Introduction
The world is witnessing a tremendous increase in human biological modification. This is a complementary concept to enhancement and covers a diverse array of techniques that attempt to modify the biology of the human body. These modifications are distinctive from traditional means of intervention, like drugs and surgery. Characterized by inscription in the body, practitioners sit at an uneasy juncture between the explicit regulatory umbrella and the black market, often facing persecution both from wider society and from law enforcement agencies. The nature of these interventions may be reparative and rejuvenating, restorative and rehabilitative, or regenerative. In some medical literature, the term enhancement is applied more broadly to encompass modification interventions, such as gender reassignment surgeries. Arguably, developments in the field of biological modification have been profound and have altered society considerably in the last 20 years.
Biohacking technologies—innovation in biological interventions—along with access and awareness of these developments, continue to advance. This is a sobering time to examine the field of human biological modification. The field is marred by the scientific and technological capabilities to undertake any number of novel and ethically murky interventions. A detailed history of thought in this field—where moral and ethical critique has been notably pervasive—is needed. In this field, discussion is often the core component, and in line with this, the societal government axis on such discussion. Ethical and regulatory considerations are important in these conversations and are an increasingly united arbiter for consideration from the arts and humanities to the natural, physical, social, life, and clinical sciences. It is also integrative, sitting at the intersection of a number of applied normative disciplines such as law, philosophy, and politics, and more broadly society, life, medicine, and science. Pushed to the extreme, it may also be encompassed by the heading applied ethics. Indeed, it is axial to rationalizing and subjecting scientific and policy frameworks to open and informed discussion. These biological modifications may, and likely will, affect us all and individuals' future life and life expectancy. It is imperative that we apply due importance to discussions in this field and drive the public conversation to be fully informed.
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Ethical Frameworks for Assessing Human Biological Modification
The prospect of altering human biology has kindled interests across an array of disciplines. This paper approaches human biological modification from the perspective of bioethics, applying ethical frameworks in order to evaluate the moral implications of this as yet largely hypothetical practice. Philosophical explorations into ethics have yielded several major approaches toward moral evaluation. Two of the most well-established are consequentialism and deontology. Consequentialist perspectives prioritize the potential outcomes or consequences of an action in order to evaluate its moral permissibility. Deontological frameworks, by contrast, appeal first to an action’s inherent moral status and specifically to whether it conforms to some duty, principle, or moral law. While fundamentally opposed, each approach is important for evaluating human biological modification or other novel neuroscientific approaches: consequentialism enables an evaluation at the level of consequences and outcomes, while deontology can identify which principles and rights are pertinent to the question at hand.
Within medicine and bioethics, the principles of autonomy, beneficence, non-maleficence, and justice are of primary concern to ethical analysis. In the context of human biological modification, these can be seen as a proxy for core concerns and possible ethical issues relevant to human biological modification. Abuses led to the first formulation of international research guidelines for human subjects. The first and primary requirement for participation in any research is free and informed consent. Other ethical codes, declarations, and regulations contain almost identical tenets and have slowly been harmonized and adopted internationally. Conceiving of a regulatory framework for human biological modification will be largely predicated on an appreciation of these principles. Ethical analysis within bioethics has taken the form of case studies. These are practical examples that illustrate the application of ethical frameworks to particular instances or problems. Case studies not only illuminate the ethical issues at play with respect to a particular situation, but often provide a basis for the development of principles and guidelines.
An ethical analysis of human biological modification will tackle numerous unresolved questions and shine a light on these questions that have lingered in many bioethical debates. The primary concern that animates this analysis will be the actual or potential threat to human rights and human dignity inherent in the manipulation of human nature. This highlights the necessity of interdisciplinary dialogue between ethicists, policymakers, scientists, and individuals working in areas far removed from scientific research. The issues broached require much more reflection and dialogue before a response and/or position can be adopted. How can we make reasonable decisions when the use of such innovations is a complete unknown and unpredictable in its effects? For example, how can the fulfillment of standard requirements, such as informed consent, be demanded in uncertain conditions? Different countries and jurisdictions negotiate these issues differently. In some, there have been escalated calls for the establishment of policies, codes, and laws that will enable responsible conduct of human biological modification.
Regulatory Approaches and Oversight Mechanisms
It is critical to recognize the difference between modifying humans for the purpose of genetic manipulation to prevent disease and for gene enhancement. These activities carry different moral significance. In the case of gene enhancement, the lingering questions about what characteristics are desirable pose regulatory challenges. Those that are discussed here address the overarching issue of people’s desire for shared norms which, in turn, point to the ethical dimensions of this nascent science that relate to human values and interpersonal relations.
