D1.2 Preliminary Data Management Plan and Ethic handbook

Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Research Executive Agency (REA). Neither the European Union nor the granting authority can be held responsible for them. Preliminary Data Management Plan and Ethic handbook. / D1.2 WP 1, Task 1.3 Authors: Alba Matamoros (KVC), Cristina Vera (KVC), Maite Ferrando (KVC) 2 ANIPH – Deliverable 1.2. Preliminary Data Management Plan and Ethic handbook. VF. Funded by the European Union Technical references Project Acronym ANIPH Project Title Avoiding the Negative Impacts produced by Plastic materials in Humanitarian contexts Project Coordinator ASOCIACION EMPRESARIAL DE INVESTIGACION CENTROTECNOLOGICO DEL CALZADOY DEL PLASTICO DE LA REGION DE MURCIA CETEC Carmen Fernandez: c.f[email protected] Project Duration Janaury 2025 – December 2028 (48 months) Deliverable No. D1.2. Dissemination level* PU - Public Work Package WP 1Project Management and coordination activities-1 Task T1.3 - Data management plan and Ethical issues management Lead beneficiary 7 - KVC Contributing beneficiary/ies 1 – CETEC, 3 – AUA, 5 - UGR Due date of deliverable 30 June 2025 Actual submission date 30 June 2025 • *PU – Public, fully open, e.g. web (Deliverables flagged as public will be automatically published in CORDIS project’s page) • SEN – Sensitive, limited under the conditions of the Grant Agreement • Classified R-UE/EU-R – EU RESTRICTED under the Commission Decision No2015/444 • Classified C-UE/EU-C – EU CONFIDENTIAL under the Commission Decision No2015/444 • Classified S-UE/EU-S – EU SECRET under the Commission Decision No2015/444 V Date Comments Author/Reviewer V0.3 15/05/2025 Initial version Alba Matamoros, Cristina Vera, Maite Ferrando (KVC) V0.4 13/06/2025 Revised version by the reviewer partner Marcello Bardellini (ICONS) V0.5 16/06/2025 Comments integrated by the authors Cristina Vera (KVC) 3 ANIPH – Deliverable 1.2. Preliminary Data Management Plan and Ethic handbook. VF. Funded by the European Union V0.6 19/06/2025 Version reviewed by the project coordinators Cristina Blaya, Carmen Fernández (CETEC) V1.0 25/06/2025 Comments integrated by the authors Alba Matamoros (KVC) VF 30/06/2025 Review of the final version Cristina Blaya, Carmen Fernández (CETEC) 4 ANIPH – Deliverable 1.2. Preliminary Data Management Plan and Ethic handbook. VF. Funded by the European Union Table of contents 1. List of Abbreviations ............................................................................. 7 2. Executive Summary .............................................................................. 9 3. Data Generation and Collection ......................................................... 10 3.1. Data types and sources .............................................................................................. 11 3.2. Data collection methodologies .................................................................................. 11 3.3. Data size and format ................................................................................................. 12 3.4. Data utility ................................................................................................................ 13 3.5. Data repository and long-term accessibility ............................................................... 14 3.6. Quality control measures .......................................................................................... 14 3.7. Data Re-use Strategy and Purpose ............................................................................. 15 4. FAIR data ............................................................................................ 17 4.1. Making data findable, including provisions for metadata ........................................... 17 4.2. Making data accessible .............................................................................................. 18 4.3. Making data interoperable ........................................................................................ 21 4.4. Increase data re-use .................................................................................................. 22 5. Other research outputs ...................................................................... 24 5.1. Software And Algorithms .......................................................................................... 24 5.2. Models And Protocols ............................................................................................... 24 5.3. Publications And Dissemination ................................................................................. 25 6. Allocation of resources ....................................................................... 27 6.1. Costs ......................................................................................................................... 27 6.2. Responsabilities ........................................................................................................ 27 7. Data security ...................................................................................... 29 7.1. Data protection: Compliance with GDPR .................................................................... 29 7.1.1. Purpose ............................................................................................................................ 29 7.1.2. Accuracy ........................................................................................................................... 29 7.1.3. Integrity and confidenciality ............................................................................................ 29 7.1.4. Accountability .................................................................................................................. 29 7.1.5. Personal information ....................................................................................................... 30 7.1.6. Anonymisation and pseudoanonymisation ..................................................................... 30 7.1.7. Informed consent procedures ......................................................................................... 30 7.1.8. Incidental findings ............................................................................................................ 30 7.1.9. International data transfer .............................................................................................. 30 7.2. Technical security measures ...................................................................................... 31 7.2.1. Access controls ................................................................................................................. 32 7.2.2. Encryption standards ....................................................................................................... 32 7.2.3. Backup procedures .......................................................................................................... 32 7.3. Data breach protocols ............................................................................................... 33 5 ANIPH – Deliverable 1.2. Preliminary Data Management Plan and Ethic handbook. VF. Funded by the European Union 7.3.1. Breach identification and reporting ................................................................................. 33 7.3.2. Containment and mitigation ............................................................................................ 33 7.3.3. Notification to authorities and individuals ...................................................................... 33 7.3.4. Documentation and follow-up ......................................................................................... 34 8. Ethics: Project overview and key ethical challenges ........................... 35 8.1. Research integrity ..................................................................................................... 35 8.1.1. Human health and PHA wound healing: ethical and scientific-technical considerations .................................................................................................................................................... 35 8.2. Open science and ethics ............................................................................................ 36 8.2.1. Measures to be implemented .......................................................................................... 36 8.3. RRI (Responsible Research Innovation) ...................................................................... 37 8.3.1. RRI and Gender ................................................................................................................ 42 8.3.2. Environmental Ethics ....................................................................................................... 42 8.4. Ethics and Artificial Intelligence (AI) ........................................................................... 43 8.4.1. AI transparency and explainability ................................................................................... 44 8.4.2. AI fairness and bias mitigation ......................................................................................... 44 8.4.3. AI robustness and safety .................................................................................................. 44 8.4.4. Human oversight and intervention .................................................................................. 44 8.4.5. Compliance with EU AI Act requirements........................................................................ 45 8.5. Ethics and human tissues ........................................................................................... 45 8.5.1. Tissue acquisition ethics .................................................................................................. 45 8.5.2. Donor rights and dignity .................................................................................................. 50 8.5.3. Storage and disposal protocols ........................................................................................ 51 8.5.4. Compliance with bioethics regulations ............................................................................ 51 8.6. Ethics and Public Participation ................................................................................... 52 8.7. Ethical risk assessment and mitigation ....................................................................... 52 8.7.1. Risk identification methodology ...................................................................................... 53 8.8. Ethical review processes ............................................................................................ 55 8.8.1. Internal ethics committees .............................................................................................. 55 8.8.2. External ethics approvals ................................................................................................. 55 8.8.3. Ongoing ethical monitoring ............................................................................................. 56 9. Conclusions ........................................................................................ 57 10. References ......................................................................................... 58 11. Annex A. Consent form ...................................................................... 60 List of Tables Table 1 Timeline of main ethics revisions .......................................................................................... 52 Table 2 Ethical concerns and recommended mitigation strategies .................................................. 53 Table 3 Risk-benefit and mitigation (ex-ante; baseline) .................................................................... 54 6 ANIPH – Deliverable 1.2. Preliminary Data Management Plan and Ethic handbook. VF. Funded by the European Union List of Figures Figure 1 Principles of RRI (source: RRI tools) ..................................................................................... 38 Figure 2 RRI dimensions (source: RRI tools) ...................................................................................... 