In November 2016, the Council for International Organizations of Medical Sciences published its revised International Ethical Guidelines for Health-related Research Involving Humans. In relation to earlier versions, the scope of the new guidelines has been expanded to include public-health research. While successful to some extent, the document does not take into sufficient account the differences between public-health research and other types of health research. It is silent on some issues of importance to public-health research, such as its definition, health inequities (...) and novel research methodologies. Its treatment of some other issues, including the need for researchethics committee approval, consent, community involvement and dissemination of research results, are deficient in some respects. The guidelines that are particularly applicable to and useful for public-health research deal with social value, the health needs of communities and populations, community engagement, disasters and disease outbreaks, cluster randomised trials and data sharing. Much further development of the foundations and applications of public-health research ethics is needed to inform future revisions of the guidelines and of other international and national research-ethics documents. (shrink)

The unknown nature of tomorrow’s research makes informed consent in biobank research a challenge. Whether the consent given by biobank participants is ‘broad’ or ‘narrow’, the ever present question remains the same: are new activities covered by the original consent? In this article, we focus on the meaning of, and the relation between, broad consent and re-consent in biobank research. We argue that broad consent should be understood as consenting to a framework—a framework which covers aims, core conditions for acceptable (...) use, governance and how these affect participants. Changes that alter the framework in a fundamental way call for re-consent. Three biobank cases of current international interest are used to debate when re-consent is an ethical necessity: whole-genome sequencing, data sharing and commercial utilization. These reflections give us a more nuanced view on what consent is for. We claim that the introduction of broad consents in biobank research has not represented a betrayal of individual participant interests, as some critics have asserted. Broad consents combined with the possible use of re-consent are in certain settings not inferior, but rather ethically superior to narrow consents. In population-based research biobanks, they allow for a reconciliation between individual interest and public matters in society at large. (shrink)

This article sketches how liberal principles can be coherently set alongside the stewardship responsibilities of regulators. It indicates how this bears on the legitimacy of public health interventions in general and interventions of the kind associated with New York City’s public health programme in particular. The key idea is that stewardship responsibilities relate to the essential infrastructural conditions for human well-being; these conditions need to be protected because they are the staging for all human activity. Liberal principles, by contrast, presuppose (...) that the basic conditions for human well-being are in place; and, given this presupposition, they present a view about how humans should live, about how they should interact and transact and about how they should flourish. Where regulators are guided by a liberal ethic, they act illegitimately if they try to dictate how individuals should lead their lives; but, acting under their stewardship jurisdiction, regulators may legitimately intervene if they are trying to protect the conditions that are essential for any kind of human life. The article concludes by suggesting that while it is a good thing that New York City’s policies provoke debate about the legitimacy of public health interventions, it is the infrastructural conditions, and not the superstructural activities, that are the regulatory priority. (shrink)

According to Stephen Holland, the challenges I mention in my original paper can be met, so that, in a way, the problem of paternalism in public health care—which I intended to put into perspective by drawing out some possible justifications for it—returns in all its might and glory. But of course, as Holland observes, I never suggested that my challenges could never be met. I only wanted to point out that for each and every particular public health policy that should (...) come to our attention we should reflect upon these challenges and see whether they could provide reasons for justification. I believe that the discussion is often stalled because these measures—in the absence of individual consent and in their aim to benefit the public's ‘best interests’—seem to be paternalist by default. In my paper, I wanted to call this assumption into question, but never intended to prove that there is no such thing as unjustified paternalism in public health care. Nevertheless, Holland's criticism is very insightful and he has done a lot to clarify my position. However, he also puts me on the spot by urging me to argue to what extent I can meet his rebuttal, and I am very grateful for that opportunity. (shrink)

The current scandal surrounds the global breast implant scare of silicone implants made by France's Poly Implant Prothese (PIP) Company. An ensuing review recognized that efforts in investigating the distress caused to so many women were hampered by a lack of reliable and comprehensive information about all the adverse incidents relating to PIP breast implants, as well as uncertainty about comparative data on similar products. One of the recommendations following the review was the investigation of the potential for re-establishing a (...) breast implant registry, which could facilitate the availability of adverse incident reporting in cases such as these. The insistence of compulsory inclusion in such registries would override the debate on informed consent in epidemiological studies and public health. The ethics of clinical research with its focus on individual consent is difficult to reconcile with the ethical requirements of research at a population level as in the case of registries. (shrink)