Ethics Procedure

Ethics is central to scientific integrity, honesty and clarity of science. This means that in any application submitted to the Horizon 2020 programme, including DOC2AMU Doctoral programme, ethics issues must be identified and addressed. Therefore, there is a complete ethics procedure from the admission of a candidate until the end of a research project.

This procedure encompasses 3 steps:

Steps

Activity

Who?

When?

How?

Step 1

Ethics Self-Evaluation

The candidate in collaboration with the future supervisor

After the Final approval of the selected fellows

Filling the Ethics Issues table

Consideration of ethical issues of the proposal

Step 2

Ethics Pre-screening/Screening

Members of the Ethical Review Committee

During the Contract preparation of the selected fellows

Review of application material

Ethics Assessment

Step 3

Ethical Follow-up and Monitoring

DOC2AMU Programme Manager

Implementation of the fellows’ research projects

Collecting ethical data and supporting documentation

STEP 1:

Selected candidates will be required to complete an Ethics Issues Table (EIT). The DOC2AMU Management team will perform a pre-screening to list the (potential) ethical issues but not to assess them. If the candidate has entered one or more ethical issue/s in the Ethical Issues Table (EIT) then they will be asked to submit, in a second phase, an Ethics Self-Assessment Report.

  1. Once an ethics issue is flagged in the EIT, the Ethics Self-Assessment Report must:
    1. For each area flagged in the Ethics Issues Table, describe how the project meets:
      1. the EU legislation on Ethics (e.g. Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes, existing EU legislation on data protection and privacy etc.);
      2. national legislation and good practices on research ethics;
      3. List the required documents provided with their expiry date and ensure early compliance of the proposed research with EU and national legislation on ethics in research. The candidate will be required to provide at the beginning of his/her employment contract, the following documents:
        1. an opinion from an Ethics Committee/Authority, required under the French law;
        2. any other ethics-related documents mandatory under EU or French legislation;
        3. In collaboration with the future supervisor, the candidate will have to explain in detail how to address the ethics issues flagged in the EIT, in particular with regard to:
          1. the research objectives (e.g. study of vulnerable populations like elderly people, sick or illiterate persons, cooperation with a Third Country, dual use, etc.);
          2. the research methodology (e.g. clinical trials, involvement of children and related information and consent/assent procedures, use of human tissues from blood banks, interviews with healthy adult volunteers, data protection and privacy issued related to data collected, etc.);
          3. the potential impact of the research (e.g. dual use issues, environmental damage, stigmatisation of particular social groups, political or financial retaliation, benefit-sharing, malevolent use, etc.).

If the candidate didn’t apply for/ receive the ethics approval/ required ethics documents yet when they begin the contract, the approximate date for the delivery of missing approval/ any other ethics documents should be communicated to the Project Manager. The candidate and their supervisor will have to commit that they will not proceed to any research with ethical implications before the Project Manager has received a scanned copy of all documents proving compliance with existing EU/ national legislation on ethics.

STEP 2:

Ethics screening by the Ethical Review Committee: After the candidate has finalized the STEP 1, all projects rising up an ethical issue will undergo an Ethics Review carried out by a discipline-appropriate Committee. The Ethics Review Procedure will focus on the compliance with ethical rules and standards, relevant European legislation, international conventions and declarations, national authorizations and ethics approvals, proportionality of the research methods and the selected ESRs’ awareness of the ethical aspects and social impact of their planned research. If there is at least one ethical issue confirmed, the research project will be subject to a complete Ethics Screening that will mainly assess the ethical aspects of its objectives, methodology and potential impact. The experts will notably identify the projects that require (ethical) approval at the national level (e.g. with regards to data protection, the conduct of clinical trials and animal welfare).

STEP 3:

Ethical issue Monitoring: Finally, during the implementation of the research project; the Project Manager will follow and monitor the flagged Ethics issues and their compliance with the French and EU legislation. She will collect all necessary data and documentation.