54-d8-9gen-requirementno-9-redacted
Dieses Dokument ist Teil der Anfrage „Documentation of the NESTOR project“
HORIZON 2020 – 101021851 – NESTOR D8.9 – GEN-Requirement No.9 4 WORK PROGRESS In order to effectively perform its role, the EtAB had regular meetings, participated in all project’s meetings and other research activities (workshops, trainings, pilot demonstrations), provided guidance to the NESTOR Consortium in the form of Ethics Guidelines, reviewed the deliverables raising ethical and/or legal concerns via an Ethics Review Table and co-drafted the ethics deliverables and other necessary documentation. • EtAB Meetings Considering its important role, the EtAB met regularly (every 3 months or similar), in order to discuss the ethical issues that were raised and the next steps that had to be followed. During the lifetime of the NESTOR project, six (6) ordinary meetings were held. No extraordinary meetings were held. The six (6) ordinary meetings that were held are the following, also reported in the relevant project’s reports: - 1st EtAB meeting : 24/11/2021 - 2nd EtAB meeting : 24/03/2022 - 3rd EtAB meeting : 31/05/2022 - 4th EtAB meeting : 20/09/2022 - 5th EtAB meeting : 27/01/2023 - 6th EtAB meeting : 22/03/2023 • Deliverable Ethics Review Procedure The WP8 deliverables, as analysed above, were drafted by KEMEA and reviewed by the other two EtAB members prior to submission. The deliverables of the other WPs were also reviewed by the EtAB prior to submission through the Ethics Review Form/Table that was prepared by the EtAB and was attached to all project’s deliverables. According to this process, each deliverable author had to respond to the questions included in the Ethics Review Form/Table prior to the submission of their deliverable. In case of at least one affirmative response, the deliverable was sent for ethics review and the EtAB members made comments and proposed modifications if needed. In addition, the EtAB contributed to the two deliverables of T1.5 “Ethics and societal issues management”, i.e., D1.5 “Ethics and societal issues management initial report and D1.6 “Ethics and societal issues management final report” that were drafted by KEMEA. • Human Participation in Research Activities and Protection of Personal Data The recruitment of human participants including both recruitment and exclusion criteria, the procedures followed within pilot demonstrations, workshops, and other research activities were subject to the approval by the EtAB. ©NESTOR Consortium Page 18 of 28
HORIZON 2020 – 101021851 – NESTOR D8.9 – GEN-Requirement No.9 The templates of Information Sheet for Research Participation and the template of the Informed Consent Form for Research Participation, as well as the Information Sheet for Data Processing and the Informed Consent Form for Data Processing have been drafted and prepared. They were included in the D8.1 H-Requirement No. 1 that has been already submitted. Depending on the nature and the specific conditions of each research activity the above- mentioned documents were modified accordingly. With respect to the NESTOR Project Meeting that took place on June 15-17,2022 in Alexandroupoli, Greece, the PEO had drafted and modified accordingly the Information Sheet for Data Processing and the Informed Consent Form for Data Processing that were distributed to all the participants. The same procedure was followed for the next Project Meeting that was held on October 24-26, 2022, in Larnaca, Cyprus. In addition, online Information Sheet and online Informed Consent Form (check boxes) were prepared by the PEO as part of the online registration regarding the NESTOR training program in the context of T6.2 “Training Courses”. Furthermore, the informed consent procedure was followed prior to the start of the Workshop for ‘Border Management Standardization Roadmap’ that was organized on the 17th of February 2023, in Brussels, Belgium. As foreseen, the informed consent procedure was also followed prior to the start of the NESTOR pilot demonstrations. In particular, prior to the start of the Lithuanian maritime trial (T6.3), of the Cypriot maritime trial (T6.4) and prior to the start of the Greek-Bulgarian land and maritime trial (T6.5), the PEO prepared the Information Sheet for Research Participation and Data Processing and the Informed Consent Form for Research Participation and Data Processing that were distributed to all trial participants. As regards the VIP Day that took place in the framework of the Greek-Bulgarian land and maritime trial on the 16th of March 2023 in Alexandroupolis, Greece, the