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ABSTRACT
This article builds on discussions on peer review in science and the role of ethics in the governance of technologies to achieve a two-fold goal. First, it shows the process of co-production of the European Commission’s (EC’s) standardised ‘ethics appraisal process’ with the development of the EC’s Framework Programmes (FPs), by looking at the standardisation of the process and the mutual shaping of data protection law and risk-based discourses around Artificial Intelligence. Second, it investigates the political and epistemic implications arising from this process for the EU governance of scientific research regarding (1) sponsorship of science and technology by the EU and (2) how many limitations or constraints researchers have in practice when carrying out their research. After sketching the origins of the ethics appraisal process and its co-production with data protection law and risk-based jargon, the article outlines the implications for the governance of scientific research and draws recommendations.
Disclosure statement
No potential conflict of interest was reported by the author(s).
Notes
1 These are referred to as ‘Mode 1’ and ‘Mode 2’ science respectively. See Michael Gibbons and others, The New Production of Knowledge. The Dynamics of Science and Research in Contemporary Societies (SAGE Publications Ltd, 1994) 4.
2 Jacob Metcalf and Kate Crawford, ‘Where are Human Subjects in Big Data Research? The Emerging Ethics Divide’ (2016) 3 Big Data & Society 1.
3 Peer review originated to validate experimental methods and empirical observations in science Sheila Jasanoff, ‘Peer Review in the Regulatory Process’ (1985) 10 Science, Technology, & Human Values 20, 21. The process originated in the referee system adopted by the Royal Society in the late seventeenth century to evaluate papers for the Philosophical Transactions, Harriet Zuckerman and Robert K Merton, ‘Patterns of Evaluation in Science: Institutionalisation, Structure and Functions of the Referee System’ (1971) 9 Minerva 66.
4 Each funding agency and country may have different institutional settings for peer review. Still, it is possible to make cross-cutting reflections about the phenomenon in general, GDL Travis and HM Collins, ‘New Light on Old Boys: Cognitive and Institutional Particularism in the Peer Review System’ (1991) 16 Science, Technology, & Human Values 322.
5 Sheila Jasanoff, The Fifth Branch. Science Advisers as Policymakers (Harvard University Press 1990) 65.
6 Gibbons and others (n 1) 3.
7 Silvio O Funtowicz and Jerome R Ravetz, ‘Science for the Post Normal Age’ (1995) 25 Futures 146.
8 Zuckerman and Merton (n 3).
9 Adrian Guta, Stephanie A Nixon and Michael G Wilson, ‘Resisting the Seduction of “Ethics Creep”: Using Foucault to Surface Complexity and Contradiction in Research Ethics Review’ (2013) 98 Social Science & Medicine 301.
10 Ron Iphofen, ‘Research Ethics in Ethnography/Anthropology’ (2021) 1 <https://ec.europa.eu/research/participants/data/ref/h2020/other/hi/ethics-guide-ethnog-anthrop_en.pdf>.
11 European Commission, ‘Ethics and Data Protection’ (2018) <https://ec.europa.eu/research/participants/data/ref/h2020/grants_manual/hi/ethics/h2020_hi_ethics-data-protection_en.pdf>; European Commission, ‘H2020 Programme Guidance How to Complete Your Ethics Self-Assessment’ (2019) <https://ec.europa.eu/research/participants/data/ref/h2020/grants_manual/hi/ethics/h2020_hi_ethics-self-assess_en.pdf>.
12 Ron Iphofen and others, ‘Roles and Functions of Ethics Advisors / Ethics Advisory Boards in EC-Funded Projects’ (2021) 1 <https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/horizon/guidance/roles-and-functions-of-ethics-advisory-ethics-advisory-boards-in-ec-funded-projects_he_en.pdf>.
13 Jasanoff (n 3).
14 Mariachiara Tallacchini, ‘Governing by Values. EU Ethics: Soft Tool, Hard Effects’ (2009) 47 Minerva 281.
15 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation), OJ L 119, 4.5.2016, 1–88.
16 European Commission, ‘Coordinated Plan on Artificial Intelligence’ (2018) <https://ec.europa.eu/digital-single-market/en/news/coordinated-plan-artificial-intelligence>; European Commission, ‘Artificial Intelligence for Europe’ (2018) <https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM%3A2018%3A237%3AFIN>.
