1.What is ELSI

New technology thanks to is being developed in our modern society, our lives are becoming more comfortable and convenient. at the same time, the fact that these technologies may cause unexpected influences on society. ELSI is a field of research that foresees these consequences in the future and evaluate how to cope with them.
The term ELSI appeared in the Human Genome Project that began in the United States in 1990. Human Genome Project is a research project with the goal of identifying and mapping all of the genes of human genome. The potential consequences of this project affects not only doctors and patients, but all human beings and the entire society. ELSI research must be done from various viewpoints including general public, policymakers and enterprises.
In addition, we will need participation from a wide range of disciplinary such as philosophers, legal scholars, sociologists and ethicists along with medical science researchers, and interdisciplinary consider these consequences. Therefore, ELSI is not only targeted for the Human Genome Project, but is also for various leading-edge technologies.
In this section, regarding our project, developing a novel molecular device, we have to assess the potential consequences of the project on humans, and discuss the measures that should be taken to prevent potential problems.

2.Analysis from each field

・Ethical issues

Regarding our research, the primary ethical issues exist in the handling of DNA and vectors in DNA synthesis. Generally, safety is the major issue in fields that handle DNA in experiments, such as genetic recombination. However, since our research utilizes DNA as a material not including any genetic information, it does not need to be taken into consideration. Regarding the handling of the DNA we ordered, it is mandatory to properly manage the material until its disposal and restrict its usage to inside laboratories; we complied with this regulation.
In addition, the DNA we handled in our experimented are those that were ordered and synthesized by outside company (Eurofins Genomics), and phage DNA was used for a scaffold or DNA origami. Phage is a name of a microscopic structure that can self-replicate using cells of other organisms (“phage has its own genes, and can grow by using cells of other organisms”). Although it has no cell, which is the smallest unit of an organism, the definition of life has not been defined.
Therefore, the current animal experiment provisions in Japan has “basic guidelines on the implementation of animal experiments at the research institutes under the agriculture, forestry, and fisheries departments”, which is based on the “International Guiding Principles for Biomedical Research” published by the Council for International Organizations of Medical Sciences (CIOMS), and regulations concerning phage are not dealt with. However, if viruses are defined as life in the future, it is necessary to consider animal experiment ethics regulation since DNA synthesis of viruses is included in the experimental process. In that case, it will be necessary for the experimenter to examine the appropriate experimental method the amount of DNA according to Article 5 of the Animal Experiment Ethics Regulation, and strive for appropriate experiments.

・Legal issues

Upon the development of synthetic biology, especially genetic recombination engineering, various international outline have been defined, including the Convention on Biological Diversity, “Law concerning the conservation and sustainable use of biological diversity through regulation on the use of genetically modified organisms” (commonly known as “Cartagena Act”), etc. Consequently, legislation in Japan is progressing, and the handling of DNA as a gene is strictly regulated. However, handling of the DNA and RNA molecules as materials used in molecular robotics is not defined in Japan nor in other countries, the management is entrusted to the person in charge of the experiment.
However, many of the designs proposed in molecular robotics are to be applied to human bodies. It is necessary to develop laws based on the possibility that these designed will be implemented in society. Since there are almost no examples of technology using biomolecules applied to the human body, when considering clinical trials of implementing drug delivery for example, it is necessary to carefully carry out clinical trials based on ethical guidelines on clinical practice in additions to complying with “ministerial order on standards for implementation of clinical trial of pharmaceuticals” (or GCP, short for Good Clinical Practice).
Also, in addition to medical applications, dual-use must be also taken into account. The fundamental purpose of our research for this project is to utilize the self-assembling properties of DNA molecules to obtain arbitrary structures, and applying transformability to the structures by adding specific signals. Thus, dual-use of our design is unlikely. However, the possibility of research in molecular robotic fields being applied for dual-use cannot be completely denied.
Throughout history, military tactics to spread biological agents or living beings carrying these to the enemy has been used in across the world. In the 20th century, along with advancements in biology and medical research, since mass-murdering weapons were developed due to the modern world-scale wars, reflecting the dangers, international frameworks to ban trading of biological weapons were proposed. The "Geneva Protocol (Protocol for the Prohibition of the Use in War of Asphyxiating, Poisonous or other Gases, and of Bacteriological Methods of Warfare)" (effective from 1928) was an international treaty deployed in order to prohibit the use of chemical weapons in warfare after the end of World War Ⅰ. However, in present day, the "Biological and Toxin Weapons Convention (BTWC)", or the "Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction" which was opened for signature in 1972 and entered into force in 1975, following World War Ⅱ, the Korean War, and the Vietnam War, is functioning as the international framework to comprehensively prohibit biological weapons including toxins. Although molecules using artificial DNA may not function in itself as a weapon or a toxin, by utilizing its self-assembling properties, there is a possibility of modifying them for dual-use. In this case, since there is a high possibility that the products do not fall under the jurisdiction of weapons or toxins defied in any existing protocols, there is a need to lay out while taking the above matters into account, in advance to the application of molecular robotics in society.

