H2020 SOCIETAL CHALLENGE 6 Proposal evaluation. Briefing for Experts Single stage 2017 calls ETHICS REVIEW

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1 H2020 SOCIETAL CHALLENGE 6 Proposal evaluation Briefing for Experts Single stage 2017 calls ETHICS REVIEW Amélie BIROT-COURCY Ethics Correspondent, REA.B3

2 OUTLINE 1. Legal bases 2. Ethics issues 3. Appraisal procedure 4. Reporting 5. Practical information

3 1. LEGAL BASES

4 1. LEGAL BASES H Rules for Participation Article 13 Proposals: A proposal which contravenes ethical principles or any applicable legislation, or which does not fulfil the conditions set out in Decision No 2013/743/EU, in the work programme, in the work plan or in the call for proposals may be excluded from the evaluation, selection and award procedures at any time. Article 14 Ethics Review: The Commission shall systematically carry out ethics reviews for proposals raising ethical issues. That 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.

5 1. LEGAL BASES H Rules for Participation Article 18 Grant Agreement: The grant agreement shall, where appropriate, contain provisions ensuring the respect of ethical principles, including the establishment of an independent ethics board and the right of the Commission to carry out an ethics audit by independent experts. Article 23 Implementation of Action: Participants shall comply with national legislation, regulations and ethical rules in the countries where the action will be carried out. Where appropriate, participants shall seek the approval of the relevant national or local ethics committees prior to the start of the action.

6 1. LEGAL BASES H2020 Grant Agreement ARTICLE 34 ETHICS AND RESEARCH INTEGRITY Article Obligation to comply with ethical and research integrity principles The beneficiaries must carry out the action in compliance with: (a) ethical principles (including the highest standards of research integrity) and (b) applicable international, EU and national law. Funding will not be granted for activities carried out outside the EU if they are prohibited in all Member States. The beneficiaries must ensure that the activities under the action have an exclusive focus on civil applications. The beneficiaries must respect the highest standards of research integrity as set out for instance in the European Code of Conduct for Research Integrity.

7 1. LEGAL BASES H2020 Grant Agreement 34.2 Activities raising ethical issues Activities raising ethical issues must comply with the ethics requirements set out as deliverables in Annex 1. Before the beginning of an activity raising an ethical issue, each beneficiary must have obtained: (a) any ethics committee opinion required under national law and (b) any notification or authorisation for activities raising ethical issues required under national and/or European law needed for implementing the action tasks in question. The documents must be kept on file and be submitted upon request by the coordinator to the Agency. If they are not in English, they must be submitted together with an English summary, which shows that the action tasks in question are covered and includes the conclusions of the committee or authority concerned (if available).

8 1. LEGAL BASES H2020 Grant Agreement 34.3 Activities involving human embryos or human embryonic stem cells Activities involving research on human embryos or human embryonic stem cells may be carried out, in addition to Article 34.1, only if: - they are set out in Annex 1 or - the coordinator has obtained explicit approval (in writing) from the Agency Processing of personal data by the beneficiaries The beneficiaries must process personal data under the Agreement in compliance with applicable EU and national law on data protection (including authorisations or notification requirements). The beneficiaries may grant their personnel access only to data that is strictly necessary for implementing, managing and monitoring the Agreement. The beneficiaries must inform the personnel whose personal data are collected and processed by the Agency. For this purpose, they must provide them with the privacy statement(s) (see above), before transmitting their data to the Agency.

9 2. ETHICS ISSUES

10 2. ETHICS ISSUES Ethics issues categories 1. Human embryos and foetuses (& HESC) 2. Humans 3. Human cells/tissues 4. Personal data 5. Animals 6. Third countries / Non-EU Countries 7. Environment & Health and Safety 8. Dual use 9. Misuse 10. Other issues

11 2. ETHICS ISSUES Ethics issues in SSH SSH definition: Social sciences include disciplines such as geography, history, political science, anthropology and sociology while humanities can include literature, philosophy, performing arts and cultural studies. Potential risks: Is the research in SSH less likely to involve risks for human participants than other disciplines (eg biomedical research)? Physical harm or inconvenience is rare, but potential for psychological, social and economic or even legal harm (disclosure of a person's identity, involvement of vulnerable groups such as illegal immigrants, victims of home violence, children etc.). Risk assessment: it must be conducted for SSH research. The most likely issues are Humans, Third/non-EU countries, Personal data, but other ethics issues can be found in the SC6 proposals.

