Transgenic animals—animals with genes added to their deoxyribonucleic acid —will no longer be limited by the gene pool of their parents. Such animals are slated to be created expressly to provide vital and novel benefits for human beings. These animals can have desirable characteristics or traits from virtually any gene pool and may also possess properties not present in nature or available through conventional breeding. They will be created for the production of new medical and pharmaceutical products and to enhance (...) meat, dairy, and fiber production efficiency. (shrink)

Despite the (serious) global concerns about the safety and genetic stability of genetically modified organisms, the Malaysian National Biosafety Board (NBB) has recently approved the field testing for genetically modified (GM) male mosquitoes. With this development, bioethical issues, which in some respect could adversely impinge on the social, economic and environmental aspects of the society, have surfaced, and these concerns must be addressed by the authorities concerned. In reviewing this application, the National Biosafety Board has followed the requirements (...) of the Biosafety Act 2007, which was created to strike a balance between promoting biotechnology and at the same time protecting against its potential environmental and human health risks in Malaysia. However, the 2007 Act fails to adequately take into account any bioethical issues in spite of the inclusion of a provision on socio-economic consideration. As part of an ongoing doctoral research project, and by way of an instrumental critique of the 2007 Act, the present paper attempts to address the role and function of the Malaysia biosafety legal framework in governing bioethical concerns relating to Genetically Modified Organisms (GMOs) within the current biotechnology background in Malaysia. Additionally, the paper suggests that the ambiguity of the provisions contained within the 2007 Act in governing such concerns, representing wider societal interests and welfare, in some ways might defeat the balancing role that this act was originally intended to fulfil. (shrink)

The risks of uncontrolled dissemination of GMOs has made it clear that biosafety is a very relevant matter that goes beyond the State boundaries. This approach has had its corresponding reflection at the policy level, which reveals that the public powers and the legislators have been sensitive to this existing preoccupation in ever-growing sectors of society. From the European regulations, one can deduce a set of principles, which must guide the decisions of the public powers in matters related to (...) biosafety: precaution, authorisation and inspection, “step by step”, “case by case”, traceability and transparency, among other. (shrink)

Synthetic biologists try to engineer useful biological systems that do not exist in nature. One of their goals is to design an orthogonal chromosome different from DNA and RNA, termed XNA for xeno nucleic acids. XNA exhibits a variety of structural chemical changes relative to its natural counterparts. These changes make this novel information‐storing biopolymer “invisible” to natural biological systems. The lack of cognition to the natural world, however, is seen as an opportunity to implement a genetic firewall that impedes (...) exchange of genetic information with the natural world, which means it could be the ultimate biosafety tool. Here I discuss, why it is necessary to go ahead designing xenobiological systems like XNA and its XNA binding proteins; what the biosafety specifications should look like for this genetic enclave; which steps should be carried out to boot up the first XNA life form; and what it means for the society at large. (shrink)

Through a discursive and organizational analysis we seek to understand the Biosafety Protocol and the place of socioeconomic regulation of agricultural biotechnology in it. The literature on the Protocol has been fairly extensive, but little of it has explored debates over socioeconomic regulation during the negotiation process or the regulatory requirements specified in the final document. This case is especially important at a time when the spread of neoliberalism is increasingly associated with deregulation, because it sheds light on the (...) conditions under which circumvention of the market is deemed legitimate and socio-economic regulation of agricultural technology is possible. (shrink)

Two theories on the origins of COVID-19 have been widely circulating in China and the West respectively, one blaming the United States and the other a highest-level biocontainment laboratory in Wuhan, the initial epicentre of the pandemic. Both theories make claims of biological warfare attempts. According to the available scientific evidence, these claims are groundless. However, like the episodes of biological warfare during the mid-twentieth century, the spread of these present-day conspiracy theories reflects a series of longstanding and damaging trends (...) in the international scene which include deep mistrust, animosities, the power of ideologies such as nationalism, and the sacrifice of truth in propaganda campaigns. Also, the threats associated with biological warfare, bioterrorism, and the accidental leakage of deadly viruses from labs are real and growing. Thus, developing a better global governance of biosafety and biosecurity than exists at present is an urgent imperative for the international community in the broader context of a looming Cold War II. For such a governance, an ethical framework is proposed based upon the triple ethical values of transparency, trust, and the common good of humanity. (shrink)

In understanding the implicative resonance of biotech applications research and development, it is necessary to apply the intricate consonance of bioethics studies like behaviourome studies in the form of mental mapping in diverse groups of society for trying to resolve moral issues such as IPR or biosafety. Social perception analysis being the subjective domain of bioethics and related biotechnological issues are the functional epitome in ensuring benevolent biotechnological entrepreneurship development. In this pursuit studies of social genomics can ascertain the (...) positive implications of functional genomics being one of the most important fragments of science of biotechnology. The development of guidelines should be culturally sensitive in the way ethical, social and legal aspects are considered. Having a map of human ideas will enable us to reflect more diversity of ideas into policy frameworks. (shrink)