38 Figure 3 IAP2 Spectrum of Public Participation ................................................................................. 41 Figure 4 Environmental sustainability and reverse logics ................................................................. 48 Figure 5 General human health effects of PHA materials and additives ........................................... 50 7 ANIPH – Deliverable 1.2. Preliminary Data Management Plan and Ethic handbook. VF. Funded by the European Union 1. List of Abbreviations • AI - Artificial Intelligence • AMR - Antimicrobial Resistance • ANIPH - Avoiding the Negative Impacts produced by Plastic materials in Humanitarian contexts • ASTM - American Society for Testing and Materials • AUA - GEOPONIKO PANEPISTIMION ATHINO • BBpP - Biobased and biodegradable plastics products • CC BY - Creative Commons Attribution International Public Licence • CC BY-NC - Creative Commons Non-Commercial License • CC BY-ND - Creative Commons No Derivatives License • CETEC - ASOCIACION EMPRESARIAL DE INVESTIGACION CENTRO TECNOLOGICO DEL CALZADOY DEL PLASTICO DE LA REGION DE MURCIA • DBP - Dibutyl Phthalate • DEHP - Di(2-ethylhexyl) Phthalate • DMP - Data Management Plan • DOI - Digital Object Identifier • DPA - Data Protection Authorities • ECHA - European Chemicals Agency • EDPB - European Data Protection Board • EOSC - European Open Science Cloud • FAIR - Findable, Accessible, Interoperable, Reusable • GA - Grant Agreement • GDPR - General Data Protection Regulation • GLP - Good Laboratory Practice • HTTPS - HyperText Transfer Protocol Secure • ICT - Information and Communication Technology • ICONS - FONDAZIONE ICONS • IEC - Independent Ethics Committee • ILS - Integrated Library System • IPR - Intellectual Property Rights • IRB - Institutional Review Board • ISO - International Organization for Standardization • KCB - Knowledge Centre for Bioeconomy • KVC – Knowledge Value Consulting • LCA - Life Cycle Assessment • LCC - Life Cycle Costing • MDR - Multidrug-Resistant Bacteria • MIME - Multipurpose Internet Mail Extensions • OECD - Organisation for Economic Co-operation and Development • OIA-PMH - Open Archives Initiative Protocol for Metadata Harvesting • OS - Open Science • PHA - Polyhydroxyalkanoates • PHBV - Poly(3-hydroxybutyrate-co-3-hydroxyvalerate) 8 ANIPH – Deliverable 1.2. Preliminary Data Management Plan and Ethic handbook. VF. Funded by the European Union • PHN - 3-hydroxynonanoic acid) • PMS - Post Market Surveillance • RRI - Responsible Research and Innovation • SFTP - Secure File Transfer Protocol • s-LCA - Social Life Cycle Assessment • SSbD - Safe and Sustainable by Design • T&E - Transparency and Explainability 9 ANIPH – Deliverable 1.2. Preliminary Data Management Plan and Ethic handbook. VF. Funded by the European Union 2. Executive Summary The ANIPH project seeks to establish an innovative polyhydroxyalkanoates (PHA) value chain for producing biodegradable wound dressings and recyclable water barrier packaging that degrade safely across all relevant environments. This ambitious initiative integrates cutting-edge AI predictive tools and digital traceability systems with comprehensive biological testing and public engagement strategies to ensure sustainable and effective product development. This deliverable (D.1.2.) represents the Preliminary Data Management Plan and Ethics Handbook, forming part of a structured three-phase approach within Work Packages 1 and 7 (Tasks 1.3 and 7.3). It will be followed by an Interim Data Management Plan (D.1.3.) and culminate in the Final Data Management Plan and Ethics Handbook (D.7.1.), ensuring continuous refinement of data governance throughout the project lifecycle. The Data Management Plan addresses the complete data lifecycle from initial generation and collection through long-term preservation, implementing FAIR principles to maximise data findability, accessibility, interoperability, and reusability. Robust data security frameworks ensure GDPR compliance through technical safeguards including encryption protocols and stringent access controls. Ethical considerations receive extensive treatment, encompassing research integrity standards, Responsible Research Innovation (RRI) principles, AI ethics aligned with EU regulatory requirements, and specialised protocols for human tissue research. The plan establishes clear resource allocation frameworks, defines organisational responsibilities, and implements comprehensive protocols for data breach management and ongoing ethical monitoring. 16 ANIPH – Deliverable 1.2. Preliminary Data Management Plan and Ethic handbook. VF. Funded by the European Union Certain datasets initially considered were ultimately discarded due to: - Inconsistent testing methodologies - Incomplete documentation of experimental conditions - Outdated measurements not meeting current standards - Incompatible data formats requiring excessive transformation 17 ANIPH – Deliverable 1.2. Preliminary Data Management Plan and Ethic handbook. VF. Funded by the European Union 4. FAIR data To ensure that research data can be used, shared, and re-used it is crucial to take care that those data are accessible, understandable, and usable. This requires clear data description, annotation, contextual information, and documentation explaining how data were created or digitised, what data mean or what their content and structure are. 4.1. Making data findable, including provisions for metadata In order to make data findable, ANIPH partners will ensure that each file of data is accompanied by a set of metadata to aid discoverability. The Consortium will adopt the following naming conventions that provides a clear version number by following time sequence (the most recent the most updated version) to make data accessible, understandable, and usable: DATA_DELIVERABLE NUMER_FILE NAME_PROJECT NAME.FORMAT The Consortium also will encourage establishing links between data collected and stored and the associated documentation, following recommendations such as the following: - Including information within the data or document itself, e.g. in the document properties function of a file or the file header. - Including information about the file’s creation (when and who), size and extension. - Keeping a database of metadata with links to files. - Storing a readme.txt file alongside the data which provides basic explanatory details. Txt. Files will be acceptable to explain very simple stuff like how to connect to a database, not the database explanation itself. - Recording relevant context in lab notebooks or associated papers and reports - Including links to websites or web pages which explain the context of the research. Metadata within Microsoft Office files is retained in the 'Properties' field associated with each file and can be adjusted in accordance with the recommendations outlined above. For alternative file formats, guidance will be sought from the respective software providers. Image metadata can be incorporated using proprietary or open-source photo editing software, or via other tools facilitating metadata modification, including file management applications. As outlined in the previous section, all datasets published in trusted repositories (e.g. Zenodo, EOSC) will be assigned a persistent identifier (e.g. DOI), ensuring long-term traceability and citability. Rich metadata will be provided to enable data discovery and reusability. This metadata will include title, authors, creation date, keywords, abstract/description, file format, and licensing terms. Where applicable, disciplinary metadata standards will be followed, and additional metadata specific to biomaterials (e.g., polymer composition, test conditions, degradation parameters) will be defined by the consortium. To improve discoverability, search keywords and thematic descriptors will be included in the metadata fields. Metadata will be deposited in repositories that support harvesting and indexing (e.g., via OIA-PMH) facilitation integration into data catalogues and aggregators. 18 ANIPH – Deliverable 1.2. Preliminary Data Management Plan and Ethic handbook. VF. Funded by the European Union 4.2. Making data accessible Research data/outputs will be openly available, whenever possible, and as soon as possible. The access to some data (e.g. personal data, confidential knowhow) will be restricted if they compromise its commercialisation or have inadequate protection. Each partner has the right to request access rights, background and results as specified in Article 16 of the Grant Agreement and Annex 5. Provisions for EU Commission access to restricted data for verification purposes will be granted. Moreover, ANIPH will i) Provide open access to biomaterials datasets, either through direct download links or by hosting them on open repositories with appropriate licenses. ii): Release analysis tools and simulation software under open-source licenses, allowing researchers to access, modify, and redistribute the code freely; iii) Offer user support and documentation for software tools Data: Accessibility means that metadata and data are understandable to humans and machines and may be retrievable by their identifier via a standardised communication protocol. As foreseen in Article 16 of the Grant Agreement (GA), the partners must grant access to each other's information, subject to the restrictions on intellectual property and any special procedures set out in Annex 5 of the GA. The ANIPH consortium intends to make all non-confidential data openly available through trusted repositories as mentioned, in accordance with FAIR principles and EU open science policies. However, specific datasets may remain restricted or partially closed due to legitimate interests, protection of intellectual property, or the presence of personal/sensitive information (e.g., from public engagement activities). These restrictions will be documented and justified on a case-by-case basis. In such cases, access may be granted under controlled conditions, such as through data use agreements or request forms validated by the data provider. If an embargo is applied, it will be temporary and justified by the need to publish results in peerreviewed journals or to secure intellectual property protection (e.g., patent filings). Embargo periods will not exceed 6 to 12 months unless otherwise agreed by the consortium. Data accessibility will be further defined in the final version of this deliverables in terms of: - Where will the data and associated metadata, documentation and code be deposited taking into consideration that where possible preference should be given to certified repositories supporting open access. - How will access be provided and if there would be restrictions on use. - The authentication procedure to authorise data access. In general, data will be accessible through free and standardised protocols (e.g., HTTPS, DOI resolution, OAI-PMH). User authentication will depend on the nature of the dataset: for open datasets, no authentication will be required; for restricted datasets, access credentials and institutional email verification may apply. The Ethics Manager (KVC) will review access conditions in case of sensitive datasets or external requests. Dissemination of results: The beneficiaries must disseminate their results as soon as feasible, in a publicly available format, subject to any restrictions due to the protection of intellectual property, security rules or legitimate 19 ANIPH – Deliverable 1.2. Preliminary Data Management Plan and Ethic handbook. VF. Funded by the European Union interests. A beneficiary that intends to disseminate its results must give at least 15 days advance notice to the other beneficiaries (unless agreed otherwise), together with sufficient information on the results it will disseminate. Any other beneficiary may object within (unless agreed otherwise) 15 days of receiving notification if it can show that its legitimate interests in relation to the results or background would be significantly harmed. In such cases, the results may not be disseminated unless appropriate steps are taken to safeguard those interests. Open science: open access to scientific publications: The beneficiaries must ensure open access to peer-reviewed scientific publications related to their results. In