Reflections on the practice of Responsible (Research and) Innovation in synthetic biology

Abstract

This paper is a critical reflection on the concepts of Responsible Innovation (RI) and Responsible Research and Innovation (RRI). We offer an account of the emergence of these related but different accounts of responsible innovation that have recently been adopted by funders. We further report on our exploration of the knowledge and understanding of these concepts through the views of senior scientists involved in synthetic biology research projects. Though most of our respondents struggled to provide a clear account of RI/RRI we identified that existing “practices of responsibility” include many aspects of RI/RRI but that this often went unrecognized as such. Most respondents associated RI/RRI with risk avoidance. While some visions of RI/RRI see scientists as taking an active role in shaping the future of innovation, we suggest that it is not for such individuals to take decisions alone on the types of futures a society should have available to it.

Keywords:

• Responsible Research and Innovation
• synthetic biology
• ELSI
• risk

1. Introduction

Much has been written about synthetic biology in the nearly two decades (Nature 2014) over which this field has developed. In that time a number of leading Science and Technology Studies (STS) scholars have studied multiple aspects of synthetic biology, charting its shifting and varied definitions, the visions of its practitioners and the promises made for its future (See for example Calvert and Martin 2009; Yearley 2009; Calvert 2013; Marris 2015; McLeod and Nerlich 2017; Meckin and Balmer 2019). Latterly, STS scholars have reflected on their work and written about the various roles they have taken in projects or had pressed upon them by the synthetic biologists (Balmer et al. 2015). Beginning a little later, a literature has grown around the concepts of Responsible Research and Innovation (RRI) that developed largely in the EU and the similar though independent strand of work on Responsible Innovation (RI) in the UK. (Examples for RRI include Von Schomberg 2011; Rip 2014; Landeweerd et al. 2015; Arnaldi and Gorgoni 2016; and for RI, Owen, Bessant, and Heintz 2013; Stilgoe, Owen, and Macnaghten 2013; Owen 2014; Macnaghten, Owen, and Jackson 2016). These concepts have applications across many scientific disciplines though much of the writing concerns nanotechnology and climate change science and more recently synthetic biology.

We have had the opportunity to observe the start of a large, interdisciplinary project,¹ funded by a UK Research Council and based solely in the UK, and to reflect on this emerging bioscience and (i) the extent to which social scientific writing has impacted on the practices and thought processes of synthetic biologists, (ii) the extent to which the concept of synthetic biology itself has developed and (iii) how notions of RRI/RI described in the literature referred to above have come to be understood by a group of scientists engaged in synthetic biology and its constituent disciplines. We have done this in the context of progressing a “Responsible Innovation” strand of work, cutting across the project’s other research areas in synthetic biology, microbiology, biochemistry, computer science and modeling.

The project is based in a single UK institution and as part of our work we have participated in many of its aspects, attending regular team meetings, workshops, review meetings and social gatherings. SW is also a member of the project Management Board. By engaging with project colleagues and conducting a number of interviews with them and other scientists from the UK and USA we sought to identify ways in which we could implement our funder’s stipulation that projects adhere to a particular vision of Responsible Innovation (for a discussion of which see Owen 2014).

This paper reports our first findings from this ongoing study. We begin by reviewing our understanding of synthetic biology, RI/RRI and other social science writings before presenting findings from empirical work that highlight the limited nature of how RI/RRI is understood and a conflation with the ubiquitous ELSI paradigm, and finally, we consider wider issues of awareness-raising and competence building that are required among synthetic biologists and those they work with.

1.1. Synthetic biology

The emerging field of synthetic biology has brought together microbiologists, geneticists, computer scientists, engineers, politicians and others in an effort to exploit biological systems for human benefit. Its political proponents have claimed that it will, “heal us, heat and feed us” (Osborne 2012) and that fostering the field, “could provide solutions to many of humanity's most pressing issues and at the same time [synthetic biology] presents significant growth opportunities” (Willets 2012).

Synthetic biology, then, is among a number of promissory sciences, such as plant genetic modification (GM), nanotechnology and human embryonic stem cell research that have been encouraged and funded by the Government as a means to drive the economy and demonstrate the UK’s world-leading scientific capabilities. To realize this promise of synthetic biology the UK Government provided the financial investment, managed by the Research Councils and the Technology Strategy Board (now known as Innovate UK), for a network of sites to develop the basic science and transfer the knowledge gained to industry.

