How Neurotech Start-Ups Envision Ethical Futures: Demarcation, Deferral, Delegation.

Like many ethics debates surrounding emerging technologies, neuroethics is increasingly concerned with the private sector. Here, entrepreneurial visions and claims of how neurotechnology innovation will revolutionize society-from brain-computer-interfaces to neural enhancement and cognitive phenotyping-are confronted with public and policy concerns about the risks and ethical challenges related to such innovations. But while neuroethics frameworks have a longer track record in public sector research such as the U.S. BRAIN Initiative, much less is known about how businesses-and especially start-ups-address ethics in tech development. In this paper, we investigate how actors in the field frame and enact ethics as part of their innovative R&D processes and business models. Drawing on an empirical case study on direct-to-consumer (DTC) neurotechnology start-ups, we find that actors engage in careful boundary-work to anticipate and address public critique of their technologies, which allows them to delineate a manageable scope of their ethics integration. In particular, boundaries are drawn around four areas: the technology's actual capability, purpose, safety and evidence-base. By drawing such lines of demarcation, we suggest that start-ups make their visions of ethical neurotechnology in society more acceptable, plausible and desirable, favoring their innovations while at the same time assigning discrete responsibilities for ethics. These visions establish a link from the present into the future, mobilizing the latter as promissory place where a technology's benefits will materialize and to which certain ethical issues can be deferred. In turn, the present is constructed as a moment in which ethical engagement could be delegated to permissive regulatory standards and scientific authority. Our empirical tracing of the construction of 'ethical realities' in and by start-ups offers new inroads for ethics research and governance in tech industries beyond neurotechnology.

Kazuto Kato: the ethics of editing humanity.

Gary Humphreys talks to Kazuto Kato about the ethical and societal challenges posed by biotechnologies that allow for the editing of the human genome.

Playing God and tampering with nature: popular labels for real concerns in synthetic biology.

Public engagement in science with diverse cross-sections of the community is considered a critical aspect of responsible biotechnological innovation. While the research community shows willingness to engage with both ambivalent and supportive audiences about potentially disruptive technological advances, there is less enthusiasm for engaging with groups who hold deeply opposing views to such advances. 'Playing God' and 'tampering with nature' are popular examples of intrinsic objections often made in opposition to the development or use of novel genetic technologies. Historically appearing in arguments against the pursuit of genetically modified organisms in agriculture and food industries, intrinsic objections have previously been labelled by the science community as inconsistent, non-scientific, and vague. Now found in a range of innovation contexts, the domain of synthetic biology appears to attract such objections consistently. We present the findings from a large Australian study (N = 4593) which suggests 'playing God' objections and their variants can be multilayered and, at times, accompanied by meaningful information about risk perceptions. We use qualitative analysis of open-ended responses from an online survey to show how these objections are articulated in response to selected synthetic biology applications across environmental and health domains. Our research invites a rethink of how the synthetic biology community perceives, and engages with, people who express intrinsic objections. These people may additionally hold extrinsic concerns that may be potentially addressed, or at least reasonably considered, through dialogue. We offer some concluding remarks for engaging with publics who employ these types of arguments to communicate unease with aspects of technology development and use.

Essential Features of Responsible Governance of Agricultural Biotechnology.

Agricultural biotechnology continues to generate considerable controversy. We argue that to address this controversy, serious changes to governance are needed. The new wave of genomic tools and products (e.g., CRISPR, gene drives, RNAi, synthetic biology, and genetically modified [GM] insects and fish), provide a particularly useful opportunity to reflect on and revise agricultural biotechnology governance. In response, we present five essential features to advance more socially responsible forms of governance. In presenting these, we hope to stimulate further debate and action towards improved forms of governance, particularly as these new genomic tools and products continue to emerge.

The ethical concerns about transgenic crops.

It is generally accepted that transgenesis can improve our knowledge of natural processes, but also leads to agricultural, industrial or socio-economical changes which could affect human society at large and which may, consequently, require regulation. It is often stated that developing countries are most likely to benefit from plant biotechnology and are at the same time most likely to be affected by the deployment of such new technologies. Therefore, ethical questions related to such biotechnology probably also need to be addressed. We first illustrate how consequentialist and nonconsequentialist theories of ethics can be applied to the genetically modified organism debate, namely consequentialism, autonomy/consent ethics (i.e. self-determination of people regarding matters that may have an effect on these people) and virtue ethics (i.e. whether an action is in adequacy with ideal traits). We show that these approaches lead to highly conflicting views. We have then refocused on moral 'imperatives', such as freedom, justice and truth. Doing so does not resolve all conflicting views, but allows a gain in clarity in the sense that the ethical concerns are shifted from a technology (and its use) to the morality or amorality of various stakeholders of this debate.

Alienation from the Objectives of the Patent System: How to Remedy the Situation of Biotechnology Patent.

