Horizon 2020 proposals focus on important scientific matters that can shift the world as we know it. Every year, a great number of research studies are being implemented under the Horizon 2020 financial framework. The results of these researches need to provide answers to significant problems that need solving. It is only rational that these researches will not violate worldwide ethical principals.
Under European Law, every Horizon 2020 proposal needs to go through an ethics review as soon as the project assessment begins. The grant agreement can only be signed only after the ethics review process has been completed and the proposal has met the required conditions.
The screening process
The reason behind the ethical assessment of the project proposal is to see whether the proposal raises any ethic issues. If the proposal does then those issues need to be adequately addressed during the implementation of the project.
The ethics review is an independent assessment. Every opinion on ethical matters, belonging to local or national ethics bodies, that will be included in the proposal will be taken into account. However, these opinions will not prejudice the outcome of the ethics review itself.
The ethics review focus points:
- Human rights and the protection of human beings
- Animal protection and welfare
- Data protection and privacy
- Environmental protection
- Malevolent use of research results
- Compliance with international, EU and national law
Other very important focal points that could be included in the ethics review:
- Research integrity,
- Fabrication, falsification, and plagiarism in proposing
- Performing or reviewing research or in report research results
- Misrepresenting credentials and improprieties of authorship
Ethics review organization
The ethics review has 2 stages.
Stage 1: Ethics screening
During the first stage, the proposals that seem to raise no ethical issue are pre-screened in an effort to identify potential issues of ethical nature. If issues do appear then the proposal goes through a full screening process and is checked on whether the applicants are giving these potential problems appropriate consideration
Stage 2: Ethics assessment
The second stage is not always necessary, but it is essential regarding complicated matters that might arise during the first stage. It is the stage that required for more in-depth analysis. Only proposals with significant issues will need the ethics assessment stage.
Both of these stages involve ethics experts
Implementing the results
When the ethics review is completed, the results will be presented to the consortia either in the beginning or right after the completion of the grant preparation. The organizations will receive a complete ethics summary report that will include suggestions regarding the ethics of the proposal, in need. Here are the five possible outcomes of the ethics review:
- No ethics issue
- Ethics clearance
- Conditional ethics clearance
- Request for additional information
- No ethics clearance
No Ethics issue
The proposal raises no ethics issue. There is no need for further actions
This is given to proposals that deliberately rise ethics issues and are addressing them appropriately. With the ethics clearance message, the proposal needs no further work in terms of ethics and the ethics section can now be transferred unchanged to the ethics section in Part B of the DoA
Conditional ethics clearance
Clearance can be given in this case, but only under conditions. In the report, the organizations will receive, there will be a set of ethical requirements that will need to be met, for the proposal to pass the clearance level. Organizations are obligated to follow those requirements. The requirements may include:
- Reporting to the Commission or the agency in concern, on a regular basis
- Appointing an independent ethics advisor or board
- Perform an ethics check
- Supply the Commission or agency with more documents and further information
- Adjusting the methodology, aiming to comply with ethical principles and relevant legislation
Certain requirements will need to be implemented in the grant agreement as well, during the presentation.
- 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.
The coordinator or the solo applicant will also have to perform certain tasks. Those tasks are the following:
- 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.
Request for additional information
In this case, the coordinator will be asked to provide the agency with additional information that will be needed to complete the ethics review process. This might occur in case of serious or complex ethics issues, missing information and many more!
No ethics clearance
Unless a proposal is given an ethics clearance status, it will not be considered eligible for funding. The proposal will be rejected. The information the coordinator will receive in term of the decision will be the following:
- The decision to reject the proposal
- The reasons for rejection
- The way the organization can appeal against it
Requirements and Deliverables
The ethics requirements of the proposal are considered deliverables and will automatically be included in the grant agreement. They are known as ethics deliverables and they will generate the ‘ethics requirements’’ work package.
That package, if applicable, will need to be added and submitted along with the grant agreement, as soon as the ethics review is completed. It will be the last package in the list of WP. The organizations, however, do have the ability to move this work package to any other position in the list, although it is recommended to keep the ‘’ethics requirements’’ WP at the end of the list as to not affect the numbering of the other work packages.