Synthetic biologists design and engineer organisms for a better and more sustainable future. While the manifold prospects are encouraging, concerns about the uncertain risks of genome editing affect public opinion as well as local regulations. As a consequence, biosafety and associated concepts, such as the Safe-by-design framework and genetic safeguard technologies, have gained notoriety and occupy a central position in the conversation about genetically modified organisms. Yet, as regulatory interest and academic research in genetic safeguard technologies advance, the implementation (...) in industrial biotechnology, a sector that is already employing engineered microorganisms, lags behind. The main goal of this work is to explore the utilization of genetic safeguard technologies for designing biosafety in industrial biotechnology. Based on our results, we posit that biosafety is a case of a changing value, by means of further specification of how to realize biosafety. Our investigation is inspired by the Value Sensitive Design framework, to investigate scientific and technological choices in their appropriate social context. Our findings discuss stakeholder norms for biosafety, reasonings about genetic safeguards, and how these impact the practice of designing for biosafety. We show that tensions between stakeholders occur at the level of norms, and that prior stakeholder alignment is crucial for value specification to happen in practice. Finally, we elaborate in different reasonings about genetic safeguards for biosafety and conclude that, in absence of a common multi-stakeholder effort, the differences in informal biosafety norms and the disparity in biosafety thinking could end up leading to design requirements for compliance instead of for safety. (shrink)

The UN Cartagena Protocol onBiosafety adopted in Montreal, 29 January, 2000and opened for signature in Nairobi, 15–26 May,2000 will exert a profound effect oninternational trade in genetically modifiedorganisms (GMOs) and their products. In thispaper, the potential effects of variousarticles of the Protocol on international tradein GMOs are analyzed. Based on the presentstatus of imports of GMOs and domestic researchand development of biotechnology in China,likely trends in imports of foreign GM food andrelated products after China accedes to WTO isexplored. Also, China's (...) potentialcountermeasures to control and regulate importsof GMOs in line with implementation of theProtocol are discussed. China, in recent times,has increased its food and agricultural importssubstantially from USA and Canada. Chinaimported soybean 10.42 mill. tons in 2000 andabout 15 mill tons in 2001, of which majorityare from USA where GM soybean accounts for60%. The plantation of US Monsanto'stransgenic Bt cotton was increased to more than1 million ha in China in 2001. Though China haspaid great attention to develop biotechnology,it appears to have little scope to export GMOsand GM products. So China may consider a rangeof administrative measures to implement theCartagena Protocol and to regulate its importof GMOs and GM agricultural products.Consequently, the Regulation on Safety ofAgri-GMOs was issued on June, 2001 and followedthree detailed rules issued in Jan. of 2002,with a priority to limit foreign GMOs importingby safety certification and labeling system.These were outlined taking into accountpolicies adopted in Western countries such asgreen barriers to international trade. (shrink)

In the United States a rapidly increasing regulatory burden for life scientists has led to questions of whether the increased burden resulting from the Select Agent Program has had adverse effects on scientific advances. Attention has focussed on the regulatory “fit” of the Program and ways in which its design could be improved. An international framework convention to address common concerns about biosecurity and biosafety is a logical next step.

:This article analyzes the ethics of synthetic biology from a consequentialist perspective, examining potential effects on food and agriculture, and on medicine, fuel, and the advancement of science. The issues of biosafety and biosecurity are also examined. A consequentialist analysis offers an essential road map to policymakers and regulators as to how to deal with synbio. Additionally, the article discusses the limitations of consequentialism as a tool for analysing synbioethics. Is it possible to predict, with any degree of plausibility, (...) what the consequences of synthetic biology will be in 50 years, or in 100, or in 500? Synbio may take humanity to a place of radical departure from what is known or knowable. (shrink)

Israel has a long history of concern with chemical and biological threats, since several hostile states in the Middle East are likely to possess such weapons. The Twin-Tower terrorist attacks and Anthrax envelope scares of 2001 were a watershed for public perceptions of the threat of unconventional terror in general and of biological terror in particular. New advances in biotechnology will only increase the ability of terrorists to exploit the burgeoning availability of related information to develop ever-more destructive bioweapons. Many (...) areas of modern biological research are unavoidably dual-use by nature. They thus have a great potential for both help and harm; and facilitating the former while preventing the latter remains a serious challenge to researchers and governments alike. This article addresses how Israel might best (1) prevent hostile elements from obtaining, from Israel’s biological research system, materials, information and technologies that might facilitate their carrying out a biological attack, while (2) continuing to promote academic openness, excellence and other hallmarks of that system. This important and sensitive issue was assessed by a special national committee, and their recommendations are presented and discussed. One particularly innovative element is the restructuring and use of Israel’s extensive biosafety system to also address biosecurity goals, with minimal disruption or delay. (shrink)

We examine whether the current regulatory regime instituted in South Korea and the United States would have prevented Hwang’s potential transgressions in oocyte procurement for somatic cell nuclear transfer, we compare the general aspects and oversight framework of the Bioethics and Biosafety Act in South Korea and the US National Academies’ Guidelines for Human Embryonic Stem Cell Research, and apply the relevant provisions and recommendations to each transgression. We conclude that the Act would institute centralized oversight under governmental auspices (...) while the Guidelines recommend politically-independent, decentralized oversight bodies including a special review body for human embryonic stem cell research at an institutional level and that the Guidelines would have provided more vigorous protection for the women who had undergone oocyte procurement for Hwang’s research than the Act. We also suggest additional regulations to protect those who provide oocytes for research in South Korea. (shrink)

Safety testing of biological pharmaceuticals is often carried out by contract testing laboratories which perform these tests on behalf of the drug’s developer. These laboratories are confronted with a number of ethical issues related to selling their services, maintaining confidentiality, and the handling of results. This paper outlines these issues, and, by way of illustration, discusses how one such laboratory addresses them.

