Team:SZU-China/Ethical Analysis



Ethical Analysis (Responsible Innovation)

The "four dimensions" model of
"responsible innovation"

Responsibility ethics is a traditional sense of responsibility often used in the process of scientific innovation. It refers to the idea that people should be held responsible for the "foreseeable consequences" or even "unpredictable consequences" of their actions (especially those of science and technology). This concept awakens people's sense of responsibility for human "existential" risk and puts forward the "enlightenment of fear," but its keynote is more of an abstract metaphysical view of responsibility.

Its limitations are also clear, too much thinking about "unpredictable consequences" will significantly reduce the room for innovation. The development of new disciplines will be stalled by "fear." Thus, the concept of "responsible innovation" emerged. "Responsible Innovation" refers to the expansion of an abstract sense of responsibility to the level of activity in the process of scientific innovation. Based on retaining the "forward-looking" core of responsibility ethics, more discussions are made on how to take measures to prevent and avoid risks and hazards. "Responsible innovation" implies the concept of active responsibility.

In the early stage of the project preparation, we learned from the literature review that British scholar Owen once put forward a "four-dimension" model for "responsible innovation," namely, the model of "prediction, reflection, negotiation and feedback." The UK Centre for Innovation, Business and Industrial Transformation in Synthetic Biology (SynbiCITE) then combined the Engineering and Physical Sciences Research Council (EPSRC) 's Area-based framework for responsible innovation with synthetic biology. We have developed a series of approaches to translate the concept of "responsible research and innovation" into the management and governance of synthetic biology. In order to gradually implement the idea of "responsible innovation," at the beginning of our project, we established the purpose that every step of our action should be carried out according to the framework of responsible innovation. The following is an analysis of the connotation of each link of "responsible innovation" and our corresponding efforts.

The contents include:


We actively seek to collaborate with synthetic biology scientists, regulators, the public and other stakeholders to anticipate the economic, environmental and social impacts of current synthetic biology research projects and understand the needs and concerns of early adopters.

Our human practice section did a lot of work in the segment called anticipation. Since the beginning of the project, we have actively grasped the opportunity to contact patients to find out their real needs. At the same time, we also conducted a large number of surveys and interviews with clinicians, nurses and other stakeholders to understand the pain points and treatment significance of this disease, and the subsequent project design was also based on what we learned. In the subsequent cooperation with the company and the writing of business plans, full consideration was also given to the project's economic, environmental, and social impacts. Macroeconomic, industry market, and market demand analysis all indicate a significant unmet clinical need in the field of IBD treatment.

Political Economic
 Medical separation policy;Policies to encourage pharmaceutical innovation  The rise of medical consumption expenditure per capita of Chinese residents;
Great potential in the internet medical content market
Social Technology
 The public's cognition and channel of medicine are blank;As the public's  awareness of health has increased, the "Internet + Medical" industry has a vast space for development The transformation trend of digital marketing of pharmaceutical enterprises;
China's innovation drug research and development focus shifted to chronic
diseases;The treatment of moderate and severe IBD has entered the era of
biological agents;Engineering bacterial drugs are widely used

At the same time, under the premise of cooperation with the company, it also helps us to predict the potential impact and risk directly related to the project itself, so that the risk can be recognized, managed and controlled within an acceptable range.


This requires partners to reflect on the purpose and motivations of their work and analyze the impact their work may have on society. Also, understand uncertainty, uncharted territory, assumptions, and problems in the innovation process. The requirement places particular emphasis on incorporating "responsible research and innovation" into the training of relevant researchers and regular skills training.

In this part, the following things we do can be reflected. After the project is established, we actively seek opinions from experts and scholars in related fields, and evaluate the necessity and feasibility of the project scientifically and objectively with their help. And analyze the possible impact of our project not only on patients, but also on the ecological environment, social environment, laboratory safety, environmental protection, biosafety and biosecurity risks. And apply our considerations to project design. For example, in the protection of the natural environment and patients, we have designed the suicide switch; In alleviating social pressure and giving care to patients, we launched a health management platform; In the pain point of patient stool sampling, we carried out hardware design and so on.

During the preparation process, our team also held several small seminars related to "responsible innovation" and "synthetic biology ethics." Make sure team members are familiar with the concept of responsible research and innovation and contribute ideas and ideas on how the project can be conducted more ethically. In our discussion, we mentioned, we hope our "responsible innovation" can extend the perspective of technology innovation to the social, ethical, and public interests, the system construction and other fields, focus on the stakeholders of the whole process of technology innovation, coordination among them are divided and even conflicting values, to achieve the win-win or multi-win.

Such thinking and discussion run through the whole process of our project.

Fig.1 Mini-seminar within the team.

Thus, in our later human practice, our vision was not limited to IBD itself, but to patients, their families, and the social and ethical implications of our project.


This encourages partners to engage in public dialogue and actively educate the public about the benefits and potential of synthetic biology applications. Support, organize and participate in a range of public-facing activities to address critical issues of public acceptability.

We have designed a number of promotional materials featuring the project, including mobile games, card games, picture books and brochures, to publicize our research, as well as spread a large amount of synthetic biology information on social media to encourage the public to participate in our innovative projects. This section is available in our Education section. Also, we've done a lot to educate the public about our program and synthetic biology. At the same time, we also made a questionnaire to investigate the public's acceptability of genetically engineered bacteria and drugs, and wrote a research report on "Bring scientific and literacy knowledge and offer medical service to rural areas" based on China's national conditions.

4. Action

This requires us to provide timely feedback to our partners on the results of these activities so that they can apply innovations for the common good and work together to address key social challenges.

We updated our project progress in our business plan and shared the results with Xbiome in a timely manner. In addition, we often discuss with the students majoring in marketing and business administration in the school of Management, hoping that their suggestions can help us better achieve the implementation of the project.

Six key dimensions of responsible innovation

In 2014, the report Responsible Research and Innovation: Europe's Capacity to Respond to Social Challenges also pointed out that "responsible research and innovation" needs to operate within six key dimensions, including public participation, gender equality, science education, open access to scientific results, ethics and governance.

Therefore, we took these six critical dimensions as a reference, combined with the content of our project, implemented a series of measures to reflect our "responsible innovation attitude."

For example, for science education, we focus on the education of children and adolescents aged 6-18, and take kindergarten, primary school, middle school, high school and university as different age groups to carry out responsible and innovative education of synthetic biology, thus meeting the operational requirements of this dimension. We also conducted a series of public education programs for the general public and patients involved in the program.

In view of the open-access scientific results, we use our WeChat public account and social media platform to share our project progress, we actively participate in various academic exchange activities at the same time, provide our innovative projects for professional counterparts to discuss, from the perspective of professional to reflect our responsible attitude for innovation. At the same time, most of our academic exchange activities are also open to the public, so that the public can keep abreast of the progress and content of our projects.

Concerning ethical issues, our projects are conducted within the relevant ethical standards and guidelines. As a competition project, we strictly adhere to the iGEM Safety Form standards, so there will be no (including potential) transgressions.

Finally, for pollution control, we have taken safety into careful consideration in the project's design. We designed a series of kill switches to prevent the escape of engineered bacteria and pollution to the natural environment. At the same time, we learned about FDA's LBP certification and approval standards, and referred to a series of regulatory documents to ensure that our products are controllable and treatable.