1 Introduction and overview
Sir Isaac Newtonâs Third Law of Physics applies as much to scientific advancement as it does to other aspects of life itself. Accordingly, for each and every action there is an equal and opposite re-action.1 For every new and daring biotechnological advancement, a new medico-legal challenge is presented; a challenge rooted in complex social, religious, moral, and ethical vectors of force.
The reality of Newtonâs law is seen dramatically within the science of Synthetic Biology.2 No doubt, the very zeitgeist animating this, the New Age of Biotechnology, is to be found among those members of the scientific community who are exploring ways to design and then develop new life forms in much the same way as either a bridge or a car is assembled.3 Predicated on the fact that organisms can, largely, be broken down into a âset of parts,â and spurred on by the previous and ongoing success of making DNA, synthetic biologists are pursuing efforts to discover a âbasicâ cell into which everything else can be âslotted.â4 One particularly tantalizing success in this field of research was reported on May 20, 2010; for, on this date, a synthetic cell was created which was controlled entirely by a bacterial genome.5 Dr. J. Craig Venter, the lead scientist working on this discovery, described the converted cell as âthe first self-replicating species weâve had on the planet whose parent is a computer.â6
Presently, genetic manipulation normally involves a process, termed cloning, whereby a gene from one cell is harvested and put into a transfer vehicleâoften a sub-cellular structure or plasmidâwhich is then inserted into a different cell which activates the gene. This process then leads to the production of a useful protein for scientific or commercial purposes.7 The new synthetic process of transplanting a genome into bacterium holds great promise for a future where microbes could be manufactured with novel functions, for example, as an absorbent for pollutants or as a means for biofuel production.8 There is a fear among some ethicists that this new process could lead to the production of biological weapons as well as dangerous life forms.9 The consensus, however, is that this new scientific advancement creates no new hazards beyond those present ones encountered when tweaking genes; neither is this process seen as a new threat to biosecurity.10
Bioethical intersections
Historically, bioethics can be seen as having no defined essence which sets it apart as a distinct study or discipline. Rather, its individuation derives from a de facto set of issues interrelated by what might be termed âfamily resemblance.â While a common thread joining all of the issues is exceedingly difficult to find, the central core comprising the list of these issuesâwithout questionâis a felt concern over the technology of control of oneâs body, mind, and quality of life.
In a very real sense, bioethics encompasses a whole political movement which seeks to harness political forces to deal with a plethora of ethical problems relating to health care delivery, both at the micro and the macro level of economic distribution.11 Consequently, many of the concerns of bioethics are concerns of public policyâor with legislation, and policy guidelines at state, local and federal levelsâthat need to be enacted and enforced with respect to all of the issues comprising the de facto set. It has been suggested that bioethical concerns are but those prohibitions all rational people urge everyone to follow in an effort to avoid evils on which common agreement exists.
Outside the individual context of determining how one treats another, at the broader societal level of moral acceptability, a democratic consensus must be reached acknowledging that a certain good must be promoted even though its promotion causes some degree or other of harm. It is within this setting where much of what is recognized as âbioethicsâ is focused. While individual morality operates primarily within a system of restraints, policies affecting society as a whole operate on a level where promotion of good is a moral option. The pivotal question thus becomes, what goods ought to be restrained (e.g., scientific research)? Of necessity, priorities, values, and goods must be weighed, balanced, and compared. Whenever the benefits and the risks of a particular course of action are weighed, it is well to remember that those very elements in the balancing test are based upon judgments about values, with the ultimate goal being the formulation and validation of a final action whichâconsistent with art utilitarianismâminimizes human suffering and maximizes the social good.12 If the pace of scientific advancement is not measured and approached rationally, a principle of precaution may well become a principle of paralysis.13
Expanding the outreach
As a discipline or field of research and study, bioethics emerged in the United States in the 1960s and 1970s as an effort to assess, critically, âthe significance of medicine in terms of its conceptual and value assumptionsâ14 and as a response to medical paternalism.15 Today, bioethics is commonly understood as focusing on ethical and legal controversies arising from the delivery of healthcare, the practice of medicine, and biomedical research.16
What originally were acknowledged as the three fundamental principles undergirding the field of bioethicsâAutonomy, Beneficence, and Justice17âhave, for some, been expanded to include one or more of the following: non-malfeasance, which holds to the premise that one held to a duty of care which forbids the infliction of evil, harm, or risk of harm on others; confidentiality, which imposes a standard of non-disclosure of information received by one person to another with the promiseâimplicit or explicitâof its secrecy; distributive justice (refined from the earlier designation as justice) to include a mandate that benefits and burdens of any medical resource allocation should not only be distributed equitably but that scarce resources be distributed fairly andâfurthermoreâno one person or group receive a disproportionate share of either benefits or burdens; and truth telling, a principle which demands honesty and integrity in the disclosure of all information about an individual to that individual, himself.18
Moving from principlism to utilitarian and Kantian theories and Natural Law teachings, today, new interactions or approaches to understanding and applying bioethical theory have been posited and include: narrative bioethics; virtue bioethics; ethics of caring; religious bioethics; casuistry; pragmatism; law and economic theory; critical race theory and feminist bioethics.19 There is an obvious overlap among all of these approaches. Indeed, most bioethical decision-making is based either on the foundational principles of this discipline or a combination of these approaches.20
As bioethical principles and analytical approaches to understanding and applying bioethics to decision-making and policy have expanded over the years, soâtooâhas the scope of it as a discipline. One such ranking of contemporary bioethics includes within it the study of: end of life care (which includes aging and dementia); genetics; research ethics; global international health issues; cloning and stem cells; organ transplants; ethics of public health; feminism (i.e., commodification of female reproduction); technology; disability; and ecogenetics.21 In another such ranking, seven other activities were listed as inclusive of contemporary bioethics: patient centered care; evidence-based medicine and pay for performance; community dialogue; cross-cultural concerns; race and health disparities; and new technologies.22 Interestingly, religion and sociobiology are both absent from these listings.23
In not only normative theory but in professional regulation, bioethics and medical ethics are being challenged today by a new extended emphasis and a growing popular transnational approach to international human rights.24 Norms which heretofore were considered as within the sole province of bioethics and medical ethics, have been re-processed and codified in not only the 2005 Universal Declaration on Bioethics and Human Rights25âknown popularly...