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ELSI Research and Publications
To ensure excellence in providing guidance on ethical, legal and societal implications (ELSI), we operate on the basis of a federated model, in partnership with a network of experts from academia and practice from across the Headquarters, the National Nodes and project partners. Focus areas are recognised in collaboration with European and international ELSI experts and based on user needs identified in projects or ELSI Helpdesk requests coming from patient advocacy groups, industry partners or biobankers.
Our vision remains to deliver reliable, practical and sustainable services based on state-of-the-art research for the immediate benefit of the life sciences community by setting standards, promoting best practices or enabling a sustainable platform for internal and public knowledge exchange. To date, our expertise has been requested in more than 30 projects. The knowhow provided and research done for a particular consortium is promoted as public knowledge for the biobanking and life sciences community via our Knowledge Base.
Areas of Expertise
Over the past decade, our ELSI Team has developed several interrelated lines of expertise on ethical, legal, and societal implications relevant for the biobanking and life sciences community.
Experts
The ELSI HQ team comprises nine experts in the fields of bioethics, social sciences, law and philosophy. Find out more via our Podcast ‘Why ELSI Matters!”
Publications, Impact & Outreach
The following are links to help you navigate to the following areas: Articles, 2022, 2021, 2020, 2019, 2018, 2016. Research. Reports. Responses to consultations.
Articles
2023
Akyüz, K., Goisauf, M., Chassang, G., Kozera, Ł., Mežinska, S., Tzortzatou-Nanopoulou, O., & Mayrhofer, M. T. (2023). Post-identifiability in changing sociotechnological genomic data environments. BioSocieties. Open access
Bernier Alexander, Molnár-Gábor Fruzsina, Knoppers Bartha M., Borry Pascal, Cesar Priscilla M. D. G., Devriendt Thijs, Goisauf Melanie, Murtagh Madeleine, Nicolás Jiménez Pilar, Recuero Mikel, Rial-Sebbag Emmanuelle, Shabani Mahsa, Wilson Rebecca C., Zaccagnini Davide, Maxwell Lauren, Reconciling the biomedical data commons and the GDPR: three lessons from the EUCAN ELSI collaboratory. Eur J Hum Genet (2023). Open access
Fortier, I., Wey, T. W., Bergeron, J., Pinot de Moira, A., Nybo-Andersen, A.-M., Bishop, T., Murtagh, M. J., Miočević, M., Swertz, M. A., van Enckevort, E., Marcon, Y., Mayrhofer, M. T., Ornelas, J. P., Sebert, S., Santos, A. C., Rocha, A., Wilson, R. C., Griffith, L. E. and Burton, P. (2023) “Life course of retrospective harmonization initiatives: key elements to consider,” Journal of Developmental Origins of Health and Disease, Cambridge University Press, 14(2), pp. 190–198. Open Access
Fritzsche, Marie-Christine, Kaya Akyüz, Mónica Cano Abadía, Stuart McLennan, Pekka Marttinen, Michaela Th. Mayrhofer, and Alena M. Buyx. Ethical Layering in Ai-Driven Polygenic Risk Scores—New Complexities, New Challenges. Perspective. Frontiers in Genetics 14 (2023-January-26 2023). Open Access
Holub, Petr, Müller, Heimo, Bíl, Tomáš, Pireddu, Luca, Plass, Markus, Prasser, Fabian, Schlünder, Irene, Zatloukal, Kurt, Nenutil, Rudolf and Brázdil, Tomáš. (2023). Privacy risks of whole-slide image sharing in digital pathology. Nature Communications, 14(1), 2577. Open Access
Marelli, L., M. Stevens, T. Sharon, I. Van Hoyweghen, M. Boeckhout, I. Colussi, A. Degelsegger-Márquez, S. El-Sayed, K. Hoeyer, R. van Kessel, D. K. Zając, M. Matei, S. Roda, B. Prainsack, I. Schlünder, M. Shabani and T. Southerington (2023). “The European health data space: Too big to succeed?” Health Policy 135: 104861. Open Access
Tzortzatou-Nanopoulou, O., Akyüz, K., Goisauf, M., Kozera, Ł., Mežinska, S., Th. Mayrhofer, M., Slokenberga, S., Reichel, J., Croxton, T., Ziaka, A., & Makri, M. (2023). Ethical, legal, and social implications in research biobanking: A checklist for navigating complexity. Developing World Bioethics. Open Access