The discovery of transgenes in maize landraces in Mexico, a center of diversity for this crop, raises questions about the potential impact of transgene diffusion on maize diversity. The concept of diversity and farmers’ role in maintaining diversity is quite complex. Farmers’ behavior is expected to have a significant influence on causing transgenes to diffuse, to be expressed differently, and to accumulate within landraces. Farmers’ or consumers’ perceptions that transgenes are “contaminants” and that landraces containing transgenes are “contaminated” could cause (...) these landraces to be rejected and trigger a direct loss of diversity. (shrink)

Most of the reports on synthetic biology include not only familiar topics like biosafety and biosecurity but also a chapter on ‘ethical concerns’; a variety of diffuse topics that are interrelated in some way or another. This article deals with these ‘ethical concerns’. In particular it addresses issues such as the intrinsic value of life and how to deal with ‘artificial life’, and the fear that synthetic biologists are tampering with nature or playing God. Its aim is to analyse (...) what exactly is the nature of the concerns and what rationale may lie behind them. The analysis concludes that the above-mentioned worries do not give genuine cause for serious concern. In the best possible way they are interpreted as slippery slope arguments, yet arguments of this type need to be handled with care. It is argued that although we are urged to be especially vigilant we do not have sufficiently cogent reasons to assume that synthetic biology will cause such fundamental hazards as to warrant restricting or refraining from research in this field. (shrink)

Results of studies that cast doubt on the safety of genetically modified crops have been published since the first GM crop approval for commercial release. These ‘alarming studies’ challenge the dominant view about the adequacy of current risk assessment practice for genetically modified organisms. Subsequent debates follow a similar and recurring pattern, in which those involved cannot agree on the significance of the results and the attached consequences. The standard response from the government—a reassessment by scientific advisory bodies—seems insufficient to (...) bring the debate to a satisfactory closure. The recurrence of the same debate every time an alarming study is published shows that science alone cannot solve the problem. We believe that further analysis is needed to investigate if and how we can prevent this repetitive cycle that creates frustration amongst all stakeholders. In this paper, we analyse the dynamics behind discussions which occur following alarming studies. We will use a selection of representative alarming GMO case studies to underpin our claim that it is likely that there will be a permanent difference in view of opinion that cannot be solved with more data or new facts. The current strategy of more research is a pitfall that is unlikely to solve this issue. Instead, the focus of the GM crop discussion should shift towards managing permanent different viewpoints and providing a platform for a broader conversation on agriculture and food production. (shrink)

The Nuffield Council on Bioethics (NCOB) is delighted to pick up the mantel of the Ethics briefings. For readers less familiar with the NCOB’s work, we are a leading independent policy and research centre, and the foremost bioethics body in the UK. We identify, analyse and advise on ethical issues in biomedicine and health so that decisions in these areas benefit people and society.1 Established in 1991, the NCOB has tackled a wide range of bioethics and medical ethics issues over (...) its thirty-two years, including issues relating to the beginning and end of life, health and society, data and technology, and research ethics. Early reports in the 1990s included, for example, ‘Genetics screening: the ethical issues’ and ‘Animal-to-human transplants: the ethics of Xenotransplantation’. More recent projects include setting out an ethical framework in the report ‘The future of ageing: ethical considerations for research and innovation’2 and a current joint project with the Ada Lovelace Institute3 considering the potential ethical implications of the convergence of AI and genomics technologies.4 In recent years, NCOB has increasingly focused on horizon scanning. What current and future national and international developments are likely to raise ethical issues in the short, medium and long-term? Insights for 2023 will soon be available at www.nuffieldbioethics.org/what-we-do/horizon-scanning, with new developments likely to be included alongside ongoing areas of medical and scientific research that we are tracking progress in, for example, in vitro derived gametes, surrogacy, biosafety and novel neurotechnologies. Disagreements between parents and healthcare teams about …. (shrink)

The discourse on the fundamental issues raised by synthetic biology, such as biosafety and biosecurity, intellectual property, environmental consequences and ethical and societal implications, is still open and controversial. This, coupled with the potential and risks the field holds, makes it one of the hottest topics in technology assessment today. How a new technology is perceived by the public influences the manner in which its products and applications will be received. Therefore, it is important to learn how people perceive (...) synthetic biology. This work gathers, integrates and discusses the results of three studies of public perceptions of synthetic biology: an analysis of existing research on how media portray synthetic biology across 13 European countries and in the USA, the Meeting of Young Minds, a public debate between prospective politicians and synthetic biologists in the Netherlands and the experiences of citizen panels and focus groups in Austria, the UK and the USA. The results show that the media are generally positive in their reports on synthetic biology, rather unbalanced in their view of potential benefits and risks, and also heavily influenced by the sources of the stories, namely scientists and stakeholders. Among the prospective Dutch politicians, there were positive expectations as well as very negative ones. Some of these positions are also shared by participants in public dialogue experiments, such as not only the demand for information, transparency and regulation but also a sense of resignation and ineluctability of scientific and technological progress. (shrink)

