Ethics

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H2020 Online Manual (http://ec.europa.eu/research/participants/docs/h2020funding-guide/index_en.htm)

Ethics

Your user account & roles

For all activities funded by the European Union, ethics is an integral part of research from beginning to end, and Login with EC AS ethical compliance is seen as pivotal to achieve real research excellence. There is clear need to make a thorough (http://ec.europa.eu/research/participants/docs/h2020funding-guide/user-account-androles/ecas-login_en.htm)

ethical evaluation from the conceptual stage of the proposal not only to respect the legal framework but also to

enhance the quality of the research. Ethical research conduct implies the application of fundamental ethical principles Roles & access rights and legislation to scientific research in all possible domains of research. The process to assess and address the ethical (http://ec.europa.eu/research/participants/docs/h2020dimension of activities funded under Horizon 2020 is called the Ethics Appraisal Procedure. funding-guide/user-account-androles/roles-and-accessObjectives rights_en.htm) Grants Applying for funding

In addition to the scientific evaluation focusing on the scientific merit, the quality of the management and the potential

impact, the Ethics Appraisal ensures that all research activities carried out under the Horizon 2020 Framework Find a call Programme are conducted in compliance with fundamental ethical principles. (http://ec.europa.eu/research/participants/docs/h2020funding-guide/grants/applyingfor-funding/find-a-call_en.htm)

Ethics Appraisal Procedure Horizon 2020 structure and budget (http://ec.europa.eu/research/participants/docs/h2020The Ethics Appraisal Procedure concerns all activities funded in Horizon 2020 and includes the Ethics Review fundingProcedure, conducted before the start of the project, as well as the Ethics C hecks and Audits. guide/grants/applying-forfunding/find-a-call/h2020When preparing a proposal, it is required to conduct an Ethics Self-assessment starting with the completion of an structure-andEthical Issues Table. budget_en.htm) What you need to know about Horizon 2020 calls (http://ec.europa.eu/research/participants/docs/h2020Ethics Review Procedure fundingguide/grants/applying-forAll proposals above threshold and considered for funding will undergo an Ethics Review carried out by independent funding/find-a-call/whatethics experts working in a panel. The Review starts with an Ethics Screening and if appropriate a further analysis you-need-to-know_en.htm)

Find partners or apply as

called the Ethics Assessment is conducted. The Ethics Review can lead to ethics requirements that become

individual contractual obligations. (http://ec.europa.eu/research/participants/docs/h2020funding-guide/grants/applyingThe Ethics Review Procedure focusses on the compliance with ethical rules and standards, relevant European for-funding/findlegislation, international conventions and declarations, national authorizations and ethics approvals, proportionality of partners_en.htm) the research methods and the applicants' awareness of the ethical aspects and social impact of their planned Register an organisation research. (http://ec.europa.eu/research/participants/docs/h2020funding-guide/grants/applyingfor-funding/register-anSTEP 1. Ethics Screening organisation_en.htm) Registration of The first phase of the Ethics Review Procedure, the Ethics Screening, is carried out during the scientific evaluation or organisation soon after. The ethics experts first perform an Ethics Pre-Screening taking into account the Self-assessment. The (http://ec.europa.eu/research/participants/docs/h2020fundingobjective of the pre-screening is to list the (potential) ethical issues but not to assess them. guide/grants/applying-forfunding/register-anWhen there is at least one confirmed ethical issues, the proposal is subject to a complete Ethics Screening that will organisation/registration-ofmainly assess the ethical aspects of its objectives, methodology and potential impact. The experts will organisation_en.htm) notably identify all proposals that require (ethical) approval at the national level (e.g. with regards to data LEAR appointment protection, the conduct of clinical trials and animal welfare). Because of the complexity or the nature of the ethical (http://ec.europa.eu/research/participants/docs/h2020issues they at stake (e.g. severe intervention on humans) the ethics experts may also recommend an Ethics fundingguide/grants/applying-forAssessment rather than formulating directly requirements. Proposals involving the use of Hu man Embryonic Stems funding/register-anC ells (hESC s) automatically proceed to the second step, the Ethics Assessment. organisation/learappointment_en.htm)

