Presentation on theme: "The European Research Council"— Presentation transcript:
1 The European Research Council The Ethics ReviewEthics review procedures in Horizon 2020Filipa Ferraz de Oliveira ERC/European Commission ERCEA, Unit B1NCP meeting – November 2013
2 Ethics in submission system New templates What is new in Ethics H2020Legal baseArt.16 in H2020 Framework ProgrammeArt.12 and 13 Rules for ParticipationList of ethics issuesERC Rules for Submission in H2020Ethics procedureEthics AppraisalEthics in submission systemIntegral part of the proposal (part A)New templatesEIT ethics issues table
3 Legal base - Article 16 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.
4 Legal base - Article 16 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.
5 Legal base - Article 12 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.
6 Legal base - Article 13 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.
7 List of ethics issues 1 Humans Data protection Which humans are involved?- vulnerable persons- persons unable to give consentChildrenAre 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 formsData protectionWhich data?- genetic datasensitive data (health, political or religious opinions, sexual orientation, etc.)Which procedure?- procedure for collection – how, by whom, information on rights, info and consent forms, anonymisationprocedure 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
8 List of ethics issues 2 Cells and Tissues Animals What type? What for? - hESCs- foetal cells/tissues- use or creation of cells/cells linesWhat for?- justification of use- origin: direct collection/ biobanks /secondary useDocuments to provide- ethics authorisations- information and consent forms- justification of right for secondary useAnimalsWhich animals are involved?- vertebrates- GMOs- Primates- wild / protected animalsFor what use?- Justification for choice of species- 3Rs, precise evaluation of number- Description of procedure, husbandry,anaesthesia, euthanasia- applicable legislationDocuments to provide- ethics authorisations / project license- personal and laboratory licenses
9 List of ethics issues 3 Non EU countries Misuse and Security 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 EUBenefit sharing measures for low income countriesDocuments to provide- National and local ethics authorisations- Authorisations for import/export- Contact with local researchers/local authoritiesBUT, if politically sensitive research there can be exceptionsMisuse and SecurityWhich threats?- health for team and/or society- misuse risks/ terrorist abuse- dual use- threats on human rightsWhat for?JustificationDocuments to provide- ethics authorisations- mitigation measures- balance of rights
10 Environment Protection List of ethics issues 4Environment ProtectionIs 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 environmentDocuments to provide- ethics authorisations- specific zone authorisationsNEW!