Periodic Reporting for period 2 - ADOPT BBMRI-ERIC (implementAtion anD OPeration of the gateway for healTh into BBMRI-ERIC)
Reporting period: 2017-04-01 to 2019-03-31
One specific goal of the ADOPT project was to gather 10,000 existing colorectal cancer (CRC) datasets. Technical and organizational measures to ensure data security and protect privacy of the persons contributing their data to the CRC-Cohort were discussed in-depth, and the agreement on data transfer was reached in compliance with the General Data Protection Regulation (GDPR), taking into consideration the differences in regulatory and ethical issues within the different European countries. A complex IT infrastructure was developed to support biobanks in delivering the data and harmonizing it to the central data model, importing and performing detailed quality checks on this data, the results of which were subsequently used by the biobanks to perform data updates."
WP2: A CRC-Cohort of 10,000 cases, a truly pan-European coverage of the cohort, was generated with detailed pathological and clinical data and available tissue samples. Technical and organizational measures to ensure data security and protect privacy of the persons contributing their data to CRC-Cohort were discussed in-depth and the agreement on data transfer was reached in compliance with GDPR, taking into consideration the differences in regulatory and ethical issues within the different European Countries.
WP3: Both goals of supporting the process of Europe-wide collection of more than 10,000 CRC cases and delivering the central BBMRI-ERIC IT infrastructure were successfully achieved. Several challenges due to the enormous heterogeneity of the CRC source data and the lack of previous experience in developing a data model to map and enrol this data were overcome. The final collection of 10,440 CRC datasets is a major and unique achievement.
WP4: A workshop was organised with the aim of addressing the sustainability issue and the future of research infrastructures. Delegates from 16 RIs attended the meeting and contributed to its recommendations. An IT tool has been developed to support and monitor access to samples and data as well as to identify the effectiveness of the process. Access procedures and services for researchers were implemented.
WP5: The ELSI Helpdesk and Knowledge Base were conceptualised, implemented and sustained as a user-oriented service within BBMRI. Key achievements include workshops and conference participations with a focus on the GDPR implementation and the work towards a Code of Conduct for Health Research, as well as the survey on informed consent practices and its analysis. Additionally, regular exchanges and collaborations with stakeholders such as EFPIA or EMA well as annual stakeholder events with patient advocacy groups were held.
WP6: In WP6 a handbook for biobanks to meet users’ needs for biomarker discovery, development and validation was produced. The handbook contains a comprehensive package of current best practice documents, regulations and standards important for sample quality; information of BBMRI-ERIC services for auditing and evaluation of biobanks; conformity testing as well as additional guidelines and information collected in several EU projects, consortia and networks. The handbook was published on the BBMRI-ERIC website.
WP7: A section in the BBMRI-ERIC Directory that highlights Rare Disease biobanks was delivered and synergized with efforts in the RD-connect project, the MIABIS standardization effort for minimum information about biobanks and the MOLGENIS open source project. Using the experience gathered within the existing Common Service initiatives and discussing the challenges with the Rare Disease community it became clear that the best and most efficient way forward would be a full incorporation of RD activities in the overall scope of BBMRI-ERIC, using its created infrastructure and governance to yield the most effective, efficient result.
WP8: WP8's main achievements were the accession of 3 new full members (Poland, Latvia, Bulgaria) and one observer (Cyprus) to BBMRI-ERIC, raising the total members of to 21, the highest of any biomedical ERIC. On a global scale, 4 workshops (in China, Brazil, Turkey and Egypt) were organised to disseminate the scientific results of ADOPT and to liaise with the global biobanking communities, helping them to develop networks and knowledge.
A solid start has been made with the Stakeholder Forum and its added value is already proven, including involvement of patient organisations, industry and policymakers. BBMRI-ERIC now pressures organizations and project consortia to include relevant stakeholders, especially patients, in project planning. BBMRI-ERIC experts have been providing support on ethical, legal and societal issues as well as quality and IT issues to biobanks across the continent and beyond.
In brief, BBMRI-ERIC and its National Nodes created a solid European biobanking community, supported strongly by ADOPT, and will continue to drive sample access and services with defined management and processes, promoting the comprehensive multinational retrospective collection of 10,000 CRC datasets as a unique demonstrator in creating a true gateway for health.