Ori Lev

Foreword The following guideline emerged from the project DUMFE: Dual Use and Misuse of Research Results (“Dual use und Missbrauch von Forschungsergebnissen”), funded by the German Federal Ministry of Education and Research (BMBF, 01GP2187). In recent years, dual use has become a significant issue in research ethics for numerous reasons, garnering considerable attention not only within the ethical community but also in the broader scientific community and among political and security circles. Among the reasons for this attention are the dissemination of scientific developments with high misuse potential, such as gain-of-function experiments (Imai et al. 2012; Herfst et al. 2012; Imperiale and Casadevall 2018); political factors, including recent shifts in the global security landscape (Nationale Akademie der Wissenschaften Leopoldina (Leopoldina) and Deutsche Forschungsgemeinschaft (DFG) 2024, 9ff.); and heightened awareness of historical misuses of science (De Block and Adriaens, 2013). There is detailed advice on the handling of dual use research of concern provided by the Joint Committee (“Joint Committee on the Handling of Security-Relevant Research”) of the German National Academy of Science Leopoldina and the German Research Foundation (DFG) (2022). The Joint Committee also provides networking and exchange opportunities for Committees for Ethics in Security-Relevant Research (Kommissionen für Ethik sicherheitsrelevanter Forschung), so-called KEFs. Nevertheless, additional information and guidance on handling dual use research of concern is a regular request in particular from scientists, but also a request often heard in forums with policy experts, managers and administrators of institutions in research and education. The present guideline provides such additional in-depth information on the definition, examples, legal as well as ethical issues and options for governance of dual use research. It has been written by ethicists and philosophers of technology, supported by lawyers and members of the commission for ethics in research of Forschungszentrum Jülich. It is intended to provide additional information supporting the design of and deliberation in institutional bodies dealing with ethics of security-relevant research. It aims to highlight decisions and options relevant to different institutions and refers to further sources of information throughout.

This article addresses the question of how the responsibilities for addressing the risks of dual use research ought to be divided. We begin by presenting the maximalist claim that proposes that since scientists are well placed to judge the potential for misuse of their studies, they alone are responsible for addressing these risks. Before assessing this position, we consider a claim that rejects the maximalist position, namely that scientists need not consider the possibility that their studies might be misused because the goods of science are so important, they should not spend time on anything but generating valuable knowledge. This claim, we argue, fails, as these goods do not always outweigh the risks of misuse. Given this conclusion we turn to assess two versions of the maximalist claim. The first suggests that when a possibility of misuse arises, scientists ought to adopt the precautionary principle (PP) to discharge their moral responsibilities. We argue that PP is problematic as it does not give much guidance on what scientists should do. An alternative to meeting scientists’ moral responsibilities is through applying a risk-benefit analysis; however, due to epistemic biases and limitations, scientists are prone to make mistakes in their analysis. We thus suggest an alternative approach, in which responsibilities are divided between scientists and agents that can conduct an analysis that is more likely to generate unbiased and comprehensive conclusions on how the risks of dual use research, should be addressed.

The standard account of informed consent has recently met serious criticism, focused on the mismatch between its implications and widespread intuitions about the permissibility of conducting research and providing treatment under conditions of partial knowledge. Unlike other critics of the standard account, we suggest an account of the relations between autonomy, ignorance, and valid consent that avoids these implausible implications while maintaining the standard core idea, namely, that the primary purpose of the disclosure requirement of informed consent is to prevent autonomy-undermining ignorance. The problem with the standard account, we argue, is that it fails to distinguish between different forms of ignorance–in particular, error and suspending ignorance–that have very different effects on individuals’ ability to provide valid consent. While error often undermines our ability to provide valid consent, suspending ignorance, we argue, does not. Once the moral weight of this distinction is appreciated, it becomes apparent that valid informed consent requires far less knowledge than suggested by the standard account.