Ethical and regulatory approaches to human biological modification come in a variety of policy packages depending on intolerance for risk and cultural value systems, among other factors. This means that countries can adopt any one of three stances, namely prohibition, permission, and control. As such, some nations are known to adopt strict regulatory measures, many others employ intermediate regulatory measures, while others have been reported to adopt more permissive measures. Recent events surrounding the use of reportedly gene-edited babies suggest that even in countries that operate under a regulatory regime, violations of the regulatory framework may occur. Finally, there are a number of regulatory bodies in different jurisdictions that are tasked with evaluating and overseeing genetic modifications for compliance with internationally recognized ethical norms and standards. However, given the rapid development of the science related to human modification, it is possible that the current regulatory framework does not suffice and the scientific and biomedical communities, which are more familiar with the contemporary state of relevant science, require regulation that is more nuanced. However, some researchers, ethicists, and regulators have already expressed concerns that a more permissive regulatory approach could undermine the human species by making humans vulnerable to potentially harmful uses and human rights abuses.
Technological Advancements and Future Implications
In recent decades, technological innovations in genetic modification have produced a variety of DNA-altering capacities, including gene editing, gene insertion, and gene deletion. Similarly, innovations in the use of biotechnology and synthetic biology have produced a wide array of biochemicals, ribonucleic acids, and in vivo and in vitro systems. It is without doubt that these advances have led to an expanding capacity to modify human beings, offering the possibility of improved health using germline interventions or human enhancement, mental, physical, or coordinative ability. Such medical breakthroughs will no longer be in the realm of science fiction.
The pioneering medical applications will no longer be confined within specialist facilities and academic institutes because they will have become broadly incentivized. Taken together, these pioneering possibilities demonstrate that human modification does not have a single future trajectory, although they also highlight some core public concerns. The speed and significance of future healthcare will be directly affected by the ethical and clinical acceptability of modification interventions. The potential of modification technologies is without question, but the exact future of their integration remains open. New modification technologies present known unknowns. First, the clinical safety and efficacy of each innovation are uncertain, depending on ambiguities about the underlying science. Second, their societal implications are unclear, as they depend on people's hopes, motivations, and ultimate population trajectories. Owing to an inability to determine exact traits or their expression, this line of research suggests that regulation based on intended outcomes has predictable limits. The shared abstract imperative inherent in conditional A's utilitarian qualification to proactively assess conditional A's is to commence a considered progression along a consultative and regulative pathway.
Conclusion and Recommendations for Policy and Practice
In this essay, we have highlighted some of the ethical and regulatory difficulties raised by human biological modification. We have noted that safety is an important part of these considerations but should not be dealt with in a purely technical or siloed manner. A second key insight is that regulations are always context-dependent, as our state of knowledge and societal value commitments change over time. Third, we believe that it is important to develop a public discourse about these issues that is sensitive to the underlying ethical considerations, rather than focusing first on technical risks and benefits.
For the reasons set out above, we suggest a number of recommendations for policy and practice in this area. We hope to see adaptability in the formulation and review of regulations. In what follows, I offer several particular recommendations to this effect.
- First, guidelines and principles should be established for thinking through the ethical issues relating to biological modifications in humans and for helping us to draw relevant distinctions and point towards ethically acceptable uses.
- Second, in order to help develop public trust in biological technologies, there needs to be much greater public engagement and involvement not only in the decisions on these matters but also in the development of the general principles and guidelines underpinning them. Such principles could be brought into being within innovative techniques, such as citizens' juries where groups of people interact with experts or other stakeholders to deliberate and report on hotly debated policies.
- Third, an important condition for any public involvement or deliberation on the matter is that citizens have an adequate understanding of the biology and the processes involved in making a judgment call on the ethical implications given their tacit consent. Potential applicants and researchers could be required to provide evidence of public debate, information, and opinions for clear indications of what the public was told before they can proceed with any request related to human genetic and biological modification.
- Fourth, as a slide towards the instrumentalization of life has become entrenched within society, too rigid a distinction between the technical and the ethical throughout this essay could limit real debate and progress. As such, it may be useful to encourage greater interdisciplinary debate and collaboration between scientific, legal, philosophical, and public audiences in this area.
- Fifth, it is also important for national regulators and the public to listen to studies in other relevant domains, such as medical and life sciences, for indications of potential risks or benefits that may not have been anticipated by the original technologically oriented forecasts. Hence, open reflections and debates should be conducted to investigate the feasibility and desirability of biological modification in humans. It is necessary to ensure that the concentration of vital public and private resources in the current set of approved research activities for transhuman technologies is not diverting them away from potentially more worthwhile research avenues.
Finally, any multinational guidelines or international regulation must also take into account the fact that comparative legislative and ethical analyses will have to encompass a range of different levels of social development and differing values on human modification by biological techniques. This inclusion is necessary to prevent the further advancement of a technological divide between the developed and developing worlds.
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