ERC Ethics process

ERC ethics appraisal process

The process of getting ethics appraisal of your project starts already when you are writing the proposal, and might be a returning issue both before signing the project contract, during and after the project's lifetime. Questions? Contact EU Research Support at UiO

There are three steps to the ethics appraisal process:

1. Ethics self assessment

This will become part of the grant agreement and may thus give rise to binding obligations that may later on be checked through ethics checks, reviews and audits. Being thorough here will save you time later if the project is granted.

In this phase, you will

• identify all potential ethical issues (Part A);
• Handle all ethics aspects of the proposal;
• Explain in sufficient detail how the ethics issues will be addressed (Part A)

Ethics issues table - part A, section 4: "Yes or No"- approach to questions. Ticking "yes" opens up for further description of the ethics issues in question. Do not think that abstaining from flagging an ethics issue will go unnoticed!

The ethics issues checklist covers the following areas:

• Human embryos/foetuses
• Human beings
• Human cells/tissues
• Personal data
• Animals
• Non-EU/Third countries
• Environment, health and safety
• Artificial Intelligence
• Other issues

In Horizon Europe, some ethics issues from H2020 are now moved to the the new Security Issues Table, also under section 4 Ethics and Security in the proposal form Part A.

Ethics self assessment - Part A: Explain in sufficient detail how the ethics issues flagged in the table will be addressed, in relation to objectives of the activities, methodology and potential impact of the activities. Demonstrate compliance with the EU and national legal and ethics requirements of the country/countries where the task raising ethical issues is to be carried out. State explicitly that you will not proceed with any research with ethical implications before obtaining (if applicable):  the necessary opinions/approvals from ethics committees OR the notification/ authorizations for activities raising ethical issues required under national and/or European law. 

Please note that from 2021 the ethics self-assessment is now included in section 4 of the online proposal submission form (not any more as an annex). Copies of ethics documentation do not count towards the page limit of your proposal.

2. Ethics review

Ethics review takes place after the proposal has been approved for funding, but the review must be concluded and accepted before the contract with the Commission can be signed. In case of outstanding ethics issues, the PI will receive a request  - "Additional Information Request" - requesting the project to comply with the proper ethical requirements.  The list of predefined ethics requirements that might be raised in the ethics screening report is presented under the heading "Ethics appraisal process - Predefined ethics requirements" below.

For approval of the ethics review, the PI must deliver the following:

Explanatory Note signed and dated by PI: Must address all requirements or questions raised in the ethics screening report that is sent to the PI.

All additional documents required to meet ethical requirements:
Approvals, authorizations, certificates etc. If authorization or approval is awaited, an indicative timetable for this must be submitted.

When the proper explanatory note and additional documents are approved by the Commission, the PI receives a so-called Ethics Appraisal Report. Now the project is ready for signing of the Grant Agreement. In some cases, the ethical approval is granted based on deliverables to be made during the project's lifetime, i.e approvals from local authorities or establishment of ethics boards.  

ERC has published the document How to reply to an ethics report that explains what is needed and how to upload the documentation in the portal.

3. Ethics check

Following the conclusion of the ethics review, at the initiative of the ethics panel, an ethics check can be undertaken during the lifetime of the project.

 When can ethics checks be requested?

• If there are outstanding ethics deliverables by the time the Grant agreement is signed
• For projects raising complex ethics issues, especially if substantial changes to the project and an amendment to the Grant agreement  is needed
• If new ethical issues comes up

Ethics checks are organized by the Commission, carried out by ethics experts, and can include ¡°on-site visits¡±. The experts will prepare an ¡°Ethics Check Report¡± that will be sent to the PI.

Ethics appraisal process - Predefined ethics requirements

If the proposal is approved for funding but there are still outstanding ethics issues, the PI must address a set of questions  to make sure the project complies with the proper ethical requirements. These questions follow the same thematical groups as the ethics issues checklist in the proposal part A, and contain a set of standard questions that can be asked depending on the issues in the given project. 