While the scientific research encouraged by this investment got underway, social scientists became involved and synthetic biology itself became an object of study and research. Their work, particularly in the field of Science and Technology Studies (STS), has revealed that while leading scientists, and those who write policy documents and media reports, refer to synthetic biology as a distinct discipline, it is possible to identify a number of different approaches and underlying principles in different projects and contexts. One classification of the field was made by O’Malley et al. (2008), who identified,

three broad approaches towards the synthesis of living systems: DNA-based device construction, genome driven cell engineering and protocell creation. (57)

In each case the degree of complexity of the biological system being manipulated increases. Differences in the approach of practitioners have also been noted, for example Benner and Sismour (2005) described two “classes” of synthetic biologists,

One uses unnatural molecules to reproduce emergent behaviours from natural biology, with the goal of creating artificial life. The other seeks interchangeable parts from natural biology to assemble into systems that function unnaturally. (Quoted in Balmer et al. 2015, 6)

In another classification, synthetic biologists were described by Schyfter and Calvert (2015) as falling into three broad groups,

1. “Epistemics” – those who see the main use and benefit of synthetic biology techniques as a way to generate new knowledge;

2. “Pragmatic Constructors” – those who see the tools and approaches of synthetic biology as one way among others to solve specific scientific questions or make specific products; and

3. “Committed Engineers” – those who are sure that the application of engineering principles will render biology understandable and open to manipulation in a reliable and predictable manner. (adapted from Schyfter and Calvert 2015)

Schyfter and Calvert describe these three groups as “communities” with “competing” views on the development of the field, and they believe that the approach taken by the “committed engineers” has come to dominate the policy and funding sphere. In their opinion, this has resulted in an increasing expectation of the delivery of tangible products to markets and benefits to the economy in short to medium timescales.

This importance of the engineering view of synthetic biology is reflected in the definition of the field in a major policy document for the UK written by the UK Synthetic Biology Roadmap Coordination Group (2012), which is itself based on a 2009 definition proposed in a Royal Academy of Engineering study,

Synthetic biology is the design and engineering of biologically based parts, novel devices and systems as well as the redesign of existing, natural biological systems. (UK Roadmap 6)

This is later expanded,

The step change in the synthetic biology approach is to engineer biological systems to perform new functions in a modular, reliable and predictable way, allowing modules to be reused in different contexts. (UK Roadmap 12)

An example of a definition provided by a University Research Centre expands on the engineering approach and highlights the biological reductionism inherent in it,

The discipline of Synthetic Biology, views cells as machines that can be built, from parts, in a manner similar to electronic circuits or airplanes and has thus sought to co-opt biological cells to perform tasks of a predefined function and utility, e.g. nano-computation or nano-manufacturing. This research area aims at making biological cells much easier to program and hence harnessed for useful purposes. (ICOS website 2019)

The implications of this view of synthetic biology as being about bringing engineering principles to biology is one to which we will return.

Synthetic biology has been identified strongly with the development of the UK bioeconomy in the last decade and as such has been the subject of a program of policy work undertaken or initiated by Government departments or UK national funding bodies. Marris and Calvert (2019) report that there was an economic assessment conducted by the UKs Technology Strategy Board (TSB) and the Government department for Business, Innovation and Skills (BIS) in 2011 and there had also been, in 2010, a public dialogue on synthetic biology conducted by a commercial market research company in collaboration with the BIS “Sciencewise programme”. The UK Synthetic Biology Roadmap itself was followed by a strategic plan to build on the work begun in 2012. “Biodesign for the Bioeconomy” (2016) describes synthetic biology and the potential contribution to the economy as,

an exciting new approach to biological research and innovation. Now, we realize even more acutely the potential growth opportunities for the bioeconomy and possibilities to address global challenges …  We now need to release the potential developed since 2012 through the next phase of the roadmap. Key to fulfilling our UK vision on the world stage is maintaining exceptional national agility and responsiveness. Technological frontiers continue to advance, attracting new investments and inspiring the formation of numerous start-up companies. (Synthetic Biology Leadership Council 2016, 1)

As such synthetic biology occupies the same policy arena as earlier biotechnologies such as human embryonic stem cell science or nanotechnology; it is an example of a promissory science that excites its practitioners and proponents and which sits in a regulatory framework that is generally permissive of cutting-edge research, encouraged by Government as a means of driving the UK economy. Synthetic biology also runs a risk of pressing forward without adequate regard for societal concerns about novel sciences, though we recognize that some applications (such as might be aimed at the food sector) are constrained by EU legislation and UK consumer opinion. Recommendations from the Roadmap included a significant financial investment in UK research on synthetic biology and as Owen (2014) discusses, such investment was forthcoming. One consequence of the inclusion of discussion of RI/RRI in the Roadmap was the adoption of this approach to considering societal issues in the funding and conduct of research, including synthetic biology.

As we noted above, the “Roadmap” was not the end of this policy development effort and the report Biodesign for the Bioeconomy (Synthetic Biology Leadership Council 2016) was commissioned and written. Like the earlier Roadmap, the later report notes that societal engagement is necessary and states,

… awareness is now embedded in all research planning as RRI …  a further dimension to the multi-dimensional skillset required of today’s synthetic biologists (19)

However, there is little indication of what RRI means in practice and precisely what skills the practitioner of synthetic biology needs to master. As a prelude to engaging with this question, we now turn to what might be argued to be the predecessor of RI/RRI; an area of work that is almost an academic industry in itself, the ethical, legal and social issues (or implications or aspects) of research; commonly referred to as ELSI.

