Deliverable D10.3 Ethic report on ASRY1 and Assessement report for AWPY2 OEI - Requirements No.3 WP1- T1.4

P-A-R-C HORIZON-HLTH-2021-ENVLTH-03 CONTRACT N. 101057014 This partnership has received funding from the European Union ’s Horizon Europe research and innovation programme under Grant Agreement No 101057014. 3 3 4 5 Document history ___________________________________________________________ 3 Abstract ___________________________________________________________________ 4 Key Words _________________________________________________________________ 4 Authors and Acknowledgements _______________________________________________ 7 Acronyms _________________________________________________________________ 7 Glossary ___________________________________________________________________ 7 1. Ethics developments: ______________________________________________________ 7 1.1 Introduction: ____________________________________________________________ 7 1.2 Constitution of the Data and Ethics Protection Board ____________________________ 8 1.3 Identification of projects’ potential ethics concerns and setting-up communication channels. 9 1.4 Development of a Decision Memo process for the validation of animal experimentation in PARC ________________________________________________________________________ 10 1.5 Development of the PARC Ethics framework __________________________________ 10 1.6 Preparation for the T4.1 HBM aligned studies _________________________________ 11 2 – Ethics overview in year 1 _________________________________________________ 11 2.1 Key takeaway __________________________________________________________ 11 2.2 Human involvement _____________________________________________________ 12 2.3 Human cells / tissues ____________________________________________________ 12 2.4 Data use and processing __________________________________________________ 12 2.5 Involvement of non-EU countries ___________________________________________ 13 2.6 Environment, health and Safety ____________________________________________ 13 2.7 Artificial Intelligence _____________________________________________________ 13 2.8 Animal experimentation __________________________________________________ 13 3 Ethics assessment for year 2 ________________________________________________ 13 3.1 Key takeaway __________________________________________________________ 13 3.2 Human Involvement _____________________________________________________ 13 3.3 Human cells/tissues _____________________________________________________ 15 3.4 Data use and processing __________________________________________________ 15 3.6 Environment, health and safety ____________________________________________ 15 3.7 Artificial Intelligence _____________________________________________________ 16 6 3.8 Animal experimentation __________________________________________________ 16 4 Conclusion ______________________________________________________________ 17 Annex: ___________________________________________________________________ 17 Annex 1 – Ethics project assessment ___________________________________________ 17 Annex 2 – PARC project ethics contact point _____________________________________ 19 Annex 3 – Animal experimentation Information/Decision Memo template _____________ 21 Annex 4 – Informed Consent Form template _____________________________________ 22 7 Acronym