Innovation has the power to transform our lives and the world we live in - the promise of innovation can bring ethical dilemmas with uncertain or unpredictable impacts. Responsible Innovation is a process that seeks to promote creativity and innovation, recognising it is a collective responsibility between funders, researchers, stakeholders, and the public who all have an important role to play.
Responsible innovation involves assessing the potential impacts of the new product or service, including the impact on the innovating company, on customers, suppliers, and investors and the impact on wider society and the environment. This can include the need to consider the potential adverse effects due to potential misuse at the same time as considering the benefits. Actions are needed to mitigate any of the potential adverse impacts. Responsible Innovation includes, but goes beyond, considerations of risk and regulation. It is particularly relevant and most effective within the early stages of development and aligns well with the RAPAT process.
Innovating responsibly should be viewed as an approach which is mutually beneficial to both business and wider society, with which there is an ever-growing pressure to support more sustainable and less wasteful innovation, so that new products and technologies work for society, without causing more problems than they solve.
Innovate UK, together with BSI recognised that although companies want to do the right thing in innovation, it is not always clear what that is. Innovate UK therefore sponsored the development of a BSI publicly available standard, PAS 440: 2020: Responsible Innovation - Guide. PAS 440 provides guidance to companies on how to structure their thinking and processes to demonstrate they are innovating responsibly while remaining competitive in national and international markets. Two main elements of Responsible Innovation are captured within PAS 440:
Following the Responsible Innovation Framework described in PAS 440 can provide an effective approach for innovators to engage with investors, funding bodies, regulators, customers, and other stakeholders and reassure them of the responsible approach that has been taken with an appropriate level of mitigation taken for each individual potential risk.
The PAS 440 approach of identifying mitigations to identified innovation risks is very similar to the risk based approach to technology development and assurance seen throughout the worksheet steps of the RAPAT tool.
The RAPAT approach to Responsible Innovation, draws from the range of user and regulatory requirements identified in the Requirements worksheet and risks identified in the Commercial and Technical Risk worksheets elsewhere in the RAPAT tool and links them to the RAPAT Responsible Innovation worksheet focussing on the aspects related to innovation-led responsibility captured within PAS 440 Table 2.
This RAPAT worksheet on Responsible Innovation, firstly points the developer to the guidance on Responsible Innovation within PAS 440, with a link to the PAS 440 webpage. The Responsible Innovation worksheet is a supplementary resource within RAPAT, designed to support efficient product acceptance within the wider stakeholder community. The table within RAPAT while aligned to PAS 440, is intended to support its implementation and not replace it. Users are strongly encouraged to read and understand PAS 440, before undertaking any of the work facilitated by the worksheet.
The “Responsible Innovation” table within the worksheet aims to reflect the important factors that PAS 440 Table 2 highlights but introduces them in a form more familiar with the other RAPAT worksheets. The Responsible Innovation table within RAPAT enables risks to be cross-referenced across the other RAPAT worksheets, minimising additional effort and resources that would otherwise be used in replicating work.
At the top of the RAPAT “Responsible Innovation” worksheet, the “Responsible Innovation Sheet Completion Status” will initially be set to “Not started”. Use the dropdown list to change this to “In progress”, “Completed” or “Updated” as appropriate.
Populate the “Responsible Innovation” table, adding further rows using the “Add Row” button as required. Each individual section has an individual “Add Row” button.
The dashboard at the top of the worksheet automatically tracks progress against the Responsible Innovation elements included in the table. Any elements within additional sections will be captured within the “Other” row of the dashboard.
For each row, identify (brainstorm) the Responsible Innovation Element that is a positive or negative potential outcome of the innovation. Select which predefined categories each RI Element should be allocated to, based on its impact; either societal, environmental, health, value chain or regulatory categories. If the RI element doesn't fit within one of these categories, then a new category can be created with the “Add Category” button at the bottom of the table with an editable title. Identify any key stakeholders related to the RI Element (such as users, community representatives, investors) and whether engagement with these is required. For example, a consultation survey may be required to understand societal impacts.
The Responsible Innovation assessment should be thought of as a living document which is reviewed and updated on a regular basis to ensure it reflects the device development status and the completion of RI mitigation actions, including the action status (“Not started”, “In progress”, “Completed” or “Redundant”).
For each element, updates should be captured in the Element Amendments & Updates column together with the date of the update. In addition, any action progress in relation to engagement with stakeholders should also be captured. These updates should be reflected in the overall revision control of the RAPAT worksheets captured on the Customer Revision Control worksheet.
