COMFOCUS aims to embed reflexivity and responsibility into its activities and to develop procedures and outcomes (frameworks, COMFOCUS Knowledge Platform and best practice guidelines) in line with the principles of RRI. Broadly defined, RRI calls for research and innovation (R&I) actors to align processes and outcomes of research with the needs and values of society. It broadens the conceptualisation of ethics, addressing the purposes, intentions, motivations, and interests early on in the process of research and innovation, with the guiding principles of transparency, reflexivity, and anticipation. It requires greater societal engagement of actors that are able to engage throughout the process, under the principles of openness, inclusion and responsiveness. It focuses on collective responsibility and care about the processes and outcomes of research and innovation.

The current document reviews the relevant literature related to RRI and highlights the ethical, legal and societal frameworks that should inform this. This is done by paying particular attention to the specific characteristics of R&I within the context of food consumer science and highlighting the unique features of research based on traditional, hypothesis-testing approach, and the data-driven approach based on big data. The report identifies a range of values that inform ethical frameworks, and summarises these in terms of respect for autonomy, beneficence, non-maleficence, justice, and explicability. Many of these are reflected in the legal frameworks that are developed to ensure transparent and enforceable procedures of research, primarily implemented through actions of ethics committees and office for data governance within research institutions. Here, the concept of privacy, anonymity, informed consent, data ownership, the right to be forgotten, conditions for data sharing and transparent data management processes are core elements.

The extant ethical values and legal principles are reinforced by the rise of open science agenda that calls for Quality and Integrity, Collective benefit, Equity and Fairness and Diversity and Inclusiveness in the process of doing science. It highlights the FAIR principles (data must be findable, accessible, interoperable and re-usable) that should help scientists comply with the principles of Open Science and drive the collective benefit and responsibility. Nevertheless, the review identifies challenges of applying open science in practice as it pre-supposes activities that can often directly contradict some of the established legal principles such as informed consent, data ownership and the rights to be forgotten. Informed consent, in particular, will need to be addressed by COMFOCUS because in the era of big data and the exponential drive towards greater openness, the main principles behind informed consent may be over-ridden by the value of collective benefit guiding the agenda of open science.

The report finishes with the framework for reflecting on ethical and legal issues, that was generated through this literature review, and elaborated upon by the members of the COMFOCUS consortium through an interactive, deliberative workshop. Through a process of collaborative reflection, the framework identifies specific tasks and activities within each WP of COMFOCUS that may pose ethical, legal and social challenges, and, through the process of co-creation, it provides solutions to resolve these.

Going forward, it is recommended that each task within each work package must have an item on the agenda dedicated to ethics and governance, so that ethics and governance are included by design. As the Open Calls application process will soon be developed, it is especially important that ethics and governance as well as societal engagement are built into to the Open Calls application process. There also is a need for systematic and broad engagement of a range of stakeholders within COMFOCUS, with Non-Governmental Organisations and citizen representatives (identified in a systematic and transparent way) having an equal say to industry participants. Prior to data collection, specific issues such as the right to be forgotten (withdrawal of data) need to be defined and mechanisms put in place whereby they may be enacted.     

It is also of great importance that consideration be given now to the future institutional structure of COMFOCUS. Governance processes need to be embedded into the operations of the future knowledge platform as it is being built. It is not too early to start thinking about the development of university-level agreements, initiatives and standards for working responsibly that will set clear expectations of those coming to COMFOCUS in terms of the conditions and processes they need to comply with.

Ethical and data governance processes, although related, need to be defined in their own right. Steps to ensure the appropriate governance of the COMFOCUS knowledge platform need to include:

>     1. a standards-setting body to ensure ethical compliance;

>     2. a minimum set of ethical standards for interacting with COMFOCUS;

>     3. a gate keeper who ensures compliance and audits the processes;

>     4. an implementation/enforcement process and structure.

Additional clarity is also needed in relation to the allocation of responsibilities within the research & innovation eco-system, which include not only legal but also ethical and societal responsibilities, in order to ensure greater transparency and instigate collective responsibility.