A model for obtaining parental informed consent for HIV clinical trials research with pediatric patients

Abstract

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.