17 Daniel Sarewitz, ‘Governance of Science’ in Encyclopedia of Science, Technology and Ethics (Macmillan Reference 2005).
18 European Group on Ethics in Science and New Technologies, Values for the Future: The Role of Ethics in European Global Governance (Publications Office of the European Union 2021) <https://data.europa.eu/doi/10.2777/595827>.
19 Gary Allen, ‘Getting Beyond Form Filling : The Role of Institutional Governance in Human Research Ethics’ (2008) 6 Journal of Academic Ethics 105; Richard Ashcroft, ‘Ethics behind Closed Doors: Do Research Ethics Committees Need Secrecy?’ (2001) 322 BMJ 1294; Guta, Nixon and Wilson (n 9) 308; Kalev Leetaru, ‘Are Research Ethics Obsolete in the Era of Big Data?’ Forbes (2016) <https://www.forbes.com/sites/kalevleetaru/2016/06/17/are-research-ethics-obsolete-in-the-era-of-big-data/>; Kalev Leetaru, ‘Should Open Access And Open Data Come With Open Ethics?’ Forbes (2017) <https://www.forbes.com/sites/kalevleetaru/2017/07/20/should-open-access-and-open-data-come-with-open-ethics/>; Metcalf and Crawford (n 2) 4.
20 Carrying out European research policies and programs became an obligation under the Amsterdam Treaty. See The Treaty on the Functioning of the European Union (TITLE XIX: Research and technological development and space), OJ C 326, 26 October 2012, p. 47–390.
21 Julia Metz, The European Commission, Expert Groups, and the Policy Process. Demistifying Technocratic Governance (Palgrave Macmillan 2015) 14.
22 For example, the number of projects funded in bioethics rose from 18 in FP2 to 60 by the end of FP4 Ruth Chadwick and others, Sequencing the Human Genome: Scientific Progress, Economic, Ethical and Social Aspects (European Parliament, Scientific and Technological Options Assessment 1998) 48.
23 The Generic Research Unit, created in FP5, extended the range of topics for ethical considerations to be funded, including Information Technology and the Internet. See Ruth Chadwick and others, Ethical Issues in Research and Technology. Final Study (European Parliament, Scientific and Technological Options Assessment 1999) 14.
24 Commission Regulation (EC) No 996/1999 of 11 May 1999 on the implementation of Council Decision 1999/65/EC concerning the rules for the participation of undertakings, research centres and universities and for the dissemination of research results for the implementation of the fifth framework programme of the European Community (1998–2002), OJ L 122, 12 May 1999, p. 9–23.
25 Chadwick and others (n 23).
26 Although the group claimed, following its mandate, that the focus was limited to ethical aspects of life sciences, Group of Advisers on the Ethical Implications of Biotechnology, ‘Report to the European Commission: The Ethical Aspects of the Fifth Research Framework Program’ (1998) 17 Politics and the Life Sciences 73, 74.
27 Decision No 1982/2006/EC of the European Parliament and of the Council of 18 December 2006 concerning the Seventh Framework Programme of the European Community for research, technological development and demonstration activities (2007–2013), OJ L 412, 30 December 2006, p. 1–43.
28 Regulation (EC) No 1906/2006 of the European Parliament and of the Council of 18 December 2006 laying down the rules for the participation of undertakings, research centres and universities in actions under the Seventh Framework Programme and for the dissemination of research results (2007–2013), OJ L 391, 30 December 2006, p. 1–18.
29 Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe – the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013, OJ L 170, 12 May 2021, p. 1–68.
30 The legal basis for it was Article 19 of Regulation (EU) No 1291/2013 of the European Parliament and of the Council of 11 December 2013 establishing Horizon 2020 - the Framework Programme for Research and Innovation (2014–2020) and repealing Decision No 1982/2006/EC, OJ L 347, 20 December 2013, p. 104–173, and Articles 13, 18, 23 of Regulation (EU) No 1290/2013 of the European Parliament and of the Council of 11 December 2013 laying down the rules for participation and dissemination in “Horizon 2020 - the Framework Programme for Research and Innovation (2014–2020)” and repealing Regulation (EC) No 1906/2006, OJ L 347, 20 December 2013, p. 81–103.