Information Sheet and the Informed Consent Form also included a confidentiality clause that was addressed to the external guests. Finally, online Information Sheet and online Informed Consent Form (check boxes) were prepared by the PEO as part of the NESTOR Demo Day & Final Workshop that will be held on 24th of April 2023 in Athens, Greece. • Data Protection Impact Assessments A risk assessment was conducted in order to evaluate the privacy risks in the framework of D8.3 POPD-Requirement No. 3. Following the risk assessment, an opinion of whether a Data Protection Impact Assessment (DPIA) is necessary according to Article 35 GDPR was included in that same deliverable. The assessment and the evaluation of the ethics/privacy risks took into consideration each data processing operation separately and based on these an opinion was drafted which considered necessary the conducting of a DPIA in two cases: (a) for the web monitoring operated by CENTRIC as part of T3.4 and (b) for the social media monitoring operated by CERTH as part of T3.4. ©NESTOR Consortium Page 19 of 28
HORIZON 2020 – 101021851 – NESTOR D8.9 – GEN-Requirement No.9 The DPIA of CENTRIC was in progress at the time of D8.3’s submission but it was finalised timely prior to the start of the relevant data processing operations and was included in D1.5. The DPIA of CERTH can be found in Appendix C of D8.3 and its updated version can be found in the Annex of D1.6. Based on the measures that were implemented and according to the opinion of CENTRIC’s and CERTH’s DPOs, the output of each DPIA was that no high risks were anticipated for the rights and freedoms of the data subjects. • Joint Controllership Arrangements The Joint Controllership Arrangements were made pursuant to Article 26 GDPR and set out the rights and obligations of the NESTOR Consortium partners who acted as Joint Controllers with respect to the processing of the “on-the-field” trial participants’ personal data as part of the NESTOR trials carried out in Lithuania under T6.3 (“Lithuanian Maritime Trial”), in Cyprus under T6.4 (“Cypriot Maritime Trial”) and in Greece under T6.5 (“Greek-Bulgarian land and maritime trial”), respectively. The Joint Controllership Arrangements can be found in the Annex of D1.6. • Other documentation In the context of D8.3 POPD-Requirement No.3, a template of Data Protection Policy was prepared in case the members of the NESTOR Consortium were not obliged by law to designate a Data Protection Officer (DPO). This template was drafted by the PEO and the EtAB members in order to facilitate the NESTOR partners. The detailed Data Protection Policy included the types of processed data, the lawful basis and the purposes, the procedures for data handling, the applicable law, and the contact details of the controller. In the context of D8.2 H-Requirement No.2, a template of Declaration of Compliance was prepared in case the members of the NESTOR Consortium were not obliged by national law to establish an ethics committee. This template was drafted by the PEO and the EtAB members in order to facilitate the NESTOR partners. The Declaration of Compliance contained all requirements that should be fulfilled by the partners conducting research activities with human participants during the lifetime of the NESTOR project. • General ethics guidance All WP8 ethics deliverables were based on the input provided by the partners of the NESTOR Consortium. The input was collected through questionnaires drafted and issued by the PEO as reviewed by the other EtAB members. The questionnaires were very analytical and contained the relative legislation so that the members of the NESTOR Consortium could be effectively informed and could provide precise responses in relation to the ethics issues, such as misuse, dual-use, personal data, etc. Furthermore, Ethics Guidelines were drafted for the T6.2 training courses based on the content of deliverables D8.5 and D8.7 (summarised information in the form of bullet points). ©NESTOR Consortium Page 20 of 28