1.2. ELSI

The rise of Ethical, Legal and Social Issues (ELSI) programs in new technosciences, including biological sciences, can be traced to the Human Genome Project and synthetic biology has not been immune. Zhang, Marris, and Rose (2011) report that between 2004 and 2011 there were 39 reports written worldwide highlighting the importance of concerns about social, legal and ethical “issues” raised specifically by synthetic biology. Balmer et al. (2015) discuss the ELSI approach and note that “while it is not explicit, the focus of ELSI is typically on the potential for negative implications” (4) and they suggest that social scientists have become “positioned as being responsible for the identification and remediation of potential negative downstream consequences of science” (4). ELSI is also seen as an activity that is undertaken by specialists, brought into work alongside, yet slightly apart from, the natural and computer scientists. Such roles have proved problematic for many social scientists and Balmer et al. (2015) review the growing criticism of the ELSI paradigm. ELSI programs are thought by some to emphasize a simplistic linear model of innovation, focus too much on outcomes at the expense of questioning practices and processes, and assume that outputs of science are bound into a narrative of an inexorable drive to a knowledge economy (Macnaghten, Owen, and Jackson 2016). Despite these reservations the ELSI approach remains an established part of the governance of biosciences.

An explanation of why this should be so is suggested in the work of Bardone and Lind (2016), who discuss how a division in expertise between scientists on one hand and ethicists on the other was established and maintained by a prevailing “technocratic approach” (4) to science governance. In this there is an “unbridgeable separation between what should be done in the technical sense and what should be done in the ethical sense” (9). A consequence of this is the designation of ethicists as experts, whose “main function is to inform researchers about the ethical constraints” on their work (9). Although their focus is on ethicists in this role, there are clearly overlaps with the roles that social scientists such as Balmer, Calvert, Marris and others have taken or been placed in.

1.3. Responsible research and innovation

One approach to address the deficiencies of the ELSI paradigm can be found in the emergence of the concepts of “Responsible Research and Innovation”, largely developed in the EU and associated with Rene von Schomberg, and Responsible Innovation, developed in the UK and associated with a group of researchers including Richard Owen, Jack Stilgoe and Phil Macnaghten.

Owen and Pansera (2019) note in their comprehensive review of RI/RRI that the development of RRI was driven in large part by policy objectives and, as such, research under this heading can be narrowly concerned with producing outcomes that are core components of the EU Science in Society program of work (Owen and Pansera 2019, 26). These authors describe how von Schomberg’s original “holistic vision” of RRI has become more rigidly applied as a “policy artifact” (37). Given that the EU is a rules-based organization, such a process was perhaps inevitable. RRI has condensed around five key policy goals, (i) public engagement, (ii) open access publication, (iii) gender balance in science, (iv) encouraging science education, and (v) applying ethical principles.

Coincidently with the emergence of the policy-driven RRI approach, the not dissimilar concept of Responsible Innovation (RI) was being developed in the UK. This concept had strong academic roots in the literature of anticipatory governance, technology assessment, ELSI, and social innovation; and as Owen and Pansera (2019) say

RI asks how we can and should meaningfully engage as a society with the futures innovation seeks to create, futures that are being created unintentionally or by design. (28)

RI as originally described by Stilgoe, Owen, and Macnaghten (2013) consisted of four key concepts, though these are perhaps less instrumental than those for RRI. They are (i) anticipation, (ii) reflexivity (both first and second order), (iii) inclusive deliberation, and (iv) responsiveness. One interpretation of this approach forms the basis of the Engineering and Physical Sciences Research Council (EPSRC) implementation of RI as required of recipients of their funds – we should note that the EPSRC are the funders of our project and of the majority of our interviewees. The EPSRC website notes that Responsible Innovation;

• is a process that seeks to promote creativity and opportunities for science and innovation that are socially desirable and undertaken in the public interest

• acknowledges, that innovation can raise questions and dilemmas,

• is often ambiguous in terms of purposes and motivations and unpredictable in terms of impacts, beneficial or otherwise

• creates spaces and processes to explore these aspects of innovation in an open, inclusive and timely way.

  (Adapted from EPSRC website, https://epsrc.ukri.org/index.cfm/research/framework/)

In this new paradigm, scientific researchers themselves are thus encouraged to consider societal issues continuously throughout the research process, rather than rely on a stand-alone analysis conducted by specialist social scientists or bioethicists (as is the case with ELSI work). A key aspect of RI that Stilgoe and colleagues express is that “public concerns cannot be reduced to questions of risk, but rather encompass a range of concerns relating to the purposes and motivations of research.” (2013, 1569). This statement draws on decades of social science research on public attitudes to new technologies that has repeatedly reported on the nuanced views and ambivalent attitude non-specialist publics exhibit.

While RI and RRI emerged as closely related concepts, there has been a divergence between the two as RRI became more focused on delivering specific policy goals. However, both remain contested in academic literature and practical implementation. A discussion of this contestation and the potential implications for political dimensions of RI/RRI by Hartley, Pierce, and Taylor (2017) has important lessons for synthetic biology and biotechnologies more generally. In their discussion of how RRI has been translated from theory to practice Hartley et al identify how “research may be become a site of politics where particular meanings of RRI intersect with an acknowledgement by actors of their general responsibilities to society” (374). Such politicization is not to be feared but rather adopted in order to strengthen what they term the “input” side of research governance. By avoiding such politicization researchers “risk squeezing politicization to the output side; in other words, significant public resistance to certain emerging technologies” (374). Thus institutional responses to the implementation of RI/RRI may have a significant role to play in developing and maintaining public trust in these promissory sciences. We will return to a discussion of RI in practice later but now turn to our empirical work.

