Guidance How to complete your ethics self-assessment

1 EUROPEAN COMMISSION Directorate-General for Research & Innovation Horizon 2020 Programme Guidance How to complete your ethics self-assessment Version 21 February 2018 PP documents: Horizon 2020 Guidance How to complete your ethics self-assessment : IMPORTANT NOTICE These guidelines are designed to help applicants in getting your proposal ethics -ready for Horizon 2020 funding ( to identify and deal correctly with any ethics issues that may arise from it).

2 They provide help both with the ethics issues table in Part A and the ethics self-assessment in Part B of your proposal (see the proposal templates on the Participant Portal). This document is however no more than a how to guide. It covers most of the ethics issues arising in research projects and gives advice on dealing with classic cases. Cases that are not covered must therefore be dealt with outside this guide. The ethics self-assessment will become part of your grant agreement (in Annex 1, as description of the action, ethics requirements, etc.)

3 And may thus give rise to binding obligations that may later on be checked through ethics checks, reviews and audits. This means the time you invest in this self-assessment is not wasted. It will actually improve your research results and: your proposed research will be in line with applicable international, EU and national law your proposal will be processed more easily during the Horizon 2020 proposal selection procedure the results of your research can be published more easily in internationally refereed journals you will contribute to the responsible conduct of research, thereby increasing its social acceptance.

4 Consider that ethics issues arise in many areas of research. Apart from the obvious example, the medical field, research protocols in social sciences, ethnography, psychology, environmental studies, security research, etc. may involve the voluntary participation of research subjects and the collection of data that might be considered as personal. You must protect your volunteers, yourself and your researcher colleagues. Start thinking about ethics while designing your research protocols. Don't wait until the last minute to seek advice or check requirements under national and EU law.

5 ethics also matter for scholarly publication. Major scientific journals in many areas will increasingly require ethics committee approval before publishing research articles. Thus, you should be prepared for ethics procedures even if your research is funded by sources other than Horizon 2020. Your first source should always be at your institution. We would ask you to seek advice from colleagues with expertise in the ethics of research, such as: specialised ethics departments relevant managers in your university/research organisation hospital research ethics committees ethics advisers in your company data protection officers.

6 They will be able to provide you with information appropriate to your specific needs and legal environment. Consider involving/appointing an ethics adviser/advisory board. From the beginning of your project, an ethics adviser can help you deal with ethical issues and put in place the procedures to handle them appropriately. If your research includes several ethical concerns or involves several significant or complex ethical issues (such as participation of children from developing countries, non-human primates (NHPs) , potential misuse or vulnerable populations) we suggest you appoint an ethics adviser or an ethics advisory board comprising several experts from different backgrounds.

7 The Commission/Agency may also make this an ethics requirement during the selection procedure. Other information For a broader overview of how Horizon 2020 grants work, see the Online Manual. For detailed information, see the Horizon 2020 AGA Annotated Grant Agreement. A comprehensive list of all Horizon 2020 reference documents (including legislation, work programme and templates) can be found on the Participant Portal Reference documents page. PP documents: Horizon 2020 Guidance How to complete your ethics self-assessment : 1 HISTORY OF CHANGES Version Publication Date Change Document revised by DGT editors Reparation of hyperlinks Reference to new data protection Regulation Adapt instructions on providing of documents to new MGA provisions.

8 Insert link to new Guidance note on research on refugees, asylum seekers and migrants Correction in ethics issues table in section H2020 is written as Horizon 2020 throughout the document. PP documents: Horizon 2020 Guidance How to complete your ethics self-assessment : 2 TABLE OF CONTENTS 1. Human embryos & foetuses .. 3 2. Human beings .. 6 3. Human cells or tissues .. 11 4. Personal data .. 15 5. Animals .. 20 6. Non-EU countries .. 23 7. Environment, health & safety.

9 27 8. Dual use .. 31 9. Exclusive focus on civil applications .. 33 10. Potential misuse of research results .. 35 11. Other ethics issues .. 38 PP documents: Horizon 2020 Guidance How to complete your ethics self-assessment : 3 1. Human embryos & foetuses This section covers research on human embryos and foetuses (mainly human embryonic stem cells (hESC)). The following fields of research are not eligible for funding under Horizon 2020 and cannot therefore be included in proposals).

10 Research activities directed at human cloning for reproductive purposes research activity intended to modify the genetic make-up of human beings that could make such changes heritable (apart from research relating to cancer treatment of the gonads, which may be financed) research activities intended to create human embryos solely for the purposes of research or stem cell procurement, including the technique of somatic cell nuclear transfer1 research that leads to the destruction of human embryos.