3. An introduction to Responsible Research and Innovation

As illustrated in the previous sections, transformations in late-modern societies and in science pose new governance challenges for Science and for R&I healthcare systems, at the local, national and global levels. RRI, like other similar approaches, wishes to contribute to facing such governance challenges.

In this section, a brief introduction to RRI is provided. It is out of the scope of this section to provide an extensive and comprehensive overview on RRI in health and of the different aspects of the CHERRIES methodology (need-demand driven approach, Open and User Innovation, co-creation). In this regard, reference is made to Part Two of this Toolbox and to the official document illustrating the CHERRIES methodology and Model (D.3.2).

Research and Innovation (RRI) is a policy framework that emerged from a particular concern in European policy circles that increasing expenditure on research and innovation was not failing to lift general welfare levels up. The launch of RRI also follows the 2009 Lund Declaration, updated in 2015, which called upon European nations and institutions to focus research on the ‘grand challenges’ facing society, such as climate change, water shortages, and ageing populations.

The RRI concept was developed within the EC, starting as a policy rather than an analytical concept. Subsequently, the Directorate-General for Research promoted RRI as an ambitious challenge for the formulation of research and innovation policies driven by the needs of society and engaging all societal actors via inclusive participatory approaches. RRI was included as a cross-cutting action in the EU Program Horizon 2020 − the world largest research and innovation programme − at its establishment in 2014.

RRI can also be found in Europe’s policy of ‘Open Innovation, Open Science and Open to the World’, launched in 2016, focusing on the advent of digital technologies as a powerful tool to make science and innovation more open, collaborative and global and able to interact more effectively with societal actors.

In these last decade, RRI has also become the focus of research programmes launched by several national research funding bodies, such as the Netherlands Council for Research (NWO), the UK Engineering and Physical Sciences Research Council (EPSRC), the US National Science Foundation (NSF) and the Research Council of Norway.

 

RRI has gained recognition over time as a guiding principle for EC research policies and has been incorporated into “Europe 2020”, the new Framework Programme that will run from 2020 to 2027.

Different definitions and perspectives have been elaborated on RRI in different geographical and organisational contexts. Some of the most common definitions are reported in the box below.

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A common point shared by different authors is the need to develop governance structures that direct or re-direct research and innovation towards societally desirable outcomes, by both mitigating the negative effects of innovation in areas with potentially adverse societal effects and actively supporting innovative activities in areas where the societal benefit is expected to be high (for instance, in addressing the societal challenges Europe and the World are facing, like climate change, food security and demographic change).

This implies making science and technology able:

  • To include a diverse range of partners and voices to plan, co-create and co-develop marketable solutions
  • To align to values, expectations, and need of society
  • To anticipate their own unexpected impacts
  • To transparently share knowledge and ideas
  • To connect people and institutions in different disciplines, sectors, and countries.

In a broader perspective, RRI can be interpreted as one of the organised and policy-oriented reactions to the transition of science (see Section One) and to the uncertainty this latter generates in the research systems and in the society as a whole. In theoretical terms, it can be also understood as including any effort for overcoming the fragmentation characterising science as a social institution and for coordinating all the actions aimed at governing the transitional processes affecting science.

As for CHERRIES, the working definition built on previous efforts in the framework of the RRI Tools Project fits well also with the aims and the framework of the project. RRI is described as a “dynamic, iterative process in which all stakeholders in research and innovation become mutually responsive and share responsibility for both the process and its outcomes”. This means the focus is not only on achieving socially desired outcomes, but also on how the research and innovation (R&I) that leads to them is conducted and on those involved in this process.

 

In practical terms, the European Commission developed an RRI policy framework including 6 keys or pillars:

  • Public Engagement – This key is aimed at engaging society more broadly in its research and innovation activities
  • Open Access – This key focuses on the need to increase access to scientific results (research data and publications)
  • Gender Equality – This key is concerned with ensuring gender equality in both the research process and research content
  • Research Ethics and Integrity – This key is aimed at ensuring due consideration of the ethical dimension of research and research practice throughout the research process
  • Science Education – This key concerns the promotion of formal and informal science education in any social sector, including youth, elderly people, and disadvantaged groups
  • Governance – This key is intended to favour the development of harmonious governance models for responsible research and innovation able to integrate the previous 5 keys.

 

These keys can be understood as possible vectors or areas of change to make R&I a more inclusive process, to ensure excellent scientific outputs, and to prevent and cope with the main risks the European research and Innovation may produce, with a focus on those raised by an inadequate connection of science with society.

RRI keys also represent the axes of a policy agenda for fostering structural changes within research organisations, through both specific actions and more systematic RRI-oriented plans.

Beside the definition of RRI as policy framework hinged upon the 5 RRI keys, many authors prefer to approach RRI in terms of specific process dimensions which, separately or in combination, are supposed to induce changes in research and innovation practices, science policies, or scientific culture.

