent procedures for future studies. More research is needed to further strengthen this process and increase its utilization.