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Oversight of Emerging Science and Technology Learning from Past and Present Efforts Around the World

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Oversight of Emerging Science and Technology Learning from Past and Present Efforts Around the World Oversight of emerging science and technology Learning from past and present efforts around the world Salil Gunashekar, Sarah Parks, Joe Francombe, Camilla d’Angelo, Gemma-Claire Ali, Pamina Smith, Daniela Rodriguez Rincon, Marlene Altenhofer, Gordon McInroy This report was prepared for Wellcome and is licensed under CC BY Wellcome. For more information on this publication, visit www.rand.org/t/RR2921 Published in 2019 by the RAND Corporation, Santa Monica, Calif., and Cambridge, UK R® is a registered trademark. RAND Europe is a not-for-profit research organisation that helps to improve policy and decision making through research and analysis. RAND’s publications do not necessarily reflect the opinions of its research clients and sponsors. Support RAND Make a tax-deductible charitable contribution at www.rand.org/giving/contribute www.rand.org www.randeurope.org III Preface Oversight of emerging science and technology oversight methods and extract learning where covers approaches or methods that encourage possible. The study adopted a mixed-methods the development of scientific and technological approach, employing a crowdsourcing exercise, innovations, and wider business arising desk research involving a rapid evidence from them, while also aiming to protect the assessment and key informant interviews, and interests of citizens and wider society. Science a workshop. and technology oversight can take place The lessons we have drawn out in our analysis through a range of mechanisms, including can be regarded as a set of guiding principles formal legislation, regulations, governance, to help stakeholders think about effective ways non-regulatory standards and guidelines, as in which to provide oversight with regard to well as other informal elements like public emerging science and technology. We envisage engagement, agreements and international that the lessons may be of interest to national co-operation. and local government policymakers, industry, Wellcome commissioned RAND Europe to innovators, funders and academia, but also undertake a qualitative comparative study more broadly to anyone – including the public of the oversight of emerging science and – interested in the development and adoption technology in past and present cases, spanning of new and emerging science and technology. different countries, sectors and time periods RAND Europe is a not-for-profit policy research to draw out common learning from these organisation that helps to improve policy examples. The study supports and feeds into a and decision making through research and wider project that Wellcome is carrying out to analysis. identify steps that would be required to position the UK as a global leader in the effective, For further information about RAND Europe efficient and ethical oversight of emerging and this document please contact: science and technology. Dr Salil Gunashekar (Research Leader) and To address the primary objective of the study, Dr Sarah Parks (Senior Analyst). we have developed a series of ten case RAND Europe, Westbrook Centre, Milton Road vignettes, both historical and current, and Cambridge CB4 1YG encompassing diverse geographical contexts, United Kingdom sectors, and science and technology areas, Telephone: +44 (1223) 353 329 to explore the effectiveness of different Email: [email protected]; [email protected] V Summary Background and context Objectives of the study Emerging science and technology has a Wellcome commissioned RAND Europe wide array of applications that cover many to undertake a qualitative comparative sectors and services. Most countries, study of the oversight of emerging science including the UK, regard emerging science and technology in past and present cases, and technology as key drivers for achieving spanning different countries, sectors and time societal and economic benefits. This ambition, periods, to draw out common learning from however, also presents numerous complex these examples. The study supports and feeds challenges. These include health, safety and into a wider project that Wellcome is carrying environmental risks that may be associated out to identify steps that would be required with novel developments, together with public to position the UK as a global leader in the concerns and perceptions about new scientific effective, efficient and ethical oversight of techniques or technologies. The challenge is emerging science and technology. To address to establish structures that capitalise on the the primary objective, we have developed ten benefits and opportunities offered by emerging case vignettes, both historical and current, and science and technology, while at the same encompassing diverse geographical contexts, time safeguarding the health and safety of sectors, and science and technology areas, to citizens and minimising risk. This process explore the effectiveness of different oversight of stewardship to shape the way emerging methods and extract learning where possible. science or technology develops over time is referred to as the process of ‘oversight’. We Methodology use an expansive interpretation of oversight in this study, broadly considering it to encompass We adopted a mixed-methods approach to methods that stimulate the development of address the objectives of the study. Specifically, science and technology, and business arising we employed the following methods: from them, while protecting the interests of citizens. This can include oversight approaches • Selecting the case vignettes such as legislation, regulations, governance, - A crowdsourcing exercise with standards and guidelines, and other informal stakeholders around the world elements like public engagement and to compile a long list of potential international cooperation. examples of emerging science VI Oversight of emerging science and technology short summaries of the ten case vignettes that and technology oversight. (The the study focuses on. stakeholders we approached included experts representing The Cartagena Protocol academia, government, regulatory on Biosafety and standards bodies, industry, The growing use of genetically and the third sector.) modified organisms during the 1990s, - A series of online searches (using particularly in the area of agricultural Google and Google Scholar) biotechnology, brought with it growing public conducted in parallel with the concern around the possible environmental crowdsourcing exercise to identify and human health risks associated with GMOs. (additional) examples of emerging This particularly was seen in developing science and technology oversight. countries that were not yet participating in - A prioritisation exercise with GMO trade and were concerned about the risks Wellcome to select the ten case of entry of GMOs into their countries without vignettes around which to focus their knowledge. To address these concerns, the study. the 2003 Cartagena Protocol on Biosafety was developed as a legally binding international • Developing the case vignettes agreement to govern the transboundary - Desk research involving an movement of genetically modified organisms. accelerated evidence assessment of the academic and grey E-government and digital literature related to each society in Estonia of the case vignettes. From the mid-1990’s onwards, - A series of interviews with Estonia emerged as an early promoter of both stakeholders connected to the case e-government and wider digital society related vignettes, in order to obtain deeper activities. Throughout the 1990s and 2000s, the insights into the specific examples. government of Estonia took measures to support the integration of ICT into government services • Comparative analysis of the case and lay the foundations for a digital society vignettes more broadly. Its oversight comprised wide- - A workshop with Wellcome to ranging mechanisms (and collaboration with cross-analyse the findings from private sector stakeholders), including: strategic the vignettes and extract common policy documents; legislation; tax incentives; themes and lessons learnt in standardisation; technological infrastructure and relation to the oversight of capacity building; and educational programmes emerging science and technology. designed to build ICT skills. Fintech regulatory sandboxes Illustrations of emerging science in the UK and beyond and technology oversight in action The emergence of new, and The case vignettes offer a ‘real-life’ illustration potentially disruptive, financial technologies of how oversight has been carried out in generates opportunities but also brings practice in different contexts. Below we present new risks, both for banking systems and VII for consumers. Borrowing from ‘sandbox’ also trying to limit the potential financial risks approaches deployed in other contexts, in associated with the technology. 2015 the UK Financial Conduct Authority (FCA) developed the concept of a fintech ‘regulatory DAMD: The Danish General sandbox’; a regulatory ‘safe space’ in which Practitioners Database eligible firms can carry out limited tests From the late 1990s onwards, on innovative fintech products while being European countries began to promote exempt from certain regulatory requirements. digitalisation in healthcare systems. As The concept has proved popular with other part of this agenda, the digitalisation of governments, particularly in the Asia-Pacific patient data had the potential to dramatically region. improve the healthcare provision and the analysis of healthcare systems. Against this The Green Revolution: backdrop, from
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