・Social issues

Molecular robotics is a field with high expectations for its possible research applications in society. However, as of now it is still under-recognized, and it could be said that most people are completely unfamiliar with the field. In truth even synthetic biology, which lies as the basic foundation of molecular robotics still has a relatively low recognition rate; this can be told from the survey performed in 2010 in Japan, involving over 1500 university students and general citizens, where only approximately 15% of the respondents replied to have heard of the word "synthetic biology". Thus it can be predicted that it will still take considerable time for the designs proposed in molecular robotics to be actually applied in real life.
In the attempt of increasing the level of familiarity of molecular robotics, "DNA" will become an important keyword. Although in the field of molecular robotics, DNA is only perceived as material, for general society, DNA is strongly associated with the image of being "genetic information". In addition, there is underlying concern about technologies such as genetic engineering, and there is a possibility of molecular robotics to be perceived in an incorrect way, Therefore, ensuring the safety of the developed designs and technologies will prove to be an obstacle in increasing the degree of recognition of molecular robotics.
When actually applying molecular robotic technology to society, the applications needed to be considered are not restricted to the human body. For example, in the past, systems such as those utilizing DNA as biopolymers to filter waste water have been proposed. Thus, researchers must conduct experiments with responsibility from the researching stages all the way to the application stages. Furthermore, since the risk of scientific technology implementing damage to people and the environment cannot be demolished, there is a need to predetermine who should shoulder the responsibility, as well as how to compensate for the damage in the case of unwanted effects being brought upon by molecular robotic designs.

3.Engineering Ethics and molecular robotics

The purpose of engineering is to make human activities, such as daily, commercial, and production activities, more simple and efficient by applying knowledge obtained from science. Therefore, in the case unjustful acts are performed in engineering, it will not only damage trust towards technology itself, but also affect the civilians using the technology. Especially in modern day society where labor division has proceeded and each individual engages mainly in their own specific area, people have no choice but to leave decision making in fields out of their knowledge to experts. More so, specialists in each profession must recognize their role in society.

However, in recent years there has been many engineering based failures, bringing upon doubt and concern towards the moral commitments of engineers. In the scientific field, as self-regulations, the three restrictions: peer-reviewing systems, evaluation systems, juridictions, have been imposed to prevent fraud. Yet, for the application of such scientific knowledge, functions to inquire the process is lacking in development. In addition, these frauds and corruptions in most cases can only be discovered by specialists. Thus, the responsibility lies with the engineer, but in addition to dishonesty of the engineer, cases in which the opinion of the engineer is smothered by the managers cannot be neglected. Since engineers are professionals with deep knowledge, it is true that they hold greater responsibility than the general public. While this is so, in many cases, engineers also can be seen from a social aspect in being a member of an organization, and the inclination to abide to power in human society can be the cause of corruption. There is a view that untruthfulness in scientific research may be permitted since it will regardlessly be fathomed along with time.
However, in engineering fields, this connotes the risk of causing damage to general public, and it is possible that the wrongdoings will only be brought to light after an accident occurs. Thus, engineers must recognize their responsibility in their roles as a member of society. It is impossible to abolish risks from scientific technology. Although the possibility of dangers may be calculated, it is up to citizens to decide where to draw the line for inacceptable acts of unjustness. Since engineering is founded upon its application, there is a need for engineers to deeply consider the effects of the products and technologies they develop would have on society.

Of course, restrictions to promote ethical practices, for example, qualification systems such as state examinations, inspection systems of the nation, strict punishments upon causing accidents, are all effective. However, these on their own will not suffice. In modern society where labor is divisioned, engineers must first be a moral citizen. For engineering education in Japan, in accordance to the start of the Japan Accreditation Board for Engineering Education (JABEE) Program, engineering ethic was integrated into education as a prerequisite, and students are given guidance on decision making based on past cases. In addition to employing education and training on a regular basis, it is necessary to measure its effectiveness and evaluate its effect. However, international uniformization and enstricting of rules have a possibility of becoming a hindrance to the freedom of research. To avoid hindrance of further development of scientific research, the contributions and risks to society through science research should continue to be discussed.

Along with globalization, scientific technology is enriching people's lives across countries. However, moreover since globalization is expected to accelerate, engineers in the field of molecular robotics should commit themselves further to ethics as specialists. Since harm inflicted by the lack of ethics is in no doubt occurring, engineers in serving must commit to the enhancement and evaluation of systems, and those who aspire to become engineers must hold a sense of dignity and responsibility as a specialist.


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