STEP 2. Ethics Assessment

Validation of organisation (http://ec.europa.eu/research/participants/docs/h2020fundingFor a limited number of proposals (e.g. severe intervention on humans, lack of appropriate ethics framework in the guide/grants/applying-forcountry where the research will be performed, etc.) the Ethics Screening can be followed by an Ethics Assessment funding/register-anprior to the signature of the grant agreement. organisation/validation-oforganisation_en.htm) he Ethics Assessment is an in-depth analysis of the ethical issues of the proposals, taking into account, when available Financial viability selfthe conclusions of the Ethics screening. As mentioned above, it is systematically performed on all proposals involving check (http://ec.europa.eu/research/participants/docs/h2020the use of Human Embryonic Stem C ells. fundingguide/grants/applying-forEthics Checks and Audits funding/register-anorganisation/financialviability-self-check_en.htm) During the Ethics Screening or the Ethics Assessment, the experts identify the projects that need an Ethics C heck, Data update which are executed during the course of the research project. The procedure can also be initiated by the C ommission (http://ec.europa.eu/research/participants/docs/h2020services. fundingguide/grants/applying-forThe objective of the procedure is to assist the beneficiaries to deal with the ethics issues raised by their research and funding/register-anorganisation/dataupdate_en.htm)

if necessary to take preventive or/and corrective measures. The Ethics C heck is conducted on the basis of the

Submit a proposal

issues at stake. On site visits can also be organised.

information provided by the concerned beneficiaries, who may be invited to a meeting in Brussels to discuss the

(http://ec.europa.eu/research/participants/docs/h2020In case of substantial breach of ethical principles, research integrity or relevant legislation, the C ommission can carry funding-guide/grants/submitproposals_en.htm) out an Ethics Audit following the provisions and procedures laid down in the grant agreement. From evaluation to grant signature

The C hecks and Audits can result in an amendment of the grant agreement. In severe cases, it can lead, upon the Evaluation of proposals decision of the C ommission services to a reduction of the grant, its termination or any other appropriate measures, in (http://ec.europa.eu/research/participants/docs/h2020accordance with the provisions of the grant agreement. funding-guide/grants/fromevaluation-to-grantsignature/evaluation-ofETHICS APPRAISAL STEPS proposals_en.htm) Grant preparation Activity (http://ec.europa.eu/research/participants/docs/h2020funding-guide/grants/fromEthics Self-assessment evaluation-to-grantsignature/grantpreparation_en.htm) Ethics Pre-screening/Screening Grant signature (http://ec.europa.eu/research/participants/docs/h2020Ethics Assessment funding-guide/grants/from(for proposals involving hESC or raising evaluation-to-grantserious ethical issues: severe signature/grantintervention on humans) signature_en.htm) Grant management Reports

Ethics C heck/Audit

Who?

When?

How?

Applicant

Application phase

C onsideration of ethical issues of the proposal

Ethics experts

Evaluation phase

Review of application material

Ethics experts

Evaluation/ Grant preparation phase

Review of application material

Ethics experts

Implementation phase

Review of project deliverables/interview with applicants

Periodic report The Ethics Appraisal Procedure is established by the Rules for submission of proposals, and the related evaluation, Financial report selection and award procedures. (http://ec.europa.eu/research/participants/docs/h2020fundingguide/grants/grantMore general information and an e-Library providing access to the most important pieces of European legislation, management/reports/periodicinternational conventions and declarations and codes of conduct relevant to research activities can be found on the report/financialEuropa website (http://ec.europa.eu/research/science-society/index.cfm?fuseaction=public.topic&id=1289&lang=1). report_en.htm)