2. Methods

This study was based on qualitative analysis of interviews with 19 senior scientists from a range of institutions and disciplinary backgrounds. Of these, four self-identified as microbiologists or biochemists (of whom three had little previous experience of working on a synthetic biology project), six identified primarily as geneticists, and four worked in computing science. Five of the interviewees described themselves as “synthetic biologists”; three from engineering backgrounds and two from biology.

Interview aide memoires were developed with the intention of eliciting information about, and interviewees’ views on, (i) the interviewee’s role in their particular projects, (ii) synthetic biology in general, (iii) the meaning and importance of the term “Responsible Research and Innovation” (RRI), (iv) social and ethical issues, and (v) public engagement. Approval to conduct the research was obtained from the appropriate Newcastle University Faculty Ethics Committee. Each interview lasted between 30 and 90 min and followed a semi-structured approach that enabled interviewees to (i) shape the discussion in ways relevant to them, (ii) express views in their own words, and (iii) broaden the scope of the research by raising topics not previously considered when designing the aide memoire. Written consent was obtained to record the interviews.

A first round of 11 interviews was conducted in late 2016 and early 2017, and a second round of eight interviews in late 2018. All interviews were fully transcribed, edited for accuracy and, as far as possible with such a small sample, have been de-identified. An analysis of interview transcripts, based on the methods of Silverman (2001), was conducted, involving constant comparison and category building procedures. Major themes were identified and refined.

In addition to interviews, observations were made of a number of formal team meetings of the project we are part of, which are attended by both senior scientists, early career researchers and doctoral students. We also reviewed policy documents and other texts and include pertinent observations on these at appropriate junctures.

3. Findings

Analysis of the interviews revealed a wide range of views on the topics of interest. Here we focus on a subset of the themes identified, views on (i) the meaning of RRI, (ii) what is understood of the term “synthetic biology”. Exploration of these themes will reveal the extent to which the concept of RRI has been understood by interviewees, any concerns they foresee with their work and, to some extent, the impact that social science literature on synthetic biology and RRI has had.

3.1. Responsible research and innovation (RRI)

When asked what the term “Responsible Research and Innovation” meant to them, many interviewees’ first reaction was to give a short, perhaps nervous, laugh or a sigh. All interviewees, however, then went on to engage with the question thoughtfully. Only one interviewee admitted to reviewing the EPSRC website ahead of the interview to acquaint themselves with the meaning of RRI adopted by the funder of their project. Even then, this interviewee noted, it remained unclear to them as to what the concept meant in practice.

Many of the key points raised by interviewees were related to safety, harm reduction and risk and these tended to be discussed in terms of existing (externally imposed) formal regulation. Common to many interviews was a conflation of RRI with formal regulation, with interviewees frequently beginning their discussion of RRI by describing how strictly laboratory work is regulated and how many rules are in place to minimize risk to both researchers and the environment. There was an awareness that RRI should be more than this, but few detailed examples of what that might mean were offered even when pressed. As an example, the following exchange took place;

KT:

thinking about responsible innovation, what is responsible innovation to you? What do you think it means?

Interviewee 1 (Synthetic biologist):

I think it is essentially being aware that actions have consequences and have reactions and do you know that it boils down to that. In the field of computer science probably {pause} being a computer scientist probably I am in an unusual position because the software we developed to try to engineer cells and then the work we do in the lab is very tightly regulated what; who is allowed in the lab, when people are allowed in the lab, you want; if you need to use an organism that lab does not have experience with you need to very clearly justify how and do risk assessments. So, so the lab work is very tightly regulated and it is much more regulated than pretty much anything else that is done in a computer science department.

This interviewee discussed responsibility more generally after further questioning, but the interesting analytical point for us is that the first reaction was to make the equation of responsibility and formal regulation of risk. Such a reaction may stem from the cultural norms of laboratory-based biological research. Formal oversight and regulation has been a part of bioscience research culture for some time and while it is important to comply with such regulation, that it was raised in response to the question on RRI by this, and most other, interviewees suggest that even after many years of engagement by social scientists the wider scope of RI/RRI still seems to be missing from discussion.

One way in which many interviewees discussed the mitigation of potential risks was by referring to their work as being “fundamental science”. The implication was that fundamental science did not create any problems that were not addressed by existing regulation. This then led to a conclusion by many interviewees that issues around RRI will only become relevant towards the end of the project, when a specific product or target molecule is being considered and the work is no longer “fundamental research” but more applied or directed to a particular goal. This appears to reflect the dominance of the ELSI paradigm in interviewees’ thinking. ELSI is acknowledged to focus on downstream consideration of risk and other negative consequences (Balmer et al. 2015). Only one interviewee was explicitly of the opinion that consideration of RRI should be an early task in the project but even in this case the subsequent discussion focused on technical aspects to mitigate or remove risk, e.g. in relation to accidental release into the environment.

