The European Research Council
Established by the European Commission
The Ethics Review
Ethics review procedures in
Horizon 2020
Filipa Ferraz de Oliveira
ERC/European Commission
ERCEA, Unit B1
NCP meeting – 19-20 November 2013
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What is new in Ethics H2020
Established by the European Commission
• Legal base
 Art.16 in H2020 Framework Programme
 Art.12 and 13 Rules for Participation
• List of ethics issues
 ERC Rules for Submission in H2020
• Ethics procedure
 Ethics Appraisal
• Ethics in submission system
 Integral part of the proposal (part A)
• New templates
 EIT ethics issues table
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Legal base - Article 16
Established by the European Commission
Ethical principles
1. All activities shall comply with ethical principles (Charter of Fundamental Rights of the
European Union and the European Convention on Human Rights and its Supplementary Protocols).
Particular attention to :
- the principle of proportionality;
- the right to privacy;
- the right to the protection of personal data;
- the right to the physical and mental integrity of a person;
- the right to non-discrimination;
- the need to ensure high levels of human health protection.
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Legal base - Article 16
Established by the European Commission
Ethical principles
2. Activities shall have an exclusive focus on civil applications.
3. The fields that shall not be financed:
(a) human cloning for reproductive purposes;
(b) modify the genetic heritage of human beings;
(c) create human embryos solely for the purpose of research or of stem
cell procurement.
4. Research on human stem cells (adult and embryonic) may be financed. No
funding shall be granted for activities prohibited in all the Member States. No
activity shall be funded in a Member State where such activity is forbidden.
5. The fields of research set out in 3. may be reviewed.
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Legal base - Article 12
Established by the European Commission
Proposals:
1. shall include a draft plan for the exploitation and dissemination of
the results.
2. shall include, for research on human embryonic stem cells,
details of licensing and control measures as well as details of the
ethical approvals that will be provided.
3. A proposal which contravenes ethical principles (…) may be
excluded from the evaluation, selection and award procedures at
any time.
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Legal base - Article 13
Established by the European Commission
Ethics review
The Commission shall systematically carry out ethics reviews for
proposals raising ethical issues.
This review shall verify the respect of ethical principles and
legislation and, in the case of research carried out outside the
Union, that the same research would have been allowed in a
Member State.
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List of ethics issues 1
Established by the European Commission
Humans
Data protection
• Which humans are involved?
• Which data?
- vulnerable persons
- persons unable to give consent
- Children
• Are some interventions on the body
foreseen?
- invasive techniques (biopsy, EEG, fMRI)
- Patients? Healthy volunteers?
• Which are the procedures for
recruitment and consent?
- genetic data
- sensitive data (health, political or religious
opinions, sexual orientation, etc.)
• Which procedure?
- procedure for collection – how, by whom,
information on rights, info and consent forms,
anonymisation
- procedure for protection of data – how it is
protected, encrypted, where, for how long?
• Documents to provide
• Documents to provide
- ethics authorisations
- information and consent forms
- data protection officer/authority authorisations
- information and consent forms
- security measures
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List of ethics issues 2
Established by the European Commission
Cells and Tissues
Animals
• What type?
• Which animals are involved?
- hESCs
- foetal cells/tissues
- use or creation of cells/cells lines
• What for?
- justification of use
- origin: direct collection/ biobanks
/secondary use
• Documents to provide
- ethics authorisations
- information and consent forms
- justification of right for secondary use
- vertebrates
- GMOs
- Primates
- wild / protected animals
• For what use?
- Justification for choice of species
- 3Rs, precise evaluation of number
- Description of procedure, husbandry,
anaesthesia, euthanasia
- applicable legislation
• Documents to provide
- ethics authorisations / project license
- personal and laboratory licenses
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List of ethics issues 3
Established by the European Commission
Non EU countries
Misuse and Security
• Which countries?
• Which threats?
- associated countries, low income, others?
- to do what with? Whom with?
• Export/import of ressources?
- which sources (including data)?
- export/import from/to EU
• Benefit sharing measures for low
income countries
• Documents to provide
- National and local ethics authorisations
- Authorisations for import/export
- Contact with local researchers/local authorities
BUT, if politically sensitive research there can be
exceptions
- health for team and/or society
- misuse risks/ terrorist abuse
- dual use
- threats on human rights
• What for?
-
Justification
• Documents to provide
- ethics authorisations
- mitigation measures
- balance of rights
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List of ethics issues 4
Established by the European Commission
Environment Protection
• Is the project taking place in sensitive
areas?
• Is the project using/collecting protected
elements?
- oceans – Directive on Oceans?
- natural areas – Directive Habitat?
- areas with endangered/protected species –
Directive on birds, CITES convention?
• What for?
- justification
- measures to minimize impact
- benefit of the research to the environment
• Documents to provide
- ethics authorisations
- specific zone authorisations
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Ethics procedure
Established by the European Commission
Ethics Appraisal
Ethics Review:
Before
Granting
After
Granting
Ethics pre-screening
Ethics screening
Ethics Checks
Ethics assessment
Ethics Audits
After
Granting
R&I
Ethics monitoring
ERCEA
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Ethics in submission system
Established by the European Commission
• Ethics Issues Table EIT
 Part A
• Ethics Self-assessment
 Part B
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New templates
Established by the European Commission
EIT
• Covering all ethics issues mentioned
• YES/NO questions and open questions
• Detailed instruction
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Ethics Clearance
Established by the European Commission
Lists with evaluated
proposals
(main + reserve lists)
Ethics PreScreening
Ethics
Screening
EIT+ Ethics SelfAssessment
Ethics
Assessment
R&I
hESCs are
submitted to :
• Programme
Committee
• EC decision
Proposals concerned
by ethics review
are frozen until
Clearance is emitted.
Ethics
Assessment
ERCEA
Ethics
Clearance
Note
Signature of
Grant
Agreements
After granting:
monitoring
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