Overview
In our human practices，We have examined ethic and laws from two perspectives. Firstly, we comply with the laws and regulations and secondly, we obtain the opinions and suggestions of the community on this project through social practice activities. In terms of laws and regulations, we have not only complied with the laws of our country, but also with international law. In our social practice activities, we have mainly used interviews to obtain the opinions of doctors and related people in echinococcosis infected areas on ethics and morality.
National Law
Our project strictly follows the Biosafety Law of the People's Republic of China, which is mainly reflected in.
(1) Article 40 in Chapter IV (Safety in Biotechnology Research, Development and Application): Clinical research on new biomedical technologies shall pass ethical review and be conducted in medical institutions with appropriate conditions; operations for clinical research on humans shall be performed by health professionals and technicians who meet the appropriate conditions.
(2) Article 35 in Chapter IV (Safety of Biotechnology Research, Development and Application): Units engaged in biotechnology research, development and application activities shall be responsible for the safety of their own biotechnology research, development and application, adopt biosafety risk prevention and control measures, develop work systems for biosafety training, follow-up and inspection, and regular reporting, and strengthen process management.
(3) Article 53 in Chapter VI (Human Genetic Resources and Safety of Biological Resources): The State shall strengthen the management and supervision of the collection, conservation, utilization and external provision of human genetic resources and biological resources in China, and safeguard the safety of human genetic resources and biological resources.
International Law
The international community's interest in biosecurity issues began in the 1980s. At present, a system of international law on biosafety has been formed in international law based on the 1992 Convention on Biological Diversity, centred on the 2000 Cartagena Protocol on Biosafety and supplemented by the 2010 Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Biosafety Protocol and other international law documents. Many countries and regions, including ours, have developed biosafety-related policies, legislation and technical guidance to provide a basis for biosafety management.
Our project strictly follows the following three principles of international law on biosafety:
(1) The principle of risk prevention
The Convention on Biological Diversity (CBD) states that the lack of full scientific certainty should not be used as a reason for postponing measures aimed at avoiding or minimising the threat of serious reduction or loss of biodiversity, and that Parties should develop or adopt approaches to regulate, manage or control biotechnologically modified living organisms that may adversely affect the conservation and sustainable use of biodiversity and human health. risks that may arise from the use and release of living organisms modified by biotechnology that may adversely affect the conservation and sustainable use of biological diversity and human health. The Cartagena Protocol on Biosafety incorporates the principle of precautionary risk throughout. The precautionary principle is fully reflected in other international legal documents on biosafety, such as the Agreement on the Application of Sanitary and Phytosanitary Measures, the International Plant Protection Convention and the Protocol to the Antarctic Treaty on Environmental Protection.
(2) The principle of precautionary development
In international law, the principle of precautionary development is reflected in the conservation and use of biodiversity, phytosanitary protection, the handling, transport and labelling of biotechnology products and specific organisms, and the protection of polar ecological environments. Of these, the relevant provisions of the Convention on Biological Diversity and the Cartagena Protocol on Biosafety are the most obvious. For example, the Convention on Biological Diversity provides for the "sustainable use" of biodiversity components on the one hand, and the "minimisation of adverse effects" on the other. The Cartagena Protocol on Biosafety does not aim to inhibit the development of biotechnology, but rather to "ensure that adequate safeguards are in place for the safe transfer, handling and use of living modified organisms obtained through modern biotechnology that may adversely affect the conservation and sustainable use of biological diversity, taking into account the risks posed to human health and with particular emphasis on the transboundary nature of biotechnology". with particular emphasis on transboundary movements".
(3) The principle of stewardship
The basis for the principle of stewardship in international law on biosafety is reflected in the Cartagena Protocol on Biosafety. From the handling, transport and packaging of genetically modified organisms, to transit, transboundary movement and emergency measures, to their use, the Protocol provides comprehensive provisions on how to achieve its objectives at different stages and aspects, in order to implement the principles, systems and measures of international law on biosafety. In terms of risk management, the Protocol stipulates that Parties shall "develop and maintain appropriate mechanisms, measures and strategies to control, manage and control the risks arising from the use, handling and transboundary movement of living modified organisms as identified in the risk assessment provisions of this Protocol", thus making risk management a cross-cutting issue at all stages.
Regulations
We strictly follow the rules and regulations as follows: Central South University laboratory safety and Environment protection network , Laboratory safety management standards of Central South University, including laboratory routine safety knowledge, emergency injury knowledge, hazardous chemical safety knowledge, fire safety knowledge, electrical safety knowledge, radiation safety knowledge, medical and biological safety knowledge, and special equipment safety knowledge.
Ethic
We used interviews to gather the opinions, attitudes and concerns about the ethical and moral aspects of our project from people in echinococcosis infected areas. And we have improved our project in response to these suggestions. For example:
(1)In the interview with Zhou Xiaotao, Xinjiang Medical University, we mention that the diagnostic means of echinococcus is mainly through imaging and immunological detection, but most of them can be diagnosed only in the middle and late stages, while our project is to use RPA and Cas12a to detect the cfDNA of echinococcus for the diagnosis of early echinococcusis, and finally a test paper product will be made.we asked her if such a new diagnostic method would be accepted by doctors and patients.
She thinks a simple, convenient and fast diagnostic kit is certainly more acceptable to doctors and patients.
(2)In the interview with Doctor LiChong,we tell him that our project uses an in vitro assay for circulating free DNA , which requires the collection of blood samples from patients and ask him if our approach could be accepted by Tibetan residents.
He thinks that due to the traditional Tibetan culture, patients are generally resistant.