particular, they must ensure that: - At the latest at the time of publication, a machine-readable electronic copy of the published version or the final peer-reviewed manuscript accepted for publication, is deposited in a trusted repository for scientific publications. - Immediate open access is provided to the deposited publication via the repository, under the latest available version of the Creative Commons Attribution International Public Licence (CC BY) or a licence with equivalent rights; for monographs and other long-text formats, the licence may exclude commercial uses and derivative works (e.g.CC BY-NC, CC BY-ND), and - Information is given via the repository about any research output, or any other tools and instruments needed to validate the conclusions of the scientific publication. Beneficiaries (or authors) must retain sufficient intellectual property rights to comply with the open access requirements. Metadata: The use of common data and metadata standards are a key aspect for semantic and technological data operability. Metadata can describe the content, context, and provenance of datasets in a standardised and structured manner, typically describing the purpose, origin, temporal characteristics, geographic location, authorship, access conditions and terms of use of a dataset. This provides structured searchable information that helps users to find existing data resources, judge whether a particular dataset is suitable for their research purpose and provides a bibliographic record for citing data. Standard dictionaries of metadata will be used for all data types produced by the data creators. Metadata will include different types and templates to gather this information: 1. Descriptive metadata: describe a resource for retrieval and identification. They may contain elements such as title, abstract, author, keywords, etc. Title [Title of the resource] Creator(s) [Name(s) of the creator(s) or author(s)] Date Created/Published [Date when the resource was created or published] Description [Brief description of the resource, including its content, purpose, or significance] Subject(s) [Keywords or phrases that describe the topic(s) or subject(s) of the resource] Language [Language(s) of the resource] Format [Format of the resource, such as text, image, audio, video, etc.] 20 ANIPH – Deliverable 1.2. Preliminary Data Management Plan and Ethic handbook. VF. Funded by the European Union Extent [Physical or digital size of the resource, duration for audio/video, number of pages for text, etc.] Publisher [Entity or individual responsible for making the resource available] Rights [Information about the copyright status or usage rights of the resource] Identifier [Unique identifier or URL assigned to the resource] Source [Information about the origin or source of the resource] Relation [Relationship of the resource to other resources, if applicable] Coverage [Geographical, temporal, or thematic coverage of the resource] Audience [Intended audience or target demographic for the resource] Contributor(s) [Names of individuals or organizations that contributed to the creation or development of the resource] Version [Version number or information about any revisions or updates] Keywords [Additional keywords or phrases relevant to the resource] 2. Structural metadata: relationships between different sets of associated data in the context of databases, such as schema describing associations between tables. Resource Identifier [Unique identifier for the resource] Hierarchy [Description of the hierarchical structure of the resource, such as chapters, sections, pages, etc.] Sequence [Order or sequence of the components within the resource] Navigation [Information about how to navigate or access different parts of the resource] Relationships [Information about the relationships between different components or parts of the resource] File Format [Format of the resource, including file extensions and MIME types] Duration [For multimedia resources, the duration or length of the resource] Resolution [For images or videos, the resolution or dimensions] Bit Rate [For audio or video files, the bit rate or quality] Compression [If applicable, information about compression methods used] Checksums [Checksum values to verify data integrity] Annotations [Information about any annotations, bookmarks, or metadata embedded within the resource] Access Restrictions [Any access restrictions or permissions associated with specific components or parts of the resource] Version [Version number or information about any revisions or updates] Keywords [Additional keywords or phrases relevant to the resource] 3. Administrative metadata: provides the information necessary to help process a resource. An example might be the date of creation or how a resource was created. It may contain several subgroups of administrative information. Among the most common are metadata on rights and metadata for long-term preservation. The latter is one of the primary purposes of repositories. 21 ANIPH – Deliverable 1.2. Preliminary Data Management Plan and Ethic handbook. VF. Funded by the European Union Resource Identifier [Unique identifier for the resource] Creator(s) [Name(s) of the creator(s) or author(s)] Contributor(s) [Names of individuals or organizations that contributed to the creation or development of the resource] Creation Date [Date when the resource was created] Publisher [Entity or individual responsible for making the resource available] Publication Date [Date when the resource was published or made available Modification Date [Date when the resource was last modified or updated] Version [Version number or information about any revisions or updates] Publisher [Entity or individual responsible for making the resource available File Format [Format of the resource, including file extensions and MIME types] Size [Size of the resource in bytes or other appropriate units] Storage Location [Location where the resource is stored or archived] Access Rights [Information about access rights or permissions associated with the resource] Preservation Metadata [Information about preservation strategies or metadata necessary for long-term preservation] Rights Management [Information about rights management or access control mechanisms] Metadata Creation [Details about the process of creating or capturing metadata for the resource] Metadata Standards [Information about the metadata standards or schemas used to describe the resource] Checksums [Checksum values to verify data integrity 4.3. Making data interoperable Interoperability is the ability to access and process machine-readable data from multiple sources, sometimes automatically, without that data losing meaning or integrity. To achieve this goal, data requires: - Syntactic interoperability: widespread adoption of standard data formats, and the implementation of application programming interfaces and connectors that allow data from multiple sources to be accessed and integrated. - Semantic interoperability: data and information must be exchanged across systems without its context and meaning being lost; and - Search interoperability: it enables a user to conduct queries across two or more collections of data. Thus, interoperability enables improved data usability and use. For this reason, putting in practice interoperability will be a priority for the Consortium to have the following benefits (among others): - Reducing time, effort and expense spent on data collection. - Eliminating frustration and risks associated with finding inconsistent and incomplete data. - Making available sustainable, disaggregated data for effective decision-making. 22 ANIPH – Deliverable 1.2. Preliminary Data Management Plan and Ethic handbook. VF. Funded by the European Union All datasets will be described using standard descriptive metadata, such as Dublin Core and DataCite Metadata Schema to ensure metadata interoperability for indexing and discoverability. Information about experimental processes, modelling, etc. will be made available with the data used to assure the reproducibility and the validation of the project results. Data will be available in easily accessible formats (when possible open formats will be used) such as: - Spreadsheets (e.g., CSV, XLSX) - Text (TXT, DOCX, RTF) - Machine readable formats (HDF5, JSON, XML, HTML) Moreover, ANIPH will: i) Ensure compatibility and integration with existing biomaterials databases, computational tools, and simulation platforms ii) Design software with well-defined APIs and user interfaces to enable interoperability with other biomaterials research tools/platforms Explore the use of controlled vocabularies to support consistent annotation of PHA-related data.Utilise standard data exchange protocols to facilitate seamless data transfer between different components of the project's ICT infrastructure To enhance interoperability specifically for AI-based tools, the project will: - Document data transformation pipelines to ensure reproducibility - Provide clear documentation of data models and algorithms - Use standardised formats for molecular descriptors and polymer properties - Implement FAIR Digital Objects approaches where appropriate These measures will ensure that data generated within ANIPH can be effectively combined with external datasets and integrated into existing research ecosystems in the fields of biodegradable materials, polymer science, and sustainable materials development. Considering the international nature of the consortium, English will be used for all published and internally shared data. In case data is generated in different languages (i.e. interviews with local stakeholders), English transcripts or translations shall be made available. 4.4. Increase data re-use The obtained data by developing the project could be made openly accessible if the General Assembly (GA) agrees to. The main aim is to make the data openly accessible for as long as possible. The decision on the long-term availability of the data collected and processed in the framework of the ANIPH project will be taken as the data are stored. After the completion of each task involving data collection, the data will be made openly accessible when the following requirements are met: - Data collection and processing are completed. - Data checking - in terms of quality control - is performed. - The exploitation plan of the consortium partners, both in terms of scientific publications and commercial purposes, is finalised. 23 ANIPH – Deliverable 1.2. Preliminary Data Management Plan and Ethic handbook. VF. Funded by the European Union ANIPH will share the collected data sets available under a CC BY NC, unless otherwise indicated, allowing the sharing and reuse of the data by stakeholders with knowledge of the legal criteria on the ownership and the use that can be made of them. Partners must provide information about tools needed for validating the results, according to protection agreements, confidentiality and ethics. Moreover, ANIPH will (i) Maintain version control for biomaterials datasets and software repositories using versioning systems like Git. (ii) Implement quality assurance measures including data validation, error correction, and documentation of experimental protocols. (iii) Foster a community around biomaterials datasets and software tools by encouraging collaboration, feedback, and contributions from researchers and developers, thereby enhancing their reusability and impact. Each partner generating data will be responsible for its quality, covering both internally shared and published data. This responsibility extends to the data's content (e.g., ensuring data originates from tests run under valid conditions, maintaining accuracy) and formal aspects (e.g., correct formatting, removal of outliers from numerical data, appropriate metadata, consistent internal referencing, correct use of data representations like pictures within project reports). Data intended for publication must meet the specific requirements outlined in this document (e.g., defined metadata standards, specified file formats). The Data Management & Ethics Manager, the Technical Manager, will work together with the Project Coordinator to review the overall data quality and ensure its coherence with the requirements of the latest version of the Data Management Plan. They will collaborate with the data owner to address any identified shortcomings. Published data is generally intended for reuse and will be deposited in the Zenodo repository for a minimum of three years, unless otherwise specified. It is acknowledged that some data may, in any case, become obsolete within a shorter period. 