HORIZON 2020 – 101021851 – NESTOR D8.9 – GEN-Requirement No.9 The ethics guidelines accompanied the On-the-Job Training Guidelines drafted by STWS and aimed to ensure that both trainers and trainees would strictly follow the health and safety procedures and the misuse mitigation strategy during the training. Copies of the guidelines were distributed to the participants prior to the start of the training courses. In addition, Ethics Guidelines were drafted for the NESTOR pilot demonstrations based on the content of all the ethics deliverables (D8.1, D8.2, D8.3, D8.4, D8.5, D8.6 and D8.7). They were adapted to each one of the three pilot demonstrations and copies of them were distributed to the NESTOR Consortium prior to the start of the three trials. Moreover, the information included in the ethics deliverables was communicated and was made available to the NESTOR Consortium through dedicated sessions during the project meetings in order to ensure that the partners were aware of any ethical/legal risks and of the recommended or necessary actions in accordance with applicable EU and national laws and the ethics standards. Any ethical issues that were likely to appear during the NESTOR project were discussed first amongst the EtAB members and then among the members of the NESTOR Consortium. Guidance was provided on a constant basis either when considered necessary by the EtAB or whenever asked by a NESTOR partner. Finally, the PEO and the EtAB members appointed for the NESTOR project monitored the research activities from an ethical and legal point of view both during the carrying out of the research activities (via ethics guidelines, Information Sheets and Informed Consent Forms, physical presence of the PEO and other EtAB members during the project meetings, physical presence of the PEO during the pilot demonstrations) and during the presentation and description of the research activities in the context of the project’s deliverables (via the Ethics Review Form/Table). 5 RECOMMENDATIONS BY THE ETHICS ADVISORY BOARD The EtAB was determined until the end of the project to continue aligning all activities including research and developments within the NESTOR project with ethical principles of the highest standard for research integrity as well as to ensure compliance with all applicable international, EU and national laws. The members of NESTOR Consortium were sufficiently informed about the ethical and legal issues that have arisen or were likely to arise in the framework of the NESTOR project and they followed the guidance provided by the EtAB. Concrete examples can be found in the analysis of the above-mentioned deliverables of the WP8 ‘Ethics Requirements’ in Section 3 as well as in the description of the general guidance provided to the NESTOR Consortium in Section 4. ©NESTOR Consortium Page 21 of 28
HORIZON 2020 – 101021851 – NESTOR D8.9 – GEN-Requirement No.9 As a final recommendation that extends beyond the research phase should be mentioned that the NESTOR partners must continue to align with the advice and guidance of the EtAB and to ensure compliance with the applicable international, EU and national laws during the deployment of the NESTOR system by the interested stakeholders. The NESTOR Consortium must respect the content of D2.2 ‘Report on the legal and security requirements for border security’, as well as of the T1.5 and WP8 deliverables and be constantly updated in order to keep up with the legislative developments. ©NESTOR Consortium Page 22 of 28
HORIZON 2020 – 101021851 – NESTOR D8.9 – GEN-Requirement No.9 6 CONCLUSION The purpose of D8.9 was to provide a report by the Ethics Advisory Board (EtAB) about how the NESTOR Consortium has dealt with the identified ethics issues in order to ensure compliance with ethical standards, the H2020 guidelines and with applicable legislation. This deliverable constitutes the updated version of D8.8 including information that covers the entire research period. In view of that, in Section 2 the composition of the Ethics Advisory Board was presented as well as its role and function. In Section 3 the work related to the compliance of the NESTOR Consortium with the WP8 ethics requirements was described in detail. In Section 4 the general work progress was presented and the role of EtAB and its contribution were outlined in a precise way. Finally, in Section 5 the final recommendations by the EtAB were included. ©NESTOR Consortium Page 23 of 28
HORIZON 2020 – 101021851 – NESTOR D8.9 – GEN-Requirement No.9
7 REFERENCES
• Grant Agreement No 101021851 – Annex A Description of the action
• Grant Agreement Amendment AMD-101021851-3
• European Commission, Horizon 2020 Programme, Guidance How to complete your
ethics self-assessment, v6.1 04/02/2019, available at
https://ec.europa.eu/research/participants/data/ref/h2020/grants_manual/hi/ethi
cs/h2020_hi_ethics-self-assess_en.pdf
©NESTOR Consortium Page 24 of 28