Although positions may differ, a general convergence can be found on four main dimensions of RRI – anticipation, reflexivity, inclusion and responsiveness – understood as “the four conditions can be seen as necessary devices for reflection that will give shape to the research and innovation process by cultivating a forward-looking approach to responsibility”.

  • Inclusion. It mainly refers to the engagement of different stakeholders from the early stages of research and innovation onward so as to give voice to all the concerned interests, values, needs, and beliefs.
  • Anticipation. It refers to the capacity of envisioning the future of R&I and understanding how current dynamics help design the future in order to prevent risks and to lead research to desirable impacts. Hence the importance recognised for implementing RRI to reliable and participatory forecasting techniques.
  • Responsiveness. It concerns the capacity to develop proactive management of new technologies so as to identify risks and develop ethically adequate responses. The concept of responsiveness also relates to transparency (responses should be open to the public debate) and accessibility (scientific results about risks and responses should be openly accessible to everyone). As it is easy to notice, responsiveness is partially overlapped with the dimension of anticipation.
  • Reflexivity. It is mainly seen as the capacity of the research system to keep control of its own activities and assumptions, to be aware of the limits of the knowledge produced and of the framing processes connected to the identification of the issues to be addressed as well as to reflect on values and beliefs connected with R&I. Reflexivity is linked to public dialogue and collaborative approaches in science.

RRI process dimensions are useful for shaping the directionality of R&I progresses for the benefit of society. RRI is about anticipating how our decisions regarding research and innovation might shape the future and about reflecting on the actions to take while being open and transparent about these decisions and actions. It should not merely recognize the needs and wishes of stakeholders, but also shape directions of research and innovation in response to a diverse set of perspectives and to changing circumstances.

RRI aims to create a society in which responsibility for our future is shared by all people and institutions involved and in which research and innovation practices strive towards ethically acceptable, sustainable, and socially desirable outcomes.

In the CHERRIES perspective, four couples of dimensions of the RRI process defined within the RRI Tools project are considered, i.e., Diversity and Inclusion, Anticipation and Reflection, Openness and Transparency, Responsiveness, and Adaptive Change. Their meaning is summarised in the figure below.

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These dimensions interact with the other components of the RRI process, i.e., the different RRI keys and the different stakeholders involved in the process. These relations are visualised in the figure below.

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This process can be assessed also in terms of the expected outcomes. At least three kinds of outcomes can be identified:

  • Learning outcomes (e.g., engaged public, responsible actors, responsible institutions)
  • R&I outcomes (ethically acceptable, environmentally sustainable, and socially desirable innovations)
  • Societal outcomes (finding solutions to the major societal challenges Europe is facing).

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The CHERRIES Project focused on the application of RRI principles at a territorial level (Territorial RRI). EU Regions are starting recently to address RRI and they are facing common challenges in the understanding and implementation of this approach at territorial level.

The concept of Territorial RRI is partially overlapped with other approaches such as open innovation, territorial innovation, or innovation milieu. However, in the Territorial RRI, the focus is on fostering more open, inclusive, reflexive, and responsive governance of the R&I regional policies and strategies. This could allow overcoming the usual criticisms toward regional R&D planning and the RIS3 process (the approach to innovation focusing on the development of national and regional research and innovation strategies for smart specialisation). These criticisms mainly concern the tendency to involve only experts in territorial dialogue initiatives, the tendency to ignore future challenges, opportunities, and even positive externalities of the innovation processes and the tendency of the stronger stakeholders (corporations, universities, etc.) to “hijack” the policy agenda and the policy process.

Similarities and differences between Territorial RRI and other approaches can be also found. Fitjar et al., for example, compare RRI with RIS3, identifying the following similarities:

  • Both look for broad stakeholder involvement in the development of research and innovation policies
  • Both orient research and innovation towards the solution of the grand societal challenges
  • Both have been defined as a policy concept rather than as a theoretically motivated framework.

As for the main differences:

  • RIS3 is primarily oriented towards regional competitiveness and therefore does not fully incorporate local institutions and lacks reflexivity on public and social values
  • RRI is mainly aimed at reconciling scientific progress with societal interest to avoid loss of legitimacy but lacks spatial and geographical dimensions (innovation processes are socially and spatially embedded) and is not explicit about the local perception of what is “responsible” or socially desirable.

A virtuous integration between RRI and RIS3 might be therefore useful for more open, reflexive and responsive innovation policies for local growth and social cohesion and for tackling European innovation challenges at territorial level.

Another view on Territorial RRI interprets it in terms of sustaining local actors in taking care of and becoming responsible for their territory, thus facing the factors leading to de-territorialisation (i.e., a social and economic impoverishment of the territory) and promoting re-territorialisation. This means making local actors as part of the “territory-making process” meant as an ongoing and open-ended process of establishing and cultivating new transformative relationships for territorial governance.