24 ANIPH – Deliverable 1.2. Preliminary Data Management Plan and Ethic handbook. VF. Funded by the European Union 5. Other research outputs The management of other research outputs potentially generated or reused within the project (e.g., software, models, new materials) will be discussed. When relevant, their compliance with the FAIR principles will be detailed. 5.1. Software And Algorithms • AI predictive models: Machine learning models will be trained on curated datasets to predict key performance indicators such as biodegradation rates, ecotoxicity, and physicochemical properties of PHAs. • Computational models and simulations: Quantum chemical and molecular dynamics models will be used to explore the behaviour of PHA materials at the molecular level, including crystallinity and degradation pathways. • ICT platform’s Evaluation & Decision tool (KPI10) which will support SSbD decision-making and composed by: (1) Traceability Tool to capture (by QR code), store (by cloud), process (by ICT devices) and communicate information securely (by a public blockchain) across ANIPH value chain; (2) Evaluation & Decision Tool: It will integrate the evaluation matrix and scoring system as defined in the SSbD and social readiness evaluation framework. This tool will enable the assessment of the different results and options helping the decision-making process based on safety and sustainability criteria; (3) Public Tool to communicate public reliable information about the ANIPH value chain and its impacts. 5.2. Models And Protocols The ANIPH project will generate a diverse set of models and experimental protocols that underpin the project’s scientific advancements, particularly in the development and assessment of biobased and biodegradable plastic products (BBpPs). These models and protocols play a central role in supporting the predictability, reproducibility, and validation of the project’s outcomes across laboratory, computational, and real-environment conditions. Types of models developed: • Safe and Sustainable by Design (SSbD) decision models: These conceptual models will operationalise sustainability and safety criteria into the material and process selection logic, enabling the comparison of design alternatives based on technical, environmental, economic and social indicators. They will be fully integrated within the ICT platform and informed by results from LCA, s-LCA and LCC models. • Life Cycle Assessment (LCA and s-LCA) models: Developed in accordance with ISO 14040/14044 standards, these models will evaluate the environmental and social impacts of materials and processes throughout the BBpP value chain. • Life Cycle Costing (LCC) models: These models will assess the economic performance of products and processes, providing input for the comparison of alternatives under the Safe and Sustainable by Design framework. 25 ANIPH – Deliverable 1.2. Preliminary Data Management Plan and Ethic handbook. VF. Funded by the European Union Experimental and operational protocols • Biodegradation testing protocols: Standardised methodologies will be applied and adapted from ISO 14851, ISO 14855-2, ASTM D6691 and UNI 11462 covering 3-tier testing approach across soil, freshwater, and marine environments. • Ecotoxicity assessment protocols: Based on the OECD 207 guidelines and ISO Standards 18763, these will assess acute and chronic effects of ANIPH materials on selected organisms. Parameters include survival, growth, reproduction, and biochemical endpoints. • PHA production protocols: Standard procedures for the fermentative synthesis and extraction of PHBV and PHN polymers will be developed, addressing key variables such as feedstock composition, microbial strain performance and crystallinity control. • Formulation and compounding protocols: they will detail the incorporation of biobased and biodegradable additives to modulate thermal, mechanical and biodegradation properties of the compounds. • Manufacturing protocols: they will be established for cast/blown extrusion, 3D printing, and spray-coating techniques, including surface-to-volume ratio control and compatibility with wound dressing and packaging applications. • Laboratory testing protocols: procedures to validate the mechanical and biological properties of the polymers, compounds, materials and final products. All relevant stages will include technical validation of the material properties, such as mechanical strength, permeability, rheology, thermal behaviour, biodegradation performance, cytotoxicity, biocompatibility, and antibacterial activity to ensure their suitability for intended end uses. Final products (e.g., wound dressing and flexible packaging prototypes) will also be validated under application-relevant conditions to assess performance, functionality, and compliance with target specifications. • Model validation protocols: AI models and computational simulations will follow defined procedures for dataset curation, preprocessing, training, cross-validation, performance reporting, and uncertainty analysis. Model development and validation will be supported by the project’s digital assets, including the AI-based predictive system and the ANIPH ICT platform. Transparent documentation of these processes will ensure replicability and compliance with trustworthiness principles. 5.3. Publications And Dissemination In addition to the above-described data, the ANIPH Consortium envisages the development of internal databases (such as stakeholder databases including organizations that could have interests and impacts on the project results) derived from the communication and dissemination activities to be executed throughout the project. Such databases are to provide an overview of stakeholders’ relevant information (e.g. names and institutional email addresses), information on the newsletter subscribers, and data on registration to events via the project website. In addition, other types of data (such as subscribers to the project newsletter or online users’ navigation data) will be collected from the ANIPH website and other platform’s analytics (like LinkedIn and YouTube) and monitoring tools (Matomo), however including no sensitive data and in line with the Privacy Notice published on the website (https://aniph.eu/privacy-notice/). 32 ANIPH – Deliverable 1.2. Preliminary Data Management Plan and Ethic handbook. VF. Funded by the European Union 7.2.1. Access controls Access to project data, models, and computational tools will be managed through role-based access permissions. Only authorised personnel from partner organisations will be granted access to datasets and system based on their involvement in specific work packages and tasks. Each data repository or digital platform (e.g., the internal cloud system, the ANIPH ICT platform) will implement the following: • User authentication via strong passwords or institutional credentials • Differentiated access levels (read, write, admin) based on roles and modular architecture • Logging of access activity and audit trails, especially for sensitive or restricted data • Immediate deactivation of access upon staff departure or change of responsibilities These controls will be regularly reviewed by the data management lead at each partner, coordinated under WP1. 7.2.2. Encryption standards All personal or confidential data stored or transferred within ANIPH systems will be protected using strong encryption mechanisms, particularly in the rare cases where sensitive data (e.g., survey responses from public engagement tasks) are collected. • At-rest encryption: All data stored on project servers, including in cloud storage (e.g., internal partner systems), will be encrypted at rest using strong, industry-standard encryption protocols. • In-transit encryption: Data exchanges across partners or external platforms will use secure protocols such as HTTPS, SFTP, or encrypted email for document exchange. • Cryptographic keys will be managed securely and will not be embedded in source code or shared via unsecured channels. No personal data will be stored or unencrypted mobile devices external hard drives, or USB keys without prior authorisation and encryption. 7.2.3. Backup procedures To prevent data loss and ensure business continuity, the following backup strategies will be applied: • Automated daily backups of project files and datasets will be implemented in primary cloudbased environments (e.g. IONOS servers and internal repositories at each partner) • Versioned backups will be maintained with retention policies (minimum 30 days) to allow recovery in case of accidental deletions or corruption. • Critical project repositories (e.g. AI model datasets, versioned protocols, deliverables) will be synchronised across redundant storage locations. • Periodic tests of backup recovery processes will be carried out to verify the integrity and accessibility of stored data. 33 ANIPH – Deliverable 1.2. Preliminary Data Management Plan and Ethic handbook. VF. Funded by the European Union These backup procedures are critical to fulfilling the obligations under Article 20 of the Grant Agreement, which requires the consortium to preserve records for five years after the final payment. 7.3. Data breach protocols In the unlikely event of a data breach affecting personal, confidential or sensitive data within the ANIPH project, a structured response protocol will be activated to contain the incident, assess its impact, and notify the appropriate stakeholders. This protocol ensures compliance with Article 15 of the Grant Agreement and the EU General Data Protection Regulation (GDPR), in particular Articles 33 and 34. 7.3.1. Breach identification and reporting All consortium partners are required to immediately report any suspected or confirmed data breach to the person responsible for data management at their organisation. The report must include: • A description of the nature of the breach • The categories and approximate number of data subjects and records affected • The potential impact on data subjects or project integrity • Any actions already taken to contain or mitigate the breach Initial reporting should occur within 24 hours of detection. 7.3.2. Containment and mitigation Upon notification, the affected partner(s) must immediately take technical and procedural actions to stop the breach and limit its impact. These actions may include: • Disabling compromised user accounts or access points • Restoring data from backups if applicable • Notifying relevant IT or legal departments • Engaging external support if necessary (e.g., cybersecurity firms) The Data Management Team (under WP1) will coordinate a centralised response and ensure consistency across the consortium. 7.3.3. Notification to authorities and individuals If the breach involves personal data and is likely to result in a risk to the rights and freedoms of individuals, the responsible organisation must notify its national Data Protection Authority within 7 hours, in accordance with GDPR Article 33. 34 ANIPH – Deliverable 1.2. Preliminary Data Management Plan and Ethic handbook. VF. Funded by the European Union When the breach poses a high risk to affected individuals, those individuals must also be informed without undue delay (Article 34 GDPR), unless appropriate technical protection measures (e.g. encryption) rendered the data unintelligible. 7.3.4. Documentation and follow-up All breaches, regardless of severity, will be documented in an internal incident register that includes: • Date and time of breach detection and notification • Description of the breach and affected systems • Mitigation measures applied and their effectiveness • Decision on whether notification was required • Lessons learned and corrective actions to prevent recurrence This documentation will be retained in compliance with Article 20 of the Grant Agreement for audit purposes. 