ELSI

What is ELSI?

ELSI refers to the field of study that revolves around the ethical, legal, and social issues by the development of science and technology, especially the novel technologies such as biotechnology, artificial intelligence, and big data. The rapid advancement of these technologies has not only brought unprecedented opportunities but also raised widespread social concerns and apprehensions. Consequently, ELSI research has emerged to delve into the ethical principles, legal norms, and societal impacts behind these technologies.

• This study does not involve any experiments on animals or humans.
• We used the human lung cancer cell line A549 cells in this project. The cells were purchased from ATCC approved by an ethics committee and adhered to international ethical guidelines for cell research.
• Gold nanoparticles were synthesized by the Chemistry Department, and the synthesis processes were carried out in compliance with legal and regulatory standards. Consideration is given to the biosafety of gold nanoparticles in in vivo studies. If the research involves animal models or potential future applications in humans, it is necessary to assess the metabolism, distribution, and excretion of gold nanoparticles within the body. For instance, gold nanoparticles may accumulate in some organs, and potentially affect their function, which requires in-depth research from an ethical standpoint aimed at protecting the health of living organisms.
• Considering the possibility of plasmid transmission between cells or organisms and its ethical implications, if plasmids can be transmitted between cells and carry expressible genes, they may alter the gene expression of surrounding cells, which could impact the entire organism in vivo. For instance, in the body, this could affect the function of normal tissue cells and trigger potential health issues. Ethically, it is necessary to fully assess these potential impacts.

• When conducting cell experiments, it is necessary to comply with national and local laws and regulations regarding the collection, preservation, and use of biological materials. For example, in China, the Regulations on the Administration of Human Genetic Resources regulate the activities such as the collection, preservation, utilization, and provision to foreign entities of human genetic resources, including cell samples. Researchers are required to go through the relevant approval or filing procedures as stipulated.
• If the results of cell experiments in this study are to be used for commercial development, such as the development of new lung cancer theraputic drugs, it is necessary to comply with the relevant laws related to drug research and development and approval, such as the Drug Administration Law. This includes legal requirements for drug clinical trials, drug quality control, and the drug registration and approval process.
• The plasmids were purchased from Addgene (United States). The construction, use, and dissemination of plasmids may involve intellectual property laws. If the plasmids contain specific gene-editing technologies or innovative gene constructs, researchers need to consider applying for patent and other intellectual property protection measures, while also avoiding the infringement of others intellectual property rights.

• The content of this study has potential implications for public health. If the research outcomes can be translated into the effective lung cancer treatment methods or diagnostic tools, they will have a positive social impact on the lung cancer patients, improving patients’ survival rates and quality of life. However, if there are any ethical or legal violations in the research process, such as inaccurate cell experiment results, it could lead to the development of incorrect treatment plans, or the application of unsafe gold nanoparticles to humans, it could pose a serious threat to public health.
• If the research outcomes involve expensive lung cancer treatment methods, such as targeted therapy drugs based on new targets, considerations of social equity and the distribution of medical resources are necessary. It is important to ensure that research outcomes would be fairly distributed among patients from different socioeconomic backgrounds, avoiding the situations if some patients are unable to access effective treatment due to economic reasons.
• In different cultural backgrounds, people may have various degrees of acceptance for cell experiments and nanotechnology. Researchers need to consider these cultural differences, and respect the values of different cultures during the research process, and improve the societal inclusiveness towards the scientific research through scientific popularization.

[1] ELSI planning and evaluation history. http://www.genome.gov/10001754.2012-2.

[2] Smith RH.Social,ethical,and legal implications of nanotechnology.//Roco MC, Bainbridge WS,ed.Science implications of nanoscience and nanotechnology,2001: 257-271.

[3] Patra D, Ejnavarzala H, Basu PK. Nanoscience and nanotechnology:ethical,legal, social and environmental issues. Current Science, 2009(5): 651-657.

[4] Bjornstad DJ, Wolfe AK. Adding to the mix:integrating ELSI into a national nanoscale science and technology center. Science and Engineering Ethics, 2011(4): 743-760.

[5] Tuma JR. Nanoethics and the breaching of boundaries:a heuristic for going from encouragement to a fuller integration of ethical,legal and social issues and science. Science and Engineering Ethics, 2011(4): 761-767.

[6] Ellerin BE, Formenti S. The impending ELSI crisis:Identifying the ethical,legal, and social issues that threaten the future of academic oncology research. International Journal of Radiation Oncology Biology Physics, 2004(1): S553-S553.

[7] Centers of Excellence in ELSI Research. http://www.genome.gov/15014773.2012-2.

[8] NHGRI launches Centers for Excellence in ethical,legal and social implications research. http://www.genome.gov/12512375.2012-2.