2. ETHICS ISSUES Ethics issues identification As ethics reviewers or screeners, in order to see whether the proposal involves Ethics issues, you will have to look at the proposal: Part A Ethics

12 2. ETHICS ISSUES Ethics issues identification As ethics reviewers or screeners, in order to see whether the proposal involves Ethics issues, you will have to look at the proposal: Part A Ethics Self-assessment table: is filled in by the applicant himself, who is responsible for identifying and listing all potential ethics issues. Part B Section 6: where the applicant provides a description of how they plan to address the Ethics issues during the project implementation. But in addition, the whole proposal should be screened!

13 2. ETHICS ISSUES H2020 Guidance on Ethics issues The Ethics Self-Assessment Guidance was initially meant for the applicants, but in fact, it also is a key document for YOUR work as Ethics expert: - It contains important details on the different ethics issues, including tables that mention the information and documents applicants must provide. - It supports the experts in looking for the necessary information in the proposals and drafting in their reports the requirements addressing missing items.

14 3. APPRAISAL PROCEDURE

15 3. ETHICS APPRAISAL Overview

16 3. ETHICS APPRAISAL Pre-Screening Is done only for those proposals where the applicants did not flag or declare any Ethics issues (the 'ethics self-assessment table' in PART A of the proposal is empty and the Ethics section in PART B also). Your role as Ethics expert is to check PART B of the proposal and confirm if ethics issue arise or not. The pre-screening is very important not to miss any ethic issue. In case of doubt, the experts should raise the ethics issue by ticking 'yes' in the pre-screening form. Each proposal is checked by two experts separately: - If both agree that there are no ethics issues, the proposal is cleared for ethics. - If at least one thinks that the proposal involves ethics issues, then the proposal proceeds to the 'Screening' stage.

17 3. ETHICS APPRAISAL Screening Is done for those proposals where the applicants themselves (in the proposal) or the Ethics experts (in the Pre-Screening) declared or flagged at least one ethics issue. The role of the expert is to check the proposal and confirm that the proposal is either: - cleared for ethics (proposal is 'ethics-ready', which means ethical principles and applicable laws are respected and no ethics requirements are needed) - conditionally cleared (clearance is subject to conditions that must be included as 'ethics requirements', i.e. the experts must draft the requirements to be fulfilled by the applicants). These requirements become contractual obligations and are included in the Grant Agreement. Each proposal is checked by two experts at the same time and both submit an individual report, which are used to reach a consensus. Once reached, a consensus report is drafted and its conclusions are sent to the applicants.

or Expert Proposal Cleared 1 Write EthIR

Ethics Consensus Report 1 Approve Ethics

18 3. ETHICS APPRAISAL Proposals likely to be funded & no ethics flagged by the applicant 1 2 Proposals likely to be funded & ethics flagged by the applicant or Expert Proposal Cleared 1 Write EthIR Write EthIR 2 Consensus Meeting Draft Ethics Consensus Report 1 Approve Ethics Consensus Report 2 Ethics Screening Report sent to applicant

19 4. REPORTING

20 4. REPORTING Pre-Screening & Screening reports Ethics Pre-Screening Report (EthPR): Both experts check that the proposals with no declared ethics issue actually have ethics issues or not. Ethics Screening Individual Report (EthIR): Both experts receive a task to draft an Individual Report. What was flagged in the Ethics Pre-screening report is shown in the Individual report. Ethics Screening Consensus report (EthCR): Once both Individual Reports have been submitted, one of the two experts assigned as 'rapporteur' drafts the Consensus Report. After she/he has submitted it, the other expert can approve or disapprove it (in case of no agreement). Ethics Screening report (EthSR): After additional and last checks done by the EC staff, the agreed consensus report is transformed into the official Ethics Screening report, which is sent to the applicant.