35 ANIPH – Deliverable 1.2. Preliminary Data Management Plan and Ethic handbook. VF. Funded by the European Union 8. Ethics: Project overview and key ethical challenges In line with the EU's commitment to responsible and ethical research practices, the ANIPH project places ethics at the core of its innovation process. This comprehensive ethical framework addresses the complex challenges inherent in developing biobased solutions for humanitarian contexts, where considerations of human dignity, environmental sustainability, and social justice intersect. This section outlines our commitment to upholding the highest ethical standards throughout the project lifecycle, ensuring that technological advancement serves the greater good while respecting individual rights, cultural values, and environmental integrity. 8.1. Research integrity Research integrity forms the foundation of ANIPH's scientific endeavour, ensuring that all research activities meet the highest standards of rigour, honesty, and transparency. The project upholds ethical principles through systematic prevention of research misconduct, including falsification, fabrication, or plagiarism, via clear protocols for data collection, verification, and documentation. Under the guidance of an external ethics advisor, all consortium members implement robust conflict of interest management systems, with mandatory disclosure requirements and independent review mechanisms to maintain objectivity throughout the research process. These measures, combined with regular audits and adherence to international research standards, foster a culture of accountability that strengthens public trust in scientific outcomes while safeguarding the credibility of innovations intended for humanitarian applications. 8.1.1. Human health and PHA wound healing: ethical and scientific-technical considerations ANIPH addresses complex ethical challenges regarding PHA in contact with human tissues, particularly for medical applications. These considerations include biocompatibility, absence of antibiotics in humanitarian contexts, environmental sustainability, and additive exposure risks. Four key areas require ongoing assessment: 1. PHA in contact with human tissue: PHAs demonstrate good biocompatibility with minimal cytotoxicity. However, crystallinity variations affect degradation rates, requiring careful balance between stability and biodegradability. 2. Absence of antibiotics in wound dressings: While PHA dressings without antibiotics align with antimicrobial stewardship principles, the high infection risk in conflict zones raises ethical questions about standard of care provision. 3. Environmental sustainability: PHA's biodegradability offers significant advantages in humanitarian contexts where waste management is challenging, reducing environmental burden while supporting sustainable development goals. 4. Additive exposure and health effects: Comprehensive safety assessment includes evaluating potential risks from plasticizers, reinforcement agents, and other processing additives used in PHA formulations. 36 ANIPH – Deliverable 1.2. Preliminary Data Management Plan and Ethic handbook. VF. Funded by the European Union All health-related risks will be addressed through rigorous testing protocols, transparent stakeholder communication, and robust post-market surveillance systems to ensure patient safety while advancing sustainable humanitarian healthcare solutions. 8.2. Open science and ethics The Open Access to research data and the free availability of research outputs will be guaranteed and maximised whilst considering the Ethics and the Data Management Plan-DMP. Research results will be openly published and at the disposal of the research and industrial communities, and the citizenship (the EOSC and other open-access repositories will be used), whilst considering the Intellectual Property Right; research will be published under Golden Open Access terms. ANIPH includes the priority use of Open Research Europe as general open access platform while, some open access platforms/journals with a relevant impact factor will be considered. Moreover, mutual learning mechanisms and approaches (public engagement, open access, gender balanced actions, project alignment with societal needs, transparency) according to Responsible Research and Innovation (RRI) will be deployed. Several actions will be held, to: a) disseminate research results; b) inform society in an accessible and inclusive way about the current research; and c) raise awareness about bioeconomy topics. Other Open Science practices: Reproducibility of results will be assured by several means: the DMP, FAIR, preprints, open peer-review; Open access to the project physical results, e.g., product samples and the open-source software AI tools and biomaterials datasets; All relevant knowledge actors, including citizens and consumers will be involved across the R&I through public engagement strategy and tailored actions such as workshops, focus groups, etc., and create an enabling framework conditions (e.g. open tools and policy recommendations delivered). Besides, ANIPH will share information and results with the Knowledge Centre for Bioeconomy (KCB), JRC, Proecesses4Planet, Circular Bio-based Europe JU, also clustering activities with other EU projects. 8.2.1. Measures to be implemented Open Science (OS) is, more than a requirement, an Ethical obligation to respond to complex and interconnected environmental, social, and economic challenges by providing solutions to advance environmental sustainability and respect for the planet’s biological and cultural diversity, foster sustainable social and economic development and promote democracy and peace[4]. Open Science includes: - Transparent documentation, methodologies and peer review: Accessible research methods and outputs widely available for rigorous review and transparent evaluation processes improve the quality, reproducibility and impact of science. - Use of open sources and open access to the research: use of open access platforms, repositories for publications, open source code for software, open labs and virtual research environments, and digital research services, in particular those that allow identifying unambiguously scientific objects by persistent unique identifiers (DOI), ensure that data are available following the FAIR (Findable, Accessible, Interoperable, and Reusable) principles, supported by regular curation and maintenance. - Facilitate access to underlying information and empirical data encompasses the use of open data infrastructures that enable collaborative and multidisciplinary data analysis, 37 ANIPH – Deliverable 1.2. Preliminary Data Management Plan and Ethic handbook. VF. Funded by the European Union required to support the requirements of different communities. Restrictions should be justified due to the protection of human rights, confidentiality and right to privacy, legal processes, or intellectual property rights, among others. - Communicate the research to the society at large: Opening-up practices and public tools make the scientific process more inclusive and accessible to the broader society, including the adoption of new forms of collaboration such as citizen science and community involvement in co-creation methodologies. This results in an enhanced dialogue with stakeholders (policymakers, civil society, industry, and public administrations) that ensures the uptake of results as they respond to societal needs and concerns. Moreover, open dialogue with society promotes the inclusion of diversity in science and fosters opportunities for scientific education and capacity development. To sum up, OS aims at “Transparency, accessibility, and solving societal challenges”. In addition, “Open science principles require that such communication with various societal stakeholders should not only be a one-way communication (academics inform the public about their research results) but instead should be a two-way communication, in which relevant stakeholders should have a significant impact on the formulation of research questions”[5]. ANIPH will be based on more collaborative, interdisciplinary, open, transparent, and reproducible science. Adopting Open Science (OS) principles, ANIPH will support the use of plastic alternatives to reduce the negative impact of the agri-food industry. This requires an approach that considers consciously adopting an ‘open’ approach to science (by, for example, exploring unforeseen turns in results). ANIPH results will be deposited into the project website and public repositories (EOSC[6] /Open Aire[7])as a research data repository and they will be accessible for third parties to exploit, reproduce and disseminate, free of charge. Both self-archiving (“green” open access) and openaccess publishing (“gold” open access) will be considered. 8.3. RRI (Responsible Research Innovation) Responsible Research and Innovation (RRI) is critical within the Ethical dimension of the project[8]. Specifically, in regards: (a) Ethical research, including its lawful appropriateness and the issues concerning data privacy, as well as the considerations specifically concerning the involvement of deprived, marginalised or vulnerable collectives; (b) Research integrity, respecting academic freedom and human rights and supporting high-quality and transparent research; and (c) Social acceptability and alignment. In sum, RRI should consider, as stated verbatim by RRI Tools 1 (Figure 2): 1. Diversity and inclusion: Be sensitive to research biases, include diverse voices and make results beneficial to a wider community 2. Anticipation and Reflection: Think about the purposes and possible implications of your research and its outcomes and envisage all possible strategies and methods 3. Openness and Transparency: Share objectives, methods and, whenever possible and appropriate, results, and inform about potential conflicts of interests 4. Responsiveness and Adaptive Change: Be responsive to changes and external inputs, adapting your research plans to changing social values and expectations 1 https://rri-tools.eu/ 38 ANIPH – Deliverable 1.2. Preliminary Data Management Plan and Ethic handbook. VF. Funded by the European Union Figure 1 Principles of RRI (source: RRI tools) RRI should consider during the whole lifecycle and evaluate the following dimensions: Figure 2 RRI dimensions (source: RRI tools) Research integrity: ANIPH will uphold the highest standards of rigour according to ethical, legal, and professional frameworks and will provide a culture of integrity, transparency, and accountable research, reviewing the project's progress regularly and openly. Research Integrity (RI) is one of the most important Ethical issues in research (and, in developing and innovating new products and services, specifically if these are publicly funded). RI is defined by “Rigour, Honesty, respect for life, Law and Public Good and Responsible communications (Listening and informing)"[9]. In other words, RI implies Honesty, rigour, transparency, care, and respect for all participants and accountability 2 . Informed consent from the ethical point of view: Explicit informed consent by data subjects is a vital part of any process involving human subjects (age, gender, education level, and socioeconomic background of affected individuals, working conditions, health and safety at the workplace, fair treatment, freedom of association, training skills…), to respect their rights of free choice and data privacy. The whole consortium will ensure that the potential subjects can reach a truly informed 2 Research Integrity means conducting research in such a way that allows others to have confidence and trust in the methods and the findings of the research. It relates both to the scientific integrity of conducted research and to the professional integrity of researchers. https://www.ed.ac.uk/research-office/research-integrity/what-is-research-integrity Diversity and inclusion •Senstive and aware of research biases •Diverse voices •Wider-community percpective Anticipation and reflection •Possible aplications and outcomes •Risk-benefit analysis Open and transparent •Objectives and methods •Open results •Communication Responsive and adaptative •Responsible to changes and external input •Changing social values or changing communities may change the research plan Why informed consent?