Ethical aspects. It is the responsibility of the contractor to safeguard the rights and welfare of human subjects involved in research performed under this agreement, in accordance with the appropriate national code of ethics or legislation, if any, and in the absence thereof, the Helsinki Declaration and any subsequent amendments. Prior to commencing any such research, the contractor shall ensure that (a) the rights and welfare of the subjects involved in the research are adequately protected, (b) freely given informed consent has been obtained for all participants, (c) the balance between risk and potential benefits involved has been assessed and deemed acceptable by a panel of independent experts appointed by the contractor, and (d) any special national requirements have been met.
Ethical aspects. The ethical aspects of collecting and storing data in MEESO are treated in three separate deliverables on ethics. These deliverables will include: - The procedures and criteria that will be used to identify/recruit research participants. - The informed consent procedures that will be implemented for the participation of humans. - Templates of the informed consent forms and information sheets covering the voluntary participation and data protection issues (in language and terms intelligible to the participants) must be kept on file (to be specified in the grant agreement). - The English version of the templates of the informed consent forms and information sheets. - Details on the experiments to be conducted and information on the procedures to ensure animal welfare and adherence to the Three Rs principle.
Ethical aspects. Clinical and patient sequencing data fall under sensitive personal data and access to them must be restricted and monitored. These are covered in more detail by the (confidential) project ethics deliverables D13.1 (D52) H - Requirement No. 1, D13.2 (D53) H - Requirement No. 2, D13.4 (D55) POPD - Requirement No. 4, and D13.5 (D5) POPD - Requirement No. 5. The patient information and consent forms for prospectively collected data include information on the possibility of the pseudonymized data being archived in repositories such as EGA. The project involves four SMEs who aim to commercialize their results, therefore IPR issues must be considered before publishing any related data. The project has an innovation management panel to discuss these matters. All journal publications and abstracts of conference presentations / posters are also submitted for project review 30 days before publication, in order to review possible IPR issues.
Ethical aspects. All the CarE-Service project partners must carry out the action in compliance with ethical principles (including the highest standards of research integrity) and applicable international, EU and national law. The partners must respect the highest standards of research integrity - as set out, for instance, in the European Code of Conduct for Research Integrity (Article 34, Grant Agreement). CarE-Service does not intend to collect, store and/or process sensitive data (health, genetic or biometric data). CarE-Service may collect, store and keep on track both “anonymously” and “non-anonymously” non-sensitive personal data. Non-anonymous personal data will be collected only in case this will be needed to achieve the targets of the project. In this case, with full freedom/awareness of the data subject will be ensured. For this purpose, a dedicated space for the consent of data subject on the non-anonymous data collection is present in the designed consent forms (Deliverable 10.1). CarE-Service may collect personal data from members of the consortium and other participants for several reasons as questionnaires or surveys, meetings, conferences etc., In all cases the partners must follow the standard procedure of getting authorization from the members to show and distribute the results, the videos the images etc. to the public. In CarE-Service, the data collection as well as processing will be fully based on consent/assent of the data subject. Regarding the general personal data collection within CarE-Service project, the data subjects’ consent/assent will be given in the context of a written declaration (by signing the forms). The templates of the informed consent/assent forms are devised to be fully compliant with EU General Data Protection Regulation (GDPR). The informed consent form is written in English and also translated and available in four more languages (German, Spanish, Italian and French) (Deliverable 10.1, §3.1 and Appendix A1, B1, C1, D1). CarE-Service partners must keep confidential any data, documents or other material (in any form) that is identified as confidential at the time it is disclosed (“confidential information”).
Ethical aspects. No ethical or legal issues are anticipated that would impact data sharing.
Ethical aspects. To be covered in the context of the ethics review, ethics section of DoA and ethics deliverables. Include references and related technical aspects if not covered by the former N/A
Ethical aspects. An Informed Consent Form needs to be signed and collected from individuals who participate in interviews or workshops. Individuals have the right to take back their consent, which means revisions would be necessary. As names and personal information are not relevant to CIRCuIT, interviews and questionnaires should be kept anonymous, where possible, to avoid any conflict with the Informed Consent Form. If data and the Informed Consent Form are used, a copy of opinion is required. Individuals participating in their professional capacity, e.g. representing private companies, non-governmental organisations or public authorities, will not be asked to fill in the informed consent form.
Ethical aspects. All personal data collected within the LAST-JD-RioE project from questionnaires, interviewers, surveys and focus groups are carefully protected in compliance with relevant national data protection legislation of the EU member states implementing the European directive 95/46/EC and with the procedures defined by the European Code of Conduct for Research Integrity. As a general principle, personal data resulting from the focus groups, interviews, observation and questionnaires will be separated from the research results and will be handled by different members of the research team. In regard to the respondents in the survey, they will be selected at random and their name and address will not be recorded. The data will be stored in a way not to allow the identification of the subject, adopting measures for anonymization (i.e. names replaced by initials or pseudonyms); results of questionnaires and interviews will be transmitted or made available to the other project partners as anonymous data. In principle, research will not involve personal sensitive data. Notwithstanding, in certain circumstances, data collected during interviews and focus groups may potentially be sensitive (e.g. participants might disclose political opinions). Only personal characteristics that are strictly necessary, for theoretical reasons and to the benefit of the research, will be collected; such characteristics may be used to compare participants and it will be clarified how such characteristics help to shape their views and opinions. Files containing questionnaire data for statistical analysis, transcripts of interviews and focus groups, transcripts of field observations, photos, minutes, videos, action diaries, etc.) are stored in computers, laptops, intranets or hard-drives of the research institutions accessible through institutional password modified periodically (every 3 months in case of storage of sensitive data), and protected by regularly updated antiviruses. Files containing “sensitive” data will be stored encrypted. Password-protected and encrypted files are accessible only to authorized members of the research teams receiving preliminarily specific information and training on the procedures for data collection, storage etc. None of the project data will be left inadvertently available by being left on desks or in unlocked rooms. All the research materials stored in computers are subjected to back up regularly (according to each institutions’ regulations) in order to safe...
Ethical aspects. Except when evaluation involves users, the data discussed in this deliverable does not contain ethical issues concerns. The eventual tests with users will be handled with appropriate ethical procedures, which are discussed in separate deliverables.
Ethical aspects. Templates of the informed consent form and an information sheet about the FORCE project has been prepared as part of the deliverables in WP1 Ethics, D1.4: H – Requirement no 4. The informed consent form will be used when beneficiaries collect information via interviews, questionnaires, workshops and similar activities in the five work packages, WP3-WP7. The form includes a brief presentation of the project, a description of how participants will be involved, and how data will be used in the project, all in the native language.
