The challenges of research ethics and integrity in response to crisis: the coronavirus pandemic and beyond
HORIZON Coordination and Support Actions
Basic Information
- Identifier
- HORIZON-WIDERA-2021-ERA-01-90
- Programme
- European Research Area
- Programme Period
- 2021 - 2027
- Status
- Closed (31094503)
- Opening Date
- June 22, 2021
- Deadline
- September 23, 2021
- Deadline Model
- single-stage
- Budget
- €5,000,000
- Keywords
- Ethics in research and innovationHuman rightsResearch integrity and misconductHealth and welfareAfricaEthics in medical sciencesForesightInternational CooperationCrisis managementResearch ethicsPandemicResearch integrity
Description
Projects are expected to contribute to the following expected outcomes:
Crises, and in particular health related ones, have become a dramatic reality for the EU and globally since the beginning of the coronavirus pandemic. Scientific knowledge focuses the attention, as it is a key element to address the urgency of the situation in an effective way and improve preparedness for the future. The extremely heavy human, social, cultural and economic consequences associated with the time pressure sets exceptional conditions calling for an adaptation of the way and procedures to work, and decide and prioritise which inevitably raises associated ethical questions. Some research topics have an intrinsically complex ethics dimension, for example research on the imposing of protection measures, health care prioritization, consequences for family life, and gender impacts on health.
In this context, the activity proposed is expected to propose an operational ethics and integrity framework, which preserves the key ethics principles while supporting a rapid and effective response to a crisis and improving overall preparedness.
Scope: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[1] 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.[2] For example, the pressing need to collect large amounts of personal data raises important questions regarding the preservation of privacy[3], 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[4]), 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[5]. 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”[6] 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)[7] and ENERI (European Network of Research Ethics Committees and Research Integrity Offices)[8]. 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[9] 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[10] 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[11]. Where relevant the EU Digital education plan[12] 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[13] (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.
Cross-cutting Priorities:Africa
Foresight
International Cooperation
[1]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
[2]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
[3]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.
[4]See European Institute for Gender Equality (2020) Covid-19 and gender equality, https://eige.europa.eu/topics/health/covid-19-and-gender-equality.
[5]Ibid. The Commission Communication calls for a “robust authorisation process” to ensure safety.
[6]https://op.europa.eu/en/publication-detail/-/publication/a1016d77-2562-11eb-9d7e-01aa75ed71a1/language-en/format-PDF/source-171481573
[9]http://ec.europa.eu/research/participants/data/ref/h2020/other/hi/h2020-ethics_code-of-conduct_en.pdf
[10]Ibid.
[12]https://ec.europa.eu/education/education-in-the-eu/digital-education-action-plan_en
[13]Detailed information of the mentioned EU funded projects can be found on CORDIS web site (https://cordis.europa.eu/ )
Destination & Scope
Introduction
Horizon Europe has a new level of ambition – to maximise the impact of EU research and innovation funding for European science, economy and the wider society. It marks a paradigm change in the design of the EU R&I Framework Programmes (FP) from an activity-driven to an impact-driven programme. Coupled to this ambition is the relaunching of the European Research Area (ERA) as described in the recently published Commission Communication entitled A new ERA for Research and Innovation (COM/2020/628 final of 30.09.2020).
The COVID-19 pandemic demonstrates the importance of R&I cooperation to deliver solutions to society’s most demanding needs. Delivering Europe’s recovery is a priority as are the green and digital twin transitions. To match these challenges, a new level of ambition that links better R&I with the economy, as well as with education and training, is necessary to put the EU’s scientific knowledge to work.
The new ERA calls for deepening existing priorities and initiatives through new and stronger approaches. The green and digital transitions and the recovery call for cooperation between the Commission and the Member States. They require the setting of new priorities, launching ambitious joint initiatives and developing common approaches between policies.
To address these requirements, Destination 3 of Annex 11 of the Horizon Europe Work Programme, will support efforts to reform and enhance the EU R&I system. Destination 3 is built around four strands corresponding to the four objectives set out in the ERA Communication: 1. Prioritise investments and reforms; 2. Improve access to excellence; 3. Translate R&I results into the economy and 4. Deepen the ERA. The principle of excellence, meaning that the best researchers with the best ideas that respond best to the societal challenges obtain funding, remains the cornerstone for all investments under the ERA.
Strand 1 recognises the importance of prioritising investments and reforms to accelerate the green and digital transformation and to increase competitiveness as well as the speed and depth of the recovery. It offers support for policy makers and addresses the need for better analysis and evidence, including simplifying and facilitating the inter-play between national and European R&I systems.