[10] • Protection • Autonomy • Preventing abusive conduct • Trust • Self-ownership • Non-domination • Personal integrity 39 ANIPH – Deliverable 1.2. Preliminary Data Management Plan and Ethic handbook. VF. Funded by the European Union decision about whether or not to participate in the research. Their explicit informed consent must be given freely, without coercion, and must be based on a clear understanding of what participation involves, including any personal data to be processed and the purposes of the same. Each partner responsible for involving end-users will guarantee the collection of explicit consents, signed by representatives as stated above before any empirical activity affecting them, including but not limited to collecting personal data. As in the case of data protection, consolidated hands-on guidance will be collected from relevant sources at an early stage of the project. A preliminary investigation has revealed some principles that should be considered for achieving informed consent from users participating in the project, concretely in tasks related with WP5-611-12: - Each potential subject must be adequately informed of the aims, methods, anticipated benefits and potential hazards of the research and any discomfort it may entail; - The expected participation of individuals and the approximate duration of each activity; - Any documentation given to potential participants should be comprehensible, and there should be an opportunity for them to raise any issues of concern; - Consent should be given in writing and records of consent should be maintained; considering the particularities in the workplace and the risks that it may entail - Potential participants must be informed that they are free to withdraw consent to participation at any time; - There should be a procedure for making complaints and participants should be made aware of this; - All participants must be volunteers. Considerable care should be taken where consent is sought from those in a dependent position; - Any inducement offered to participants should be declared and should be by appropriate guidelines. Specific considerations concerning working conditions and operators’ involvement: - Workers representatives’ consent: If workers are involved during their regular schedule, and if obtaining individual consent from each worker is not feasible, labour union representatives will discuss and agree on the participation with the staff and then, sign the consent. - Consent Form: The information in the consent form should be individualized and communicated in a way that is more sensitive to the needs of participants. The number of questions in the “Consent Form” has to be appropriate to each participant's profile (highskilled workers and managers, chiefs and directors, low-skilled workers, labour union officers, etc.); As previously introduced, ANIPH will collect and process various personal data, mainly offline but potentially online as well. Additionally, the project will potentially process sensitive personal data (e.g., ideology, incidentally collected during co-creation workshops, values/ beliefs, and even health conditions collected in task 5.3). Any unnecessary data unexpectedly received will be then discharged. Therefore, some of the ANIPH activities envisaging the involvement of human participants (Task 5.3) will require their informed consent to be carried out. The informed consent of participants will allow beneficiaries to 1) process personal data; 2) obtain and use images and/or recordings of participants for project purposes only; and/or 3) observe workers in the workplace. Informed consent to the processing of personal data will be required for any activity involving some of the forms of processing of personal data identified in Article 4 (2) GDPR: collection, recording, 40 ANIPH – Deliverable 1.2. Preliminary Data Management Plan and Ethic handbook. VF. Funded by the European Union organisation, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, restriction, erasure, or destruction. In addition, informed consent will be required for video/audio recording or image taking for those activities for whose primary purpose it is essential, as well as for the dissemination tasks of the project. Whilst not restricted to them, these tasks involve participants, and are matter of particular concern from an Ethical perspective: - T2.4 Selection of safe raw materials and additives, and preliminary adaptations - T2.5 Development of ANIPH AI predictive system and traceability tool - T5.1 Feed and implementation of the tools of the ICT platform - T5.2 Safety assessment - T6.3 Public engagement because it involves direct interaction with citizens and the collection of perception data - T8.1 Cellulose@probiotic additives development as an alternative to antibiotics - T8.2 PHBV and PHN-based adhesives and coatings manufacturing - T8.3 Manufacturing of wound dressing and packaging at small scale with programmed biodegradation - T10.4 Validation in a real environment by in vitro testing of the final ANIPH products - T11.2 Safety assessment - T11.3 Sustainability assessment Issues on data gathering and data protection, as well as responsible AI development are also being addressed. All volunteer research participants in ANIPH will receive informed consent forms containing basic project information in accessible languages prior to research commencement. Researchers will review the form with participants, providing verbal summaries if needed, before obtaining voluntary consent without pressure. Participants may ask questions and receive clear answers, and must sign and date the consent form, with both parties retaining copies. The completed consent forms will be stored by the relevant Data Controller, ensuring participants understand and consent to data collection and processing within ANIPH. Ethics and public participation: Additionally, some ethical issues are intrinsically attached to research in this project . Ethics is an integral part of research that will be considered from the beginning to the end of the project implementation. Thus, all the activities developed along the project will comply with ethical principles and relevant national, EU and international legislation, for example, the Charter of Fundamental Rights of the EU and the European Convention on Human Rights. Provisions of Directive 95/46/EC and the General Data Protection Regulation principles of rights and consent and data processing as stipulated in Articles 6, 7, 10, 12, 25 and 35 (GDPR, 2018g) are shown to be highly relevant to the protection of research participants and service users. Moreover, Regulatory compliance is within the scope and this project aligns with: - The General Data Protection Regulation (GDPR). - The Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data 41 ANIPH – Deliverable 1.2. Preliminary Data Management Plan and Ethic handbook. VF. Funded by the European Union and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation). - Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector - the Charter of Fundamental Rights of the EU (2000/c 364/01). - Gender policy of the EU and Public Engagement and Responsible Research and Innovation inclusive approach. Public Participation and stakeholders’ involvement Significant stakeholder engagement, defined as long-term involvement, commitment, and participation (i.e., active contributions to the dialogue), is needed to develop adaptation-integrated strategies that fully reflect the complexities and conflicts that must be explored and negotiated by all stakeholders. ANIPH will encourage the involvement of stakeholders in different ways but must be always aligned with the IAP2 Core Values for Public Participation[11], entailing different levels of public participation based on the Spectrum of Public Participation (Figure 3), according to the goals of the specific action, its complexity and sensitivity. Figure 3 IAP2 Spectrum of Public Participation ANIPH also proposes to engage stakeholders and experts in the definition of the Safe and Sustainable by Design (SSbD) framework, as well as in the Social Sustainability Assessment that will take place in WP5 and WP11. By having citizens, stakeholders and experts participate in the project, ANIPH will increase its impact and will help raise awareness about the issues and humanitarian challenges tackled by our project. Three dimensions will be considered: - Community readiness analyses the degree to which a community is ready to take action on an issue, in a specific, dimensional, and stratified way. Community efforts, knowledge of the efforts, leadership, willingness or awareness, knowledge and resources should be analysed prior to implementing public engagement methods. - Community engagement and Community participation in citizen science activities, workshops, and contests will promote the ownership of the project results. - Evaluation of engagement and participatory processes will consider both quantitative factors (e.g. the number of stakeholders; gender balance; equitable representation of age 48 ANIPH – Deliverable 1.2. Preliminary Data Management Plan and Ethic handbook. VF. Funded by the European Union indication) could worsen resistance. The ICRC has developed antibiotic stewardship protocols for war wounds, aiming to “enhance antibiotic stewardship, reduce misuse of antibiotics” in conflicts In conflict scenarios, comprehensive microbiology services are rarely available, whereas wound infections are very common. The ICRC Antibiotic Protocol for Weapon Wounded is an evidence informed protocol created to enhance antibiotic stewardship, reduce misuse of antibiotics and provides recommendations for both prophylaxis and treatment of established infection[24]. Traditional “antibiotic dressings” often contain agents like cetrimide20, neomycin, gentamicin, or mupirocin incorporated into a gauze or collagen matrix. From a public health ethics perspective, there is a duty to preserve antibiotic efficacy for the future. This means using antibiotics judiciously even in acute situations. Consequently, removing antibiotics from dressings could be an intentional strategy to prevent overuse, relying instead on good surgical care and systemic antibiotics only when necessary. From an ethical standpoint, if a PHA dressing without antibiotics is to be used, it should be compared against available alternatives. The current ethical consensus is that in conflict care, the highest priority is life and limb saving through surgical intervention, with local dressings being secondary support. If PHA dressings do not impede the standard practices (and indeed if they encourage proper wound care by simplifying logistics), their use can be justified. Transparent communication with humanitarian patients is also key: they should know if a new type of dressing is being used and why (particularly if it deviates from what they might consider “normal” care). This respects patient autonomy and builds trust, even in crises. 