72 - Content Analysis of Informed Consent Documents Approved for Research by the Research Ethics Committees of Health Institutions in South-East Nigeria

Background: Informed consent (IC) is a sine qua non for ethical conduct of research. Variability and inadequacies in the contents of informed consent documents (ICDs) affect the quality of the informed consent process and can undermine the autonomous choice and rights of the research participants. There is limited data on the content, readability and conformation to requirements of the ICDs approved for biomedical research in South-East Nigeria.

Methods: All ICDs in the protocols approved for research in the four tertiary health institutions in Southeast Nigeria registered and recognized by the National Health Research Ethics Committee (NHREC) to legally conduct research-oversight from 2019 to 2021 were analyzed for readability and conformation to contents of basic elements recommended in the revised Common Rule and the National Code of Health Research Ethics (NCHRE). Information on the presence of basic elements for IC documentation was obtained using a checklist. The Flesh readability assessment calculator in Microsoft Word was used to measure readability of the ICDs. Data was presented in frequencies and proportions.

Results: A total of 671 ICDs were analyzed in the 1031protocols approved for research in the institutions. Most ICDs mentioned confidentiality (94.3%) and voluntary participation (93.9%). Ten ICDs did not contain any of the basic elements. Over 50% of the ICDs failed to meet the NCHRE content requirements. A total of 21(3.1%) and 18(2.7%) of the ICDs had readable standard FRE and FKGL at 8th grade or lower respectively.

Limitations: Although it is advocated that to ensure comprehensibility, ICDs are produced in any language (in English and local language of the participants), this study measured the readability of ICDs written only in English language. The use of Microsoft Word Readability in the analysis is primarily for convenience. Other readability tools may have addressed the complexity of medical terminologies and provided more reliable readability indices.

Discussion: Contents of ICDs used in biomedical research from NHREC-approved institutions in the Southeast Nigeria from 2019 to 2021 needed to be adequate. With lower FRE and higher FKGL readability scores, these ICDs fall short of the recommended readability standards set by international and local regulatory bodies. Researchers and REC members should develop templates with specific guidelines aimed at standardizing consent documents to produce comprehensive, reliable documents that are easy to read and yet uphold the validity and credibility of research.