Vears, Danya F., Hallowell Nina, Bentzen Heidi Beate, Ellul Bridget, Nøst Therese Haugdahl, Kerasidou Angeliki, Kerr Shona M., Mayrhofer Michaela Th, Mežinska Signe, Ormondroyd Elizabeth, Solberg Berge, Sand Birgitte Wirum, Budin-Ljøsne Isabelle. A practical checklist for return of results from genomic research in the European context. Eur J Hum Genet (2023). Open Access
2022
Casati S, Ellul B, Mayrhofer MT, Lavitrano M, Caboux E, Kozlakidis Z. Paediatric biobanking for health: The ethical, legal, and societal landscape. Front Public Health. 2022 Sep 27;10:917615. doi: 10.3389/fpubh.2022.917615. PMID: 36238242; PMCID: PMC9551217. Open Access
David R, Ohmann C, Boiten JW, Abadía MC, Bietrix F, Canham S, Chiusano ML, Dastrù W, Laroquette A, Longo D, Mayrhofer MT, Panagiotopoulou M, Richard AS, Goryanin S, Verde PE. An iterative and interdisciplinary categorisation process towards FAIRer digital resources for sensitive life-sciences data. Sci Rep. 2022 Dec 5;12(1):20989. doi: 10.1038/s41598-022-25278-z. PMID: 36470968; PMCID: PMC9723099. Open Access
Fortier I, Wey TW, Bergeron J, Pinot de Moira A, Nybo-Andersen AM, Bishop T, Murtagh MJ, Miočević M, Swertz MA, van Enckevort E, Marcon Y, Mayrhofer MT, Ornelas JP, Sebert S, Santos AC, Rocha A, Wilson RC, Griffith LE, Burton P. Life course of retrospective harmonization initiatives: key elements to consider. J Dev Orig Health Dis. 2022 Aug 12:1-9. doi: 10.1017/S2040174422000460. Epub ahead of print. PMID: 35957574. Open Access
Bak M, Madai VI, Fritzsche MC, Mayrhofer MT, McLennan S. You Can’t Have AI Both Ways: Balancing Health Data Privacy and Access Fairly. Front Genet. 2022 Jun 13;13:929453. doi: 10.3389/fgene.2022.929453. PMID: 35769991; PMCID: PMC9234328. Open Access
Goisauf M, Cano Abadía M. Ethics of AI in Radiology: A Review of Ethical and Societal Implications. Front Big Data. 2022 Jul 14;5:850383. doi: 10.3389/fdata.2022.850383. PMID: 35910490; PMCID: PMC9329694. Open Access
2021
Colombo C, Mayrhofer MT, Kubiak C, Battaglia S, Matei M, Lavitrano M, Casati S, Chico V, Schluender I, Carapina T, Mosconi P. The CORBEL matrix on informed consent in clinical studies: a multidisciplinary approach of Research Infrastructures Building Enduring Life-science Services. BMC Med Ethics. 2021 Jul 17;22(1):95. doi: 10.1186/s12910-021-00639-x. PMID: 34273983; PMCID: PMC8285862. Open Access
Akyüz K, Chassang G, Goisauf M, Kozera Ł, Mezinska S, Tzortzatou O, Mayrhofer MT. Biobanking and risk assessment: a comprehensive typology of risks for an adaptive risk governance. Life Sci Soc Policy. 2021 Dec 13;17(1):10. doi: 10.1186/s40504-021-00117-7. PMID: 34903285; PMCID: PMC8666836. Open Access
Oldoni E, van Gool A, García Bermejo L, Scherer A, Mayrhofer MT, Florindi F, Demotes J, Kubiak C, Fauvel AC, Bietrix F, Ussi A, Andreu AL. Biomarker Research and Development for Coronavirus Disease 2019 (COVID-19): European Medical Research Infrastructures Call for Global Coordination. Clin Infect Dis. 2021 May 18;72(10):1838-1842. doi: 10.1093/cid/ciaa1250. PMID: 33091118; PMCID: PMC7665366. Open Access
2020
Goisauf, M., Akyüz, K. & Martin, G.M. Moving back to the future of big data-driven research: reflecting on the social in genomics. Humanit Soc Sci Commun 7, 55 (2020). Open Access
Holub P, Kozera L, Florindi F, van Enckevort E, Swertz M, Reihs R, Wutte A, Valík D, Mayrhofer MT; BBMRI-ERIC community. BBMRI-ERIC’s contributions to research and knowledge exchange on COVID-19. Eur J Hum Genet. 2020 Jun;28(6):728-731. doi: 10.1038/s41431-020-0634-8. Epub 2020 May 22. PMID: 32444797; PMCID: PMC7242892. Open Access
Catchpoole DR, Florindi F, Ahern C, Garcia DL, Mullins P, Van Enckevort E, Zaayenga A, Mayrhofer MT, Holub P. Expanding the BBMRI-ERIC Directory into a Global Catalogue of COVID-19-Ready Collections: A Joint Initiative of BBMRI-ERIC and ISBER. Biopreserv Biobank. 2020 Oct;18(5):479-480. doi: 10.1089/bio.2020.29075.drc. Epub 2020 Sep 15. PMID: 32936006.