8.5.1.3. Environmental Sustainability and Reverse Logistics Figure 4 Environmental sustainability and reverse logics A notable benefit of PHA-based wound dressings is their environmental sustainability, especially in settings where medical waste disposal is challenging. This section explores the life-cycle impacts of PHAs, the feasibility of “green” supply chains and reverse logistics, and potential risks like crosscontamination with conventional plastics. The ethical lens here is twofold: environmental stewardship (responsibility to “do no harm” to the environment and communities) and practical logistics in humanitarian operations. Waste management and Life Cycle Analysis (LCA) of PHAs: Conventional plastic medical waste (e.g. used bandages with synthetic polymer backings) contributes significantly to pollution, often ending up in incinerators or landfills. In contrast, PHAs are biodegradable biopolymers – they can be broken 49 ANIPH – Deliverable 1.2. Preliminary Data Management Plan and Ethic handbook. VF. Funded by the European Union down by microbes into natural substances like water, carbon dioxide (and biomass) under the right conditions, offering a compelling advantage in a life-cycle perspective. A PHA wound dressing made from renewable resources could have a lower environmental footprint than a petrochemical-based dressing. Life cycle assessment studies indicate that PHAs can outperform not only conventional plastics (like polypropylene) but even other bioplastics (like PLA) in certain impact categories. Key environmental advantages include the renewable feedstock, that PHA products can biodegrade in natural environments (soil or marine) within months to a few years. This means a discarded PHA dressing is far less likely to become long-lasting litter or harmful microplastic fragments. In humanitarian contexts, these benefits are magnified. Conflict and disaster zones often lack formal waste management – no systematic recycling or safe trash disposal. By using biodegradable PHA dressings and packaging, the ANIPH project aims to avoid pollution in humanitarian contexts where appropriate waste management systems are usually not feasible. Moreover, as technology improves and if renewable energy and waste feedstocks are used, PHAs’ production impacts are dropping. The literature encourages integrating PHA production into biorefineries and waste treatment facilities to improve sustainability and economics17. Besides, a comprehensively ‘greener’ and environmentally responsible supply chain, logistics and transport management involves the consideration of all these factors at each step: sourcing, manufacturing, distribution, use, and reverse logistics (return or disposal). The logistical feasibility in conflict zones is a critical angle: Traditional medical supply chains face difficulties in retrieving used products (reverse logistics) because the priority is delivering new aid, not collecting waste. PHA dressings offer a form of built-in reverse logistics via biodegradability – even if you cannot physically retrieve the used dressing, the environmental harm is being reduced. Also, traceability and forecasting can help ensure that the PHAs are degrading as intended and not accumulating. From a feasibility perspective, biodegradable dressings reduce the burden on local waste systems. Medical teams won’t need to burn or bury as much waste (both of which have downsides: open burning can emit toxic smoke; burying can contaminate water). To manage this, training and clear labelling are needed: health workers should know that the PHA dressing and its packaging are compostable/biodegradable and ideally dispose of them separately from recyclables. In conclusion, PHA-based wound dressings offer substantial environmental advantages in challenging settings: their biodegradable nature alleviates the burden of medical waste disposal, aligning with ethical obligations to protect the environment and local populations from pollution. 8.5.1.4. General Human Health Effects of PHA Materials and Additives While PHAs are largely biocompatible, the overall safety profile of PHA-based products depends on more than the polymer itself. Additives used to process or enhance PHAs (plasticisers, stabilisers, reinforcement fibres/nanoparticles, etc.) can introduce health risks. Additionally, chronic exposure scenarios – for instance, consumers using many PHA-based items over time, or communities exposed to environmental residues – need to be considered. This section discusses the potential human health impacts from additives in PHAs, the possible effects of long-term exposure to PHA degradation products or microplastics, and the frameworks for post-market surveillance and risk assessment to manage these concerns. 50 ANIPH – Deliverable 1.2. Preliminary Data Management Plan and Ethic handbook. VF. Funded by the European Union Figure 5 General human health effects of PHA materials and additives Pure PHAs like PHB are often stiff and brittle; to make flexible films or dressings, manufacturers may add plasticisers. Some phthalates (DEHP, DBP) are classified as reproductive toxicants and possible human carcinogens. Thus, transparency is an ethical matter in regard the manufacturers’ practices and the use of certain additives and civil surveillance mechanisms might be required [25]. Similarly, reinforcement agents might be added to PHAs to improve mechanical properties. These could be fibres (glass fibre, carbon fibre, cellulose) or nano-fillers (nanoclay, silica, graphene). While these can strengthen the material or alter its degradation, they might introduce inhalation or tissue reaction hazards, especially for workers in manufacturing settings. The European Chemicals Agency (ECHA) and other regulatory bodies keep lists of restricted substances in medical products – ensuring no prohibited or high-risk additive is used as part of ethical manufacturing. No matter how much pre-market testing is done, unanticipated health effects can sometimes emerge when a product is used in the real world, across diverse populations and over longer durations. Post-market surveillance (PMS) is therefore a cornerstone of medical device safety. Regulatory authorities require manufacturers to actively monitor and report any adverse events or trends once the product is on the market [26]. For PHA wound dressings, potential signals to watch might include incidence of wound irritation or allergic reactions beyond expected, or any other unusual infection patterns (perhaps related to material handling), or any systemic reactions. An ethical company will have a robust PMS plan: collecting feedback from fieldwork during the project in using the dressings and setting up a system to capture any adverse incident. One emerging area of surveillance is environmental health monitoring tackled within the SSbD framework. 8.5.2. Donor rights and dignity The ethical foundation for isolating human skin cells begins with donor autonomy, informed consent, and dignity. Consent must be fully informed, voluntary, and specific, as per the principles outlined in the Declaration of Helsinki (WMA) and EU Directive 2004/23/EC on human tissue use. Consent forms must clearly explain the purpose, risks, potential commercial uses, storage periods, and the right to withdraw consent at any time without repercussions. Transparency in the collection process is critical. Donors must be informed if the cells will be used for commercial applications, shared internationally, or stored long-term. To uphold dignity, 51 ANIPH – Deliverable 1.2. Preliminary Data Management Plan and Ethic handbook. VF. Funded by the European Union anonymisation protocols—such as pseudonymisation and irreversible coding—must be implemented to protect privacy under GDPR (EU Regulation 2016/679). Donor engagement through feedback mechanisms (e.g., opt-in for research updates or results) fosters trust. Furthermore, cultural sensitivities—especially in humanitarian contexts where ANIPH products may be deployed—must be respected. Tailored consent procedures should reflect local customs and languages, with special attention to vulnerable populations. Provisions must address power imbalances and avoid coercion, particularly in low-resource or emergency settings. 8.5.3. Storage and disposal protocols Ethical tissue storage hinges on security, traceability, and respectful handling. Human skin cells must be stored in validated, access-controlled environments with proper temperature monitoring, following ISO 20387:2018 standards for biobanking. Data on the sample’s origin, storage conditions, and chain-of-custody must be meticulously documented to comply with Good Laboratory Practice (GLP) and OECD guidelines. For disposal, tissues should be discarded respectfully when research is concluded or consent is withdrawn, using biosecure incineration or other approved biomedical disposal methods. Researchers must develop policies governing how long unused samples are retained, who can authorize their destruction, and how this is recorded. When transferring samples between institutions or countries, Material Transfer Agreements (MTAs) must specify permissible uses, access restrictions, and conditions for return or destruction. This is particularly important for tissues with potential downstream use in commercial or diagnostic tools, or those deployed in humanitarian scenarios where oversight may vary. 8.5.4. Compliance with bioethics regulations Human skin cell research must conform to a network of EU, national, and international bioethics frameworks. Key regulations include: • EU Directive 2004/23/EC and its technical directives (2006/17/EC and 2006/86/EC), which govern tissue procurement, testing, processing, preservation, storage, and distribution. • General Data Protection Regulation (GDPR) ensuring data privacy and control for donors. • WHO Guidance on Ethics in Health Research, emphasizing equity, benefit-sharing, and protection of vulnerable groups. • National-level biomedical ethics laws, often requiring dual approval from scientific and ethics committees. Ethical review by an Independent Ethics Committee (IEC) or Institutional Review Board (IRB) is mandatory before tissue collection begins. These bodies must ensure that the study design upholds respect for persons, beneficence, and justice. Documentation of approval must include: • Consent protocols • Anonymisation strategies • Risk-benefit analysis • Cultural context considerations (especially for deployments in humanitarian crises) 52 ANIPH – Deliverable 1.2. Preliminary Data Management Plan and Ethic handbook. VF. Funded by the European Union Post-approval, compliance monitoring is essential. This includes periodic audits, annual ethics reporting, and channels for whistleblowing or reporting ethical breaches—particularly important when working in low-governance environments. For projects involving humanitarian deployments, there must be additional safeguards: • Local ethics committee approvals (where feasible) • Ethical impact assessments on local communities • Transparency in data use and equitable benefit-sharing 8.6. Ethics and Public Participation Ethical considerations in ANIPH ensure that scientific activities are conducted with integrity, fairness, and respect for fundamental human rights. Researchers are expected to consider the broader societal implications of their work, promoting accountability and fostering public trust. Moreover, actively involving citizens, civil society, and stakeholders throughout the research process and public engagement activities enriches the knowledge produced, ensuring that it reflects diverse perspectives and societal needs. The strict alignment to GDPR will guarantee that data are handled responsibly. For example, information of newsletter subscribers and registrees to project events will be collected, handled and stored according to the GDPR regulations. A Privacy Notice is available on the project website (https://aniph.eu/privacy-notice/) to provide subscribers with very detailed information on data being collected and the purposes of such collection. Users have the option to opt in/opt out and thus to decide whether they want to receive project-related updates and communications, being thus the data used for the declared purposes only. Should users opt out, their information will be destroyed once the purpose of their subscription (i.e. newsletter or event) is no longer applicable. 