Reference AI Artificial Intelligence DEPB Data and Ethics Protection Board EWS Early Warning System GB Governing Board GSB Grant Signatory Board IB International Board IPR Intellectual Property Rights MB Management Board ML Machine Learning NAMs New Approach Methodologies NH National Hubs PARC CT PARC Coordination Team SF Stakeholder Forum WP Work Package 8 9 Question Please indicate if the activities described in the project: (between brackets, you will find some information regarding the questions related to the activities.) Answer (Yes/No) 1 Involve Human Embryonic Stem Cells (hESCs)? (Be aware that EU funding cannot be used for activities involving hESCs.) Y/N 2 Respect the relevant national and EU legislations? (Be advised that activities implemented in non EU-countries must be legal in at least one EU country.) Y/N 3 Involve human participants? (If yes ensure that the due process to collect, acquire and store informed consent is followed.) Y/N 4 Use human cells / tissues (other than hESC or human embryos)? (If yes, please ensure that the collection and use of the material follow all relevant national and EU legislations.) Y/N 5 Involve processing of personal data or further processing of existing personal data? (If yes, please follow existing national and EU legislations for the processing of personal data (ex: GDPR), notably for special categories of personal data (ex: biometric and health data).) Y/N 6 Involve animals for research/testing? (If yes ensure that all applicable national and EU legislations are adhered to, notably on the use of animals for scientific purpose.) Y/N 7 Involve non EU-countries? (Be advised that activities implemented in non EU-countries must be allowed in at least one EU country.) Y/N 8 Involve the use of substances or processes that may reasonably cause harm to the environment, to animals or plants? (If yes, ensure that all applicable legislations are adhered to, such as precautionary principles and legislation on nature conservation and pollution control, legislation on public-health control, and legislation on safety at work.) Y/N 16 17 Project acronym hESCs involvement Respect national and EU legislations Involve human participants Use of human cells/tissues Use and process personal data animal research/testing Non-EU countries involvement Use of potentially harmful substances Started Y1 WP4 P4.1.1.2.a_Y1_GenHBMSurvey_VITO No Yes Yes Yes Yes No Yes No P4.1.1.4.a_Y1_OccupFeasability_TTL No Yes No No Yes No No No P4.1.1.4.b_Y1_SentinelSystem_KULeuven No Yes Yes Yes Yes No Yes No P4.1.1.4.c_Y1_HealthCareSurvey_TTL_RU MC No Yes Yes Yes Yes No No Yes P4.1.1.4.d_Y1_OccupWaste_ENSP_TTL No Yes Yes Yes Yes No No No P4.1.3.1.a_Y1_DerivationofHBMGVs_UBA No Yes No No No No Yes No P4.1.3.3.a_Y1_RoadmapLinkingHBMhealt h_SpF_VITO No Yes Yes Yes Yes No Yes No P4.1.4.2.a_Y1_DataAnalysisHBM4EU_VIT O No Yes Yes Yes Yes No Yes No P4.1.5.a_Y1_SustainHBMSystem_VITO No Yes No No No No No No P4.2.a_Y1_ENVMonitoringPilotSurvey_IN ERIS_AU No Yes No No No No No No P4.3.1.a_Y1_T01-Concept Paper_MU No Yes No No No No No No P4.3.1.b_Y1_T02-QAQC_WR No Yes No No No No No No P4.3.1.c_Y1_T03-EWStools_SLU No Yes No No No No No No 18 P4.3.1.d_Y1_T04-Data Processing Worflow_EHESP No Yes No No Yes No No No P4.3.2.a_Y1_H01-Perinatal exposure_INRAE No Yes Yes Yes No No No Yes P4.3.3.a_Y1_E01-Wastewater based epidemiology_UFZ-UBATH