Strand 2 addresses the need to improve access to excellence and to increase the performance of R&I systems, building on dedicated Horizon Europe measures as well as complementarities with smart specialisation strategies under the Cohesion Policy.
Strand 3 addresses the importance of translating R&I results into the economy. R&I policies should aim to boost the resilience and competitiveness of our economies and societies.
Strand 4 addresses the challenge of deepening the ERA and includes Open Science, Higher Education and Researchers, Citizen Science, Science Education, Gender and Ethics. It aims at underpinning a new ERA benefiting from knowledge creation, circulation and use. This empowers higher education institutions and research organisations to embrace a transformative process; where a highly skilled workforce circulate freely; where research outputs are shared; where gender equality is assured; where the outcomes of R&I are understood, trusted and increasingly used, by educated informed scientists and citizens to the benefit of society.
Expected impact:
Proposals for topics under this Destination should set out a credible pathway to contributing to the following expected impacts:
- Reform and Enhance the EU R&I system
- Prioritisation of investments and reforms, realisation of the recovery and the twin transitions
- Improved access to excellence
- Greater quality of the scientific production and stronger translation of R&I results into the economy
- Deepen the ERA
- Coordinated national and regional R&I programmes by pooling national resources and contributing to the alignment of national research and innovation policies
- Improved knowledge for policy making about the networking patterns of research support staff and research management
- Synergies between research & innovation and higher education policies and programmes
- Modernised higher education sector, benefitting from targeted transformations in higher education, research, and innovation
- Increased number of interconnected knowledge ecosystems, strong in knowledge creation, circulation and use
- Researchers benefit from attractive careers
- Inclusive gender equality is promoted in the European research and innovation system
- A more open and inclusive research and innovation system
- Increased capacity in the EU R&I system to conduct open science and to set it as a modus operandi of modern science
- Increased engagement of citizens with research and innovation
- Increased alignment of strategic research with society needs, expectations and values
- Identified synergies between second and third level education, and between education and business;
- Increased trust in science and R&I outcomes, and greater two-way communication between science and society
- Knowledge and a highly skilled workforce circulate freely
- Improved capacities within the EU R&I system to conduct open science
- A more open and inclusive research and innovation system
Eligibility & Conditions
General conditions
1. Admissibility conditions: described in Annex A and Annex E of the Horizon Europe Work Programme General Annexes
Proposal page limits and layout: described in Part B of the Application Form available in the Submission System
2. Eligible countries: described in Annex B of the Work Programme General Annexes
A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon Europe projects. See the information in the Horizon Europe Programme Guide.
3. Other eligibility conditions: described in Annex B of the Work Programme General Annexes
Legal entities established in non-associated third countries may exceptionally participate in this Coordination and support action.
Due to the scope of this topic, in addition to the minimum number of participants set out in the General Annexes, proposals must include at least two participants from China, Korea and/or African countries non-associated to Horizon Europe. Participants from countries, which are not eligible for funding according to the General Annexes, may take part in the project as associated partners.
4. Financial and operational capacity and exclusion: described in Annex C of the Work Programme General Annexes
5. Evaluation and award:
- Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes
- Submission and evaluation processes are described in Annex F of the Work Programme General Annexes and the Online Manual
- Indicative timeline for evaluation and grant agreement: described in Annex F of the Work Programme General Annexes
6. Legal and financial set-up of the grants: described in Annex G of the Work Programme General Annexes
Beneficiaries will be subject to the following additional dissemination obligations:
Proposals must include structured cooperation with the e-platform Embassy of Good Science[[www.embassy.science]], and the European Networks ENERI (European Network of Research Ethics Committees and Research Integrity Offices)[[http://eneri.eu/]] and ENRIO (European Network of Research Integrity Offices)[[http://www.enrio.eu/]].
The output material of the action must be made available on the e-platform Embassy of Good Science.
Specific conditions
7. Specific conditions: described in the specific topic of the Work Programme
Documents
Call documents:
Standard application form — call-specific application form is available in the Submission System
Standard application form (HE CSA)
Standard evaluation form — will be used with the necessary adaptations
Standard evaluation form (HE CSA)
MGA
Call-specific instructions
Essential Information for Clinical Studies
Additional documents:
HE Main Work Programme 2021–2022 – 1. General Introduction
HE Main Work Programme 2021–2022 – 12. Missions
HE Main Work Programme 2021–2022 – 13. General Annexes
HE Framework Programme and Rules for Participation Regulation 2021/695
HE Specific Programme Decision 2021/764
Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment
EU Grants AGA — Annotated Model Grant Agreement
Funding & Tenders Portal Online Manual
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