Center for Biomedical and Population Health Informatics, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Stud Health Technol Inform. 2022 Jun 6;290:777-781. doi: 10.3233/SHTI220184.
Informed consent process assures that research study participants are properly informed about the study prior to their consent. Due to the increasing significance of electronic informed consent (eIC) platforms, particularly during the COVID-19 pandemic, we conducted a scoping review of eIC systems to address the following characteristics: 1) technological features of current eIC platforms, 2) eIC platforms usability and efficacy, and 3) areas for future eIC research. We performed a literature search using publically available PubMed repository, where we included studies discussing an eIC platform or multimedia educational module given to patients prior to signing a consent form. In addition, we tracked first author, year of publication, sample size, study location, eIC procedure, methodology, and eIC's comparison to paper consent. Our results showed that with a few noted exceptions, electronic consent improves patient usability, satisfaction, knowledge, and trust scores when compared to traditional paper consent.
知情同意过程可确保研究参与者在同意参与研究之前，充分了解研究情况。由于电子知情同意 (eIC) 平台的重要性日益增加，特别是在 COVID-19 大流行期间，我们对 eIC 系统进行了范围性审查，以解决以下特征：1）当前 eIC 平台的技术特征，2）eIC 平台的可用性和功效，以及 3）未来 eIC 研究的领域。我们使用公共可用的 PubMed 存储库进行了文献检索，其中包括讨论电子知情同意平台或多媒体教育模块的研究，这些模块在签署同意书之前提供给患者。此外，我们还跟踪了第一作者、发表年份、样本量、研究地点、eIC 程序、方法学，以及 eIC 与纸质同意书的比较。我们的结果表明，除了一些值得注意的例外，与传统的纸质同意书相比，电子同意书提高了患者的可用性、满意度、知识和信任评分。
