Abstract
In 1990, the National Institutes of Health (NIH) and the Department of Energy (DOE) established the Ethical, Legal, and Social Implications (ELSI) Research Program, with its functions and objectives being: to anticipate and address the impactof human genome sequencing on individuals and society; to scrutinize the ethical, legal, and social consequences of human genome sequencing; to stimulate public discourse on such issues; and to promote the development of policies and programs that ensure the use of information in a manner consistent with the interest of individuals and the society.
The ELSI Research Program has shown a profound impact. It has made the general public aware of the various ethical issues brought about by modern scientific and technological advancements, including potential ethical issues that may arise during the scientific research process, as well as the potential impacts of scientific research on nature and society. At the same time, it has made society aware of the scientific community's emphasis on the various consequences brought about by scientific development.
The advent of DNA origami technology has revolutionized the field of nanorobotics, enabling the construction of sophisticated nanoscale structures with potential applications in drug delivery, molecular computing, and diagnostics. As these technologies advanced, they raise a plethora of ethical, legal, and social implications (ELSI) that demand thorough examination. This study aims to provide a comprehensive analysis of the ELSI aspects associated with the development and application of DNA origami nanorobots.
Ethical
The Ethics section typically facilitates ensuring that research is ethically acceptable and garners societal trust and support.
Research Ethics
• Autonomy of Participants: No human subjects were involved in the laboratory procedures. Interviews conducted under the Social Implications section were all obtained with informed consent.
• Informed Consent: Participants were fully informed about the purposes of the interviews.
• Privacy Protection: To safeguard the privacy of participants, we have refrained from disclosing their personal information on our website.
Equity and Justice
We strive for equity and fairness in both research outcomes and processes, with no form of discrimination or bias present in the research conduct.
Transparency
Our research process is characterized by transparency, with raw data being publicly accessible on our website. Throughout the experimental procedures, the laboratory is subject to external supervision and scrutiny by instructors and other qualified individuals at any time.
Legal
The Legal section ensures that our research is lawful, compliant with institutional, national, and international regulations, and contributes to conducting research within a reasonable scope that does not threaten societal security.
Biosafety
Ensuring biosafety during the research process involves preventing potential hazards to the environment and human health.
• The plasmid scaffold we utilize is M18mp13 p7249, which is non-infectious to humans or any other organisms.
• When preparing agarose gels for DNA electrophoresis, we opt for non-toxic red fluorescent dyes in place of ethidium bromide, which are non-toxic and non-mutagenic.
• In verifying the functionality of light-controlled switches, we employed a near-infrared laser emitter. Higher power near-infrared lasers can damage vision, cause skin burns, and ignite fires. Therefore, we strictly adhere to the user manual and university regulations, using near-infrared lasers within a safe power range.
• During electron microscopy sample preparation, we used negative staining techniques, which involve the use of uranyl acetate, a highly hazardous reagent to biological entities. Consequently, the corresponding experiments are conducted under strict experimental records and supervision to ensure the use and disposal of highly toxic reagents comply with university regulations.
Information Security
We ensure the security of data and information, including experimental data and potentially involved genomic sequence information.
• The sequence of the plasmid scaffold M18mp13 p7249 we use is publicly available (ordered from Biorule), and there is no risk of revealing sensitive personal or genetic information.
• The staple strands are designed using the caDNAno software, which, to our knowledge, does not carry genetic information or the risk of information leakage.
Copyright
DNA sequences, as part of the research outcomes in the field of DNA origami, may involve patent and copyright issues.
• We ensure that there is no unauthorized use of any patented technology during the research process. We utilize publicly available software such as caDNAno and CanDo.
Clinical Safety
Our research does not involve any clinical data. Should it be applied to clinical aspects in the future, it should strictly comply with relevant laws, regulations, and ethical standards, clarifying the design, approval, implementation, and monitoring processes of clinical trials to ensure compliance with GCP (Good Clinical Practice) standards.
Social implications
In the Social Implications section, we intend to outline the potential audience and relevant demographics for Doara, presenting our interviews and their thoughts on the potential social impacts of Doara through a Q&A format. To protect the privacy of the interviewees, we do not display their personal information on our website. If interested in this section, please contact cuitong0808@163.com.
Potential Social Aspects Affected
Our team conducted a brainstorming session to list the following social aspects that may be affected by Doara: government (formulating relevant policies), biotech companies (developing products), healthcare industry (applying products), patients (using products), and educational sector. We then conducted interviews with practitioners from these industries and briefly described our interviews. We hope that the concerns and issues they raised during the interviews can provide guidance for the ELSI research of this project.
Government Officials
Q: (Briefly introduced Doara) So, what positive impacts do you think this technology could bring to the group you represent/your work?
From a social planning perspective, if this therapy can improve patients' medical experiences and reduce their suffering, then it has value in being implemented. Additionally, as a new potential means of precision medicine/diagnosis, it may reduce healthcare expenditure, which is also very beneficial.
From your perspective, do you think this technology has any negative social impacts? What potential risks do you see?
Many technologies with clinical application prospects face challenges in translation to practical use. The costs associated with implementing could be very high, which is a concern that must be considered.
Biotech Businesspeople
Q: (Briefly introduced Doara) So, what positive impacts do you think this technology could bring to the group you represent/your work?
A: In my opinion, technological progress is definitely more beneficial The application of technology in the medical field for disease detection or direct destruction of pathogens is a beneficial direction.
Q: From your perspective, do you think this technology has any negative social impacts? What potential risks do you see?
A: I believe that the control systems for nanorobots are still very limited, and even the control systems for larger robots are not perfect. They are not sensitive enough, and perhaps future applications of artificial intelligence will improve this. On the other hand, if this technology is applied to the military, it could also harm people's privacy or safety.