Gain-of-function research involves experimentation that aims or is expected to increase the transmissibility and/or virulence of pathogens. Such research, when conducted by responsible scientists, usually aims to improve understanding of disease causing agents, their interaction with human hosts, and/or their potential to cause pandemics. The ultimate objective of such research is to better inform public health and preparedness efforts and/or development of medical countermeasures. Despite these important potential benefits, GOF research can pose risks regarding biosecurity and biosafety. In 2014 (...) the administration of US President Barack Obama called for a “pause” on funding of GOF experiments involving influenza, SARS, and MERS viruses in particular. With announcement of this pause, the US Government launched a “deliberative process” regarding risks and benefits of GOFR to inform future funding decisions—and the US National Science Advisory Board for Biosecurity was tasked with making recommendations to the US Government on this matter. As part of this deliberative process the National Institutes of Health commissioned this Ethical Analysis White Paper, requesting that it provide review and summary of ethical literature on GOFR, identification and analysis of existing ethical and decision-making frameworks relevant to the evaluation of risks and benefits of GOFR, decision-making about the conduct of GOF studies, and the development of US policy regarding GOFR, and development of an ethical and decision-making framework that may be considered by NSABB when analyzing information provided by GOFR risk-benefit assessment, and when crafting its final recommendations. The ethical and decision-making framework ultimately developed is based on the idea that there are numerous ethically relevant dimensions upon which any given case of GOFR can fare better or worse : research imperative, proportionality, minimization of risks, manageability of risks, justice, good governance, evidence, and international outlook and engagement. Rather than drawing a sharp bright line between GOFR studies that are ethically acceptable and those that are ethically unacceptable, this framework is designed to indicate where any given study would fall on an ethical spectrum—where imaginable cases of GOFR might range from those that are most ethically acceptable, at one end of the spectrum, to those that are most ethically problematic or unacceptable, at the other. The aim should be that any GOFR pursued should be as far as possible towards the former end of the spectrum. (shrink)

On December 18, 2014, a yellow female fly quietly emerged from her pupal case. What made her unique was that she had only one parent carrying a mutant allele of this classic recessive locus. Then, one generation later, after mating with a wild‐type male, all her offspring displayed the same recessive yellow phenotype. Further analysis of other such yellow females revealed that the construct causing the mutation was converting the opposing chromosome with 95% efficiency. These simple results, seen also in (...) mosquitoes and yeast, open the door to a new era of genetics wherein the laws of traditional Mendelian inheritance can be bypassed for a broad variety of purposes. Here, we consider the implications of this fundamentally new form of “active genetics,” its applications for gene drives, reversal and amplification strategies, its potential for contributing to cell and gene therapy strategies, and ethical/biosafety considerations associated with such active genetic elements. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:In the Belly of the Whale:Some Thoughts on Preserving the Integrity of the New Bioethics CommissionF. Daniel Davis (bio)10 July 2010. Washington, D.C. President Obama's Presidential Commission for the Study of Bioethical Issues has just concluded its inaugural meeting, designed as a primer—the first of three that it plans to hold—on synthetic biology. As a topic for deliberation by a national bioethics commission, "synbio" is ideal. A cloud of (...) equipoise hangs over the practical implications of recent developments in this, the latest phase in the evolution of biotechnology—a seemingly genuine uncertainty about the need for additional mechanisms of oversight to mitigate potential risks to biosafety or biosecurity. Despite these concerns, its advocates and practitioners enthusiastically champion the prospect of eventual, perhaps significant benefits to be gained with progress in "synbio," including, for example, enhanced processes for the mass production of vaccines and biofuels. And yet like the advent of recombinant DNA technologies in the mid-1970s, synthetic biology has generated not only hope for benefits and concern for risks, but also questions variously described as "deep," "profound," "fundamental," and "philosophical": Is the capacity to synthesize novel, living entities yet another technological invitation to hubris on the part of humankind? Will that capacity alter the relationship between humankind and nature? How should we think about the moral status of living entities created de novo in the laboratory? Should we even care? How will wide-scale applications of synthetic biology tip the scales of social justice? And finally, the democratization of synthetic biology, the growth of DIY-BIO (do-it-yourself-biology) communities beyond the usual scientific arenas of academia and industry, has infused old questions about scientific freedom and responsibility with new complexities—all in the midst of an American public that is reportedly unaware and uneducated about this new chapter in the often triumphant, unsettling history of biotechnology.Thus, the topic of synthetic biology presents the new commission with several possibilities. It could very well make a substantial contribution to public policies responsive to both the current capabilities and the possible trajectories of [End Page 291] these emergent biotechnologies. The very fact that the President explicitly asked the Commission to take up the topic and report back to him (in six months) means that that potential is especially promising. It could, as well, delve into the "deeper" philosophical questions that "synbio" raises with the aim of bringing both depth and breadth to the tasks of critically analyzing and reflecting upon what currently is known and what, with regard to the future, can only be glimpsed of this amalgam of the life sciences, engineering, and other disciplines. The Commission could also set its sights on diminishing the apparent deficit in public understanding of these biotechnologies. And finally, with this topic as well as any others it takes up, the Commission, along with the administration that established it, could make an effort to reinvigorate public bioethics in the United States. At the very least, in the sobering light of experience with the President's Council on Bioethics, certain actions or behaviors could be avoided in the interests of preserving the integrity—the moral and political legitimacy—of the new commission. Although each of these possibilities warrants further explanation, my focus here is the final one.The Belly of the WhaleIn several decades, some future historian of public bioethics in the U.S. will be able to look back on the bioethics commissions established to date and offer an insightful, comprehensive—maybe even magisterial—account of their beginnings and endings, their deliberations and the political forces that shaped them, and perhaps most important, their ultimate value as public bodies. Lacking the strategic perch of historical distance, and fresh from the trenches, I can only offer a few somewhat informed but partial observations and arguments about public bioethics in the context of contemporary American politics, acknowledging at the outset that my thoughts are open to, and needful of, critical amendment or supplement by others.In the U.S., bioethics commissions are political creatures, established through the authority of the Congress or the President for the purpose of providing counsel to the legislative and/or executive... (shrink)

