Clinical trials of nanotechnology medical products present complex risk management challenges that involve many uncertainties and important risk-risk trade-offs. This paper inquires whether the precautionary principle can help to inform risk management approaches to nanomedicine clinical trials. It concludes that prudent precaution may be appropriate for ensuring the safety of such trials, but that the precautionary principle itself, especially in its more extreme forms, does not provide useful guidance for specific safety measures.

This essay examines the relationship between the precautionary principle and uncertainty factors used by toxicologists to estimate acceptable exposure levels for toxic chemicals from animal experiments. It shows that the adoption of uncertainty factors in the United States in the 1950s can be understood by reference to the precautionary principle, but not by cost-benefit analysis because of a lack of relevant quantitative data at that time. In addition, it argues that uncertainty factors continue to be relevant to efforts to implement (...) the precautionary principle and that the precautionary principle should not be restricted to cases involving unquantifiable hazards. (shrink)

Tolerance for blood transfusion risks is very low, as evidenced by the implementation of expensive blood tests and the rejection of gay men as blood donors. Is this low risk tolerance supported by the precautionary principle, as defenders of such policies claim? We discuss three constraints on applying the precautionary principle and show that respecting these implies tolerating certain risks. Consistency means that the precautionary principle cannot prescribe precautions that it must simultaneously forbid taking, considering the harms they might cause. (...) Avoiding counterproductivity requires rejecting precautions that cause more harm than they prevent. Proportionality forbids taking precautions that are more harmful than adequate alternatives. When applying these constraints, we argue, attention should not be restricted to harms that are human caused or that affect human health or the environment. Tolerating transfusion risks can be justified if available precautions have serious side effects, such as high social or economic costs. (shrink)

The precautionary principle has been widely discussed in the academic, legal, and policy arenas. This paper argues, however, that there is no single precautionary principle and we should stop referring to ?the? precautionary principle. Instead, we should talk about ?precaution? and ?precautionary approaches? more generally and identify and defend distinct precautionary principles of limited scope. Drawing on the vast literature on ?the? precautionary principle, this paper further argues that the challenges of decision making under conditions of uncertainty necessitate taking a (...) precautionary approach to decision making that will enable us to understand what particular precautionary principles require of us on a case-by-case basis. (shrink)

The Precautionary Principle is a highly influential feature of an extensive body of environmental law, and is also highly controversial and continues to generate scholarly debates along several dim...

According to Bedau and Triant decision-makers will be substantially ignorant about the consequences of their candidate choices when making decisions about synthetic biology. Bedau and Triant charac...

Medical technologies, including nanomedicine products, are intended to improve health but in many cases may also create their own health risks. Medical products that create their own health risks differ from most other risk-creating technologies in that the very purpose of the medical technology is to prevent or treat health risks. This paradox of technologies intended to reduce existing risks that may have the effect of creating new risks has two conflicting implications. On one hand, we may be more tolerant (...) of health risks from medical technologies because these products are intended to, and often do, reduce overall health risks and improve our health. The health benefits of a medical technology may outweigh the unavoidable adverse effects of that same technology in an individual patient or in the overall treated population. (shrink)

The dilemma objection charges that ‘weak’ versions of the precautionary principle (PP) are vacuous while ‘strong’ ones are incoherent. I respond that the ‘weak’ versus ‘strong’ distinction is misleading and should be replaced with a contrast between PP as a meta-rule and PP proper. Meta versions of PP require that the decision-making procedures used for environmental policy not be susceptible to paralysis by scientific uncertainty. Such claims are substantive because they often recommend against basing environmental policy decisions on cost–benefit analysis. (...) I argue that the second horn of the dilemma fails as a result of disregarding the role of proportionality in applications of PP. (shrink)

Introduction The bioethics literature reflects significant interest in and concern with the use of genetic and genomic information in various settings. Because psychiatric treatment and research raises unique ethical, legal, and social issues, we conducted a scoping review of the biomedical, bioethics, and psychology literature regarding the application of genetic and genomic tools to psychiatric disorders (as listed in the DSM-5) and two associated behaviors or symptoms to provide a more detailed overview of the state of the field. Objectives The (...) primary objective was to examine the available bioethics, biomedical, and psychology literature on applying genetic and genomic tools to psychiatric disorders (other than neurodevelopmental disorders) and two behaviors or symptoms sometimes associated with them (aggression or violence and suicidality) to identify the disorders to which these tools have been applied, the contexts in or purposes for which they have been applied, the ethical, legal, or social concerns associated with those uses, and proposed recommendations for mitigating those concerns. Methods We used Arksey and O’Malley’s scoping review framework: (1) identify the research question; (2) identify relevant studies; (3) select studies; (4) chart the data; and (5) collate, summarize, and report results (2005). We relied on Levac et al. to inform our application of the framework (2010). The PRISMA extension for scoping reviews checklist informed our reporting (2018). We searched three electronic databases MEDLINE (PubMed), Embase, and PsycInfo (EbscoHost) for peer-reviewed journal articles in English to identify relevant literature. One author screened the initial results and additional screening was done in consultation with other authors. A data extraction form using DSM-5 diagnostic categories (excluding neurodevelopmental disorders) was developed and two authors independently each reviewed approximately half of the articles. Inter-rater reliability was ensured by double-coding approximately 10% of the papers. An additional author independently coded 10% of the articles to audit the data. Results In 365 coded publications, we identified 15 DSM-5 diagnostic categories in addition to the two pre-selected behaviors or symptoms (aggression or violence and suicidality) to which genetic or genomic tools have been applied. We identified 11 settings in or purposes for which these tools were applied. Twenty-two types of ethical, legal, or social concerns associated with the application of genetic or genomic tools to these disorders or behaviors/symptoms were identified along with 13 practices or policies that could mitigate these concerns. Conclusion Genetic and genomic tools have been applied to a wide range of psychiatric disorders. These raise a range of ethical, legal, and social concerns. Additional research is warranted to better understand the concerns and effective ways to address them. Advancing the literature to identify relevant ethical, legal, or social concerns and solutions to those problems likely requires greater attention to specific applications of genetic or genomic tools to particular psychiatric disorders and associated behaviors/symptoms as well as broad stakeholder engagement. (shrink)

The precautionary principle is often invoked in relation to pregnant women and may be one of the underlying reasons for their continuous underrepresentation in clinical research. The principle is appealing, because potential fetal harm as a result of research participation is considered to be serious and irreversible. In our paper, we explore through conceptual analysis whether and if so how the precautionary principle should apply to pregnant women. We argue that the principle is a decision-making strategy underlying risk-benefit decisions in (...) clinical research, which can be applied to pregnant women. However, the current application is a strong one, leading to the promotion of absolute exclusion or, less often, absolute inclusion of pregnant women. In order to change this paralyzing situation, a shift toward weak precautionary thinking is necessary. Instead of automatic extreme precaution, a balance will be found between harms and potential benefits of including pregnant women in clinical research. (shrink)

The breadth of themes addressed in this issue of the Journal of Medicine and Philosophy is striking. These articles brim with some of the most foundational questions one can ask in bioethics and the philosophy of medicine: Under what circumstances might we risk some harm in pursuit of a greater good? In the setting of experimental therapies, how should we weigh the potential risk and benefit for an individual patient against the broader potential benefit realized for society as a whole? (...) How might we consistently differentiate health from pathology? Under what circumstances might we say that a human being has died? Does acknowledging particular things as good generate duties? Duties for whom and enforced by whom? These articles share a preoccupation with foundational questions that must be addressed in any sound bioethics curriculum, and they make clear that our answers to these questions are not simply theoretical but manifest in policy and in practice. (shrink)