31 J Hughes, D Hunter and M Sheehan, European Textbook on Ethics in Research (Publications Office of the European Union 2010).
32 European Commission, ‘Ethics for Researchers. Facilitating Research Excellence in FP7’ (2013).
33 European Commission, ‘Data Protection and Privacy Ethical Guidelines’ (2009) <https://ec.europa.eu/research/participants/data/ref/fp7/89827/privacy_en.pdf>.
34 European Commission, ‘Guidance Note for Researchers and Evaluators of Social Sciences and Humanities Research’ (2010) <http://ec.europa.eu/research/participants/data/ref/fp7/89867/social-sciences-humanities_en.pdf>.
35 European Commission, ‘Ethics and Data Protection’ (n 11).
36 European Commission, ‘H2020 Programme Guidance How to Complete Your Ethics Self-Assessment’ (n 11).
37 Ioannis Benekos and others, ‘Identifying Serious and Complex Ethics Issues in EU-Funded Research’ (2021) <https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/horizon/guidance/guidelines-on-serious-and-complex-cases_he_en.pdf>.
38 European Commission, ‘HE Program Guidance How to Complete Your Ethics Self-Assessment’ (2021) <https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/common/guidance/how-to-complete-your-ethics-self-assessment_en.pdf>.
39 Kathleen Montgomery and Amalya L Oliver, ‘Shifts in Guidelines for Ethical Scientific Conduct’ (2009) 39 Social Studies of Science 137.
40 Robert J Levine, Ethics and Regulation of Clinical Research (Yale University Press 1986).
41 Tom L Beauchamp and James F Childress, Principles of Biomedical Ethics (Oxford University Press, 8th edn, 2019).
42 Philip Hamburger, ‘The New Censorship: Institutional Review Boards’ (2004) 2004 The Supreme Court Review 271, 292.
43 European Commission, ‘Data Protection and Privacy Ethical Guidelines’ (n 33) 5–6.
44 Despite the fact that the EU had already been addressing personal data protection issues in legislation, see Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data, OJ L 281, 23 November 1995, p. 31–50.
45 What counts as research in the GDPR is intended in a broad sense, which includes technological development, fundamental and applied research and privately funded research and ‘studies conducted in the public interest in the area of public health’ (Recital 159 GDPR). This is in line with the idea of Mode 2 Science.
46 Article 89 of Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation), OJ L 119, 4 May 2016, p. 1–88.
47 See Recitals 33 and 73 of Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation), OJ L 119, 4 May 2016, p. 1–88.
48 Dara Hallinan, ‘A Normative Framework for the Reconciliation of EU Data Protection Law and Medical Research Ethics’ (2021) 29 Medical Law Review 446.
49 Niels van Dijk, Simone Casiraghi, and Serge Gutwirth, ‘The “Ethification” of ICT Governance. Artificial Intelligence and Data Protection in the European Union’ (2021) 43 Computer Law & Security Review 105597.
50 European Commission, ‘Ethics and Data Protection’ (n 11).
51 For instance, in the guidance on SSH European Commission, ‘Ethics in Social Science and Humanities’ (2018) 13 <https://ec.europa.eu/research/participants/data/ref/h2020/other/hi/h2020_ethics-soc-science-humanities_en.pdf>.
52 European Commission, ‘Ethics and Data Protection’ (n 11) 14.
53 ibid 7, 9, 21.
54 Raphaël Gellert, The Risk-Based Approach to Data Protection (Oxford University Press 2020); Niels van Dijk, Raphaël Gellert and Kjetil Rommetveit, ‘A Risk to a Right? Beyond Data Protection Risk Assessments’ (2016) 32 Computer Law & Security Review 286.
55 These are not only risks to participants but also risks to institutions that carry out the research. The risk is very much related to the accountability of researchers and the funding organisation. See how risk assessment is part of ‘accountability’ in Brandt Dainow and Philip Brey, ‘Ethics By Design and Ethics of Use Approaches for Artificial Intelligence’ (2021) <https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/horizon/guidance/ethics-by-design-and-ethics-of-use-approaches-for-artificial-intelligence_he_en.pdf>; High-Level Expert Group on Artificial Intelligence, ‘The Assessment List for Trustworthy Artificial Intelligence’ (2020) <https://data.europa.eu/doi/10.2759/002360>.
