article · Journal of Empirical Research on Human Research Ethics
Variability and inadequacies in the contents of informed consent documents (ICDs) affect the quality of the informed consent (IC) process. This study assessed the content and readability of the 241 ICDs approved for biomedical research in South-East Nigeria from 2019 to 2021. The presence of basic elements for IC in the revised Common Rule and National Code was assessed, and the Flesh readability scores measured. Only 2 (0.8%) of the ICDs had all basic elements required by the Common Rule. Most ICDs fall below recommended readability indices. To improve the quality of the IC process, HRECs are to ensure that, while upholding research validity and credibility, ICDs are easy-to-read yet contain the basic information needed for decision-making by participants.
This page summarises published work. The authoritative version sits with the publisher.
DOI: 10.1177/15562646251350200
Is something wrong with this record? Report it or request removal.
Discussion
Have you built on this work, tried to replicate it, or seen it applied in practice? Share what you know. Verified researchers and MARATTO™ domain experts can open a discussion, and any member can reply. Contributions are reviewed before they appear.
No discussion yet. Open the first thread.
New to MARATTO™? Create a free account.
