Section 8: Proposals for the Institutional Structure of Ethics Assessment in the European Union and its Constituent Countries

This section outlines proposals for the institutional structure of EA in the EU and its constituent countries. The following recommendations address the institutional setup of eight different types of ethics assessors on an EU level. These types are universities, national science academies, RFOs, RECs, NECs, academic and professional organisations, CSOs, and companies. Additionally, some recommendations are made regarding the national level of some EU countries. All recommendations are based on previous SATORI reports, especially the annexes of Deliverable 1.1 on the respective types of ethics assessors and some subtasks of Work Package 4, concerning models for EA and guidance in some of the named types of ethics assessors. For general recommendation (indicated by a numeral), actions (indicated by a letter) are listed that should be taken by specific actors.

SATORI Framework Web Icons_UniversitiesUniversities

The main instruments for EA in universities are scientific integrity boards and RECs. For both instruments, the recommendations aim at transparency, consistency and effectiveness.

Scientific integrity boards

  1. There must be clarity in the legal framework regarding which organisations are responsible for particular aspects of the inquiry and investigation processes.1 Different entities should handle the investigation, adjudication/sanctions and appeal phases of an allegation of misconduct.2
    • The relevant body at the national level should establish clear guidelines on investigating scientific misconduct, including overarching principles and standard procedures. It should also decide upfront whether different organisations or bodies within or outside the research organisation are responsible for different categories of allegation of wrongdoing, to ensure that all are covered.3
  2. The independence of those investigating alleged misconduct should be protected. Conflicts of interest (real and apparent) must be avoided, and the integrity board should have the necessary resources to perform its work without having to rely on other sections of the institution.4
    • The relevant body should make the integrity body separate from the research-performing institution and write out explicit rules aimed at avoiding conflicts of interest.5
    • The relevant body should have all investigators and staff make a “Conflict of interest declaration” both when hired and thereafter on a yearly basis.6
    • Investigators of alleged scientific misconduct should not report to the research management under investigation7 and they should have an independent budget.8

SATORI Framework Web Icons_Research Ethics CommitteesResearch Ethics Committees (RECs)

  1. University associations and national academies of sciences should, with the help of professional organisations, establish and commit to a joint framework that would set general standards at a national level regarding RECs in the higher education system.9 For that framework, an official committee should be established.
  2. Accreditation committees, in the course of evaluating teaching programmes, should assess whether research ethics are a part of the curricula and based on and reflective of the general standards adopted by the institution, ensuring their quality.
  3. EA in institutions of higher education should be organised into one or more RECs. In order to address discipline-specific issues in project evaluation, the principle of interdisciplinarity and independence should be respected in committee membership.
    • Each institution should decide, based on its size and volume of research, whether it should have multiple standing committees or one committee that has the authorisation to form sub-committees as needed.10
    • Committees should consider appointing a chairperson who is not from the focus field for the committee or the institution, to ensure minimal bias.
  4. The institutions’ governing bodies should appoint members of RECs. They should not be picked by current members of the committee, but rather be suggested by community leaders. When choosing members, persons with a potential conflict of interest should be avoided. Finally, the committee should be allowed to seek the advice from outside experts.

SATORI Framework Web Icons_National Science AcademiesNational Science Academies

National science academies (NSAs) usually have an influential position in science and society. The following recommendations focus on how NSAs can use these positions in ethics assessment.

  1. In the majority of cases, there is no systematic monitoring of compliance with NSA recommendations. Therefore, monitoring and compliance programs should be incorporated into National Science Academies.
    • NSAs should establish a compliance officer to monitor the number of mentions and citations of Academy results by policy, decision, and public actors.
  2. Too often, the decision-makers do not accept/follow recommendations established by academic committees or see the need to conduct EA, and try to avoid difficult topics.
    • NSAs should try to develop closer connections, while retaining their autonomy, to work in conjunction with policy and decision makers by establishing liaisons or programs to work alongside decision-makers.
  3. 3. Another pressing challenge is the lack of necessary resources (administrative staff, budget).
    • The EC should encourage the establishment of NSAs as a part of its requirements for countries to receive funding for R&Is projects.
    • Governments (i.e., EU, UN, OECD and potentially other organisations) should create a multi-stakeholder platform on a global level, in which the UN, OECD, and the EU could collaborate in pursuit to harmonised NSA objectives. This platform can build upon the existing work of associations that currently exist.

