Tait Joyce, Brown Alex, Lalinde Isabela Cabrera, Barlow Daniel, Chiles Matthew, Mason Paul
Innogen Institute University of Edinburgh High School Yards Edinburgh UK.
Strathclyde Institute of Pharmacy and Biomedical Sciences University of Strathclyde Glasgow UK.
Eng Biol. 2021 Mar 29;5(1):2-9. doi: 10.1049/enb2.12005. eCollection 2021 Mar.
In the development of innovative technology products, companies of all sizes are being encouraged to innovate responsibly and regulators are encouraged to adapt their regulatory systems to be smarter, more proportionate and adaptive to the needs of innovative technologies. The British Standards Institution Responsible Innovation (RI) Guide (Publicly Available Specification [PAS] 440) is an industry-wide standard relevant to both these policy trends. It supports companies by providing a framework to demonstrate the balance between the potential benefits and harms and, if necessary, to take action to maximise the benefits and/or minimise the harms. It includes guidance on engagement with stakeholders and will codify what stakeholders can expect from companies undertaking responsible innovation, paving the way to more harmonious relationships among stakeholders with differing interests and values. A cross-sectoral survey of innovative companies showed that 90% favoured the development of such a standard. PAS 440 was also trialled in two early-stage biotechnology companies and its expected benefits included contributing to coordinated responsible behaviour along a supply chain; better company and stakeholder understanding of the product properties; supporting decision-making on whether or not to start a company; considering the risks of not developing the product and avoiding reputational risks. Benefits were expected to be increasingly significant as the RI standard becomes widely adopted.
在创新技术产品的开发过程中，各类规模的公司都被鼓励进行负责任的创新，监管机构也被鼓励调整其监管体系，使其更智能、更适度且能适应创新技术的需求。英国标准协会的《负责任创新（RI）指南》（公开可用规范[PAS] 440）是一项与这两种政策趋势相关的全行业标准。它通过提供一个框架来支持公司，以展示潜在利益与危害之间的平衡，并在必要时采取行动以最大化利益和/或最小化危害。它包括与利益相关者互动的指导，并将编纂利益相关者对进行负责任创新的公司的期望，为利益不同和价值观各异的利益相关者之间建立更和谐的关系铺平道路。一项对创新型公司的跨部门调查显示，90%的公司赞成制定这样一项标准。PAS 440还在两家早期生物技术公司进行了试验，其预期效益包括促进供应链上的协调负责任行为；公司和利益相关者更好地了解产品特性；支持关于是否创办公司的决策；考虑不开发产品的风险以及避免声誉风险。随着RI标准被广泛采用，预计效益将越来越显著。
