D8.10 sets the framework for monitoring the ethics throughout the MOOD project execution and covers the issues raised by the European Commission Ethics Review, specifically: the involvement of humans in surveys, workshops and activities, the protection of the data used and collected in the frame of the project, the involvement of NON-EU countries and the risk of misuse of research findings.
D8.10 points to the deliverables D8.1 to D8.5 dedicated to the ethics requirements requested by the European Commission Ethics Committee. D8.10 relies on the work produced in the frame of MOOD:
- D7.4 MOOD Data Management Plan.
- D8.1 – H – Requirement No 1: 1. Details on the procedures and criteria that will be used to identify/recruit research participants. 2. Detailed information on the informed consent procedures that will be implemented for the participation of human beings. 3. Templates of the informed consent forms and information sheet (in language and terms intelligible to the participants). These documents must be complete. 4. Copies of opinions/approvals by ethics committees and/or competent authorities for the research with human beings.
- D8.2 – POPD – Requirement No 2: 1. The beneficiary must explain how all of the data they intend to process are relevant and limited to the purposes of the research project. 2. A description of the technical and organizational measures that will be implemented to safeguard the rights and freedoms of the data subjects/research participants must be given. 3. A description must be given of the security measures that will be implemented to prevent unauthorized access to personal data or the equipment used for processing must be provided. 4. Descriptions of the anonymization/pseudo anonymization techniques that will be implemented.5. In case personal data are transferred from a non-EU country to the EU (or another third country), it must be confirmed that such transfers comply with the laws of the country in which the data were collected. 6. Detailed information on the informed consent procedures with regard to data processing. In addition, clarifications must be provided as to the following issues: a. When stating that “I consent my participation will be video recorded and these images can be made public for dissemination purposes”, there is a need to more precisely describe where the videos will be made public, i.e. on TV / social media / local channels / streaming channels, etc.? b. When stating that “I consent to the information collected in the frame of this project, once anonymized (so that I cannot be identified), to be used for other research purposes related to the MOOD project” it must be specified what are other research purposes. c. When it is the case that “The information sheet and consent form have been read aloud to me and I fully understand their contents” it is mandatory that this be witnessed, and that the witness signs the form. d. When discussing the potential risks of the participation, it is stated that: “Low risks have been identified for your participation in the interviews, questionnaires, workshops or prototypes testing”. These ‘low’ risks must be specified. 7. Each host institution must confirm that it has appointed a Data Protection Officer (DPO) and the contact details of the DPO are made available to all data subjects involved in the research. 8. In case of further processing of previously collected personal data, an explicit confirmation that the beneficiary has lawful basis for the data processing and that the appropriate technical and organizational measures are in place to safeguard the rights of the data subjects must be provided
- D8.3 – NEC – Requirement No 3: In case activities undertaken in non-EU countries raise ethics issues, the applicants must ensure that the research conducted outside the EU is legal in at least one EU Member State.
- D8.4 – M – Requirement No 4: A risk assessment (identifying each of the groups that is at risk of stigmatization) and details of the measures/safeguards that will be implemented to prevent misuse of research findings must be provided.
- D8.5 – GEN – Requirement No 5: Ethics and Data Protection Board Instalment.