Scientific report For assistance please contact us at the Ethics Helpdesk (http://cordis.europa.eu/MailAnon/index.cfm? (http://ec.europa.eu/research/participants/docs/h2020fundingfuseaction=Hiding.PostalForm&address=0069007300690064006f0072006f0073002e006b0061007200610074007a00610073004000 guide/grants/grantmanagement/reports/periodicreport/scientificReference Documents report_en.htm) Deliverables IMPORTANT NOTE: In case of general and domain-specific guidance documents, although some of the documents (http://ec.europa.eu/research/participants/docs/h2020refer to FP7 they remain valid for Horizon 2020 programme. funding-guide/grants/grantmanagement/reports/deliverables_en.htm) Domain-specific guidance Patents & publications Horizon 2020 Legislation General guidance documents notes (http://ec.europa.eu/research/participants/docs/h2020-

funding-guide/grants/grantmanagement/reports/patentsand-publications_en.htm) Report on the final distribution of EU Legal basis (Decision No ...) contribution Ethical principles (Article 16) (http://ec.europa.eu/research/participants/docs/h2020Article 34 of the Grant funding-guide/grants/grantAgreement management/reports/distributionStatements by the C ommission of-eu-contribution_en.htm) on human embryonic stem cell Project technical review research (http://ec.europa.eu/research/participants/docs/h2020Rules for submission of funding-guide/grants/grantproposals, and the related management/reports/technicalevaluation, selection and award review_en.htm) procedures Final report C harter of Fundamental Rights (http://ec.europa.eu/research/participants/docs/h2020of the European Union funding-guide/grants/grantmanagement/reports/finalEuropean C ode of C onduct for report_en.htm) Research Integrity Dissemination of results (http://ec.europa.eu/research/participants/docs/h2020funding-guide/grants/grantmanagement/dissemination-ofresults_en.htm) Amendments (http://ec.europa.eu/research/participants/docs/h2020funding-guide/grants/grantmanagement/amendments_en.htm) Audits & certifications (http://ec.europa.eu/research/participants/docs/h2020funding-guide/grants/grantmanagement/audits-andcertifications_en.htm) Working as an expert Expert registration (http://ec.europa.eu/research/participants/docs/h2020funding-guide/experts/expertregistration_en.htm) C ontracting & payment (http://ec.europa.eu/research/participants/docs/h2020funding-guide/experts/contractingand-payments_en.htm) Expert roles & tasks (http://ec.europa.eu/research/participants/docs/h2020funding-guide/experts/expert-

Ethics for Researchers European Textbook on Ethics in Research (2010) A comprehensive strategy on how to minimize research misconduct and the potential misuse of research in EU funded research Integrating Ethics in EU Research

Guidance Note for Researchers and Evaluators of Social Sciences and Humanities Guidance Note - Ethics and Food-Related Research Research on Human embryos/foetus Ethics for C linical Trials on Medicinal Products C onducted with Paediatric Population Privacy Informed C onsent Ethics in IC T Research on Animals Research Involving Developing C ountries Dual Use Research Ethics in Ethnography/Anthropology Misuse/Malevolant use Guidance Notes

roles-and-tasks_en.htm) C ross-cutting issues International cooperation (http://ec.europa.eu/research/participants/docs/h2020funding-guide/cross-cuttingissues/internationalcooperation_en.htm) Regional aspects (http://ec.europa.eu/research/participants/docs/h2020funding-guide/cross-cuttingissues/regional-aspects_en.htm) Ethics Intellectual property (http://ec.europa.eu/research/participants/docs/h2020funding-guide/cross-cuttingissues/intellectualproperty_en.htm) Gender (http://ec.europa.eu/research/participants/docs/h2020funding-guide/cross-cuttingissues/gender_en.htm) SMEs (http://ec.europa.eu/research/participants/docs/h2020funding-guide/cross-cuttingissues/sme_en.htm) FP7 Funding Guide (http://ec.europa.eu/research/participants/fp7documents/fundingguide/) © E uropean C ommunities

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Ethics

H2020 Online Manual (http://ec.europa.eu/research/participants/docs/h2020funding-guide/index_en.htm) Ethics Your user account & roles For all activ...

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