The dominance of the ELSI paradigm is not only to be found among scientists but also among the writers of policy documents and statements. For example, the reply by then Universities Minister to the publication of the “Synthetic Biology Roadmap”,

For the first time the TSB [Technology Strategy Board] has introduced the use of a Responsible Innovation Framework to help assess the ethical, societal and legal issues’ in the development of synthetic biology projects. (Willets 2012)

Responsible Innovation appears to be seen here as ELSI by another name. Similarly, a 2015 British Standards Institute / Innovate UK white paper noted that,

there is as yet, no consensus amongst synthetic biology stakeholders on what the basic principles are for responsible innovation, and it is possible that the establishment of such a consensus is desirable to support the successful emergence of the technology. (BSI/Innovate UK 2015, 7)

The document text then turns to how this uncertainty is not “simply an academic concern” because “there may be risks associated with the emergence of synthetic biology on a large scale”. Such thinking, the association of RI with risk assessment (both scientific and in terms of public reaction), the assumption that a consensus on approach to RI is “desirable” to help the “emergence” of synthetic biology – seems to be symptomatic of a view that RRI is something to be added on to projects in order to ameliorate risk. Again, ELSI by another name.

The interviewees’ responses when discussing risk indicated that all were well acquainted with the regulations specific to their area of work. The frequent observation on regulation was that it was tight and adequate for laboratory-based microbiology and genetic manipulations, though with the possible exception of gene drives.² However, there was a feeling that regulation was somewhat lacking in the field of computer science. This lack of regulatory oversight or governance of computer science was seen as a potential problem, not within the interviewees’ own work but more generally, given its power and potential to impact on society. Interviewees spoke about the development and implementation of decision-making algorithms, data security and automation of computer aided design as particular areas of concern. However, there was little appetite for tight regulation, which was described by some as having the potential to stifle research and progress, particularly in the field of medicine and human health.

The interviewees thought their work to be inherently safe by virtue of their working with non-pathogenic organisms, and a common trope was that the strains of bacteria in use have been “cosseted” in laboratories for many years and so would not survive in the wild should they somehow be released. Stringent control of containment, and therefore not exposing “the public” to modified organisms, was invoked to further demonstrate the safety of the work that is being done. One interviewee expressed a concern in terms of not doing anything “stupid” and that,

Interviewee 2 (Microbiologist):

really, the responsible side is not creating the super-pathogen or the potential for that.

This, we feel, is an example of a scientist reflecting to some extent on the direction research might take and considering the kind of challenges to look for. Similarly, when discussing the design strategy for a particular genetic construct,

Interviewee 3 (Microbiologist):

So I think that’s a good thing, you know, I think you could say maybe what we’re trying to do is envision ways that genetic engineering could be controlled a bit more than what it has been historically.

This thought was reflected in another interview,

Interviewee 5 (Computer scientist):

… somebody pointed this out the other day, I mean cross species vectors and plasmids which work in multiple organisms, there’s an obvious flaw there which is if somebody {pause} or if we do something stupid, by design or by accident, the potential um scope of that is much wider. …  Again I mean all of that stuff is fairly tightly regulated and we would be looking at restricted strains because the whole point of this would be that we probably need to do something in the strain to support that, but I think thinking about that is an important because if you would probably want to do that in a way where at least some of the genes necessary for doing that are actually part of the host genome and integrated in, [sic] rather than plasmids which can combine and go into other things more freely than host based stuff.

In these examples we see aspects of RRI in action, reflecting on the work being done, and anticipating directions to take and those to avoid. The capability to undertake this is based on the depth of knowledge and experience these scientists have built up over their careers.

Other than the considerations of risk, the most frequently expressed examples of behaving “responsibly” were (i) remaining within the law, (ii) not causing damage to the University’s reputation, (iii) to ensure that the work being done was making best use of public funding and (iv) that any outputs, either knowledge or products such as software and algorithms, should be freely available to anyone. This latter response was particular to those with a computer science background, rather than biology. Such a distinction may result simply from the realities of the products of the research of the two groups; software is easily disseminated and made freely available while genetic constructs, modified bacteria or other physical items are less easy, and perhaps less appropriate, to share. However, it may also be an expression of a cultural difference between the disciplines.

3.2. Synthetic biology as a field

Policy documents that identified key technologies which were to be supported in order to enlarge the UK’s bioeconomy take for granted the existence of a defined field of “synthetic biology”. We were interested to explore the views of this group of scientists on synthetic biology as a field, and one that not all interviewees self-identified as belonging to.

Analysis of the interviews revealed four main response categories defining “synthetic biology”, broadly consistent with the range of views already reported in the academic literature;

1. Unsure

2. Defined by example

3. A new name for what has been done for years

4. Bring engineering principles to biology

When asked what the term “synthetic biology” meant to them, again, a common response from those interviewees with limited experience of working in the field was first to laugh, then say they were unsure. However, when pressed further, interviewees often defined the field by giving examples before frequently suggesting that these could better be described as genetic engineering rather than synthetic biology.