Below, these thematic groups are presented with some information about how they should be addressed. UiO's central EU-office has collected ample experience based on the large number of ERC-projects that has been through the review process, and can offer advise and support in the process. Please contact eu-office(at)admin.uio.no for further guidance to specific questions.

Human embryos/foetuses

The following ethical issues typically need clarification:

• Confirm that the proposal does not include research activities which destroy embryos including for the procurement of stem cells
• Describe the origin of the Human Embryonic Stem Cells (hESC)
• The Scientific Evaluators of your proposal will have to confirm the necessity to use hESC in the project.
• hESC-projects will have to undergo an additional approval procedure at EU level

Involvement of human participants

The guiding principles when involving human participants is respect for their autonomy, non-maleficence, beneficience and justice.

As a researcher, you need to demonstrate that the research ensures the participants' free informed consent. Pay particular attention to this when involving vulnerable individuals such as patients, children, minorities, discriminated persons, or persons unable to give consent. 

If due to the research context or methodology, standard written informed consent procedures are not applicable or advisable, you need to explain how you will still ensure consent in an appropriate way.

Human participants in the social sciences and humanities

With regard to proposals in the field of social sciences and humanities, it is important to specify what type of work with humans is involved (e.g. interviews, observation, experiments with volunteers), and discuss the ethical implications of the chosen methodologies. 

Human participants in medical research

With regard to medical research, the Declaration of Helsinki and the Bioethics Convention (Oviedo) specifies the main principles.

Frequently asked by the ERC Executive Agency

Based on previous ERC projects, we have identified issues that may reoccur more often in the Ethics Review process. When relevant for your project's research design, the ERC may ask you for:   

• Details on the procedures and criteria that will be used to identify/recruit research participants.
• Detailed information on the informed consent procedures that will be implemented for the participants
• Templates of the informed consent forms and information sheet in the language and terms understandable by the participants.
• If vulnerable individuals/groups will be involved, details on the measures taken to prevent the risk of enhancing vulnerability/stigmatisation of individuals/groups 
• Details on the incidental findings policy.
• Copies of ethics approvals for the research with humans must be submitted.

It is suggested to pay attention to this already when completing the ethics self-assessment.

Find links to resources at the bottom of this page

Human cells/tissues

The following ethical issues typically need clarification:

• Commercially available; details regarding origin, source
• Obtained within the project; ethics approval
• Originate from another laboratory or from clinical practice; autorisation for secondary use
• Biobanks; details and access
• Keep track on the origin of the cells
• Authorizations/licenses/ethics approvals must be provided
• Fully informed consent of the donors

Protection of personal data

Personal data means information relating to an identified or identifiable natural person.

Explain how you will ensure that data protection, privacy and confidentiality in personal data collection and processing are in accordance with national and EU legislation.

As an applicant, you shall ensure that data protection is a key consideration in the early stages of your research project when designing it, and then ensure that the strictest privacy settings are automatically applied throughout its lifecycle (privacy by design and by default).

All research projects that process personal data must apply to Sikt, the Norwegian Agency for Shared Services in Education and Research for an assessment of privacy. In some cases, it is also necessary to do a data protection impact assessment (DPIA). 

Frequently asked by the ERC Executive Agency

Based on previous ERC projects, we have identified issues that may reoccur more often in the Ethics Review process. When relevant for your project's research design, the ERC may ask you for:   

• An explanation of how all of the data they intend to process is relevant and limited to the purposes of the research project (in accordance with the ¡®data minimisation ¡®principle). 
• An explanation of why the research data will not be anonymised/ pseudonymised. 
• A description of the technical and organisational measures that will be implemented to safeguard the rights and freedoms of the data subjects/research participants.
• A description of the security measures that will be implemented to prevent unauthorised access to personal data or the equipment used for processing.
• Description of the anonymisation/pseudonymisation techniques that will be implemented.
• In case personal data are transferred from a non-EU country to the EU (or another third state), a confirmation that such transfers comply with the laws of the country in which the data was collected.
• Detailed information on the informed consent procedures in regard to data processing.
• Templates of the informed consent forms and information sheets (in language and terms intelligible to the participants).
• In case the research involves profiling, an explanation on how the data subjects will be informed of the existence of the profiling, its possible consequences and how their fundamental rights will be safeguarded. 
• An explicit confirmation that the data used in the project is publicly available and can be freely used for the purposes of the project .
• To check if special derogations pertaining to the rights of data subjects or the processing of genetic, biometric and/or health data have been established under the national legislation of the country where the research takes place and submit a declaration of compliance with respective national legal framework(s).
• The host institution must confirm that it has appointed a Data Protection Officer (DPO) and the contact details of the DPO are made available to all data subjects involved in the research. 

