Ethics review

Ethics review (ethics screening & assessment)

Background Neither the EU nor Euratom fund proposals that violate ethical principles. Our ethics appraisal scheme includes: an ethics self-assessment (in your proposal) an ethics review (see below) ethics checks and audits (during the project and up to 2 years afterwards if necessary). Each proposal considered for funding is subject to an ethics review. For more information on ethics, see the ethics section of the manual.

Where does the ethics review fit in? When are proposals reviewed?

The ethics review starts while the project is being scientifically assessed, or soon after. The grant agreement cannot be signed until the review is complete and the required conditions met.

How are proposals screened for ethics issues?

Projects are assessed to see whether they raise ethics issues and, if so, whether these are adequately addressed (while the project is being carried out, as well as at other times).

The ethics review is an independent assessment. Opinions issued by local or national ethics bodies as part of a proposal will be taken into account, but will not prejudice the outcome of the ethics review.

The ethics review focuses on issues as:

• human rights & protection of human beings
• animal protection & welfare
• data protection & privacy
• environmental protection
• malevolent use of research results
• compliance with international, EU & national law.

It may also cover issues of research integrity, including, fabrication, falsification and plagiarism in proposing, performing, or reviewing research or in reporting research results; this includes misrepresenting credentials and improprieties of authorship.

How is the ethics review process organised?

The ethics review falls into 2 stages:
Stage 1 - Ethics screening
During ethics screening, proposals that raise no immediate ethics issues are pre-screened to identify any potential issues of this nature. If such issues arise, the proposals are then fully screened to check whether applicants are giving due consideration to these potential problems.
Stage 2 - Ethics assessment (if necessary)
If screening reveals any serious or complex issues that call for more in-depth analysis, they will be subject to an ethics assessment. Ethics experts are involved in both screening and assessment.

Exception
All proposals involving the use of human embryonic stems cells (hESCs) will undergo an ethics assessment. Funding for research involving hESCs is subject to the conditions set out in the Declaration of the Commission to the Horizon 2020 Framework Programme (OJ C 373, 20.12.2013, p. 12).

Implement the results of an ethics review

We will let you know the outcome of your ethics review at the beginning of the grant preparation phase or soon after. You will receive an ethics summary report with an ethics opinion on your proposal. The possible outcomes of the ethics review are:

1. No ethics issues (clearance)
2. Ethics clearance
3. Conditional ethics clearance
4. Request for additional information (intermediate outcome)
5. No ethics clearance

1. No ethics issues (clearance)

Ethics review confirmed that the proposal does not raise any ethics issues. No further action is needed.

2. Ethics clearance

Proposals that give rise to ethics issues and address all of them appropriately are granted 'ethics clearance'. This means that no further steps have to be taken. The ethics section in the proposal can be transferred unchanged to the ethics section in Part B of the DoA.

3. Conditional ethics clearance

In this case clearance is subject to conditions. Your ethics summary report will list one or more 'ethics requirements' which become contractual obligations. They must be implemented in the grant agreement before the agreement can be signed. They may include:

• regular reporting to the Commission or the agency concerned
• appointing an independent ethics advisor or ethics board (possibly with a task to report on compliance with ethics requirements)
• an ethics check
• supplying further information/documents
• adjusting methodology so as to comply with ethical principles and relevant legislation

Ethics requirements must be implemented in the grant agreement during grant preparation.

• Ethics requirements due after project start are automatically included in the grant agreement in the form of 'ethics deliverables'.
• Ethics requirements due before grant signature normally require that you update the ethics section in the narrative part (Part B) of the description of the action (Annex 1). However, other parts of Annex 1 may also be affected. Exceptionally, additional supporting documents may be required before the grant agreement can be signed.

Tasks of the coordinator or sole applicant

• update the description of the action (DoA) whenever appropriate to address the ethics requirements and describe how they are to be met in the course of the project
• provide supporting documents if exceptionally requested before grant signature,
• take into account any recommendations set out in the ethics summary report.

4. Request for additional information (intermediate outcome)

You may be asked to provide additional information if this is needed to complete the ethics review (e.g. in case of serious or complex ethics issues or missing information).

5. No ethics clearance

• If your proposal is not given ethics clearance, it is not eligible for funding and will be rejected.

You will be informed of

• the decision to reject your proposal
• the reasons for the decision
• how you can appeal against it.

Ethics Requirements and Ethics work package

Ethics deliverables: All ethics requirements due after project start are automatically included in the grant agreement in the form of deliverables. These deliverables are known as 'ethics deliverables' and will be placed in an automatically generated work package called 'ethics requirements'.

Work package 'ethics requirements' - if applicable - is added to your grant agreement as soon as the ethics review has been completed. At this point in time it will appear as the last work package in the list of work packages (WP). During grant preparation you can move this WP to any other position in the list by drag & drop. It is recommended to keep the 'ethics requirements' WP at the end of the list where it will not affect the numbering of the other work packages.

Move WPs up and down by drag & drop to position them in the order of your preference: drag at the beginning of the line (and without releasing the mouse), move it before or after the WP you wish until a blue line appears, then release the mouse button. When a WP is moved to a new position, the numbering of WPs (and also the relative numbering of deliverables) is automatically adapted.