Electronic informed consent criteria for research ethics review: a scoping review

• Published in: BMC medical ethics Vol. 23; no. 1; pp. 1 - 117
• Main Authors: Yusof, Mohd Yusmiaidil Putera Mohd, Teo, Chin Hai, Ng, Chirk Jenn
• Format: Journal Article
• Language: English
• Published: London BioMed Central Ltd 21.11.2022; BioMed Central; BMC
• Subjects: Autonomy; Committees; Electronic informed consent; Electronic records; Ethical aspects; Informed consent; Informed consent (Medical law); Institutional review board; Legal documents; Medical ethics; Medical research; Medicine, Experimental; Research ethics; Research ethics committee; Malaysia
• ISSN: 1472-6939; 1472-6939
• 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.