This paper reviews the location of Responsible Research and Innovation approaches within the access and benefit sharing policy spaces of the Convention on Biological Diversity and Nagoya Protocol. We describe how a range of dialogues on ethical research practices found a home, almost inadvertently, within the ABS policy process. However, more recent RRI dialogues around emerging technologies have not been similarly absorbed into ABS policy, due in part to the original framing of ABS and associated definitional and scope issues. Consideration (...) is given to the challenges posed to these policy processes by the transformative and rapid nature of scientific and technological change today, including the emerging field of synthetic biology. Drawing on experiences from regulating ABS, we emphasize that the integration of RRI into policies for new, emerging, or poorly understood activities such as synthetic biology faces deficiencies such as limits to government capacity, jurisdictional confusion, shortages in funds, and an absence of strategic approaches. We conclude that a coordinated combination of diverse policy processes within the CBD might provide an invaluable space for RRI dialogues on social justice, sustainability, biosafety, and other issues raised by emerging technologies. (shrink)

Continuing rapid developments in the life sciences offer the promise of providing tools to meet global challenges in health, agriculture, the environment, and economic development; some of the benefits are already being realized. However, such advances also bring with them new social, ethical, legal, and security challenges. Governance questions form an increasingly important part of the discussions about these advances--whether the particular issue under debate is the development of ethical principles for human genome editing, how to establish regulatory systems for (...) the safe conduct of field trials of gene drive-modified organisms, or many others. However there are continuing concerns that the knowledge, tools, and techniques resulting from life sciences research could also enable the development of bioweapons or facilitate bioterrorism. Between June 10 and 13, 2018, more than 70 participants from 30 different countries and 5 international organizations took part in an international workshop, The Governance of Dual Use Research in the Life Sciences: Advancing Global Consensus on Research Oversight, in Zagreb, Croatia. Hosted by the Croatian Academy of Sciences and Arts, the workshop was a collaboration among the InterAcademy Partnership, the Croatian Academy, the Croatian Society for Biosafety and Biosecurity, and the U.S. National Academies of Sciences, Engineering, and Medicine. This publication summarizes the presentations and discussions from the workshop."--Publisher's description. (shrink)

Many instances of scientific research impose risks, not just on participants and scientists but also on third parties. This class of social risks unifies a range of problems previously treated as distinct phenomena, including so-called bystander risks, biosafety concerns arising from gain-of-function research, the misuse of the results of dual-use research, and the harm caused by inductive risks. The standard approach to these problems has been to extend two familiar principles from human subjects research regulations—a favorable risk-benefit ratio and (...) informed consent. We argue, however, that these moral principles will be difficult to satisfy in the context of widely distributed social risks about which affected parties may reasonably disagree. We propose that framing these risks as political rather than moral problems may offer another way. By borrowing lessons from political philosophy, we propose a framework that unifies our discussion of social risks and the possible solutions to them. (shrink)

In the United States a rapidly increasing regulatory burden for life scientists has led to questions of whether the increased burden resulting from the Select Agent Program has had adverse effects on scientific advances. Attention has focussed on the regulatory “fit” of the Program and ways in which its design could be improved. An international framework convention to address common concerns about biosecurity and biosafety is a logical next step. Keywords Biosafety - Biosecurity law - Biosecurity regulations - (...) Scientist - Laboratories - Research - Bioterrorism - Terrorism. (shrink)