21 4. REPORTING Reporting sections: requirements Identification of Ethics issues: As expert, you first need to list all the Ethics issues identified in the proposal (sections 1 to 10 of the reports). Under each Ethics issues category, you should indicate (Yes/No) whether the proposal raises issues or not. You can add details + the corresponding page. Drafting Ethics requirements: When issues are flagged, you have to indicate how the applicant can address them by drafting 'requirements'. Again, under each Ethics issues category, you can select a predefined text (using the scroll down menu) or type your own requirement if you prefer. For each requirement you must indicate if it should be addressed: - before the signature of the Grant Agreement (clarifications, confirmations) - during the project implementation, by month X (e.g. for documents). For requested documents (e.g. approvals, informed consent) you should also indicate which organisations (beneficiary) must provide them (by month X).

22 4. REPORTING Reporting sections: opinion 1) Ethics clearance: - Pre-screened proposals without ethics issues; - Screened proposals with no requirements (already fulfilled in proposal). 2) Conditional ethics clearance: Screened proposals with requirements (that applicants should address before and/or after Grant Agreement signature. 3) Ethics assessment recommended: Additional and deeper assessment, carried out by DG RTD. For proposals including HESC and very sensitive cases. 4) Additional information needed: To be used only exceptionally because this stops the workflow! Please inform us beforehand, in case you wish to go for this option.

23 4. REPORTING Reporting sections: check This section of the reports allows you to recommend some checks to be performed during the project implementation, for instance to check the way the consortium is handling the Ethics issues. If a check is requested, it is mandatory to include a justification as well as the timing (month X of the project) When to request an Ethics check? - in case of complex and difficult ethics issues - when documents provided are not satisfactory - when compliance with Ethics requirements by the beneficiaries needs to be checked during the implementation

24 4. REPORTING Requirements: Ensure requirements are aligned with the ethical issues identified and that they are entered in the correct section Requirements can be drafted using pre-defined standard sentences in SEP or/and project specific requirements Remember that requirements are instructions to the applicants and REA staff: they must be clear and properly justified Consistency: Reporting tips Ethics reports must be accurate, concise, project specific All ethical issues identified in the proposal must be addressed in the report Do not base your evaluation on the proposal Self-Assessment table only: check the entire proposal If you come across sensitive proposals according to your experience, let us know for reinforced monitoring.

25 5. PRACTICAL INFORMATION

26 5. PRACTICAL INFO Planning The Ethics review for our 2017 single stage-sc6 calls, will be performed from 08/05/2017 to 12/05/2017. It will consist in two different phases: (1) REMOTE PHASE: From Monday 08/05/2017 to Wednesday 10/05/2017, you will working from your place (at your own premises) on: - Pre-Screenings Reports - Screenings Individual Reports - Screenings (draft) Consensus Reports (2) CENTRAL PHASE: From Thursday 11/05/2017 to Friday 12/05/2017, you will be invited to come to Brussels in order to: - Finalise all Individual Screening Reports - Attend Screening consensus meetings and finalise consensus reports

27 5. PRACTICAL INFO Useful links Participant Portal H2020 Ethics section: Ethics issues Self-Assessment Guidance: hics/h2020_hi_ethics-self-assess_en.pdf Other Ethics documents: European Code of Conduct for Research Integrity 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

28 5. PRACTICAL INFO Contact REA STAFF Call coordinator: Margaux GENACHTE Ethics correspondent: Amélie BIROT-COURCY SEP SUPPORT Phone: The service desk is available on weekdays between 8:00 and 20:00 (Brussels time)

The Ethics Appraisal Scheme in Horizon Mr Isidoros Karatzas Head of the Ethics and Reserach Integrity Sector DG RTD

The Ethics Appraisal Scheme in Horizon 2020 Mr Isidoros Karatzas Head of the Ethics and Reserach Integrity Sector DG RTD I think that the task of philosophy is not to provide answers, but to show how the