Commentary

Views of neonatologists and parents on consent for clinical trials

Trust is an important theme running through the literature on the ethics of biomedical research, but it is rarely given centre stage. In this paper, we present data gathered from a study aimed at exploring community views regarding the informed consent processes carried out by a large research centre on the Kenyan Coast. The findings point to the centrality of trust and elements of mistrust in general community views, in parents’ (mis)understanding of studies they consent their children to be involved in, in refusals and concerns, and in community members’ views about whether informed consent is a relevant and practical model to follow. Tentative ideas on how trust and a healthy mistrust might be balanced highlight the importance of strengthening communication surrounding basic health care as well as research, and of fostering ‘an inner generated ethic of service’. The latter is particularly fundamental, but cannot be built and regulated through the laws, policies and guidelines that currently govern biomedical research practice.

The recent publication of guidelines for ethical decision making for resuscitation of infants has highlighted the problems inherent in using the currently available data to define those situations in which resuscitation should be or might be withheld or withdrawn. Prior selection criteria for resuscitation, criteria for inclusion into the study group, incomplete resuscitation, gestational age determination, intrauterine growth restriction, subjective assessment of ‘poor’ outcome, and other factors make setting specific parameters for acting or not acting difficult, if not dangerous, and possibly impossible. Research in neonatal resuscitation poses some potential ethical obstacles, but national and international regulations and guidelines are available to assist investigators in study design.