First-in-Human Trial Participants: Not a Vulnerable Population, but Vulnerable Nonetheless

The 21st-century translational science campaign could lead to an increase in first-in-human (FIH) trials. As tests of investigational interventions move from the laboratory to human research, scientists, officials, and review committees should address ongoing concerns about the ethics of FIH trials. In this article, I describe three ethical considerations relevant to all FIH trials: (1) the requirement for adequate preclinical research; (2) study design safeguards; and (3) choice of subject population. I also examine specific ethical considerations relevant to the three subject populations (healthy volunteers, seriously ill patients lacking standard treatment options, and stable patients) involved in FIH research. I recommend a variety of actions that could increase subject protection and the value of the information generated in FIH trials.     

Ethics of Population-Based Research

This paper considers the morally relevant ways in which population-based research is a distinct type of human subjects research that have unique moral considerations relevant for public health practitioners and researchers. By defining population-based research, the authors distinguish it from public health practice and then consider, in more detail, the ways in which population-based research differs from clinical human subjects research. Based upon the distinctions between these types of research and practice, they identify five important issues that arise in the design and conduct of certain kinds of population-based research. The authors hope that public health practitioners find these distinctions useful in determining when their work may actually be population-based research and that public health researchers use them to identify the areas where ethical issues in their research may arise.     

The Moral Distinction Between Combatants and Noncombatants: Vulnerable and Defenceless

In Sparing Civilians, Seth Lazar claims that in war, with rare exceptions, killing noncombatants is worse than killing combatants. This paper raises some doubts about whether this is an important principle – at least, once we understand Lazar’s clarifications. It also suggests that however it is clarified, it seems false. And it suggests a related principle that more plausible. This related principle applies only to those with just aims, and it applies only to intentional killing rather than to all forms of killing.     

Population Genomics and Research Ethics with Socially Identifable Groups

In this paper, the author questions whether the research ethics guidelines and procedures are robust enough to protect groups when conducting genetics research with socially identifiable populations, particularly with Native American groups. The author argues for a change in the federal guidelines in substance and procedures of conducting genetic research with socially identifiable groups.     

Radicalization in Adolescence: the Identification of Vulnerable Groups

European Journal on Criminal Policy and Research - Given that the normative search for identity and belonging, as well as political socialization, plays an important role during adolescence, this...