SATORI Framework Web Icons_Research Funding OrganisationsResearch Funding Organisations

RFOs widely ask funding applicants for EA, but the EA itself is mostly outsourced and not based on a broad set of criteria. To secure the high quality of EA, an in-house EA should be considered.

  1. Large RFOs (spending more than 100 million Euros a year) should themselves be responsible for conducting EAs of research proposals submitted to them. Smaller RFOs (usually privately funded NGOs) can continue to rely on external EA.
    • Large RFOs should institute in-house ethics panels for conducting full ethics review of all project proposals that have been flagged as ethically problematic during a pre-screening phase. Staff members of the RFO who are involved in project selection and who have received prior training in the field of ethics would conduct this pre-screening phase.
  2. RFOs should organise an on-going structured exchange with their international counterparts to discuss (good practices in) EA in response to new and emerging technologies. They should also do more to raise awareness of ethics among researchers who submit research project proposals.

SATORI Framework Web Icons_Research Ethics CommitteesResearch Ethics Committees

RECs are not only important in universities, but can operate on various levels outside universities. It is therefore crucial to clarify the legal conditions under which RECs are operating.

  1. It should be clear in a legal sense when RECs are to be included in the practice of EA.
    • Local and national governments should make the necessary legal provisions at the appropriate level – whether institutional, local, regional, or national – for when RECs are to be included in the EA practice.
  2. For the sufficient funding of the REC, including any necessary secretariat or administrative staff, means of accomodating the costs of the REC should be established. They can be either directly funded by the government or a respective institution, or incorporated into the research project proposals.
  3. RECs should have representatives that participate in (e.g. national) forums directed at the discussion and guidance of emerging ethical issues and guidelines. This participation is to ensure harmony with international trends, but also to provide input in their developments.

SATORI Framework Web Icons_National Ethics CommitteesNational Ethics Committees

NECs usually focus on bioethics and could benefit from broadening their focus. As they are supposed to advise national governments, stakeholders should participate in the EA process.

  1. 1. NECs should broaden their focus to encompass all other scientific fields besides the medical and life sciences. In order to do so, NECs should institute special sub-committees for different disciplines.
  2. 2. NECs should create an organisational structure that allows for the consultation of citizens, CSOs, external experts and possibly other external groups. To investigate how this might be achieved, individual NECs should institute a temporary sub-committee.
  3. 3. NECs should establish a special committee that monitors for compliance with the ethical guidance they offer to ethics assessors.
  4. 4. NECsshouldbemoreactivelyinvolvedinensuringthe quality of the EAs made by REC members and other ethics assessors, e.g. by offering training programs.

SATORI Framework Web Icons_Academic And Professional OrganisationsAcademic And Professional Organisations

As academic and professional organisations often work together with NSAs, the three recommendations for NSAs also apply to them.

  1. Academic and professional organisations should create forums for consolidating developments in EA, which produce unambiguous results that can be implemented and monitored by membership groups.
  2. Academic and professional organisations should utilise their positions as membership-granted organisations to train members to instil responsible research and practices through the development of partnerships with universities and other research conducting organisations that account for its membership group.
    • The EC should recognise academic and professional organisations as potential conduit points for the implementation of training programmes for responsible research.

SATORI Framework Web Icons_Civil Society OrganisationsCivil Society Organisations

Recommendations for CSOs focus on making their two ways of participation in EA more effective: 1) to participate in RECs, and 2) to cooperate with each other to build their own structures for EA.