We extend recent conversation about the ethics of human challenge trials to tuberculosis (TB). TB challenge studies could accelerate vaccine development, but ethical concerns regarding risks to trial participants and third parties have been a limiting factor. We analyse the expected social value and risks of different challenge models, concluding that if a TB challenge trial has between a 10% and a 50% chance of leading to the authorisation and near-universal delivery of a more effective vaccine 3–5 years earlier, then (...) the trial would save between 26 400 and 1 100 000 lives over the next 10 years. We also identify five important ethical considerations that differentiate TB from recent human challenge trials: an exceptionally high disease burden with no highly effective vaccine; heightened third party risk following the trial, and, partly for that reason, uniquely stringent biosafety requirements for the trial; risks associated with best available TB treatments; and difficulties with TB disease detection. We argue that there is good reason to consider conducting challenge trials with attenuated strains like Bacillus Calmette-Guérin or attenuatedMycobacterium tuberculosis. (shrink)

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. (shrink)

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. (shrink)

Recent results confirm that long‐term expression of therapeutic transgenes can be achieved by using a transposon‐based system in primary stem cells and in vivo. Transposable elements are natural DNA transfer vehicles that are capable of efficient genomic insertion. The latest generation, Sleeping Beauty transposon‐based hyperactive vector (SB100X), is able to address the basic problem of non‐viral approaches – that is, low efficiency of stable gene transfer. The combination of transposon‐based non‐viral gene transfer with the latest improvements of non‐viral delivery techniques (...) could provide a long‐term therapeutic effect without compromising biosafety. The new challenges of pre‐clinical research will focus on further refinement of the technology in large animal models and improving the safety profile of SB vectors by target‐selected transgene integration into genomic “safe harbors.” The first clinical application of the SB system will help to validate the safety of this approach. (shrink)

DNA and RNA are the only known natural genetic materials. Systematic modification of each of their chemical building blocks (nucleobase, sugar, and phosphate) has enabled the study of the key properties that make those nucleic acids genetic materials. All three moieties contribute to replication and, significantly, all three moieties can be replaced by synthetic analogs without loss of function. Synthetic nucleic acid polymers capable of storing and propagating information not only expand the central dogma, but also highlight that DNA and (...) RNA are not unique chemical solutions for genetic information storage. By considering replication as a question of information transfer, we propose that any polymer that can be replicated could serve as a genetic material.Editor's suggested further reading in BioEssays Xenobiology: A new form of life as the ultimate biosafety tool Abstract. (shrink)

The World Trade Organization has been the target of social justice activists since its inception in 1994, with many seeking to reshape or rescind the WTO agreements. This article instead explores possible interventions into WTO adjudication by compelling the reinterpretation of existing WTO documents. Such an approach can take several forms: mobilizing professional expertise, engaging technical standards, and constructing companion regimes. Using the recent United States/european Community genetically modified organisms case as a reference point, this article explores opportunities for implementing (...) the last two strategies. The Codex Alimentarius, an international food standards regime, seems to provide a particularly promising location for reconstructing WTO risk and governance procedures. The Cartagena Biosafety Protocol, an international environmental regime, deeply challenges narrow readings of WTO texts but may not have enough legal force in the WTO. These alternative locations for intervention hold promise and risks for activists seeking international justice in environment, food, and trade. (shrink)

Besides having potential medical and biosafety applications, as well as challenging the foundations of biological engineering, xenobiology can also shed light on the epistemological and metaphysical questions that puzzle philosophers of science. This paper reviews this philosophical aspect of xenobiology, focusing on the possible multiple realizability of life. According to this hypothesis, what ultimately matters in understanding life is its function, not its particular building blocks. This is because there should, in theory, be many different ways to build the (...) same function. The possibility of multiple realizability was originally raised in the context of AI’s hypothesized capacity to realize mental functions. Because we still do not have any incontrovertible examples of digital minds, not to mention alien life of foreign biochemistry, the best way to test this philosophical idea is to examine the recent results and practices of synthetic biology and xenobiology. (shrink)

The extent to which machine metaphors are used in synthetic biology is striking. These metaphors contain a specific perspective on organisms as well as on scientific and technological progress. Expressions such as “genetically engineered machine”, “genetic circuit”, and “platform organism”, taken from the realms of electronic engineering, car manufacturing, and information technology, highlight specific aspects of the functioning of living beings while at the same time hiding others, such as evolutionary change and interdependencies in ecosystems. Since these latter aspects are (...) relevant for, for example, risk evaluation of uncontained uses of synthetic organisms, it is ethically imperative to resist the thrust of machine metaphors in this respect. In addition, from the perspective of the machine metaphor viewing an entity as a moral agent or patient becomes dubious. If one were to regard living beings, including humans, as machines, it becomes difficult to justify ascriptions of moral status. Finally, the machine metaphor reinforces beliefs in the potential of synthetic biology to play a decisive role in solving societal problems, and downplays the role of alternative technological, and social and political measures. (shrink)

‘Ethics first’ reform in China significantly changes the governance framework for the research of emerging technologies. The misapplication of human genome editing technology reflects the urgent need to reform the governance framework. Strengthening ethics governance in medical research has become a consensus in China, where legal and ethical reforms are proceeding in parallel. The protection of human dignity, the prevention of biosafety risks, as well as the regulation of technological crimes are at the core of the legal system, which (...) has been embodied in numerous fundamental legislations following the CRISPR-babies incident. Establishing a national ethics committee to coordinate ethics governance, and reinforcing ethics review and external oversight are significant steps in ethical reform. Essentially, ethics governance requires implementing the basic concept of ‘ethics first’, focusing on forward-looking and preventive governance rather than delayed intervention, while maintaining openness and collaboration. (shrink)

