Compliance of undergraduate research informed consent forms with Nigerian National ethical guidelines

Abstract

Informed consent (IC) is a sine qua non for ethical conduct of research. ensuring prospective participants receive adequate, comprehensible information to make voluntary decisions. The Nigerian National Code of Health Research Ethics (NCHRE) mandates that IC forms (ICFs) include specific essential elements in a comprehensible format. This study assessed the adequacy and comprehensibility of ICFs approved by Research Ethics Committees (RECs) for undergraduate research in Southeast Nigeria. A cross-sectional review was conducted on ICFs from research protocols approved between 2019 and 2023. A checklist evaluated compliance with NCHRE requirements, and the Microsoft Word readability calculator measured Flesh readability. Among 430 reviewed ICFs, 71.0%, 68.5%, and 66.2% included information on research risks, study title, and confidentiality, respectively. Only one (0.2%) ICF contained 18 of the 19 NCHRE-recommended elements. Readability was also suboptimal, with just 1.9% of ICFs achieving readable FRE scores and 4.1% meeting the recommended 8th-grade reading level. Significant gaps exist between NCHRE standards and the content of ICFs used in undergraduate research. These deficiencies highlight the need for strengthened ethical oversight, improved researcher training, and institutional support to enhance compliance. Strengthening ethical review processes and fostering awareness among stakeholders will promote a research culture that prioritizes participant rights and well-being.