Responses that referred to the application of engineering principles to biology were common among those with computer science or strong synthetic biology backgrounds. While the discipline of engineering was recognized by all interviewees as contributing to the development of synthetic biology, those with little or no previous experience in synthetic biology projects did not mention the application of engineering “principles” to biology. When this notion was raised in interviews, biologists from several organizations questioned its validity; the inherent variability and randomness of biology (its “stochastic nature”) rendering it impossible to “engineer” predictably. The interdisciplinary nature of synthetic biology was recognized, however, and all interviewees were open to the idea of exploring what different disciplines might bring to their own work.

Analysis revealed that interviewees’ views map well onto the classification developed by Schyfter and Calvert (2015) described above. “Epistemics”, “pragmatic constructors” and “committed engineers” were all identifiable, though it is important to note that many individuals exhibited characteristics of more than one category, depending on the context in which they were working.

One unexpected finding was that some interviewees constructed imaginaries of scientists from other disciplinary backgrounds. This appeared to be similar in form to the construction of imaginaries of the public by scientists revealed by Marris (2015). While all interviewees were clear on their own role in the particular synthetic biology project they worked on, differing levels of understanding of the work of others contributing to the same project was evident. In one example a biologist remarked,

Interviewee 4 (Biologist):

… for me it is still a mystery what other people are doing on the project, the computer people for instance.

… when [Colleague] will be talking about, or whoever, about computer stuff I am pretty sure I will not understand a single word out of it and because I am not very interested I am not going to go to the library and read it. …  I am pretty much sure when you go and talk to them and just occasionally ask them what transcription is you are not going to get an answer because they don’t know and they’re not interested.

Imagining what members of other disciplines might know, be capable of understanding or be interested in is indicative of the way that science specialisms have developed as each constituent discipline becomes ever more complex and narrowly delineated. It is, perhaps, also a reflection on the fact that interviews were conducted early in the life of a multi-year project. It would be instructive to speak with the same group towards the end of the project and examine any shifts in attitudes. One interviewee, a biologist, suggested that the creation of doctoral studentships in synthetic biology was perhaps a way forward in bridging the gaps that exist between various disciplines, because of the interdisciplinary training required.

A feature of some of the interviews was the recognition that synthetic biology (however defined) was being promoted by government and funding bodies as a way to stimulate the economy. In some instances there was a feeling that the lack of clarity in defining synthetic biology might be useful; the use of “synthetic biology” as a “buzzword” in order to leverage funding for work previously done under a different name. However, interviewees with more experience of synthetic biology projects recognized that the wider political and economic landscape gave them the opportunity to accelerate the development of the field. These interviewees tended to be those who self-identifed as synthetic biologists and whom we could categorize as “committed engineers” using Schyfter and Calvert’s typology. They were also those who responded to questions about RI/RRI with the greatest degree of understanding. We saw above that interviewees were engaging in reflexive thinking about their work or contribution to a particular project and so we suggest that, at least among this subset of interviewees, there is evidence of second order reflexivity (see Owen and Pansera 2019, 45). That is, interviewees are reflecting on the political and economic environment within which they are enmeshed. While they considered the work they were engaging in was “basic science” and thus well-regulated and so “responsible”, there was the awareness that (i) the political drive to encourage synthetic biology gave them access to funds for their work, and (ii) that if they were open – ensured that results, computer models and gene sequences were made freely available – then they were also contributing to this wider societal aim. Such second-order reflexivity and commitment to openness are key components of the concept of RI as developed in the UK (see Owen and Pansera 2019, 31–32). While such thinking could be seen as being purely instrumental, redefining their research to fit the current political context in order to access increased funding, in some instances the interviewees demonstrated a considered and cogent understanding of how their research might impact and be impacted upon by society.

In summary, our interviews and observations have revealed that (i) RRI is conceived of as being essentially similar to the ELSI paradigm, (ii) “responsible research” is being conducted and processes of anticipation and reflection are being enacted by colleagues, without being necessarily being recognized and labeled as RRI activity, (iii) RRI is most frequently thought to be concerned with risk and its regulation, though there was an understanding that openness and “responsible” use of public funds were important too, (iv) colleagues in different disciplines sometimes constructed imaginaries of other disciplines (especially of computer science) when they had no experience of them, (v) the term “synthetic biology” remains contested and is not yet seen as a clearly defined discipline and (vi) there is evidence of second order reflexivity at least among some interviewees.

4. Discussion

Our findings may come as no surprise to social scientists who have been engaged in research on synthetic biology for some time. The dominance of the ELSI paradigm and varying accounts of what synthetic biology might be as a subject (field, area, discipline?) would all have been expected responses some time ago. The interesting point, we argue, is that these same views are still prevalent. The focus on risk as a first response to questions about RRI might be interpreted as believing that risk would be the primary concern of “the public”. As we know from decades of work, especially by Clare Marris, this notion persists despite its inaccuracy. That we have found these responses suggests that work remains to be done in getting the results of the labors of social scientists across and into the thinking of practitioners of synthetic biology and its component specialisms. When specifically asked, interviewees admitted to little knowledge of relevant social science literature or the ideas and concepts developed within it; where there was some understanding, this derived from having worked with social scientists on earlier projects.