HORIZON 2020 —- 101021851 — NESTOR D83.9 - GEN-Requirement No.9 Appendix A: Quality Review Report NESTOR Consortium uses this Quality Review Report process internally in order to assure the required and desired quality assurance for all project’s deliverables and consequently the consistency and high standard for documented project results. The Quality Review Report is used individually by each deliverable’s peer reviewers with allocated time for the review to be 7 calendar days. The author of the document has the final responsibility to reply on the comments and suggestions of the peer reviewers and decide what changes are needed to the document and what actions have to be further undertaken. 1.1 Reviewers Project Coordinator Management Team Member Internal Peer Reviewers CENTRIC — (EtAB member), External ethics (who have also drafted this deliverable) expert- (EtAB Member) 1.2 Overall Peer Review Result The Deliverable is: Fully accepted U] Accepted with minor corrections, as suggested by the reviewers U] Rejected unless major corrections are applied, as suggested by the reviewers 1.3 Consolidated Comments of Quality Reviewers Deliverable contents thoroughness Reviewers’ comments: Good he Innovation level Reviewers’ comment: Good 7 Correspondence to project and | Reviewers’ comment: Good Relevance with the objectives of the | iyes deliverable DO No U] Partially U] Not applicable Reviewers’ comment: Author’s reply: Completeness of the document | Xiyes according to its objectives OD No U] Partially L] Not applicable Reviewers’ comment: Author’s reply: ©NESTOR Consortium Page 25 of 28
HORIZON 2020 —- 101021851 — NESTOR Methodological framework soundness Quality of the results achieved Structure of the deliverable with clear objectives, methodology, implementation, results and conclusions Clarity and quality of presentation, language and format DdYes DJ No U] Partially U] Not applicable Reviewers’ comment: Author’s reply: DiYes DJ No U] Partially U] Not applicable Reviewers’ comment: Author’s reply: Yes U] No U] Partially L] Not applicable Reviewers’ comment: Author’s reply: DlYes U] No U] Partially LJ] Not applicable Reviewers’ comment: Author’s reply: D8.9 - GEN-Requirement No.9 fe fe O©NESTOR Consortium Page 26 of 28
HORIZON 2020 - 101021851 — NESTOR Appendix B: Deliverable Ethics Review This deliverable includes the opinion/input of aDPO, Legal or Ethics Advisor. This deliverable is based on research activities (questionnaires, workshops, pilots or other tasks) that involve human participants. This deliverable is based on research activities (either during pilots or during the execution of other tasks) that may involve children or adults unable to give informed consent or vulnerable individuals/groups. Informed Consent Forms for the participation of humans in research have been/will be signed. Measures for the protection of vulnerable individuals/groups have been/will be implemented. Incidental findings, i.e., findings that are outside the research’s scope, may be detected as part of the research activities described in this deliverable (criminal activity or personal data of non-volunteers during trials). This deliverable is based on research activities that involve processing of personal data. This deliverable is based on research activities that involve processing of special categories of personal data according to Article 9 GDPR. Special categories of personal data means personal data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, or trade union membership, and the processing of genetic data, biometric data for the purpose of uniquely identifying a natural person, data concerning health or data concerning a natural person's sex life or sexual orientation). This deliverable is based on research activities that involve further processing of previously collected personal data or publicly available personal data. Informed Consent Forms for the personal data processing have been/will be signed and data subjects have been duly informed about their rights. The conditions for consent cannot be fulfilled. Another legal basis exists. This deliverable is based on research activities that involve transfer of personal data from/to non-EU/EEA countries (non-EU/EEA partner sor advisory board members from non-EU/EEA countries) or processing of personal data during the use of platforms regulated by non-EU/EEA law. This deliverable implements appropriate technical measures that constitute safeguards (encryption or anonymisation or pseudonymisation). ©NESTOR Consortium D8.9 - GEN-Requirement No.9 Yes EtAB comments: Due to its nature the deliverable is drafted by the PEO and the EtAB members. EtAB comments: EtAB comments: EtAB comments: EtAB comments: EtAB comments: EtAB comments: EtAB comments: EtAB comments: EtAB comments: EtAB comments: EtAB comments: EtAB comments: Page 27 of 28