56 Roughly, the US equivalent of ethics committees.
57 Levine (n 40) 41.
58 See the recording of the event ‘Key changes to the Ethics Appraisal Process in Horizon Europe, identifying serious and complex issues in EU-funded projects and addressing ethics of Artificial Intelligence’, organised by DG RTD and held on 9 July 2021. https://www.ope-connect.urjc.es/en/news/key-changes-to-the-ethics-appraisal-process-in-horizon-europe/ (accessed 4 April 2023).
59 Ulrike Felt and others, Taking European Knowledge Society Seriously (Publications Office of the European Union 2007) <https://op.europa.eu/en/publication-detail/-/publication/5d0e77c7-2948-4ef5-aec7-bd18efe3c442>.
60 Guta, Nixon and Wilson (n 9) 305.
61 European Commission, ‘HE Program Guidance How to Complete Your Ethics Self-Assessment’ (n 38) 10.
62 ibid 24–25.
63 ibid 42.
64 Called ‘politicisation’ also in previous works by the authors, e.g. Adam Briggle, ‘The Kass Council and the Politicization of Ethics Advice’ (2009) 39 Social Studies of Science 309, 314; Simone Casiraghi, ‘Anything New under the Sun? Insights from a History of Institutionalized AI Ethics’ (2023) 25 Ethics and Information Technology. In fact, rather than being politicised, it can be argued that ethics advice is here de-politicised: political discussions are “neutralised”, which has nevertheless political effects. The way the review is organised around consensus, which experts are selected, and the openness of the process all influence what research is deemed appropriate for public funding and how scientific research is organised. Therefore, the word ‘instrumentalisation’ was preferred in this context.
65 Aurora Plomer, ‘The European Group on Ethics: Law, Politics and the Limits of Moral Integration in Europe’ (2008) 14 European Law Journal 839, 845.
66 Jasanoff (n 3) 24.
67 In her ethnography of IRBs, Stark notes how IRB votes to produce decisions ‘have an uncanny likeness to each other’. The outcomes of the discussions she observed were almost always unanimous, and individuals never voted against the group, at most they abstained from voting to express disagreement Luna Stark, Behind Closed Doors: IRBs and the Making of Ethical Research (The University of Chicago Press 2012) 22.
68 See the ethics evaluation briefing script of the EC. https://ec.europa.eu/info/sites/default/files/2._h2020_msca_rise_2020_ethics_evaluation_briefing_script.pdf (accessed 4 April 2023).
69 John T Kalberer, ‘Peer Review and the Consensus Development Process’ (1985) 10 Science, Technology & Human Values 63, 65.
70 In the study by Buljan et al. 2021, out of 8482 proposals analysed, 58% received conditional ethics clearance and 42% either had no issues or received ethical clearance. None of them was rejected on ethical grounds, Ivan Buljan, David G Pina and Ana Marušić, ‘Ethics Issues Identified by Applicants and Ethics Experts in Horizon 2020 Grant Proposals’ (2021) 10 F1000Research 1.
71 In an informal document, the ‘RISE 2020 Ethics Evaluation Expert Briefing Notes’, it is stated that ‘in principle, not more than 1% of proposals should go to assessment’, i.e., the additional phase for serious ethical issues of the appraisal process, and that ‘in principle, not more than 10% of proposals should have an ethics check’. https://ec.europa.eu/info/sites/default/files/2._h2020_msca_rise_2020_ethics_evaluation_briefing_script.pdf (accessed 4 April 2023).
72 Matthias Leese, Kristoffer Lidén and Blagovesta Nikolova, ‘Putting Critique to Work: Ethics in EU Security Research’ (2019) 50 Security Dialogue 59.
73 Les Levidow and Susan Carr, ‘How Biotechnology Regulation Sets a Risk/Ethics Boundary’ (1997) 14 Agriculture and Human Values 29, 31.