We recognize the need for a continued critical appraisal of synthetic biology by social scientists, and that discussion and debate in the pages of specialist journals is essential for the development of ideas, concepts and critique. The large body of social science scholarship thus far has produced valuable insights into synthetic biology (and other novel and controversial technologies) and its place in and for society. Largely, this literature has been aimed (reasonably) at a social science readership. What has been revealed in our (admittedly small) study is that, with the exception of individuals who have worked on projects with social scientists, the concepts and findings of this literature have not generally made their way into the consciousness of the scientists involved in the fields studied. Some social scientists have made great efforts to engage synthetic biologists and policymakers with the results of social scientific scrutiny of the subject. An important example of this is Marris and Calvert (2019), who report on the difficulties of their attempts to do so, and quote Wynne as experiencing similar frustrations a decade earlier. In their paper Marris and Calvert ask a number of questions in relation to an “open-ended STS involvement in policy” (21) that highlight the difficulty of influencing policy relating to biotechnologies. We might add another question – would the chances of success be increased if the scientists engaged in leading biotechnology projects were more aware of the knowledge and opinion generated by the years of study undertaken by social scientists? While there is a concern among some STS scholars that social scientists should not merely adopt the role of facilitators in interdisciplinary projects, we believe that it would be useful to do so even if only for a period of time and in particular with early- and mid- career scientists, in order to engage in knowledge transfer and encourage thinking about these important issues. Owen (2014) highlights the importance for social scientists to avoid a deficit model approach to this kind of engagement, but in our work on this project, we have been conscious of our work being a two-way engagement. Such capacity building among scientists is, of course, a long-term strategy but, as we have seen with for example human embryonic stem cell research and nanotechnology, the promised returns from the science are often decades later than were originally predicted and so such a strategy may yet prove worthwhile.

It seems reasonable that at this stage in the development of RI/RRI that scientists from across a range of disciplines are unsure what the term means, particularly as Ribeiro, Smith, and Millar (2017) have shown, there is no academic consensus. Consideration of RI/RRI by our interviewees is therefore construed in terms of what has gone before, and approaches that are understood, and it is the ELSI approach that seems most appropriate to those scientists. It should be noted that one of the major funding bodies of synthetic biology in the UK has developed a clear framing of RI, informed by the writings of Owen, Stilgoe and others. The AREA framework³ and this is available to researchers through the EPSRC website referred to above.

The approach most often taken to implementing the ELSI paradigm has been for projects to bring in specialists, bioethicists and social scientists, to perform an analysis and identify the ELS issues that the output from the particular project may generate (Balmer et al. 2015). Typically, ELSI work was done when a product was close to market or to an end-user. Such an approach has rightly been criticized for often being implemented too late in the process; the scientists involved may have too much invested to be able to simply abandon the output of their research. ELSI work has therefore often been concerned with identifying potential problems the output may create and finding ways to ameliorate them. In equating ELSI and RI/RRI all but one of our interviewees suggested such work would be more important if and when projects are close to producing outputs that might reach the market. Another response from several of our interviewees when discussing the role of RI/RRI work in projects was to describe how early implementation creates a risk of “stifling” research.

In the case of our interviewees, a frequently expressed view was that the work that they were engaged in was “basic research” and not “innovation”. “Responsible Innovation” was therefore not really applicable and “Responsible Research” was taken care of by the normal research governance arrangements in place, particularly those relating to risk. Our participation in project meetings at our host institution where RI/RRI is specifically discussed leads us to speculate that by excluding the word “research” from “Responsible Innovation”, as the EPSRC AREA framework does, led to practitioners of biological research not recognizing that the RI/RRI agenda is something they needed to engage with and therefore understand as being different from ELSI.

It may be the case that funders need to be more proactive in communicating their interpretations of RI/RRI to the scientists they support in order to overcome the still prevalent views and dominant cultural norms involving ELSI as the paradigmatic approach to considering societal concerns.

We noted earlier that the lack of a single agreed definition of, or approach to, RI/RRI was held to be a problem by the BSI and Innovate UK; a problem to be overcome in order to permit the widespread introduction of synthetic biology and its products into the UK (and global) economy. This clearly presupposes that synthetic biology should be supported and encouraged to develop products that then should be available to society. Such a view merely reinforces an approach to new biotechnology in which ethical oversight could appear to be little more than an “ethical fig leaf”; a standardized, institutionalized statement that RRI (like ethical assessment) has been “done” and a strategy planned for how to overcome any societal concerns about the end products.

The absence of a standardized approach to RI/RRI may not, however, be problematic. Such a situation provides for flexibility in the implementation of RI/RRI in different contexts, as noted by Owen et al. (2013). A project in which the generation of fundamental knowledge is the main aim can adopt a light-touch implementation. A project with more of a direct industrial application may need a different means of implementation of RI/RRI, and projects in which a product may be released into the environment, or be directly used in human medicine, would involve yet other approaches that will interact more strongly with regulatory oversight mechanisms.

