Ethical decision-making is inherent to the research ethics committee deliberation process. While ethical codes, regulations, and research standards are indispensable in guiding this process,...

Launch of clinical investigation represents a substantial escalation in commitment to a particular clinical translation trajectory; it also exposes human subjects to poorly understood interventions. Despite these high stakes, there is little to guide decision-makers on the scientific and ethical evaluation of early phase trials. In this article, we review policies and consensus statements on human protections, drug regulation, and research design surrounding trial launch, and conclude that decision-making is largely left to the discretion of research teams and sponsors. We (...) then review what is currently understood about how research teams exercise this discretion, and close by laying out a research agenda for characterizing the way investigators, sponsors, and reviewers approach decision-making in early phase research. (shrink)

This study aims to characterise Human Research Ethics Committee (HREC) members’ perceptions on five main themes associated with ethics reviews, namely, the nature of research, ethical/moral issues, assent, participants’ risk and HREC prerogatives issues. Three hundred and sixteen HREC members from over 200 HRECs throughout Australia responded to an online questionnaire survey. The results show that in general, HREC members’ beliefs are reasoned and align with sound principles of ethical reviews. There seems to be a disposition for living up to (...) ethical/moral values, avoiding the issue of consent waivers and respecting participants’ welfare, as well as a sense of ambiguity about HREC prerogatives. Problematic areas were a tendency towards over-valuing quantitative research methods for their perceived validity and a neutral view on issuing consent waivers to participants with intellectual disability and, finally, the belief that research that limits disclosure, plans deception or actively conceals is morally unjustifiable. Implications for professional development and policy-making are discussed. (shrink)