An audit of the informed consent process in postgraduate dissertation studies at the College of Health Sciences, University of Nairobi, Kenya

Abstract

Background. Informed consent ensures respect for individual autonomy and safeguards against abuses of human participants. However, the high prevalence of poverty, inaccessibility of healthcare services, diseases, social insecurity and low literacy in developing countries such as Kenya increases participants’ vulnerability to research exploitation and abuse. Biomedical and behavioural studies conducted on the vulnerable population in Kenya raise concerns about voluntary participation.

Objective. The purpose of this study was to assess the process of obtaining informed consent by postgraduate students in the College of Health Sciences at the University of Nairobi, Kenya.

Method. The study was observational, descriptive and quantitative. A convenience sample of 20 postgraduate students at the data collection stage was selected to participate in the study. Each student was observed during four episodes of administering informed consent, totalling 80 episodes of observed student-subject interaction. Data were collected for a period of 6 weeks by means of an observation checklist and analysed using the SPSS version 14 computer package. Descriptive statistics were used to answer the research questions.

Results. The main finding was that performance scores were better on the items that had a positive influence on patient participation than on those that would negatively influence patient participation.

Conclusions. The consent form was mainly used for the students’ legal protection and not for the patients’ benefit.

Recommendation. A further study on a large sample drawn from all the schools of the college is needed to confirm the practice of obtaining informed consent and compare performance in all the schools.