74 Simone Casiraghi, J Peter Burgess and Kristoffer Lidén, ‘Social Acceptance and Border Control Technologies’ in J Peter Burgess and Dariusz Kloza (eds), Border Control and New Technologies. Addressing Integrated Impact Assessment (Academic and Scientific Publishers 2021); Kristrún Gunnarsdóttir and Kjetil Rommetveit, ‘The Biometric Imaginary: (Dis)Trust in a Policy Vacuum’ (2017) 26 Public Understanding of Science 195.
75 Leese, Lidén and Nikolova (n 72) 9.
76 Stephen Cole, Leonard Rubin and Jonathan R Cole, ‘Peer Review and the Support of Science’ (1977) 237 Scientific American 34.
77 The 2017 version is available online <https://ec.europa.eu/research/participants/data/ref/h2020/experts_manual/h2020-experts-mono-contract_en.pdf> (accessed 4 April 2023).
78 It seems to be more about what one can prove, such as participation in other ethics activities, publications on ethics and keywords.
79 For privacy reasons, when you register as an expert on the Participant portal, it is possible to decide ‘who can see my profile’, therefore making such profile public or private (only the EC and its relevant bodies can see it).
80 Since the Horizon 2020 Programme the Commission also publishes an annual list of experts, but it only includes names and claimed expertise. There is no reference to the organization that the experts work for, nor to which experts worked on which project proposals or calls.
81 Iphofen and others (n 12) 9.
82 Member of the European Parliament Patrick Breyer filed a lawsuit in 2019 for the release of confidential deliverables on the ethical justifiability and legality of the technology developed by the H2020 iBorderCtrl research project. The European Court of Justice (Case T-158/19) ruled that the public can partially access documents discussing the ethics and legality of such technology, but commercial interests rule out public access to information on the specific iBorderCtrl technology. Similarly, entrepreneur and academic Kalev Leetaru tells, referring to the US context, how he experienced multiple cases in which public universities denied him access (or ignored his requests) to documents containing ethical and privacy considerations on federally funded data science projects. Different justifications were provided, e.g. the need to keep ethical reviews secret to protect researchers from having their methods subjected to external scrutiny, Leetaru, ‘Should Open Access And Open Data Come With Open Ethics?’ (n 19).
83 Jasanoff (n 3) 29.
84 Iphofen and others (n 12) 1.
85 Under the HE FP, open access has become the default option for the scientific outputs of the projects European Commission, Open Innovation, Open Science, Open to the World. A Vision for Europe (Publications Office of the European Union 2016) <http://europa.eu/rapid/press-release_SPEECH-15-5243_en.htm>.
86 Leetaru, ‘Should Open Access And Open Data Come With Open Ethics?’ (n 19).
87 Corinne Cath and Os Keyes, ‘Your Thoughts for a Penny? Capital, Complicity and AI Ethics’ in Thao Phan and others (eds), Economies of Virtue. The Circulation of ‘Ethics’ in AI (Institute of Network Cultures 2022); Rodrigo Ochigame, ‘The Invention of “Ethical” AI: How Big Tech Manipulates Academia to Avoid Regulation’ in Thao Phan and others (eds), Economies of Virtue. The Circulation of ‘Ethics’ in AI (Institute of Network Cultures 2022).
88 Nevertheless, studies that have analysed how researchers identify ethical issues in their research seem to assume that there is an objective, neutral method to identify ethical issues. The idea is that, were the researchers aware of the ethical issues of their research, their assessment would be the same as that of the reviewers Buljan, Pina and Marušić (n 70) 3.
89 Bob Simpson, ‘Ethical Moments: Future Directions for Ethical Review and Ethnography’ (2011) 17 Journal of the Royal Anthropological Institute 377.
90 This case is even more difficult given that the precursor disciplines of data science, e.g. computer science, statistics and applied mathematics, have not even been considered as conducting research on human subjects, and therefore had little contact with the structures of ethics review Metcalf and Crawford (n 2) 3. New guidelines on anthropology and ethnography ethics have been published for HE, but have not been yet reflected in the appraisal process, Iphofen (n 10).
91 How human subject in biomedical research is defined has also been long contested by scientists and ethicists, George J Annas, ‘The Changing Landscape of Human Experimentation: Nuremberg, Helsinki and Beyond’ (1992) 2 Health Matrix: Journal of Law-Medicine 119.
92 Simpson (n 89) 384.
93 ibid 385.