In a recent article, Steel, Buchak and Eyal (SBE) argue that current levels of uncertainty do not present a good reason to bar controlled human infection (CHI) trials of COVID-19 vaccines from proceeding. We argue that their argumentation for this conclusion is flawed. SBE are mistaken about the effects which different forms of ignorance have on participants’ ability to provide valid informed consent. Decision-makers considering whether to allow such trials, we argue, must ultimately consider the likelihood that consent to participation in such trials under current conditions would be valid, and whether this likelihood is high enough to permit such trials. This is a question that SBE completely ignore. We conclude that there indeed are valid concerns about conducting CHI trials given the current state of knowledge about COVID-19, concerns which SBE fail to address.

Prominent thinkers such as Jurgen Habermas and Michael Sandel are warning that biomedical enhancements will undermine fundamental political values. Yet whether biomedical enhancements will undermine such values depends on how biomedical enhancements will function, how they will be administered and to whom. Since only few enhancements are obtainable, it is difficult to tell whether these predictions are sound. Nevertheless, such warnings are extremely valuable. As a society we must, at the very least, be aware of developments that could have harmful consequences. Indeed, if important values were to be jeopardized, we should take appropriate measures to protect them. This paper focuses on four central values: solidarity, personal responsibility, equality and autonomy. It delineates the conditions under which biomedical enhancements would undermine these values. It also details the circumstances under which these values would be unaffected by enhancements as well as those under which they would be promoted. Specifying these conditions is valuable; it would enable society to prepare appropriate ethical guidelines and policy responses in advance

Traditionally, biomedical research has been devoted to improvement in the understanding and treatment or prevention of disease. Building on the knowledge generated by the long history of disease-oriented research, the next few decades will witness an explosion of biomedical enhancements to make people faster, stronger, smarter, less forgetful, happier, prettier, and live longer (Turner et al. 2003; Vastag 2004; Rose 2002). As with other biomedical interventions, research to assess the safety and efficacy of these enhancements in humans should be conducted before their introduction into clinical practice.1 However, various concerns regarding the ethics of enhancement research could be raised. Those who ..

There is an ongoing debate over the ethical permissibility of using biomedical enhancement interventions. This debate has generated a variety of concerns; one worry that stands out in this regard is the question of coercion. Curiously, although pointed out by many, this concern has not received close scrutiny. The aim of this paper is to begin addressing this conceptual gap. In order to explore this concern, I employ Alan Wertheimer’s understanding of coercion. According to Wertheimer’s account coercion involves a wrongful threat in which one has little choice but to succumb. Moreover, the wrongfulness of the threat stems from the fact that it violates the coercee’s rights. I suggest that if one accepts this account, it follows that coercing people to enhance would be impermissible. Using this framework, the paper assesses the claim that competition over jobs, goods, and positions coerces people to enhance. I argue, however, that competition pursued within a proper legal framework cannot be coercive since it neither involves a wrongful threat nor violates a person’s rights. Nonetheless, I propose that although competition is not coercive, enhancing because of competitive pressure can be morally problematic as it could restrict personal autonomy and harm well-being. The paper explores strategies the State could devise in order to address both these concerns. The paper then examines whether there are noncoercive permissible ways to induce people to cognitively enhance. Using a number of hypothetical cases, I delineate criteria that could be used to determine whether a particular enhancement should be considered mandatory or otherwise encouraged. Specifically, I consider the circumstances under which it would be justified to use incentives and penalties in order to induce people to enhance.

Health behaviors such as tobacco use contribute significantly to poor health. It is widely recognized that efforts to prevent poor health outcomes should begin in early childhood. Biomedical enhancements, such as a nicotine vaccine, are now emerging and have potential to be used for primary prevention of common diseases. In anticipation of such enhancements, it is important that we begin to consider the ethical and policy appropriateness of their use with children. The main ethical concerns raised by enhancing children relate to their impact on children’s well-being and autonomy. These concerns are significant, however they do not appear to apply in the case of the nicotine vaccine; indeed the vaccine could even further these goals for children. Nevertheless, concerns about broadly applying this enhancement may be more challenging. The vaccine may be less cost-effective than alternative public efforts to prevent tobacco use, utilizing it could distract from addressing the foundational causes of smoking and it might not be publically acceptable. Empirical research about these concerns is needed to ascertain their likelihood and impact as well as how they could be minimized. This research could help determine whether behavior-related enhancements hold promise for improving children’s health