Inmaculada de Melo-Martin

We focus here on high-risk pediatric research with the prospect of direct benefit and point out some aspects that have raised significant debate. In particular, we call attention to disagreements related to two essential aspects of this type of research: (i) determining what constitutes a “prospect of direct benefit” in phase I trials that involve gene transfer technologies and (ii) assessing when in these trials the risk is justified by the anticipated benefit to the participant children. Although much of our discussion is applicable to other types of high-risk pediatric trials, as an example of the dilemma this type of research poses we use pediatric trials that involve gene transfer technologies. We focus on clinical trials for late infantile neuronal ceroid lipofuscinosis (LINCL). Exploring the ethical implications of some of these disagreements might identify resources for determining how best to deal with the ethical concerns at stake in high-risk pediatric research. We thus offer some recommendations for responding to these concerns.

It is argued here that bioethicists might inadvertently be promoting genetic determinism: the idea that genes alone determine human traits and behaviours. Discussions about genetic testing are used to exemplify how they might be doing so. Quite often bioethicists use clinical cases to support particular moral obligations or rights as if these cases were representative of the kind of information we can acquire about human diseases through genetic testing, when they are not. On other occasions, the clinical cases are presented in simplistic ways that portray genetic testing as yielding information more accurate than it actually is. It is concluded that, because of the problematic implications that the ideology of genetic determinism might have for individuals’ wellbeing and for our public policies, bioethicists should be careful to present these issues in ways that do not promote questionable ideas about the causal role of genes in human diseases and behaviours

Recent advances in biotechnologies have led to speculations about enhancing human beings. Many of the moral arguments presented to defend human enhancement technologies have been limited to discussions of their risks and benefits. The author argues that in so far as ethical arguments focus primarily on risks and benefits of human enhancement technologies, these arguments will be insufficient to provide a robust defence of these technologies. This is so because the belief that an assessment of risks and benefits is a sufficient ethical evaluation of these technologies incorrectly presupposes that risk assessments do not involve value judgements. Second, it presupposes a reductionist conception of ethics as merely a risk management instrument. Each of these assumptions separates ethical evaluation from discussion and appraisal of ends and means and thus leaves important—indeed, essential—ethical considerations out of view. Once these problematic assumptions are rejected, it becomes clear that an adequate defence of human enhancement technologies requires more than a simple balance of their risks and benefits.