94 Strictly speaking, the GDPR does not define what a ‘data subject’ is, but this can be inferred from the definition of personal data at Art. 4(1).
95 Metcalf and Crawford (n 2) 2.
96 ibid 3.
97 To be correct, Germany had already strict regulations on research before WWII, for instance on informed consent Simpson (n 89) 383.
98 Hamburger (n 42) 297.
99 The regulatory scheme known as the ‘Common Rule’ establishes a system under which researchers willing to carry out any research on human subjects need to submit a research proposal to an IRB.
100 Social and behavioral researchers already contested the first drafts of the Common Rule, since it applied the level of scrutiny of medical experiments to sociologists’ interviews of human subjects Troy Duster, David Matza and David Wellman, ‘Field Work and the Protection of Human Subjects’ (1979) 14 The American Sociologist 136. This gave rise to the reform of the Common Rule in 2018, which nevertheless still has shortcomings in this regard.
101 Jules Polonetsky, Omer Tene and Joseph Jerome, ‘Beyond the Common Rule: Ethical Structures for Data Research in Non-Academic Settings’ (2015) 13 Colorado Technology Law Journal 333, 339; U.S. Department of Homeland Security, ‘The Menlo Report. Ethical Principles Guiding Information and Communication Technology Research’ (2012) 5 <https://www.dhs.gov/sites/default/files/publications/CSD-MenloPrinciplesCORE-20120803_1.pdf>.
102 Brent Mittelstadt, ‘Principles Alone Cannot Guarantee Ethical AI’ (2019) 1 Nature Machine Intelligence 501, 501.
103 This would be like attributing to journalists the duty to treat their subjects of investigation in a way that prevents harm and almost favours them, avoiding causing distress Hamburger (n 42) 340.
104 Mittelstadt (n 102) 502.
105 See U.S. Department of Homeland Security (n 101); Metcalf and Crawford (n 2) on publicly available datasets.
106 Levine (n 40) 28.
107 European Commission, ‘H2020 Programme Guidance How to Complete Your Ethics Self-Assessment’ (n 11).
108 G Derrick Hodge, ‘The Problem with Ethics’ (2013) 36 PoLAR: Political and Legal Anthropology Review 286, 286.
109 Mittelstadt (n 102) 503.
110 van Dijk, Gellert and Rommetveit (n 54).
111 Ulrich Beck, ‘The Digital Freedom Risk: Too Fragile an Acknowledgment’ (2022) 10 Quaderns de la Mediterrània 141.
112 Danah Boyd and Kate Crawford, ‘Critical Questions for Big Data: Provocations for a Cultural, Technological, and Scholarly Phenomenon’ (2012) 15 Information Communication and Society 662.
113 Danah Boyd, Karen Levy and Alice Marwick, ‘The Networked Nature of Algorithmic Discrimination’ in Seeta Peña Gangadharan, Virginia Eubanks and Solon Barocas (eds), Data and Discrimination: Collected Essays (2014) <https://d1y8sb8igg2f8e.cloudfront.net/documents/data-and-discrimination.pdf>.
114 This has already been discussed in the case of science in, e.g. E. S., ‘Alternatives to Judgement by Peers’ (1975) 13 Minerva 341; Rustum Roy, ‘Funding Science: The Real Defects of Peer Review and an Alternative To It’ (1985) 10 Science, Technology & Human Values 73. Arguments in favour of healthy disagreement in science are provided, Stevan Harnad, ‘Rational Disagreement in Peer Review’ (1985) 10 Science, Technology, & Human Values 55. For a defence of peer review, instead, see Richard C Atkinson and William A Blanpied, ‘Peer Review and the Public Interest’ (1985) 1 Issues in Science and Technology 101.
115 van Dijk, Casiraghi and Gutwirth (n 49).
116 As it was argued, for instance, in the case of clinical ethics consultations. See Ana S Iltis and Mark Sheehan, ‘Expertise, Ethics Expertise, and Clinical Ethics Consultation: Achieving Terminological Clarity’ (2016) 41 Journal of Medicine and Philosophy 416; Leah McClimans and Anne Slowther, ‘Moral Expertise in the Clinic: Lessons Learned from Medicine and Science’ (2016) 41 Journal of Medicine and Philosophy 401.
