The challenges of research ethics and integrity in response to crisis: the coronavirus pandemic and beyond
The first priority is to analyse what characterises, from an ethics perspective, a crisis of a global, sudden and unexpected nature of the type of the Covid-19 pandemic, and isolate what are the related ethics and integrity challenges as regards the production, sharing and use of scientific knowledge and data[[The need for the sharing of data was emphasised in the Commission Communication on the on additional COVID-19 response measures, COM(2020) 687 final, https://ec.europa.eu/info/sites/info/files/communication-additional-covid-19-response-measures.pdf]] in designing and implementing responses as well as in anticipating future global urgencies.
Derogations of human rights and freedoms, albeit in the interests of the public good, must be temporary, proportionate, used only as last resort, and critically there must be clear transparent criteria for their suspension e.g. in the form of sunset clauses to emergency legislation. The greatest danger – during and after the end of any formal ‘state of emergency’ – is a ‘new normal’ of eroded rights and liberties.[[Statement on European Solidarity and the Protection of Fundamental Rights in the COVID-19 Pandemic, European Group on Ethics in Science and New Technologies https://ec.europa.eu/info/sites/info/files/research_and_innovation/ege/ec_rtd_ege-statement-covid-19.pdf]] For example, the pressing need to collect large amounts of personal data raises important questions regarding the preservation of privacy[[The full respect of the data protection law with regard to contact racing technologies was reaffirmed in the Commission Communication on the on additional COVID-19 response measures.]], and should be assessed carefully against the need to ensure information of data subjects and the possibility to pursue alternative means.
An important element that characterises major crises is that they go beyond the impact on the wellbeing of persons and touches the society more globally notably in terms of solidarity and social justice, as well as gender equality. Mid and long-term social, cultural and economic consequences are also more prominent in these unusual research contexts. The issues related to the role of ethics and integrity experts (as advisors, for example), informed consent, undue inducement, the right to know, and to opt out should be among the elements to tackle.
Based on this analysis, the action should draw the lessons and examine how to adapt processes followed under normal conditions (e.g. for informed consent, regulatory approvals etc.).
The scope should also cover the ethics of the scientific work on public health measures (such as behavioural studies, communication strategies, gender impacts on health[[See European Institute for Gender Equality (2020) Covid-19 and gender equality, https://eige.europa.eu/topics/health/covid-19-and-gender-equality.]]), including those aiming at an increased preparedness. The objective is to cover emerging ethics issues related to new concepts like “immunisation certification” that are at the centre of vivid debates involving fundamental values.
The action should clearly highlight what cannot be accepted or neglected in the name of coping with the urgency and the magnitude of the impact of a crisis (including the moral distress of the front line personnel, a large majority of which are women). Another important example is the need to always conduct, prior to the start of a research, an independent ethical review, which remains a necessary safeguard for the individuals involved and enhance the trust from the impacted communities and the society as a whole[[Ibid. The Commission Communication calls for a “robust authorisation process” to ensure safety.]]. Emergency needs adaptation should not lower ethics and integrity standards.
The work should be based on existing know how and identification of preparedness need. The joint advise on “Improving Pandemic Preparedness and Management”[[https://op.europa.eu/en/publication-detail/-/publication/a1016d77-2562-11eb-9d7e-01aa75ed71a1/language-en/format-PDF/source-171481573]] by the Group of Chief Scientific Advisors (GCSA), the European Group on Ethics in Science and New Technologies (EGE) and Peter Piot, special advisor to the President of the European Commission, should be considered. In a bottom-up approach, involving all relevant stakeholders (e.g. researchers, research funders, policy-makers, publishers and citizens) through the organisation of participatory events (workshops, consultations, ‘town hall’ meetings) the activities should propose ways and means to encourage changes in the research culture, and promote openness, communication and dialogue. This must be done in cooperation with ENRIO (European Network of Research Integrity Offices)[[http://www.enrio.eu/]] and ENERI (European Network of Research Ethics Committees and Research Integrity Offices)[[http://eneri.eu/]]. The cooperation with other relevant networks can be envisaged.
The action should result in (A) the identification of policy options at EU level (including those to address possible legislation gaps) and practical ways to support the work of relevant stakeholders notably the ethics committees and integrity bodies. The European Code of Conduct for Research Integrity[[http://ec.europa.eu/research/participants/data/ref/h2020/other/hi/h2020-ethics_code-of-conduct_en.pdf]] should be a main reference.
The work undertaken should also result in (B) operational (“how-to”) guidelines to support the work of research teams.
The need to complement the European Code[[Ibid.]] with specific guidelines should be assessed and a proposal (C) for short documents complementing the Code should be made, focusing for example on fast track processes (ethics review, publication etc.).
In addition, this action should produce (D) traditional and online training material (reflecting the guidelines) for students, early career and experienced researchers. Case studies (for example on mobile tracing apps) should be included in order to facilitate practical learning. The material, as well as all other outputs of the action, must be made available on the e-platform Embassy of Good Science[[www.embassy.science]]. Where relevant the EU Digital education plan[[https://ec.europa.eu/education/education-in-the-eu/digital-education-action-plan_en]] should be taken into account.
Although the main focus should be on the recent Covid-19 pandemic, it is also important to have in mind the wider objective of addressing the ethics of global crisis of the same kind (manmade or not). The action should in this regard present a generalised version of the produced recommendations and guidelines and training material.
Publicly available results from relevant EU funded research projects[[Detailed information of the mentioned EU funded projects can be found on CORDIS web site (https://cordis.europa.eu/ )]] (e.g. SHERPA, SIENNA, Panelfit, SOP4RI) should be taken into account. Structured cooperation with the e-platform Embassy of Good Science and the European Networks ENERI and ENRIO, with clear attribution of research ethics and research integrity responsibilities, is necessary.
In order to achieve the expected outcomes, cooperation with actors from China, Korea and/or African countries non-associated to Horizon Europe is required.