No Yes No No No No Yes Yes WP5 P5.1.1.a_Y1_Toxins_BfR_UNIVIE No Yes No Yes No No Yes Yes P5.1.1.b_Y1_BPA_HumTox_BfR No Yes No Yes No No No Yes P5.1.2.a_Y1_NaturalToxinsAqua_UGent No Yes No No No No No No P5.1.2.b_Y1_BPAalternatives_BPI_MU No Yes No No No Yes Yes Yes P5.2.1.a_Y1_NGTXCs_INRAE No Yes No Yes No No No Yes P5.2.1.b_Y1_MD-EDC_INRAE No Yes No Yes No No No No P5.2.1.c_Y1_EDThDisruption_DTU No Yes No Yes No No No Yes P5.2.1.d_Y1_Immunotox_Inserm No Yes Yes Yes No Yes No No P5.2.1.e_Y1_Neurotox_UFZ_IUF_UU No Yes No Yes No No No Yes P5.3.1.a_Y1_SystemsToxicology_ULLACDR No Yes No Yes No No No No P5.3.2.a_Y1_AOPDevelopment_Inserm No Yes Yes No Yes No Yes No P5.3.4.a_Y1_PBK_Kinetics_Fraunhofer No yes No Yes No No No No WP6 P6.1.1.a_Y1_HumanRelevance_RIVM No yes No Yes no No Yes No P6.1.1.b_Y1_IATA-ED_UAntwerpen No yes No Yes No Yes Yes Yes P6.1.1.c_Y1_IATA_GENTOX_Sciensano No Yes No Yes No No Yes No P6.1.1.d_Y1_IATA_STOT_UL-LACDR No Yes No Yes No No Yes No P6.2.1.a_Y1_SourcetoDose_VITO No yes No No No No No No P6.2.1.b_Y1_Aggregate_Anses No yes Yes No yes No No No P6.2.2.a_Y1_PBPK_INERIS_AUTH No Yes No No Yes No No No P6.2.3.a_Y1_RealLifeMixtures_RIVM No Yes Yes No Yes No No No P6.2.4.a_Y1_HIADataAvailability_VITO No Yes No No Yes No Yes No P6.2.4.b_Y1_HIAMethod_UU-IRAS No Yes No No Yes No Yes No P6.2.4.c_Y1_HIACaseStudies_UU-IRAS No Yes No No Yes No Yes No P6.2.4.d_Y1_HIAIndicators_VITO No Yes No No Yes No Yes No P6.3.1.a_Y1_SubstanceRA_SU No Yes No No No No Yes No P6.3.1.b_Y1_EffectRA_BPI No Yes No No No No Yes No P6.3.2.a_Y1_ToolsRA_SU No Yes Yes No No No Yes No P6.4.1.a_Y1_OPREMIXCS1_BRUNEL_UGot No Yes No No yes No Yes No P6.4.1.b_Y1_MONAMMIXCS2_UFZ No Yes No No No No Yes No P6.4.2.a_Y1_LandscapingSurv_UNIBAS No Yes yes No No No Yes No P6.4.2.b_Y1_NGRApractice_VKM_NIPH No Yes Yes No No No Yes No P6.4.2.c_Y1_NAMAM_UT No Yes No No No No Yes No P6.4.3.a_Y1_SuProM_MU No yes No No No No Yes No P6.4.4.a_Y1_CRNCS1_KEMI No Yes No No No No No No P6.4.4.b_Y1_PPPEXPCS2_SLU No Yes No No No No No No P6.4.4.c_Y1_PPPEFFCS3_UFZ No Yes No No No No No No P6.4.4.d_Y1_PPPBENCHCS4_UKOLD No yes No No No No No No P6.4.4.e_Y1_PPPOSCS5_ISCIII No yes No No No No No No WP7 P7.2.2.a_Y1_chemicals-inenvironment_MU_VITO No yes No No Yes No Yes No P7.2.2.b_Y1_HBMdatasets_VITO No Yes Yes No Yes No Yes No P7.3.3.a_Y1_ALT-IST_IISPV No Yes No No No No No No In iti at io n Y 2 W P 4 P4.2.b_Y2_Monitoringframe_AU_INERIS No Yes No No No No No No 19 P4.3.2.b_Y2_H02-Occupational exposure_INRS No Yes Yes No Yes No No No P4.3.3.b_Y2_E02-Sentinel animals_ONIRIS No Yes No Yes No No No Yes P4.3.4.a_Y2_F02-Food items exposure_ANSES No Yes No No No No No Yes Project acronym Ethics referent Started Y1 WP 4 P4.1.1.2.a_Y1_GenHBMSurvey_VITO [email protected] P4.1.1.4.a_Y1_OccupFeasability_TTL [email protected] P4.1.1.4.b_Y1_SentinelSystem_KULeuven [email protected] P4.1.1.4.c_Y1_HealthCareSurvey_TTL_RUMC [email protected] P4.1.1.4.d_Y1_OccupWaste_ENSP_TTL [email protected] P4.1.3.1.a_Y1_DerivationofHBM-GVs_UBA [email protected] P4.1.3.3.a_Y1_RoadmapLinkingHBMhealth_SpF_ VITO Hardiesse.BESSONNEAU@santepubliquefranc e.fr P4.1.4.2.a_Y1_DataAnalysisHBM4EU_VITO [email protected] P4.1.5.a_Y1_SustainHBMSystem_VITO [email protected] P4.2.a_Y1_ENVMonitoringPilotSurvey_INERIS_AU [email protected].dk; Valeria.du[email protected] P4.3.1.a_Y1_T01-Concept Paper_MU [email