Physicians
Q: (Briefly introduced Doara) So, what positive impacts do you think this technology could bring to the group you represent/your work?
A: I believe this technology can greatly assist in precision medicine. More accurate and convenient diagnostic and therapeutic tools are very much needed in modern medicine.
Q: From your perspective, do you think this technology has any negative social impacts? What potential risks do you see?
A: In my opinion safety is always the most concerning issue. The cost of nanorobots going out of control in clinical scenarios would be very high.
Patients
Q: (Briefly introduced Doara) So, what positive impacts do you think this technology could bring to the group you represent/your work?
A: Is it a new kind of medicine?
Q： No, Doara is actually a delivery platform. In layman's terms, it has the potential to be a therapeutic, diagnostic, and transportation tool. Or you can imagine nanorobots that can wander in your body, performing various functions among cells. What expectations do you have for them?
A: Actually, I am very excited about this technology! There are still many diseases that current medical treatments cannot cure or are too costly. I hope nanorobots can cure diseases that were previously incurable or have fewer side effects than current medications.
Q: From your perspective, do you think this technology has any negative social impacts? What potential risks do you see?
A: I am concerned about whether this new technology is mature and safe enough. If it fails to function properly, could it cause damage to ourbody? I would definitely feel anxious when trying this therapy.
Education Professionals (An Elementary School Teacher)
Q: (Briefly introduced Doara) So, what positive impacts do you think this technology could bring to the group you represent/your work?
A: I think this cool new technology can spark students' interest in science. It can attract students who love science and help them understand the professions they might pursue.
Q: From your perspective, do you think this technology has any negative social impacts? What potential risks do you see?
A: I can't really think of any risk that this new technology could bring to the education industry. I believe new technology is a reflection of societal and human progress, which is what education aims to teach children. Perhaps there might be issues with safety or social risks, but from an educational standpoint, technological innovation is generally worth encouraging.
Summary
The above interview content may include the views of various sectors of society on Doara. In summary: the main concerns people have include the potential progress that it could bring to clinical therapeutic methods and worries about its safety risks, which remind us to pay particular attention to the verification and evaluation of these aspects.
Conclusion
As the field of DNA origami nanotechnology advances with groundbreaking developments, we are confronted with a complex array of ethical, legal, and social issues. This study delves into these ELSI concerns, aiming to provide the scientific community, policymakers, and the public with a comprehensive perspective to understand and address these challenges.We call for a collective effort from the scientific community, policymakers, and the public to ensure that the development of these technologies benefits humanity while respecting ethical principles and societal values. We look forward to future research continuing to explore these ELSI issues and providing guidance and insights towards achieving this goal.
References
Chemical safety
[1] Regulations on the Safety Management of Hazardous Chemicals (State Council Order No. 344, 2013 Revision)
《危险化学品安全管理条例》国务院令第344号 2013年修正
http://www.gov.cn/gongbao/content/2002/content_61929.htm
[2] Regulations on the Control of Precursors for the Manufacture of Narcotic Drugs and Psychotropic Substances (State Council Order No. 445, 2018 Revision)
《易制毒化学品管理条例》国务院令第445号 2018年修正
http://www.gov.cn/gongbao/content/2005/content_91170.htm
[3] Administrative Measures for Toxic Drugs Used in Medical Treatment (State Council Order No. 23)
《医疗用毒性药品管理办法》国务院令第23号
http://www.moh.gov.cn/mohzcfgs/pfg/200804/18300.shtml
Safety of radiation
[4] Classification Method for Radioactive Sources (Announcement No. 62, 2005, State Environmental Protection Administration)
《放射源分类办法》国家环境保护总局公告 2005年 第62号
http://www.gov.cn/gzdt/2005-12/28/content_140242.htm
[5] Classification Method for Radiation Apparatus (Announcement No. 26, 2006, State Environmental Protection Administration)
《射线装置分类办法》环境保护总局公告 2006年 第26号
http://www.zhb.gov.cn/info/gw/gg/200605/t20060530_77223.htm
Special purpose equipment
[6] Supervision and Administration Measures for Special Equipment Operators (Order No. 70, General Administration of Quality Supervision, Inspection and Quarantine, 2011 Revision)
《特种设备作业人员监督管理办法》质量监督检验检疫总局令第70号 2011年修改
http://www.gov.cn/flfg/2011-05/24/content_1870206.htm
[7] Regulations on the Reporting and Investigation of Special Equipment Accidents (Order No. 115, General Administration of Quality Supervision, Inspection and Quarantine)
《特种设备事故报告和调查处理规定》质量监督检验检疫总局令第115号
http://www.gov.cn/flfg/2009-07/10/content_1361894.htm
Protection of the environment
[8] Environmental Protection Law of the People's Republic of China (Chairman's Order No. 22)
《中华人民共和国环境保护法》主席令第二十二号
http://www.gov.cn/fwxx/bw/hbzj/content_810469.htm
[9] Environmental Impact Assessment Law of the People's Republic of China (Chairman's Order No. 77)
《中华人民共和国环境影响评价法》主席令第七十七号
http://www.hbepb.gov.cn/hbfg/fl/200606/t20060606_8646.html
[10] National Catalogue of Hazardous Wastes (Ministry of Environmental Protection Order No. 1)
《国家危险废物名录》环境保护部第1号
http://www.gov.cn/flfg/2008-06/17/content_1019136.htm
Special thanks
iGEM2024 Jilin-China Project Safty Form
https://teams.igem.org/5446/safety/905a6e1c-6acc-41a8-8d06-6949d03f3325