It is suggested to pay attention to this already when completing the ethics self-assessment.

Find links to resources at the bottom of this page

Animals

The following ethical issues typically need clarification:

• Information about how 3Rs, animal welfare will be ensured
• Non-human primates: strict limits to their use
• Directive 2010/63/EU
• Authorisations/licences for staff involved in animal experiences must be provided

Research in non-EU countries

Pay attention to that the proposal must demonstrate compliance with the EU and national legal and ethics requirements of the country/countries where the task raising ethical issues is to be carried out.

The following ethical issues typically need clarification:

• Involving the communities where research takes place
  • Assessment of vulnerability
  • Benefit sharing
  • Absence of local ethics structures
• Use of local resources
  • Use of local materials or human resources
  • Compensation policy
• War, epidemics and political pressure
  • Safety of participants
  • Safety of researchers

Frequently asked by the ERC Executive Agency

Based on previous ERC projects, we have identified issues that may reoccur more often in the Ethics Review process. When relevant for your project's research design, the ERC may ask you for:   

• A confirmation that the ethical standards and guidelines of Horizon 2020 will be rigorously applied, regardless of the country in which the research is carried out.
• Detailed information on foreseen measures to minimise the risks to research participants and staff involved in this project.

It is suggested to pay attention to this already when completing the ethics self-assessment.

Environmental protection and safety

The following ethical issues typically need clarification:

• Toxic chemicals and/or explosives
• Radioactive material
• Pathogens
• GMOs
• Is the project taking place in sensitive areas?
• Is the project using/collecting protected elements?

Artificial Intelligence

This section concerns projects with activities involving the development or/and use of artificial intelligence (AI)-based systems or techniques.

All AI-based systems/techniques must be ethical and comply with the principles and values as enshrined in the EU Charter of Fundamental rights and the EU Treaties. This requires specific ethically-focused approach during the design, development, deployment and/or use of AI based solutions.

Such approach must be built upon the following key prerequisites for ethically sound AI systems:

• Human agency and oversight 
• Privacy and data governance
• Fairness, diversity and non-discrimination
• Accountability
• Transparency 

Other ethics issues

The following ethical issues typically need clarification:

• Ethics issues in the project not covered by the other questions
• The need for an independent Ethics advisor/Advisory Board

 EU resources 

• ERC ethics guidance
• Guidance: How to complete your ethics self-assessment
• Horizon 2020 Online Manual - Ethics: Here you will find relevant reference documents: Rules& Codes of Conduct, General Guidance as well as Domain Specific Guidance
• Identifying serious and complex ethics issues in EU-funded research
• How to reply to an ethics report

Resources at national level

• Å·ÖÞ±­ÔÚÏßÂòÇò_Å·ÖÞ±­Í¶×¢ÍøÕ¾ÍƼö@setikkloven (Lovdata - in Norwegian)
• Research Ethics Commitees - National ethics guidelines
• Sikt - Norwegian Agency for Shared Services in Education and Research

Resources at UiO

• Å·ÖÞ±­ÔÚÏßÂòÇò_Å·ÖÞ±­Í¶×¢ÍøÕ¾ÍƼö@setikk ved UiO (in Norwegian); 
• Personvern / Privacy and data protection; here you will find
  • Data protection and role
  • Contact points at UiO
  • Regulations and routines
• Policies and guidelines for research data management 
• TSD - Services for sensitive data