protected] P4.3.1.b_Y1_T02-QAQC_WR [email protected] P4.3.1.c_Y1_T03-EWStools_SLU [email protected] P4.3.1.d_Y1_T04-Data Processing Worflow_EHESP [email protected] P4.3.2.a_Y1_H01-Perinatal exposure_INRAE [email protected] P4.3.3.a_Y1_E01-Wastewater based epidemiology_UFZ-UBATH werner.brac[email protected] WP 5 P5.1.1.a_Y1_Toxins_BfR_UNIVIE [email protected]; jessica.dietri[email protected]und.de; [email protected] P5.1.1.b_Y1_BPA_HumTox_BfR [email protected] P5.1.2.a_Y1_NaturalToxinsAqua_UGent [email protected] P5.1.2.b_Y1_BPAalternatives_BPI_MU [email protected]; [email protected]; k.kyriakop[email protected]r P5.2.1.a_Y1_NGTXCs_INRAE marc.audeber[email protected]; [email protected] P5.2.1.b_Y1_MD-EDC_INRAE [email protected] P5.2.1.c_Y1_EDThDisruption_DTU [email protected].dk; [email protected] P5.2.1.d_Y1_Immunotox_Inserm [email protected]; [email protected] P5.2.1.e_Y1_Neurotox_UFZ_IUF_UU [email protected]; [email protected]; joelle.ru[email protected]u.se 20 P5.3.1.a_Y1_SystemsToxicology_UL-LACDR [email protected]enuniv.nl P5.3.2.a_Y1_AOPDevelopment_Inserm [email protected] P5.3.4.a_Y1_PBK_Kinetics_Fraunhofer [email protected] WP 6 P6.1.1.a_Y1_HumanRelevance_RIVM [email protected] P6.1.1.b_Y1_IATA-ED_UAntwerpen [email protected] P6.1.1.c_Y1_IATA_GENTOX_Sciensano [email protected] P6.1.1.d_Y1_IATA_STOT_UL-LACDR [email protected]enuniv.nl P6.2.1.a_Y1_SourcetoDose_VITO [email protected] P6.2.1.b_Y1_Aggregate_Anses amelie.crepe[email protected] P6.2.2.a_Y1_PBPK_INERIS_AUTH [email protected]r P6.2.3.a_Y1_RealLifeMixtures_RIVM [email protected] P6.2.4.a_Y1_HIADataAvailability_VITO jurgen.bu[email protected]; [email protected] P6.2.4.b_Y1_HIAMethod_UU-IRAS [email protected]; Jurgen.b[email protected] P6.2.4.c_Y1_HIACaseStudies_UU-IRAS [email protected]; Jurgen.b[email protected] P6.2.4.d_Y1_HIAIndicators_VITO [email protected]; Jurgen.b[email protected] P6.3.1.a_Y1_SubstanceRA_SU [email protected] P6.3.1.b_Y1_EffectRA_BPI [email protected] P6.3.2.a_Y1_ToolsRA_SU [email protected] P6.4.1.a_Y1_OPREMIXCS1_BRUNEL_UGot [email protected]; [email protected]; [email protected] P6.4.1.b_Y1_MONAMMIXCS2_UFZ [email protected]; [email protected] P6.4.2.a_Y1_LandscapingSurv_UNIBAS [email protected] P6.4.2.b_Y1_NGRApractice_VKM_NIPH [email protected] P6.4.2.c_Y1_NAMAM_UT uk[email protected] P6.4.3.a_Y1_SuProM_MU [email protected] P6.4.4.a_Y1_CRNCS1_KEMI Johan.axel[email protected] P6.4.4.b_Y1_PPPEXPCS2_SLU [email protected] P6.4.4.c_Y1_PPPEFFCS3_UFZ [email protected] P6.4.4.d_Y1_PPPBENCHCS4_UKOLD [email protected] P6.4.4.e_Y1_PPPOSCS5_ISCIII [email protected]s WP 7 P7.2.2.a_Y1_chemicals-inenvironment_MU_VITO Richard.hu[email protected]ni.cz P7.2.2.b_Y1_HBMdatasets_VITO Jan.theun[email protected] P7.3.3.a_Y1_ALT-IST_IISPV [email protected] Initiation Y2 WP 4 P4.2.b_Y2_Monitoringframe_AU_INERIS [email protected].dk; Valeria.du[email protected] P4.3.2.b_Y2_H02-Occupational exposure_INRS [email protected]r; Radu.d[email protected] P4.3.3.b_Y2_E02-Sentinel animals_ONIRIS [email protected] P4.3.4.a_Y2_F02-Food items exposure_ANSES julien.pari[email protected] 21 Information/Decision Memorandum on use of live animal testing APPLICATION DATE: .................................................................................................. FROM: TO: MANAGEMENT BOARD MEMBERS RELATED DOCUMENTS: - - - - - 22 - - - -   23 24 Don’t contact me. 25