  1. CSO representatives should make efforts to be involved in RECs as representatives of a specific vulnerable group (e.g., consumers or patients) or spokespeople for a specific interest (e.g., the animal welfare).
  2. There should be support at the EU level for the development and exchange of EA related CSO networks. These networks could vary in terms of structure, level of interdependence, aims etc. The purpose of networking would be to exchange information (knowledge and experience) and learn from each other (through sharing best practices, coordinating activities, obtaining common funding, organising advocacy campaigns, influencing the adoption of new regulative acts, etc.).

SATORI Framework Web Icons_IndustryIndustry

This section provides recommendations for meeting the challenges in the institutional structures of EA in industry.

  1. A broad institutional structure of corporate responsibility (CR) including R&I should be formed as a cross-sectoral approach based on collaboration.11
  2. The institutional structures should enable engagement with stakeholders to evaluate and review impacts and actions. Multi-stakeholder approaches should be adopted.
  3. CR (including R&I activities) should be based on an appropriate mix of bottom-up and top-down approaches to promote CSR, also taking into account local context and values.
  4. The institutional structures for EA of R&I for industry should be incorporated with already existing general CR institutional structures, e.g. by businesses, the EU and the UN.
  5. For the benefits of stakeholders, the institutional structures for EA of R&I should promote recognition of the companies as their members, e.g. via certificates and rewards.
  6. The EU should enforce the currently existing legislation.
  7. The membership of a company in the institutional structures should not be granted indefinitely. The adherence to the ethical requirements should be verified regularly (e.g. annual or biennial verification).
  8. The institutions for the EA of R&I in industry should respond to the needs of different types of businesses.

SATORI Framework Web Icons_National Institutional Structures for Ethics AssessmentNational Institutional Structures For Ethics Assessment

In this section, recommendations are given for EA on the national level, including national level coordination, networking between RECs, ethical guidance and training, EA in non-medical fields and institutional problems.

  1. In countries without a NEC, governments should establish a NEC to coordinate RECs, and to develop EA and guidance procedures. The NEC should also provide a platform for discussion and cooperation.
  2. NECs should expand to include special sub-committees for different fields and disciplines, perhaps in cooperation with professional associations, which can provide insight into field-specific research practices and their ethical issues.
  3. Institutions with the knowledge, experience and authority to provide ethical guidance are NECs and REC networks as well as national academies and professional associations in specific fields and disciplines. These institutions, especially NECs, should provide training programs.
  4. Governments should take actions towards a functioning national system of EA, providing the necessary funding and impetus to national-level institutions as well as to take measures to implement national regulations.
  1. Boesz, Christine C., “Developing Research Integrity Structures: Nationally and Internationally”, in Tony Mayer and Nicholas Steneck (eds.), Promoting Research Integrity in a Global Environment, World Scientific Publishing, Singapore, 2012, pp. 7–16 [p. 11].
  2. Boesz, 2012, p. 14.
  3. European Science Foundation (ESF), and All European Academics (ALLEA), The European Code of Conduct for Research Integrity, 2011, pp. 8–9, 12.
  4. Boesz, 2012, p. 11–12.
  5. European Science Foundation, 2011, p. 14.
  6. Hin, Lee Eng, “Research Integrity Challenges—A Singapore Perspective”, in Tony Mayer and Nicholas Steneck (eds.), Promoting Research Integrity in a Global Environment, World Scientific Publishing, Singapore, 2012, pp. 21–25 [p. 23].
  7. Boesz, 2012, p. 11.
  8. Boesz, 2012, p. 11–12.
  9. Eksioglu, Subhan, Hatice Beyza and Mercan Sezer, “Ethics Committees in Turkish Universities,” Procedia – Social and Behavioral Sciences, 174, 2015, pp. 2882 – 2890 [p. 2889].
  10. Economic and Social Research Council, 2015, p. 14.
  11. STM Electronics (WP1 interview): “Compare and share experiences with other (external) organisations is generally useful and interesting at company level; (…) There is a need of an appropriate mix of bottom-up and top-down approaches to promote CSR, also taking into account local context and values.”