Some fundamental biotechnologies hold unprecedented potential to eradicate many incurable diseases. However, in absence of regulations, the power of patent makes the future use of some important biotechnology in few institution's hands. The excessive patents restrict researcher access to the fundamental technologies. It generates concerns and complaints of deteriorating the public health and social welfare. Furthermore, intellectual curiosities, funding, respect among colleagues etc., rather than patents, are the real motivations driving a major ground-breaking discoveries in biotechnology. These phenomena reveal that some biotechnology patents are alienated from the purpose of patent system. Therefore, it is necessary to take some approaches to stop over-patenting these fundamental biotechnology inventions. This article proposes a model regulatory framework for controlling biotechnology patent alienating from the purpose of patent system.

Patenting Foundational Technologies: Lessons From CRISPR and Other Core Biotechnologies.

In 2012, a new and promising gene manipulation technique, CRISPR-Cas9, was announced that seems likely to be a foundational technique in health care and agriculture. However, patents have been granted. As with other technological developments, there are concerns of social justice regarding inequalities in access. Given the technologies' "foundational" nature and societal impact, it is vital for such concerns to be translated into workable recommendations for policymakers and legislators. Colin Farrelly has proposed a moral justification for the use of patents to speed up the arrival of technology by encouraging innovation and investment. While sympathetic to his argument, this article highlights a number of problems. By examining the role of patents in CRISPR and in two previous foundational technologies, we make some recommendations for realistic and workable guidelines for patenting and licensing.

The Food Warden: An Exploration of Issues in Distributing Responsibilities for Safe-by-Design Synthetic Biology Applications.

The Safe-by-Design approach in synthetic biology holds the promise of designing the building blocks of life in an organism guided by the value of safety. This paves a new way for using biotechnologies safely. However, the Safe-by-Design approach moves the bulk of the responsibility for safety to the actors in the research and development phase. Also, it assumes that safety can be defined and understood by all stakeholders in the same way. These assumptions are problematic and might actually undermine safety. This research explores these assumptions through the use of a Group Decision Room. In this set up, anonymous and non-anonymous deliberation methods are used for different stakeholders to exchange views. During the session, a potential synthetic biology application is used as a case for investigation: the Food Warden, a biosensor contained in meat packaging for indicating the freshness of meat. Participants discuss what potential issues might arise, how responsibilities should be distributed in a forward-looking way, who is to blame if something would go wrong. They are also asked what safety and responsibility mean at different phases, and for different stakeholders. The results of the session are not generalizable, but provide valuable insights. Issues of safety cannot all be taken care of in the R&D phase. Also, when things go wrong, there are proximal and distal causes to consider. In addition, capacities of actors play an important role in defining their responsibilities. Last but not least, this research provides a new perspective on the role of instruction manuals in achieving safety.

3D Bioprinting Technology: Scientific Aspects and Ethical Issues.

The scientific development of 3D bioprinting is rapidly advancing. This innovative technology involves many ethical and regulatory issues, including theoretical, source, transplantation and enhancement, animal welfare, economic, safety and information arguments. 3D bioprinting technology requires an adequate bioethical debate in order to develop regulations in the interest both of public health and the development of research. This paper aims to initiate and promote ethical debate. The authors examine scientific aspects of 3D bioprinting technology and explore related ethical issues, with special regard to the protection of individual rights and transparency of research. In common with all new biotechnologies, 3D bioprinting technology involves both opportunities and risks. Consequently, several scientific and ethical issues need to be addressed. A bioethical debate should be carefully increased through a multidisciplinary approach among experts and also among the public.

A Crispr Future for Gene-Editing Regulation: a Proposal for an Updated Biotechnology Regulatory System in an Era of Human Genomic Editing.

Recent developments in gene-editing technology have enabled scientists to manipulate the human genome in unprecedented ways. One technology in particular, Clustered Regularly Interspaced Short Pallindromic Repeat (CRISPR), has made gene editing more precise and cost-effective than ever before. Indeed, scientists have already shown that CRISPR can eliminate genes linked to life-threatening diseases from an individual's genetic makeup and, when used on human embryos, CRISPR has the potential to permanently eliminate hereditary diseases from the human genome in its entirety. These developments have brought great hope to individuals and their families, who suffer from genetically linked diseases. But there is a dark side: in the wrong hands, CRISPR could negatively impact the course of human evolution or be used to create biological weaponry. Despite these possible consequences, CRISPR remains largely unregulated due to the United States's outdated regulatory scheme for biotechnology. Moreover, human embryo research, which is likely critical to maximizing the therapeutic applications of CRISPR, is not easily undertaken by scientists due to a number of federal and state restrictions aimed at preventing such research. This Note examines the possible benefits and consequences of CRISPR and discusses the current regulations in both the fields of biotechnology and human embryo research that hamper the government's ability to effectively regulate this technology. Ultimately, this Note proposes a new regulatory scheme for biotechnology that focuses on the processes used to create products using CRISPR, rather than the products themselves, with a focus on enabling ethical research using human embryos to maximize the potential benefits of CRISPR.

