This article argues that we could improve the design of research protocols by developing an awareness of and a responsiveness to the social contexts of all the actors in the research enterprise, including subjects, investigators, sponsors, and members of the community in which the research will be conducted. ?Social context? refers to the settings in which the actors are situated, including, but not limited to, their social, economic, political, cultural, and technological features. The utility of thinking about social contexts is (...) introduced and exemplified by the presentation of a hypothetical case in which one central issue is limitation of the probability of injury to subjects by selection of individuals who are not expected to live long enough for the known risks of the study to become manifest as harms. Benefits of such considerations may include enhanced subject satisfaction and cooperation, community acceptance, and improved data quality, among other desirable consequences. (shrink)

Non-beneficial paediatric research is vital to improving paediatric healthcare. Nevertheless, it is also ethically controversial. By definition, subjects of such studies are unable to give consent and they are exposed to risks only for the benefit of others, without obtaining any clinical benefits which could compensate those risks. This raises ethical concern that children participating in non-beneficial research are treated instrumentally; that they are reduced to mere instruments for the benefit of science and society. But this would make the research (...) incompatible with the widely endorsed principle of the primacy of the human subject, which stipulates that the interests of the participating individual should prevail over the interests of science and society. This paper deals with this conflict. It analyses solutions to this problem developed in the literature, and shows that they are unsuccessful. Finally, it offers a new idea of how to reconcile the conduct of non-beneficial paediatric research with the PP. The paper argues for a new formula of the PP, and shows that it implies a specific non-comparative definition of the minimal risk threshold. (shrink)

Vulnerability in research is often understood as a diminished ability to protect one's own interests, manifested by a compromised capacity to give informed or voluntary consent. Certain groups of people are thought to be more vulnerable than others and therefore are at risk of being exploited or mistreated in research. Accordingly, the federal regulations call for additional safeguards to protect vulnerable groups.There remains some ambiguity and contradiction, however, regarding what groups are vulnerable in research and why,3 since the available codes (...) of research ethics and regulations describe many groups as vulnerable. When so many groups are considered vulnerable, but no specification is offered as to how they are vulnerable or what particular protections are appropriate, the possibility of meaningful safeguards is diminished. In addition, current concepts of vulnerability are usually applied to whole groups of people, without distinguishing between individuals in a group who might truly have a compromised capacity to protect their own interests from those who do not. (shrink)