117 This is about ‘research activities that could generate knowledge, materials and technologies that could be adapted for criminal/terrorist activities; or result in the development of chemical, biological or radiological or nuclear (CBRN) weapons and the means for their delivery’ European Commission, ‘Guidance Note – Potential Misuse of Research’ (2021) 1 <https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/horizon/guidance/guidance-note-potential-misuse-of-research-results_he_en.pdf>. In the previous FPs, security was part of the ethics appraisal process, e.g. in H2020.
118 Ilse De Waele and others, ‘Ethics Appraisal Procedure in 79,670 Marie Skłodowska-Curie Proposals from the Entire European HORIZON 2020 Research and Innovation Program (2014–2020): A Retrospective Analysis’ (2021) 16 PLOS ONE 1, 1.
119 Proposal for a Regulation of the European Parliament and of The Council Laying Down Harmonised Rules On Artificial Intelligence (Artificial Intelligence Act) and Amending Certain Union Legislative Acts, COM/2021/206 final.
120 Gellert (n 54); Article 29 Data Protection Working Party, ‘Statement on the Role of a Risk-Based Approach in Data Protection Legal Frameworks’ (2014).
121 Sven Ove Hansson, The Ethics of Risk: Ethical Analysis in an Uncertain World (Palgrave Macmillan 2013).
122 van Dijk, Gellert and Rommetveit (n 54).
123 Felt and others (n 59) 40.
124 ibid 33.
125 Iphofen (n 10).
126 Ryan Calo, ‘Consumer Subject Review Boards: A Thought Experiment’ (2013) 66 Stanford Law Review Online 97; Polonetsky, Tene and Jerome (n 101).
127 Polonetsky, Tene and Jerome (n 101) 353.
128 Buljan, Pina and Marušić (n 70); De Waele and others (n 118) 12.
129 See the EC’s ethics evaluation script, https://ec.europa.eu/info/sites/default/files/2._h2020_msca_rise_2020_ethics_evaluation_briefing_script.pdf or the training provided by Universidad Rey Juan Carlos for ethics evaluators. https://www.ope-connect.urjc.es/en/news/key-changes-to-the-ethics-appraisal-process-in-horizon-europe/ (accessed 4 April 2023).
130 Simpson (n 89) 388.
131 Jasanoff (n 3) 28.
132 Leetaru, ‘Should Open Access And Open Data Come With Open Ethics?’ (n 19).
133 Margaret Sleeboom-Faulkner and others, ‘The Formalization of Social-Science Research Ethics’ (2017) 7 HAU: Journal of Ethnographic Theory 71, 73.
134 Casiraghi, Burgess and Lidén (n 74); Gunnarsdóttir and Rommetveit (n 74).
135 Leese, Lidén and Nikolova (n 72).
136 Guta, Nixon and Wilson (n 9).
Additional information
Funding
Notes on contributors
Simone Casiraghi
Simone Casiraghi is a doctoral researcher at the Vrije Universiteit Brussel (VUB), with Prof. Niels Van Dijk and Paul de Hert as promoters. His PhD work focuses on the intersection of law and institutionalised ethics in the context of data protection and AI, combining a traditional legal analysis with Science and Technology Studies (STS) perspectives and scrutinising the discourses and institutions underpinning EU initiatives on AI ethics, including policy, regulation, and industry-driven standardisation efforts. He is a member of the Brussels Laboratory for Data Protection & Privacy Impact Assessments (d.pia.lab) and Treasurer of the Belgian Section of the International Association for Philosophy of Law and Social Philosophy (B-IVR). His research interests are in philosophy of technology, the intersection between law and STS, legal philosophy and impact assessments.
Niels van Dijk
Niels van Dijk is associate professor at the faculty of law & criminology of the Vrije Universiteit Brussels (VUB), where he teaches legal philosophy and legal sociology. He is also senior researcher at the VUB Centre for Law Science Technology and Society (LSTS) and director of the Brussels Laboratory for Data Protection & Privacy Impact Assessments (d.pia.lab). His research has broadly focused on the challenges of digital technologies for practices of law, especially privacy, data protection, intellectual rights and legal personhood. More broadly, his research is situated at the intersection between legal philosophy, Science and Technology Studies (STS), and governance of digital innovation.