Bioethical Considerations of Advancing the Application of Marine Biotechnology and Aquaculture.

Normative ethical considerations of growth of the marine biotechnology and aquaculture disciplines in biopharming, food production, and marine products commercialization from a bioethical perspective have been limited. This paucity of information begs the question of what constitutes a bioethical approach (i.e., respect for individuals or autonomy; beneficence, nonmaleficence, and justice) to marine biotechnology and aquaculture, and whether it is one that is appropriate for consideration. Currently, thoughtful discussion on the bioethical implications of use, development, and commercialization of marine organisms or their products, as well as potential environmental effects, defaults to human biomedicine as a model. One must question the validity of using human bioethical principlism moral norms for appropriating a responsible marine biotechnology and aquaculture ethic. When considering potential impacts within these disciplines, deference must be given to differing value systems in order to find common ground to advance knowledge and avoid emotive impasses that can hinder the science and its application. The import of bioethical considerations when conducting research and/or production is discussed. This discussion is directed toward applying bioethical principles toward technology used for food, biomedical development (e.g., biopharming), or as model species for advancement of knowledge for human diseases.

The Bioethicist Who Cried "Synthetic Biology": An Analysis of the Function of Bioterrorism Predictions in Bioethics.

This article analyzes a specter that has haunted bioethics almost since its inception, namely the specter of the misuse of biotechnology by maleficent agents bent on mass destruction, or the complete eradication of human kind and life as we know it. The article provides a general account of why bioethicists cry "catastrophic bioterrorism potential" when new biotechnologies emerge, and an analysis of the arguments that flow from the prediction, especially in relation to synthetic biology.

A Personalist Ontological Approach to Synthetic Biology.

Although synthetic biology is a promising discipline, it also raises serious ethical questions that must be addressed in order to prevent unwanted consequences and to ensure that its progress leads toward the good of all. Questions arise about the role of this discipline in a possible redefinition of the concept of life and its creation. With regard to the products of synthetic biology, the moral status that they should be given as well as the ethically correct way to behave towards them are not clear. Moreover, risks that could result from a misuse of this technology or from an accidental release of synthetic organisms into the environment cannot be ignored; concerns about biosecurity and biosafety appear. Here we discuss these and other questions from a personalist ontological framework, which defends human life as an essential value and proposes a set of principles to ensure the safeguarding of this and other values that are based on it.

Synthetic Biology and the Moral Significance of Artificial Life: A Reply to Douglas, Powell and Savulescu.

I discuss the moral significance of artificial life within synthetic biology via a discussion of Douglas, Powell and Savulescu's paper 'Is the creation of artificial life morally significant'. I argue that the definitions of 'artificial life' and of 'moral significance' are too narrow. Douglas, Powell and Savulescu's definition of artificial life does not capture all core projects of synthetic biology or the ethical concerns that have been voiced, and their definition of moral significance fails to take into account the possibility that creating artificial life is conditionally acceptable. Finally, I show how several important objections to synthetic biology are plausibly understood as arguing that creating artificial life in a wide sense is only conditionally acceptable.

Navigating Bioethical Waters: Two Pilot Projects in Problem-Based Learning for Future Bioscience and Biotechnology Professionals.

We believe that the professional responsibility of bioscience and biotechnology professionals includes a social responsibility to contribute to the resolution of ethically fraught policy problems generated by their work. It follows that educators have a professional responsibility to prepare future professionals to discharge this responsibility. This essay discusses two pilot projects in ethics pedagogy focused on particularly challenging policy problems, which we call "fractious problems". The projects aimed to advance future professionals' acquisition of "fractious problem navigational" skills, a set of skills designed to enable broad and deep understanding of fractious problems and the design of good policy resolutions for them. A secondary objective was to enhance future professionals' motivation to apply these skills to help their communities resolve these problems. The projects employed "problem based learning" courses to advance these learning objectives. A new assessment instrument, "Skills for Science/Engineering Ethics Test" (SkillSET), was designed and administered to measure the success of the courses in doing so. This essay first discusses the rationale for the pilot projects, and then describes the design of the pilot courses and presents the results of our assessment using SkillSET in the first pilot project and the revised SkillSET 2.0 in the second pilot project. The essay concludes with discussion of observations and results.

Implantable Smart Technologies (IST): Defining the 'Sting' in Data and Device.

In a world surrounded by smart objects from sensors to automated medical devices, the ubiquity of 'smart' seems matched only by its lack of clarity. In this article, we use our discussions with expert stakeholders working in areas of implantable medical devices such as cochlear implants, implantable cardiac defibrillators, deep brain stimulators and in vivo biosensors to interrogate the difference facets of smart in 'implantable smart technologies', considering also whether regulation needs to respond to the autonomy that such artefacts carry within them. We discover that when smart technology is deconstructed it is a slippery and multi-layered concept. A device's ability to sense and transmit data and automate medicine can be associated with the 'sting' of autonomy being disassociated from human control as well as affecting individual, group, and social environments.