8.7. Ethical risk assessment and mitigation During the Project lifecycle, and apart from the ethics reporting (mid-term and final reports), ethical risks will be surveyed by revising the technical work after its submission as long as reviewers of each Deliverable will have at their disposal the present Ethics guidelines. Specifically, risks will be revised regarding these activities: Table 1 Timeline of main ethics revisions Month (M) Task (T) Plain description M13 T2.5 (WP2) – M12 AI system design M24 D1.3 Mid term ethics report M27 D8.1 and D8.2 (M26) Biodegradable wound dressing and packaging M37 D8.3, D8.4 and D8.5 (M36) Small-scale of wound dressings and AI predictive model assessment M47 D10.4 Validation in a real environment by in vitro testing of the final ANIPH products M47 T7.3 Final Ethics report and analysis 53 ANIPH – Deliverable 1.2. Preliminary Data Management Plan and Ethic handbook. VF. Funded by the European Union This ethical framework provides a robust foundation for ensuring that the ANIPH project's technological innovations are deployed in a manner that maximises benefit while systematically addressing potential ethical challenges in humanitarian applications. The literature supports ANIPH's objective to "develop ANIPH Safe and Sustainable by Design (SSbD) framework" (SO8), while suggesting several ethical considerations: 1. Multi-stakeholder engagement: The framework should incorporate perspectives from humanitarian workers, healthcare practitioners in conflict settings, and potential patients to ensure the design meets actual needs rather than presumed ones. 2. Lifecycle assessment comprehensiveness: The economic and social sustainability metrics (KPI11) must include genuine evaluation of accessibility in humanitarian contexts, considering the target price (25€/kg) in relation to humanitarian budget constraints. 3. Information transparency: The contribution to "Information and Labelling Systems" (KPI12) should include clear communication about the limitations and intended use cases of these materials, avoiding overpromising or minimizing potential drawbacks. In essence, the introduction of PHA wound dressings should be guided by a commitment to do no harm – to patients, to communities, and to the environment. With proper validation and oversight, PHA dressings could represent an innovation that aligns medical care with sustainable and ethical best practices, addressing immediate needs while safeguarding future well-being. Table 2 Ethical concerns and recommended mitigation strategies Ethical Dimension Concerns Mitigation Safety & Health (PHA in Human Tissue) Risks of endotoxin contamination Unknown effects of altered crystallinity Rigorous ISO 10993 testing Proper sterilisation/purification Equity (Absence of Antibiotics in Conflict Dressings) Potentially higher infection rates in war injuries Transparency about care levels Ethical antibiotic stewardship Environmental Sustainability (Reverse Logistics) Risk of greenwashing if waste management is poor Complex end-of-life disposal Clear labelling & waste segregation SSbD analysis Additive Exposure & Long-Term Health Chronic low-level toxicity not well-studied Need post-market surveillance, if commercially exploited Perform extended toxicological assessments Strong post-market reporting & risk management 8.7.1. Risk identification methodology Ex ante ethical impact assessment matrix. Specific ethical considerations for humanitarian contexts. PHA-based wound dressings are expected to be safe for human health, but vigilance is needed. The base polymers have a good biocompatibility track record. 54 ANIPH – Deliverable 1.2. Preliminary Data Management Plan and Ethic handbook. VF. Funded by the European Union Long-term and chronic exposure risks appear low, especially compared to conventional plastics, since PHAs do not persist and their metabolites are benign. Nevertheless, comprehensive risk assessments must include worst-case exposure scenarios, and ongoing post-market surveillance should verify the safety assumptions in real-world conditions. By adhering to international safety standards and ethical risk management practices, manufacturers and health providers can ensure that the introduction of PHA wound dressings benefits patients and society without unintended adverse health consequences. Table 3 Risk-benefit and mitigation (ex-ante; baseline) Dimension Description Mitigation measures Safety (human health) and research integrity The efficacy of literature mining depends crucially on the methodological robustness of the systematic review protocol—including comprehensive search string development, inclusion/exclusion criteria specification, and inter-rater reliability assessment mechanisms The feasibility of constructing a sufficiently robust predictive system from these data sources warrants deeper analytical consideration: • Data density thresholds: The proposal lacks specificity regarding the minimum data density requirements across various physicochemical, biological, and toxicological domains necessary for developing statistically valid predictive models. • Dimensional coverage assessment: A systematic gap analysis framework would be essential for evaluating whether the collated datasets achieve sufficient coverage across all relevant PHA formulation parameters to enable comprehensive predictive capabilities. • Temporal validity considerations: The dynamic nature of materials science research necessitates explicit mechanisms for continuous dataset updating and recalibration to maintain predictive validity as the knowledge landscape evolves. Non-maleficence principle in humanitarian aid context & conflict zones The implementation of wound dressings in conflict areas requires special safeguards • Contextualised informed consent: Standard consent procedures may be unfeasible in humanitarian emergency situations. • Post-implementation monitoring: Mechanisms for monitoring adverse effects in vulnerable populations are not specified. Intervention sustainability The project's implicit economisation of biodegradation (through mechanisms like target pricing) raises fundamental questions about the distribution of benefits across diverse socioeconomic contexts. The economic accessibility of resulting technologies requires systematic consideration. • Technological dependency: how to avoid creating new forms of dependency in already fragile contexts. • Local capacity building: Absence of strategies to develop local capabilities in managing these advanced biomaterials. Bioethical considerations The ANIPH proposal sustains and maintains primary bioethical considerations for human tissue interfaces; however, ethical risks arise. For instance, the claim of "healing without antibiotics" (SO4) requires a • Robust verification framework, ensuring comparable efficacy to conventional approaches, particularly in high-risk humanitarian contexts Predictive models The integration of AI predictive tools requires structured approaches to ensuring interpretability and accessibility • Sequential validation protocols • Dataset provenance tracking: comprehensive data lineage documentation systems that record the origination, transformation, and utilisation of all data incorporated into predictive models • Meta-analytical calibration: weighted meta-analytical techniques based on methodological robustness, sample size, and replicability metrics. • Model architecture documentation: including network architectures, feature importance rankings, and decision boundaries. 55 ANIPH – Deliverable 1.2. Preliminary Data Management Plan and Ethic handbook. VF. Funded by the European Union • Interpretability enhancement techniques: Integration of model-agnostic interpretation methods; e.g., SHAP (SHapley Additive exPlanations4) values to render complex algorithmic decisions comprehensible to non-specialist stakeholders. Access and equality The implementation in humanitarian contexts might reproduce NorthSouth technological dependency dynamics. • Multi-stakeholder advisory consortium: Formation of a formally constituted governance body with designated representation from healthcare practitioners in humanitarian contexts, patient advocates, and local institutional partners with voting authority on key development decisions • Implementation of context-sensitive assessment protocols that can be calibrated to diverse deployment environments, recognising the limitations of standardised testing approaches • Implementation of a cyclical feedback mechanism whereby initial prototypes undergo sequential refinement through structured feedback from practitioners and recipients in simulated and actual deployment contexts. • Development of standardised protocols for evaluating the cultural acceptability of wound care approaches in diverse deployment contexts Effective knowledge transfer requires structured approaches that emphasise local capacity development: • Articulation of staged knowledge transfer pathways that identify prerequisite skills, intermediate competencies, and advanced capabilities required for local ownership of the technology 8.8. Ethical review processes ANIPH employs a multi-layered ethical review framework designed to ensure comprehensive ethical oversight throughout the project lifecycle. This framework integrates internal governance structures with external expertise and continuous monitoring mechanisms to identify, assess, and mitigate potential ethical challenges proactively. 8.8.1. Internal ethics committees The project operates with a dedicated internal ethics committee comprising representatives from each consortium partner, ensuring cross-disciplinary expertise across biotechnology, social sciences, and humanitarian ethics. This committee meets quarterly to review research protocols, assess data protection measures, and address emerging ethical concerns. The committee's responsibilities include maintaining ethical compliance logs, coordinating with work package leaders on sensitive activities (particularly tasks involving human subjects in 5.2 and 5.3), and developing responsive guidance for ethical dilemmas encountered during project implementation. 8.8.2. External ethics approvals ANIPH maintains external ethical oversight through periodic consultations with the appointed external ethics advisor and submission of protocols to relevant national ethics boards where required. Prior to commencing any activities involving human participants, data collection, or AI systems development, proposals undergo rigorous external review. External approvals are 4 https://datascientest.com/en/shap-what-is-it 56 ANIPH – Deliverable 1.2. Preliminary Data Management Plan and Ethic handbook. VF. Funded by the European Union particularly crucial for studies involving wound dressing testing and stakeholder engagement in humanitarian contexts. All external ethics opinions are integrated into the project's decision-making processes and documented for accountability and transparency. 8.8.3. Ongoing ethical monitoring Continuous ethical monitoring forms the backbone of ANIPH's ethical governance, featuring regular assessments aligned with key project milestones. This includes bi-annual comprehensive ethical audits, focused reviews during critical tasks, and responsive evaluations triggered by unexpected ethical issues. The monitoring system employs a combination of quantitative metrics (compliance indicators, informed consent completion rates, data protection measures) and qualitative assessments (stakeholder feedback, ethical culture indicators). All findings feed into iterative improvement processes, with mandatory reporting to both the consortium and the European Commission at designated intervals. 57 ANIPH – Deliverable 1.2. Preliminary Data Management Plan and Ethic handbook. VF. Funded by the European Union 9. Conclusions The ANIPH Data Management Plan establishes a comprehensive framework for ethical data governance throughout the project's PHA value chain development. This preliminary plan demonstrates commitment to the highest standards of data protection, research integrity, and responsible innovation whilst supporting the creation of biodegradable wound dressings and recyclable water barrier packaging. The implementation of FAIR principles and GDPR-compliant data security frameworks ensures appropriate protection of sensitive information, throughout the research lifecycle. Moreover, the extensive ethical framework addresses interdisciplinary challenges from AI transparency and EU AI Act compliance to human tissue research protocols, whilst RRI principles ensure societal impact encompasses sustainability and inclusivity goals beyond technological advancement. Also, structured resource allocation, defined responsibilities, comprehensive data breach protocols, and ongoing ethical monitoring provide the operational foundation for effective implementation and proactive risk management. As this preliminary plan evolves through interim and final iterations (D.1.3 and D.7.1), it will adapt to emerging challenges whilst maintaining flexibility to support innovative research outcomes.