薬理と治療

Abstract

Background　Face‒to‒face explanation and paper‒based consent acquisition protocol commonly used for obtaining informed consent may increase the risk of infection spread between the participants and the investigators of coronavirus disease（COVID‒19）‒related studies. We examined the use of electronic informed consent（e‒Consent）, obtained through REDCap, an electronic data capture（EDC）system developed by Vanderbilt University, as an alternative. Methods　We utilized the REDCap e‒Consent framework as an alternative to face‒to‒face method for obtaining informed consent in an observational pilot study. We collected requests, inquiries and issues from the pre‒construction to production phase, determined if they are major or minor problems, and analyzed the solutions. We set to judge for the feasibility using EDC like Redcap, if there were no adverse major or minor problems and all participants can complete informed consent with the e‒Consent. Results　Between August and November 2020, a total of 26 participants completed the informed consent from the two centers using REDCap. Since no adverse problems were encountered during e‒consent acquisition, participant enrollment, or data collection, the feasibility was confirmed. Conclusions　Non‒face‒to‒face informed consent can be obtained from study participants using an e‒Consent like REDCap for a single site or a small multicenter study. In cases of a large multisite clinical study, either the site settings should be managed by an organization such as a data center or an alternate method should be used till the usage of e‒Consent is upgraded due to system updates. （Jpn Pharmacol Ther 2022；50 suppl 2：s154‒65）