All research involving human subjects should be conducted in accordance to the general
ethical principles of autonomy or respect for persons, beneficence and justice. Competent
adults can exercise their autonomy and can choose to take on risk for the sake of others,
therefore are able to protect their own interests while in the pediatric research the ‗best
interests of the child‘ takes precedence over autonomy. In other words giving informed
consent in the pediatric context, is not ‗who decides‟ but „what is the best decision for the
child‟. Due to lack of consensus gold standard to guide researchers and assess the quality of
parental informed consent in Botswana, the practical and ethical challenges posed in
obtaining parental informed consent for child enrolment in pediatric HIV clinical trials were
examined. The study aimed to determine the readability of the consent forms used in
pediatric HIV clinical trials; assess communication methods, practices and perceptions of the
trial staff regarding the informed consent process; assess the extent to which parents recall
and understand the information disclosed to them and their satisfaction with the informed
consent process as well as to identify and describe the reasons for parental approval to child
enrolment into HIV clinical trial studies. The study used a cross-sectional exploratory
descriptive design and applied triangulation methods which included readability analysis of
consent forms; in-depth interviews and two focus group discussions with trial staff who
conduct the informed consent process as well as face-to-face semi-structured interviews
conducted with 151 parents/guardians. Results showed that all the 10 consent forms analyzed
for readability were found to be difficult to read as they were written for higher grade level
than that of most participants. Majority of trial staff were females with relevant qualifications
in various medical disciplines and multiple tasks. Majority of trial staff were of the opinion
that possession of good background knowledge of participants‘ culture; research ethics
regulations, clinical trials research, and pre-assessment of readability of consent forms were
an asset to obtaining valid informed consent. Trial staff were of the opinion that the
information disclosed to the parents was too much and complex for comprehension and valid
decision making. The common method of disclosing information was found to be mainly the
paternalistic type which does not promote autonomy of the parents. The parents who
participated in this study were mostly females, with low education levels, social economic
status and mainly from the rural areas. Bivariate analyses from the parents‘ results showed
that the age, previous experience in research and relationship of parent to the child were
significantly associated with the parents‘ ability to recall disclosed information. Motivation of
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the parent to child enrolment was significantly associated with the numbers of clinic visits,
previous experience in research, being a biological parent and being paid for participation in
the study. Overall, findings seemed to suggest that the main motivation factor for child
enrolment into HIV clinical trials by parents was the illness of the child and accessing health
care for the child rather than altruism. This raises questions about the autonomy,
voluntariness of the parents and the validity of the consent obtained. These findings were
used to develop a model. The study demonstrated the need to develop a standard model
consent form to guide research involving children, the importance of researchers having
knowledge of participants‘ culture and the need for availability of context standard guidelines
and laws to guide researchers conducting research involving children.