The Convention on Biological Diversity opens the possibility to negotiate a legally binding Biosafety Protocol to assess and minimize risks in the field of transboundary transfer, handling, and use of organisms modified by genetic engineering. Two principles— the Precautionary Principle and the Principle of Familiarity—guiding the risk assessment as basis of import decisions on such organisms are discussed. Developing and European industrialized countries favor the Precautionary Principle. The U.S., Australia, Japan, and some others call for the Principle of Familiarity. (...) These two principles exhibit opposite effects on scientific progress in general and on scientific methodology of risk assessment in particular. With the example of risk assessment by the U.S. company Monsanto discussed below, it could be illustrated that the Principle of Familiarity opens the way for superficial evaluations based on citing arbitrary references while the Precautionary Principle is an incentive for developing and applying sound methodology in experimental risk assessment. on the transboundary transfer of such LMOs, for example, on the international exchange of and trade with transgenic seeds, grains, animals, or bacteria. The negotiations are based on Articles 19.3 and 8(g) of the Convention on Biological Diversity, elaborated during the Earth Summit in Rio de Janeiro, Brazil, in 1992, and on Decision II/5 of the Second Conference of the Parties to this Convention in Jakarta, Indonesia, in 1995 (see the appendix; for more documents, see www.biodiv.org). Until the Fourth Conference of the Parties in 1998, 172 states ratified this convention. This conference decided to finish the Biosafety Protocol in February 1999. In 1998, transgenic crops were allowed to be planted in eight (75%) countries of the world. As the country with the largest acreage of transgenic crops and as the main trader of LMOs, the United States cannot become a member of the protocol until it has ratified the Convention on Biological Diversity. (shrink)

Abstract The introduction of genetically modified plants into the environment has been marked by different positions, either in favor of or against their release. However, the problem goes well beyond such contradictory positions; it is necessary to take into account the legislation, ethics, biosafety, and the environment in the considerations related to the release of genetically modified organisms (GMOs). To this end, the Brazilian Committee of Biosafety (CTNBio), a consultative and deliberative multidisciplinary collegiate, provides technical and advisory support (...) to the Brazilian Federal Government. This committee consists of scientists and non-scientists who participate in evaluating the dossiers of companies that are requesting approval by the Brazilian Government; consequently, the aim of this study was to investigate whether commercial approvals of GMOs were associated with the profile of the CTNBio members. Research was based on the minutes taken at CTNBio meetings carried out from 2006 up to 2009, considering law 11.105/2005 and the Constitution of 1988 as legal frameworks, to determine the number of voters in favor of or against releasing genetically modified Bt-maize, Bt-cotton, and herbicide resistant soybeans to be used in Brazilian agriculture. Via the internet, we had access to the curriculum vitae of the CTNBio members through the Plataforma Lattes database of the National Council for Scientific and Technological Development (CNPq), where we found their area of expertise. CTNBio members were divided into expert-for, expert-against, non-expert-for, and non-expert-against. Results showed that CTNBio decisions could be based on technical criteria as well as on the policy of the institution that expert-members were representing. Content Type Journal Article Category Articles Pages 1-11 DOI 10.1007/s10806-011-9347-x Authors Glenda Morais Rocha Braña, Programa de Pós-Graduação em Bioética da Cátedra/UNESCO, Faculdade de Ciências da Saúde, Universidade de Brasília, Brasília, DF, Brazil Ana Luisa Miranda-Vilela, Departamento de Genética e Morfologia, Laboratório de Genética Toxicológica, Instituto de Ciências Biológicas, Universidade de Brasília, Brasília, DF, Brazil Cesar Koppe Grisolia, Departamento de Genética e Morfologia, Laboratório de Genética Toxicológica, Instituto de Ciências Biológicas, Universidade de Brasília, Brasília, DF, Brazil Journal Journal of Agricultural and Environmental Ethics Online ISSN 1573-322X Print ISSN 1187-7863. (shrink)

