established by the european commission │ 1 the european research council filipa ferraz de oliveira...
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Established by the European Commission
│ 1
The European Research Council
Filipa Ferraz de OliveiraERC/European Commission
ERCEA, Unit B1
NCP meeting – 19-20 November 2013
The Ethics Review
Ethics review procedures in Horizon 2020
Established by the European Commission
What is new in Ethics H2020
• 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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Established by the European Commission
Legal base - Article 16
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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.
Established by the European Commission
Legal base - Article 16
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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.
Established by the European Commission
Legal base - Article 12
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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.
Established by the European Commission
Legal base - Article 13
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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.
Established by the European Commission
List of ethics issues 1
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Humans• Which humans are involved?
- 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?
• Documents to provide- ethics authorisations
- information and consent forms
Data protection• Which data?
- 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- data protection officer/authority authorisations
- information and consent forms
- security measures
Established by the European Commission
List of ethics issues 2
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Cells and Tissues• What type?
- 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
Animals• Which animals are involved?
- 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
Established by the European Commission
List of ethics issues 3
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Non EU countries• Which countries?
- 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
Misuse and Security• Which threats?
- 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
Established by the European Commission
List of ethics issues 4
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NEW!
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
Established by the European Commission
Ethics procedure
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Ethics Appraisal
Ethics Checks
Ethics Audits
ERCEA
Before Granting
After Granting
R&I
Ethics Review:
Ethics pre-screeningEthics screening
Ethics assessment
Ethics monitoring
After Granting
Established by the European Commission
Ethics in submission system
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• Ethics Issues Table EIT Part A
• Ethics Self-assessment Part B
Established by the European Commission
New templates
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EIT
• Covering all ethics issues mentioned
• YES/NO questions and open questions
• Detailed instruction
Established by the European Commission
After granting: monitoring
EthicsAssessment
R&I
hESCs aresubmitted to :• Programme Committee• EC decision
EthicsScreening
Ethics Clearance
Note
Signature ofGrant
Agreements
EthicsAssessment
ERCEA
Proposals concerned by ethics review are frozen until Clearance is emitted.
Ethics Pre-Screening
Ethics Clearance
Lists with evaluated proposals
(main + reserve lists)
EIT+ Ethics Self-Assessment
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