Maxwell Smith

In democratic theory, “legitimacy” refers to the set of conditions that must be in place in order for the claims to authority of somebody to be deemed appropriate, and for their claims to compliance to be warranted. Though criteria of legitimacy have been elaborated in the context of democratic states, there is no reason for them not to be drawn up, with appropriate amendments, for other kinds of authority structures. This paper examines the claims to authority made over researchers by international bodies governing research ethics, who exercise their authority by the research ethics guidelines they produce (including recent revisions to the Declaration of Helsinki and CIOMS Guidelines). We argue that discussions of such bodies and sets of guidelines often elide questions of justification and questions of legitimacy, and that the grounds that might allow us to mount a strong case for the latter are at present sorely underdeveloped.

Drug regulatory bodies aim to ensure that patients have access to safe and effective drugs; however, no matter the quality of pre-licensure studies, uncertainty will remain regarding the safety and effectiveness of newly approved drugs until a large and diverse population uses those drugs. Recent analyses of Canada’s post-market drug surveillance system have found that Canada is not keeping pace with international requirements for PMDS, and have noted that efforts must be improved to monitor and address the safety and effectiveness of approved drugs among vulnerable populations. Given the uncertainty that exists when drugs enter the market, some have suggested that the precautionary principle is relevant to guiding decision-making in this context. This paper responds to recommendations that the Canadian PMDS system should be responsive to the health needs of vulnerable populations by assessing the utility of deploying the precautionary principle to guide a post-market strategy for vulnerable populations.

Accelerated changes to the planet have created novel spaces to re-imagine the boundaries and foci of environmental health research. Climate change, mass species extinction, ocean acidification, biogeochemical disturbance, and other emergent environmental issues have precipitated new population health perspectives, including, but not limited to, one health, ecohealth, and planetary health. These perspectives, while nuanced, all attempt to reconcile broad global challenges with localized health impacts by attending to the reciprocal relationships between the health of ecosystems, animals, and humans. While such innovation is to be encouraged, we argue that a more comprehensive engagement with the ethics of these emerging fields of inquiry will add value in terms of the significance and impact of associated interventions. In this contribution, we highlight how the concept of spatial and temporal scale can be usefully deployed to shed light on a variety of ethical issues common to emerging environmental health perspectives, and that the potential of scalar analysis implicit to van Potter’s conceptualization of bioethics has yet to be fully appreciated. Specifically, we identify how scale interacts with key ethical issues that require consideration and clarification by one health, ecohealth, and planetary health researchers and practitioners to enhance the effectiveness of research and practice, including justice and governance.