Assessing comprehension of informed consent among research participants enrolled in a malaria prevention study at Masafu Hospital, Busia District

Abstract

Introduction: Comprehension of informed consent by research participants is a fundamental pillar of the informed consent process. Participants quite often have low comprehension of medical procedures, risks and complications. An incomplete understanding of key issues of informed consent is a problem exacerbated by language barriers and lack of familiarity with research concepts. These often compromise the aspect of meaningful informed consent. Objectives: The study aimed at assessing comprehension of informed consent among research participants enrolled in a malaria prevention study at Masafu Hospital, Busia District. Methods: This was a cross-sectional study with mixed methods of data collection. A survey was conducted among 372 HIV uninfected pregnant mothers enrolled in the Birth cohort 3 malaria study. The study was conducted at the Infectious Diseases Research Collaboration (IDRC) research clinic in Masafu Hospital, Busia District where the Modular Informed Consent Comprehension Assessment (MICCA) questionnaire was administered to participants. A total of 7 Key informant interviews (KIIs) were conducted with 2 members of the Institutional Review Boards, 3 members of the Community Advisory Board and 2 researchers. A total of 3 focus group discussions (FGDs) were conducted with pregnant and post-partum women who had participated in the Birth Cohort 3 study to explore individual, institutional and community factors that influenced comprehension of informed consent. The comprehension level of participants was expressed as a proportion. Logistic regression analysis was performed to determine the association between the comprehension level of participants and independent variables. Results: The key finding for this study is that comprehension of informed consent was low among participants in a malaria prevention study at the Masafu Hospital, Busia district. Comprehension of informed consent was influenced by individual, community, and institutional factors. Significant factors such as the socioeconomic status of the participants, age, previous participation in research, and the language of the consent document. Conclusion: This study found that comprehension of informed consent among the research participants was low. The Institutional framework, process of obtaining informed consent and time allocated to the consent process are major determinants of comprehension that need to be revisited and modified.