科技伦理与安全审查的内在理路与二元结构——以《生物安全法》为中心展开

The internal logic and dual structure of scientific and technological ethics and safety review——Focusing on biosafety law

科技研发应当遵循“科技向善”的理念,科技伦理与安全审查机制的建立十分重要。科技伦理与安全审查机制是生物安全风险防控和治理体系建设的重要组成部分,科技伦理与安全审查从“形式要件”到“实质要件”,均应当体现实体伦理正义和程序伦理正义的科技善治。我国应当构建科技伦理与安全审查二元体系结构:在内部审查结构中,制定具有统一性的科技伦理与安全审查实体性规则、程序性规则,从审查方式、审查标准、审查类型、主体法律责任四个方面对科技研发行为和科技产出成果予以规范。在外部审查结构中,建立信用机制及负面清单制度,形塑公众参与式审查模式,以期从源头有效规避科技伦理与安全风险。

Science and technology research and development should follow the concept of"science and technology for good",and the establishment of science and technology ethics and safety review mechanisms is very important.The scientific and technological ethics and safety review mechanism is an important part of the construction of the biosafety risk prevention and governance system.In order to ensure that the order value of scientific and technological innovation is not destroyed,the scientific and technological ethics and safety review must be transparent from"formal elements"to"substantial elements",rigorous and standardized.At present,China has formulated many norms in terms of scientific and technological ethics and safety review.However,there are many overlapping and complicated contents between the norms,and the level of effectiveness is also low.Therefore,the dual structure of China’s science and technology ethics and safety review mechanism should be shaped.Establish a scientific review mechanism from two aspects:internal review structure and external review structure.In the internal review structure,an independent review agency should be established.From the perspective of functions and scope of authority,the National Science and Technology Ethics Committee and the Local Science and Technology Ethics and Safety Review Committees are independent review organizations,and they have the entitlements to formulate science and technology ethics and safety review standards.In terms of the scope of review obligations,the science and technology ethics committee shall be obliged to disclose the review information of science and technology projects,the handling of major science and technology ethical risk events,and the review decisions of science and technology projects in accordance with the law.The linkage between review agencies can effectively avoid potential hidden dangers of scientific and technological ethics and safety,so as to ensure that the review subjects can be fully covered and coordinated.The review agency shall formulate unified scientific and technological ethics and safety review substantive rules and procedural rules,and deal with the scientific and technological research and development activities,scientific and technological output results from the four aspects of review methods,review standards,review types,and subject legal responsibilities.Under the coordination of the Biosafety Law,the principles of science and technology review,ethical justice,transparency,and public participation have been clarified.In the external review structure,establish a credit mechanism and a negative list system to shape a public participatory review model.Institutions engaged in major scientific and technological research and development shall truthfully disclose the information of scientific and technological ethics review to the public,including clinical trials,standard operating procedures,informed consent,suspicious and unexpected serious adverse reactions,and take corresponding modification and relief measures for the review results,which shall be subject to social supervision,with a view to effectively regulating the experimental behavior and results output in scientific research and development,in order to effectively avoid scientific and technological ethics and safety risk.Reasonably protect the legal rights and interests of the subject in the process of biotechnology research and development,avoid the risks of scientific and technological ethics,and truly realize the good governance of science and technology that integrates substantive ethical justice and procedural review justice.