Comprehension of Information for Informed Consent Among Hemato-Oncology Study Participants in Eldoret, Kenya

摘要

The use of Informed consent (IC) became a prerequisite for research in response to abuses of human subjects during the last half-century, yet participant's comprehension of presented information is rarely explored. Major ethical concerns arise when information offered is not well comprehended by research participants. It is therefore a fundamental concern for all researchers to ensure that there is good comprehension of informed consent information in biomedical researches hence the current study endeavored to evaluate the comprehension of information for informed consent by Hemato- Oncology study participants. A descriptive cross sectional study design was used where systematic and convenience sampling techniques were used to sample the mothers who had assented to the study and research assistants involved in recruiting (recruiters) respectively. Two sets of semi-structured questionnaires were administered to 201 mothers and 6 recruiters, separately. Data from mothers and recruiters was collected for a period of one month and analyzed using descriptive and non- parametric correlation technique of multiple correspondence analysis (MCA). The response rate was 187 (93%) and 6 (100%) for the mothers and research assistants respectively. The mean age of the mothers was 28 ± 2.24 years with most having either secondary 89 (48%) or college education 67 (36%). Their preferred language of communication was English 165 (88%) or Kiswahili 22 (12%). The mean comprehension index of IC contents by the mothers was 73.27% (Std. Dev: 28.72%). Recruiters who had more than one year experience in research used ≥ 30 min in IC process compared to ≥ 1 hour for those who had been in research for less than one year. Low comprehension levels were found among older mothers (≥ 35 years) and those with primary education, however, comprehension was higher in participants who considered the consent form to be of appropriate length 181 (97), written in an easy to understand language 173 (96) and preferably written in English 165 (88%). The level of comprehension among the mothers on IC contents was relatively high with a few recording low comprehension. 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.