Technological advancement has an ambivalent character concerning the impact on biodiversity. It accounts for major detrimental environmental impacts and aggravates threads to biodiversity. On the other hand, from an application perspective of environmental science, there are technical advancements, which increase the potential of analysis, detection and monitoring of environmental changes and open a wider spectrum of sustainable use strategies.The concept of biodiversity emerged in the last two decades as a political issue to protect the structural and functional basis of earthbound (...) life. In this respect, it represents a great challenge for science, in particular for ecology, which is the scientific discipline mainly involved in contributing to understand biodiversity issues.In this paper, we state a strong necessity for ecologists to work in close connection with other disciplines and within their own discipline across the different organisation levels. Each level has some specific properties to which ecological terminology has been adapted, and joint views are necessary to understand complex networks. In this context, ecological theory provides the background to analyse biological complexity and the relationship of structure and dynamics on different integration levels and provides the interface to mediate social and political issues.Important features of new technologies for advances in ecological theory refer to an increase in information processing capacities, more efficient automatic data acquisition and device operation, and an increase in resolution.One crucial consideration we analyse is the trend that a quantitative development in one particular discipline may open a new potential for qualitative advancement in other disciplines when the quantitative advancement is applied in a new disciplinary context.We illustrate these qualitative developments that are based on technological advancements and which helped to advance ecological theory qualitatively with two examples: The underlying mechanisms causing regularly oscillating rodent populations are subject to a decade long discussion in ecology. Using the possibilities of modern information processing, it is possible to represent the discussed hypotheses in an integrative object oriented model and analyse how the underlying causal net works. The second example originates from biosafety research dealing with the environmental impact of genetically modified organisms. The project GenEERA develops a complex up-scaling procedure from below field-level information to the landscape scale in order to investigate spread and persistence of GM oil seed rape under different scenarios. The approach gives an example, how ecological modelling can be used to combine different information levels to derive conclusions on a higher spatial scale.In an overall conclusion we relate the described approaches to a wider system analytical context in which we interpret theory developments and biodiversity issues with a system theoretical description of growth processes. We obtain the view that in self-organising systems there is a tendency for autonomous development which tends to be dominating far away from capacity limitations. However, while approaching capacity limitations, a tendency towards closer coupling of internal and external cause-effect networks emerges. We also find that the relation of biodiversity, ecosystem services, and social dynamics can be interpreted in this framework. In this context, the demand for closer interdisciplinary cooperation to solve existing problems appears as an indication of emerging capacity limitations both, in the theoretical as well as in the physical domain. (shrink)

This book examines the field of bioethics from an international and regional legal perspective. It focuses on major international law documents such as the United Nations Universal Declaration on Bioethics and Human Rights and UNESCO declarations on human cloning and the human genome. Coverage of regional legal instruments includes the Council of Europe Convention on Human Rights and Biomedicine (the Oviedo Convention) and its Protocols on cloning, transplantation, and research with human beings. Work on surrogacy issues by the Hague Conference (...) on Private International Law is also discussed, as are some African regional legal instruments on biosafety, and stem cell research. (shrink)

The aim of this article is to analyse the role of metaphors for the infertile body in the context of assisted reproduction, using conceptual metaphor theory as a framework, and to evaluate the moral significance of these metaphors. This sub-study is part of a larger study examining the biosafety practices of new biotechnologies in Latvia. In the sub-study, special attention was paid to metaphors used by assisted reproductive technology users, egg donors and experts. It can be concluded that not (...) only does the infertility experience influence the choice of metaphors, but the use of certain metaphors can also change the infertility experience. In this process the practice of infertility treatment and the meaning of the body are socially and culturally shaped. The main groups of metaphors for the infertile body discovered through interview analysis are: order/disorder, the body as a resource, the body as a container, the body as a project, and anthropomorphization of gametes. (shrink)

This study assessed the knowledge and perception of human biological materials (HBM) and biorepositories among three study groups in South Korea. The relationship between the knowledge and the perception among different groups was also examined by using factor and regression analyses. In a self-reporting survey of 440 respondents, the expert group was found more likely to be knowledgeable and positively perceived than the others. Four factors emerged: Sale and Consent, Flexible Use, Self-Confidence, and Korean Bioethics and Biosafety Action restriction (...) perception. The results indicate that those who are well aware of the existence of biobanks were more positively inclined to receive the Sale and Consent perception. As a result of the need for high quality HBMs and the use of appropriate sampling procedures for every aspect of the collection and use process, the biorepository community should pay attention to ethical, legal, and policy issues. (shrink)

This study assessed the knowledge and perception of human biological materials (HBM) and biorepositories among three study groups in South Korea. The relationship between the knowledge and the perception among different groups was also examined by using factor and regression analyses. In a self‐reporting survey of 440 respondents, the expert group was found more likely to be knowledgeable and positively perceived than the others. Four factors emerged: Sale and Consent, Flexible Use, Self‐Confidence, and Korean Bioethics and Biosafety Action restriction (...) perception. The results indicate that those who are well aware of the existence of biobanks were more positively inclined to receive the Sale and Consent perception. As a result of the need for high quality HBMs and the use of appropriate sampling procedures for every aspect of the collection and use process, the biorepository community should pay attention to ethical, legal, and policy issues. (shrink)

This study assessed the knowledge and perception of human biological materials (HBM) and biorepositories among three study groups in South Korea. The relationship between the knowledge and the perception among different groups was also examined by using factor and regression analyses. In a self‐reporting survey of 440 respondents, the expert group was found more likely to be knowledgeable and positively perceived than the others. Four factors emerged: Sale and Consent, Flexible Use, Self‐Confidence, and Korean Bioethics and Biosafety Action restriction (...) perception. The results indicate that those who are well aware of the existence of biobanks were more positively inclined to receive the Sale and Consent perception. As a result of the need for high quality HBMs and the use of appropriate sampling procedures for every aspect of the collection and use process, the biorepository community should pay attention to ethical, legal, and policy issues. (shrink)