Centre of Oral & Maxillofacial Diagnostics and Medicine Studies, Faculty of Dentistry, Universiti Teknologi MARA, Sungai Buloh Campus, 47000, Sungai Buloh, Selangor, Malaysia.
Institute of Pathology, Laboratory and Forensic Medicine (I-PPerForM), Universiti Teknologi MARA, Sungai Buloh Campus, Jalan Hospital, 47000, Sungai Buloh, Selangor, Malaysia.
BMC Med Ethics. 2022 Nov 21;23(1):117. doi: 10.1186/s12910-022-00849-x.
The research shows a growing trend in using an electronic platform to supplement or replace traditional paper-based informed consent processes. Instead of the traditionally written informed consent document, electronic informed consent (eConsent) may be used to assess the research subject's comprehension of the information presented. By doing so, respect for persons as one of the research ethical principles can be upheld. Furthermore, these electronic methods may reduce potential airborne infection exposures, particularly during the pandemic, thereby adhering to the beneficence and nonmaleficence principle. This scoping review aims to identify the ethics related criteria that have been included in electronic informed consent processes and to synthesize and map these criteria to research ethics principles, in order to identify the gaps, if any, in current electronic informed consent processes.
The search was performed based on internet search and three main databases: PubMed, SCOPUS and EBSCO. PRISMA Extension for Scoping Reviews (PRISMA-ScR): Checklist and Explanation guideline was used to report this work.
Of 34 studies that met the inclusion criteria, 242 essential original constructs were collated, and 7 concepts were derived. Digital content showed the highest percentage of collated original constructs (27%, n = 65) followed by accessibility (24%, n = 56), comprehension engagement (18%, n = 43), autonomy (14%, n = 34), confidentiality (11%, n = 25), language (5%, n = 13), and parental consent (1%, n = 2). Twenty-five new items were synthesized for eConsent criteria which may provide guidance for ethical review of research involving eConsent.
The current study adds significant value to the corpus of knowledge in research ethics by providing ethical criteria on electronic informed consent based on evidence-based data. The new synthesized items in the criteria can be readily used as an initial guide by the IRB/REC members during a review process on electronic informed consent and useful to the future preparation of a checklist.
研究表明，使用电子平台来补充或替代传统纸质知情同意流程的趋势日益增长。电子知情同意（eConsent）可用于评估研究对象对所提供信息的理解，而不是采用传统的书面知情同意文件。这样做可以维护尊重人的研究伦理原则之一。此外，这些电子方法可以减少潜在的空气传播感染暴露，特别是在大流行期间，从而遵守有利和不伤害原则。本范围综述旨在确定已纳入电子知情同意流程的与伦理学相关的标准，并将这些标准综合并映射到研究伦理原则，以确定当前电子知情同意流程中是否存在任何空白。
根据互联网搜索和三个主要数据库（PubMed、SCOPUS 和 EBSCO）进行了搜索。采用 PRISMA 扩展范围综述（PRISMA-ScR）：清单和解释指南来报告这项工作。
符合纳入标准的 34 项研究中，共整理了 242 个基本原始构建，并得出了 7 个概念。数字内容显示，整理的原始构建比例最高（27%，n=65），其次是可访问性（24%，n=56）、理解参与度（18%，n=43）、自主权（14%，n=34）、保密性（11%，n=25）、语言（5%，n=13）和父母同意（1%，n=2）。综合了 25 项新的 eConsent 标准项目，可为涉及 eConsent 的研究的伦理审查提供指导。
本研究通过基于循证数据提供电子知情同意的伦理标准，为研究伦理学知识库增添了重要价值。标准中的新综合项目可以作为 IRB/REC 成员在电子知情同意审查过程中的初步指南，并为未来制定清单提供有用的参考。