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Looking at the different RRI-oriented experiences in biosciences and medical research, it is worth noticing that there are no rigid and universal models, adaptable anytime and anywhere.

Although RRI is characterized as a whole by specific elements, formalized over time, it has an intrinsically “contextual” character. As suggested in the Starbios2 strategic document “Mainstreaming RRI in biosciences and beyond: a quadruple contextualisation”, different frames of “Responsibility” (meant as issues at stake concerning the relationship between science and society) are important for a mainstreaming of RRI at different levels:

  • The organisational frame (going beyond the “business as usual”)
  • The disciplinary or sectoral frame (adapting RRI to the sectoral challenges)
  • The geopolitical and cultural frame (identifying what territorial challenges and needs and what territorial key actors to engage)
  • The historical frame (preventing and responding to historical challenges, e.g., the COVID19 Pandemic).

In the healthcare sector, the issue of making research and innovation more responsible could be of pivotal importance.

In fact, technological innovations can exert pressure on available resources. In publicly financed systems, this puts the State in a position where it fosters innovations with the aim of creating a competitive economy while, at the same time, it is the main purchaser of innovative and expensive medical technology. This is posting an enormous and increasing challenge to balance growing public health spending and providing patients with access to the best possible care.

Therefore, it is imperative that “new technologies resolve and not create problems for healthcare systems”. This led to the development of a new model for the design, development, and governance of medical innovation able to carefully examine moral and social issues and to encourage greater inclusion of the actors concerned by the innovation. The assumption is that such a model might be better suited to respond to the multiple challenges and needs of health care systems and make it easier for the State to manage the delicate trade-off between investments and control in the governance of medical innovations. In this context, RRI could help to anticipate social risks and to reduce unforeseen and undesirable consequences of innovations.

It is to consider that responsibility is already embedded in healthcare systems since their creation in the 1970s and imposed through a set of long-standing rules and routines that govern the provision of medical services. These regulations require public and private actors to deliver the necessary services to maintain and improve the health and wellbeing of the population. Accountability is embedded in the policies and regulations that frame R&D, manufacturing and distribution of medical devices and pharmaceutical products by ensuring the quality, effectiveness, and safety of these products.

In this framework, according to Demers-Payette a specific role can be played by the RRI approach, i.e., contributing to identify innovation needs and to better integrate innovations within the healthcare system by providing a future-oriented framework. RRI is in fact more concerned with the dynamics that drive the innovation process. Therefore, it might help understand how responsible medical innovation could better address the needs and challenges of health care systems.

An attempt is also made by the authors to define the application scope of the RRI dimensions in healthcare innovations.

  • The dimension of anticipation in healthcare innovations addresses the identification of new preclinical opportunities for innovation, as well as their social, ethical, and political risks.
  • The dimension of reflexivity refers to a socio-political analysis of the context in which medical innovations are produced and used as well as to the assessment of the value system and societal practices governing R&D processes in healthcare.
  • The dimension of inclusion has to do with the involvement of a wider public and users in R&D as well as with the development of mechanisms of public deliberation on health issues and medical innovation process.
  • The dimension of responsiveness concerns the ability to mobilise emerging views, norms, and knowledge in the R&D process and subsequently create funding, regulations, and audit processes that allow for an adaptive medical innovation process.

The application of these dimensions might offer the opportunity to reflect on the fore challenges of medical innovation that responsible medical innovation could address by articulating: (1) a clearer understanding of the uses of medical innovations and their context; (2) a better alignment between health and innovation value systems and social practices; (3) a sustained engagement of users and the public in the innovation process; and (4) flexible steering of innovation trajectories within a highly regulated environment.

Another approach inspired by the application of RRI is that of Responsible Innovation in Health (RIH). It is defined as a “collaborative endeavour wherein stakeholders are committed to clarify and meet a set of ethical, economic, social and environmental principles, values and requirements when they design, finance, produce, distribute and use socio-technical solutions to address the needs and challenges of health systems in a sustainable way”.

RIH refers to the innovation as well as to the organisation that develops and makes it available to intended users. The principles, values and requirements of RIH are applied throughout a technology’s lifecycle, promoting the best social and environmental practices.

In this sense, RIH is understood as a policy framework providing an integrated set of dimensions through which health and innovation policy-makers “can envision what types of innovations health systems need and how they should be produced and brought to market in order to support equitable and sustainable health systems around the world”.

In such a perspective, five value domains have been identified as characterising RIH:

  • Population health value (relevance, inequality, ELSI – ethical, social, and legal implications)
  • Health system value (inclusiveness, responsiveness, level of care)
  • Economic value (frugality, i.e., greater value with lesser resources)
  • Organisational value (business models creating value for users, purchasers, and society)
  • Environmental value (eco-responsibility).

The interaction between these values domains and the different components of innovation (process, organisation, and product) is schematized in the figure below.

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