Abstract:
Background:. Several studies on informed consent in health research have been
conducted, but few have focused on the three levels of obtaining informed consent on
a Health Demographic and Surveillance System research, namely consenting the
Community, Household, and Individual. Before consenting an individual participant
in a Health Demographic Surveillance System, the researcher must obtain consent
from two higher levels: The goal of this study was to describe how these three levels
of consent, along with various socio-cultural factors, influenced the process of
obtaining voluntary informed consent on the Kombewa Health Demographic
Surveillance System. The study also looked into the difficulties that the researchers
faced. on the Health Demographic Surveillance System and how they used best
practices to solve presenting challenges to the consenting process.
Objectives: The study addressed three specific objectives. (i) To describe the process
of obtaining informed consent on Kombewa Health Demographic Surveillance
System in Western Kenya. (2) To establish socio-cultural factors that influenced the
ethical practice of obtaining informed consent on the Kombewa Health Demographic
Surveillance System. (3) To explain the challenges and best practices of obtaining
informed consent on the Kombewa Health Demographic Surveillance System.
Method: A cross-sectional study, utilizing mixed methods. Simple random sampling
was used to select 384 research participants for the questionnaire. In addition,
purposive sampling was applied to enlist 12 researchers for key informant interviews.
The analysis was done to evaluate consenting and its relationship with socio-cultural
factors, with a focus on intrapersonal factors like gender influence, interpersonal
factors like household head influence, and community factors like community gate
keepers influence. In addition, thematic content analysis was applied to analyse
qualitative data.
Results: The three levels of consenting in the Health Demographic Surveillance
System influenced the process of obtaining informed consent. Furthermore, the study
discovered that researchers on the Health Demographic Surveillance System faced a
variety of sociocultural challenges, such as reliance on authority, the influence of
household heads, and individual and community expectations to consent to participate
in research. Despite the difficulties participants faced and the monotony of re-
consenting, researchers made every effort to overcome them. These best practices are
presented as lessons for future health researchers to learn from, as well as solutions to
challenges. Researchers overcame the challenges by using strategies to obtain
voluntary informed consent on the Kombewa Health Demographic Surveillance
System, which other health researchers should follow.
Conclusion: The Health Demographic Surveillance System consenting process
occurred at three levels, with consent from the top two levels, community and
household, influencing individual consenting autonomy.
Recommendation: Health researchers should strive to protect individual autonomy in
the Health Demographic Surveillance System by obtaining individual informed
consent.