Comprehension of Information for Informed Consent among Hemato-Oncology study participants at Ampath, Eldoret, Kenya

Abstract

ackground: The use of informed consent(IC) became a prerequisite for research in response to abuses of human subjects during the last half of the 20th Century, yet participant's comprehension of presented information is rarely explored. Major ethical concerns arise when participants do not comprehend information offered them. It is therefore a fundamental concern for all researchers to ensure that there is good comprehension of informed consent information among participants. Objectives: The study aimed to assess the level of comprehension of information given before consenting for the study, explore the recruiters’ experiences on administering informed consent, and determine the factors that influence comprehension of information for informed consent by AMPATH-Hemato-oncology study participants. Methods: The study employed a descriptive cross sectional design to collect data. The target populations were all the 833 participants (mothers) enrolled for one month in the AMPATH Hemato-Oncology study and six recruiters involved in the drafting of the participants in the study. Systematic random sampling was used to select 201 participants into the study whereas the entire population (census) of the six recruiters was used in the study. Two sets of semi-structured questionnaires were administered to the sample, and data was analyzed using descriptive and non- parametric correlation technique of multiple correspondence analysis (MCA). Results: A total of 201 and 6 questionnaires were administered and the response rate was (93%) and (100%) for the study participants and recruiters, respectively. The mean age of the mothers was 28 years (Std. Dev., 2.24) with majority having secondary (48%) and college (36%) education. The mean comprehension index of IC contents by the mothers was 73.27% (Std. Dev. 28.72%), suggesting a reasonably high ability to understand IC information. There was a low comprehension levels among older mothers (35years or older) and those with primary education. High comprehension was observed in participants who considered the consent form to be of appropriate length (97%) ,written in an easy to understand language (96%) and preferably written in English (88%). Recruiters who had more than one year experience in research used less than 30 minutes in IC process compared to more than an hour for those who had been in research for less than one year. Half of the recruiters were found to have no understanding of the study hence could not properly administer the informed consent, affecting negatively the mothers’ comprehension of consent information. Conclusion: The level of comprehension among the mothers on IC contents was relatively high. Age, education level, language of transmission, length and readability of the consent form as well as recruiter experiences were all found to influence comprehension of IC information. Recommendations: Researchers should ensure that recruiters and respondents adequately comprehend information. Since age, education level, language of transmission, length and readability influence comprehension, knowledge uptake of study participants should be tested before consenting.