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ECRAID-Base Data

Maximising the utility of connected data in ECRAID-Base, Part 2: Ethics, data harmonisation & sharing

Data plays a pivotal role in clinical research and can be utilised to strengthen sustainability and improve clinical care. In the second part of our series dedicated to the Data team within the ECRAID-Base project, we shine a spotlight on Workstream 9B – ethics, data harmonisation and data sharing.


The EU-funded ECRAID-Base project allocates significant resources to ensure that Ecraid, its networks, and the affiliated studies set an example in managing, utilising, and sharing data. This ambitious task is entrusted to the project’s Work Package 9 (WP9), which is organised into four workstreams: Data management (9A); Ethics, data harmonisation and data sharing (9B); Epidemiological research (9C); and Statistical research (9D).

Ethics, data harmonisation & sharing

Workstream 9B, led by the University Hospital Heidelberg (UKHD), focuses on driving innovation in FAIR-by-design and FAIR convergence and ensuring data reuse complies with multiple countries' complex data protection policies and legislation.

We sat down with Lauren Maxwell, Ankur Krishnan and Priya Shreedhar to try and make sense of topics that many in the clinical research field perceive as important yet often too complex to comprehend.


ECRAID-Base data team

What are the FAIR principles and why is ‘FAIR-by-design’ so important to your team and what practical contribution does it make to the project’s goals?

The FAIR (Findable, Accessible, Interoperable and Reusable) principles1 act as guiding principles to enable Open Science by enhancing the discovery and reuse of data (i.e. any digital object), metadata (i.e. information about that digital object), infrastructures for data reuse, and other resources for identifying and reusing digital objects, including data2. Ecraid is invested in making data, metadata, and samples FAIR to maximise the utility of the ECRAID-Base network of POSs and Ecraid contributions to addressing priority infectious diseases (ID) in Europe.

ECRAID Base is ‘FAIR-by-design,’ meaning that ECRAID invests in FAIR for all project outputs, ranging from protocols and CRFs to data and publications. ECRAID Base’s FAIR by design approach was developed to maximise the scientific value, impact, and utility of European investments in ECRAID Base. ECRAID Base’s ‘FAIR-by-design’ strategy fosters the quality, utility, efficiency, and effectiveness of evidence generation and data-driven decision-making in infectious disease and antimicrobial resistance research beyond ECRAID through providing open source, FAIR-by design tools that can be reused by studies beyond ECRAID Base to facilitate coordination in the preparedness and response to (re)emerging IDs. 


Why are data harmonisation and standardisation such a strong focus for you?

Standardising the various data types generated by clinical research to existing standards for biomedical data is central to fostering interoperability3, 4 within and across related disease areas.  The known (e.g., AMR) and unknown (e.g. Disease X) public health challenges facing Europe require a coordinated response to data generation and response to ensure that data can be used across studies and jurisdictions. Through building ‘FAIR-by-design’ within and beyond ECRAID-Base, we are working towards the common goal of ensuring investments in research can be rapidly translated into evidence for clinical care, research investment, and public health decision-making. 

ECRAID-Base is positioned at the intersection of observational and interventional research. To build efficiencies in trial development and conduct, we chose to prospectively standardise ECRAID-Base electronic case report forms (eCRFs) to CDASH, which is the most commonly required standard from regulators (e.g., FDA, PMDA). ECRAID-Base is investing in converting POS eCRFs to the OMOP-CDM, which is more commonly used in observational studies, to foster the interoperability between intervention and observational studies needed for more efficient trials.

Centralised approaches to data reuse are difficult to deploy in epidemic response, where the data-to-evidence pipeline must be as frictionless as possible. To address the specific challenges of data reuse in epidemic response, ECRAID-Base has partnered with EHDEN, an innovative European programme to standardise biomedical health data, and joined the OHDSI network, a global partnership to facilitate the federated reuse of standardised biomedical data, i.e., to enable the reuse of participant-level data across countries and studies without directly accessing the data.  These collaborations at the European and global level help ECRAID-Base deliver on its mission to reduce the impact of IDs.


Can you explain the ethical considerations and challenges related to sharing de-identified data, samples, and other sensitive data collected from patients in ECRAID-Base studies?

ECRAID-Base upholds best practice in data and sample reuse through securing broad consent from study participants for future use of data and samples in keeping with local regulations. As ethical requirements for study participation differ across sites and countries, we work closely with the study teams, Data Protection Officers (DPO), bioethicists, and experts in data protection law to ensure ECRAID-Base data are collected and managed in keeping with both country and site-level policies and concerns. While the structure and content of site-level consents must adhere to the site or country format, we strive for interoperability and machine-readability of consents within and beyond ECRAID-Base in keeping with global best practice from the Global Alliance for Genomics and Health and other leaders in ethical data reuse.


How do you ensure that data and samples can be useful beyond the studies they were collected for?

We are establishing ECRAID-Base Data and Sample Access Committees to ensure transparent and equitable decisions around data and sample reuse with clear guidelines for requesting data and samples, including who can access the data and samples and for what purposes in keeping with participant consent and other concerns. 


What metrics and indicators are considered for evaluating the impact of data and sample sharing?

The benefits, costs, and harms of data and sample reuse are largely unknown, leaving policymakers in the dark. ECRAID-Base is conducting a scoping review to identify and describe qualitative and quantitative approaches to measuring the impact of data sharing on researchers’ careers, clinical or public health practice, and science for informed policies to support equitable, ethical data and sample reuse5.

If you've missed the first part of our series on the project's Data work package, read it here.


1 Wilkinson, M., Dumontier, M., Aalbersberg, I. et al. The FAIR Guiding Principles for scientific data management and stewardship. Sci Data 3, 160018 (2016).




5 Maxwell L, Shreedhar P and Krishnan A. How do we measure the costs, benefits, and harms of sharing data from biomedical studies? A scoping review [version 1; peer review: 2 approved with reservations]. Open Res Europe 2023, 3:151 (