RESEARCH ETHICS in Horizon2020 (MSCA-IF) getting your proposal 'ethics-ready'

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1 RESEARCH ETHICS in Horizon2020 (MSCA-IF) getting your proposal 'ethics-ready' Inge Lerouge Research Integrity & Ethics Coordinator Research Coordination Office June 2017 Ethics in the context of Horizon 2020 Ethics is an integral part of all research activities funded by the European Union. Ethics should be embedded in the research design, implementation and dissemination. All possible domains of scientific research can raise ethical issues (not only in life sciences). Include reflection on ethics right from the start do not take care of ethics in the last 5 minutes before submission of the proposal! 1

2 Ethics in the context of Horizon 2020 The process to assess and address the ethical dimension of activities funded under Horizon 2020 is called the Ethics Appraisal Procedure. Ethics Self-Assessment Ethics Review Ethics Checks/Audits Application phase by the applicant Evaluation phase by ethics experts Implementation phase by ethics experts Ethics Self-Assessment by the applicant Ethics Issues Table Part A: o Headings on the Ethics Issues Table: yes-no approach Human Embryos/Foetuses Humans Human Cells/Tissues Protection of Personal Data Animals Third Countries Environment & Health and Safety Dual Use Exclusive Focus on Civil Applications Misuse Other Ethical Issues o Do not abstain from ticking thinking that it will go unnoticed (and/or that it will be less work to do!) o There is a column for page numbers leading to further description of the ethics issues in the proposal.! see guidance document How to Complete your Ethics Self-Assessment 2

3 Ethics Self-Assessment by applicant Ethics self-assessment Part B Section 6: o Explain in sufficient detail how the ethics issues flagged in Table part A will be addressed, e.g.: Involving human participants: detail the recruitment procedure and the informed consent procedure Processing of personal data: protect personal data and comply with general data protection regulation Using local genetic resources from other countries: think about benefit sharing and comply with the Nagoya Protocol Generating and exporting research results that are regarded as dual-use items (= normally used for civilian purposes but which may have military applications) minimise the risk of misuse Ethics Self-Assessment by applicant Ethics self-assessment Part B Section 6: o 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. o 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. 3

4 Ethics Self-Assessment by applicant Ethics self-assessment Part B Section 6: o KU Leuven expects you to present your research proposal, once it has been selected for funding, to the necessary ethical committees. In case you will work with primates, you already have to present your proposed research during the application phase to the ethical committee for animal experimentation. o The documents must be kept on file and be submitted upon request by the beneficiary to the EC Agency. o If they are not in English, they must be submitted together with an English summary. research/associatienet/ethics/com mittees/index 4

5 EC Research UZ/ KULv SMEC Ethics Committee Research UZ / KU Leuven (EC Research): evaluates medical and health related research (clinical and invasive experiments on patients/volunteers) - experiments conducted on humans in order to develop medical knowledge for WUG-professions (covered by the law of May ) WUG-professions = physician, dentist, pharmacist, nurse, physiotherapist, midwive, paramedical practioners Social and Societal Ethical Committee (SMEC): evaluates research in the humanities and the behavioral or social science research traditions with particular methodological tools (e.g. surveys, questionnaires, interviews, standardised tests, direct observation, ethnography, recordings ). Also protocols in engineering, natural or life science Ethics Review by the ethics experts Proposal passes scientific evaluation Source: slide Isidoros Karatzas 5

6 Guidance EC Guidance document How to Complete your Ethics Self-Assessment Visit KU Leuven website on Research ethics Contact Research Integrity & Ethics Coordinator 6