As a first step, HBM4EU identifies and collates existing human biomonitoring data that is held by our broad range of partners in 28 countries across Europe. This data is reviewed against current policy questions, to determine what questions might be addressed by currently available data.
Where we identify gaps in the available evidence, we will generate new human biomonitoring data through the implementation of targeted surveys and the analysis of biobanked samples.
Please find below relevant information on:
- HBM4EU Data Management Plan and Data Policy
- Multiplying the benefits of data
HBM4EU Data Management Plan and Data Policy
In order to ensure that our work with data respects all relevant ethics and legal requirements at both national and European level, we have developed a Data Management Plan and a Data Policy.
The Data Management Plan describes the data management life cycle for all datasets collected, processed and generated under the project. It describes:
- How research data is handled during and after the project
- What type of data will be collected, processed and used
- What methodologies and standards will be applied
- Whether and how the data will be made accessible
- How the data are stored
The Data Policy describes the data management procedures to be followed by the consortium. These procedures ensure that data on human subjects are transferred and used in a secure setting, in compliance with ethico-legal requirements.
To enhance compliance of HBM4EU data management procedures with the GDPR, an amendment of HBM4EU Data Management Plan and Data Policy has been compiled (Oct 18th 2018). The amendment is available on the internal project webpages (https://www.hbm4eu.eu/work-package-webpage/pillar-2-european-hbm-platform/ > Work Package 10). In the event of any contradiction between the amendment and the original Data Management Plan and Data Policy, the amendment overrides the terms and conditions of the original documents.
The documents apply to the exchange of research data on human subjects within HBM4EU. This includes exchange of data to answer research questions and policy questions, as well as exchange of data associated with samples transferred to and from laboratories.
Exchange of data to answer research questions and policy questions
In some cases, this concerns anonymised data such as appropriately aggregated data (i.e. descriptive statistics) and anonymised single measurement data. When possible, the exchange and use of anonymised data is preferred. When anonymisation is detrimental to the study and/or to answer the research question, non-anonymised data may be exchanged and used. To reduce the risk of re-identification of data subjects, it is requested that such data are pseudonymised before exchange.
Different legal restrictions apply to the exchange and use of anonymised versus non-anonymised data. The GDPR )applies for the exchange and use of personal data. Anonymised data are not considered personal data, while non-anonymised data (including pseudonymised data) are. Hence, we discriminate in the documents between the sharing of anonymised and pseudonymised data. Anonymised data are to be shared via the IPCHEM portal website (https://ipchem.jrc.ec.europa.eu/). To exchange pseudonymised data within HBM4EU, the HBM4EU data repository (https://ipchem.jrc.ec.europa.eu/share/) was set up as an option under IPCHEM. The HBM4EU data repository is part of the IPCHEM platform and ensures save transfer, storage and access of the data only to authorised accounts.
The Data Transfer Form, guidance to prepare data for HBM4EU exchange, guidance to obtain access to data, and guidance for establishing a processing agreement for pseudonymised data is included in the Data Management ZIP file, which is available for download at: https://www.hbm4eu.eu/private/work-package-webpage/pillar-2-european-hbm-platform/ > Work Package 10)
Exchange of data associated with samples transferred to and from laboratories
A Standard operating procedure (SOP) has been developed for Sample Exchange in HBM4EU. The SOP describes how sample associated data shall be managed. Prior to the exchange of samples, a material and associated data transfer agreement (HBM4EU MDTA) has to be completed and signed between the data controller and the recipient (i.e. laboratory performing the analyses of the samples (data processor)). Transfer of all Materials and its associated Data by or to HBM4EU Consortium Members under this HBM4EU MDTA shall be documented through the completion of a Material and associated Data Transfer Record Form.
Questions can be submitted via the helpdesk for data management.
Multiplying the benefits of data
It is a principle aim of the project to increase the availability of human biomonitoring data to policy makers, stakeholders and the broader research community, in order to multiply the benefits that can be generated through its use.
As such, all human biomonitoring data generated under the project will be made available to policy makers and all metadata will be accessible via IPCHEM – the Information Platform for Chemical Monitoring. Existing data used under HBM4EU may also be made available via IPCHEM to the extent possible while respecting all ethics and legal restrictions that might apply.
IPCHEM is the reference access point for discovering chemical monitoring data collections which are managed by and are available to European Commission bodies, Member States, international and national organisations and research communities.
The Platform aims to support a more coordinated approach for collecting, storing, accessing and assessing data related to the occurrence of chemicals and chemical mixtures, in relation to humans and the environment. This responds to the need identified in the European Commission’s 2012 Communication on the combination effects of chemicals.
IPCHEM is designed and implemented as a de-centralised system, providing remote access to existing information systems and data providers.