We have noted that aspects of RI appear to be a part of normal working practice of the scientists we engage with and interviewed, such as (i) reflecting on the direction of their research, (ii) considering how best to use public funds, (iii) ensuring that openness to the wider academy is a core part of disseminating findings and products (such as algorithms). As such we may be seeing aspects of what Randles (2017) describe as “defacto rri”, that is “what actors already do, in collective fora, in order to embed institutionalized interpretations of what it means to be responsible into the practices, processes, organizational structures and outcomes of research and innovation” (20). This is a subject that we are writing on with laboratory-based colleagues at present, in which we will explore the overlaps between everyday practices and considerations (rri) and the implementation of RI/RRI in a project.

Our observations in this study suggest that work on the different disciplines that comprise synthetic biology takes place in laboratories that already have a framework of accepted standards and practices: what could be called “practices of responsibility”. If Responsible (Research and) Innovation is to be more than a top-down, imposed, bureaucratic completion of a specified set of rules to be followed, or a replication of the now criticized ELSI model, then consideration of RI/RRI may be better focused at the stages of the research process before projects reach the laboratory bench. This could take place during the development of funding proposals and indeed during the policymaking process where funding priorities are decided. An early example of such an approach is described in Owen and Goldberg (2010) and we would encourage further experiments in this direction.

Owen and Pansera (2019) describe RI as asking, “what kind of future we want innovation to create, and secondly, given that the future is inherently uncertain and unpredictable, how we should proceed under conditions of ignorance, ambiguity and uncertainty” (29). It seems to us that this question goes beyond what might be expected of the laboratory scientist or even project Principal Investigator. It is not for such individuals to take decisions alone on the types of futures a society should have available to it. Rather it is a question which needs to involve others, including funders and policymakers. The role of the individual scientist might be to reflect on their work and to recognize the potential practical and societal problems that may arise (such as the continued reliance on antibiotic resistance genes in their work) or to articulate clear benefits their work may permit. However, to do this these scientists must be aware of the social context within which they work. Individual scientists cannot be expected to undertake the necessary social science research or even to be overly familiar with the specialist social science literature. It seems necessary then, that for RI to become an intrinsic part of UK biotechnological research, a multi- or interdisciplinary approach to constructing research projects is necessary; incorporating the necessary social scientific research expertise. One important arena in which this might be achieved was suggested by Hartley, Pierce, and Taylor (2017) and we agree with their observation that Universities will be a “key site” (374) in the determination of how RI/RRI is implemented in practice. That this will be a challenging process is not in doubt but, as Hartley et al note, it will be crucial to address it.

UK Government policy led to the large-scale funding of efforts in synthetic biology, with the implicit assumptions detailed above. While subsequent developments, such as the 2017 industrial strategy, have had less emphasis on synthetic biology specifically, there is still a drive to a high-technology, knowledge led economy. This policy is driving the creation of start-up companies to exploit the knowledge generated in the public sector and this leads to commercial pressure to succeed. Unfortunately, the industrial strategy does not include specific reference to RI/RRI and so an opportunity outside the public sector in which notions of responsible innovation could be instilled in those engaging in science has, perhaps been missed. While the conduct of public-sector-funded projects can be kept within the rules and regulations and meet many of the goals of Responsible (Research and) Innovation, this may not be true of private sector science in which the innovations that will impact on societies will take place. There remains, therefore a need for continued social scientific scrutiny of developments in this field.

Acknowledgements

The authors would like to thank the interviewees for their time and candor and the participants at the Policy, Ethics and Life Sciences (PEALS) Research Centre 19th International Symposium “The implications and impacts of a responsibility agenda for synthetic biology” for stimulating discussions. We also extend our thanks to the two anonymous referees whose constructive critiques helped us clarify our thinking and made this a better paper. This work was supported by an award from the UK Engineering and Physical Sciences Research Council, EPSRC grant EP/N031962/1.

Disclosure statement

No potential conflict of interest was reported by the authors.

Additional information

Funding

This work was supported by an award from the Engineering and Physical Sciences Research Council, EPSRC grant EP/N031962/1.

Notes

1 Synthetic Portabolomics: Leading the way at the crossroads of the Digital and the Bio Economies, funded by the Engineering and Physical Sciences Research Council (EPSRC), award EP/N031962/1.

2 “Gene drives are systems that bias the inheritance of a particular DNA sequence. They can be used to increase the persistence of an introduced trait that would otherwise disappear from a population very rapidly because the introduced trait puts the organism at a disadvantage. They can also spread a desired trait through a population. Many such systems occur naturally, and these are inspiring the development of new gene drives using synthetic biology techniques.” (https://royalsociety.org/-/media/policy/Publications/2018/08-11-18-gene-drive-statement.pdf) In this way gene drives could be designed to quickly spread a trait that for example could aim to eliminate malaria carrying mosquitoes from a particular environment. There are significant socio-ethical concerns about such work and debate continues worldwide on the risk versus benefit of such a strategy.

3 The acronym AREA represents the four key components of RI: Anticipate, Reflect, Engage, Act.