2019
Goisauf M, Martin G, Bentzen HB, Budin-Ljøsne I, Ursin L, Durnová A, Leitsalu L, Smith K, Casati S, Lavitrano M, Mascalzoni D, Boeckhout M, Mayrhofer MT. Correction: Data in question: A survey of European biobank professionals on ethical, legal and societal challenges of biobank research. PLoS One. 2019 Dec 2;14(12):e0226149. doi: 10.1371/journal.pone.0226149. Erratum for: PLoS One. 2019 Sep 18;14(9):e0221496. PMID: 31790510; PMCID: PMC6886846. Open Access
Goisauf M, Martin G, Bentzen HB, Budin-Ljøsne I, Ursin L, Durnová A, Leitsalu L, Smith K, Casati S, Lavitrano M, Mascalzoni D, Boeckhout M, Mayrhofer MT. Data in question: A survey of European biobank professionals on ethical, legal and societal challenges of biobank research. PLoS One. 2019 Sep 18;14(9):e0221496. doi: 10.1371/journal.pone.0221496. Erratum in: PLoS One. 2019 Dec 2;14(12):e0226149. PMID: 31532777; PMCID: PMC6750647. Open Access
Saunders G, Baudis M, Becker R, Beltran S, Béroud C, Birney E, Brooksbank C, Brunak S, Van den Bulcke M, Drysdale R, Capella-Gutierrez S, Flicek P, Florindi F, Goodhand P, Gut I, Heringa J, Holub P, Hooyberghs J, Juty N, Keane TM, Korbel JO, Lappalainen I, Leskosek B, Matthijs G, Mayrhofer MT, Metspalu A, Navarro A, Newhouse S, Nyrönen T, Page A, Persson B, Palotie A, Parkinson H, Rambla J, Salgado D, Steinfelder E, Swertz MA, Valencia A, Varma S, Blomberg N, Scollen S. Leveraging European infrastructures to access 1 million human genomes by 2022. Nat Rev Genet. 2019 Nov;20(11):693-701. doi: 10.1038/s41576-019-0156-9. Epub 2019 Aug 27. Erratum in: Nat Rev Genet. 2019 Sep 13;: PMID: 31455890; PMCID: PMC7115898. Open Access
Saunders G, Baudis M, Becker R, Beltran S, Béroud C, Birney E, Brooksbank C, Brunak S, Van den Bulcke M, Drysdale R, Capella-Gutierrez S, Flicek P, Florindi F, Goodhand P, Gut I, Heringa J, Holub P, Hooyberghs J, Juty N, Keane TM, Korbel JO, Lappalainen I, Leskosek B, Matthijs G, Mayrhofer MT, Metspalu A, Navarro A, Newhouse S, Nyrönen T, Page A, Persson B, Palotie A, Parkinson H, Rambla J, Salgado D, Steinfelder E, Swertz MA, Valencia A, Varma S, Blomberg N, Scollen S. Author Correction: Leveraging European infrastructures to access 1 million human genomes by 2022. Nat Rev Genet. 2019 Nov;20(11):702. doi: 10.1038/s41576-019-0178-3. Erratum for: Nat Rev Genet. 2019 Nov;20(11):693-701. PMID: 31520075. Open Access
Salman A, Baber R, Hannigan L, Habermann JK, Henderson MK, Mayrhofer MT, Afifi N. Qatar Biobank Milestones in Building a Successful Biobank. Biopreserv Biobank. 2019 Dec;17(6):485-486. doi: 10.1089/bio.2019.0083. PMID: 31833810. Open Access
Salman A, Baber R, Hannigan L, Habermann JK, Henderson MK, Mayrhofer MT, Afifi N. Quality Matters: A Global Discussion in Qatar. Biopreserv Biobank. 2019 Dec;17(6):487-490. doi: 10.1089/bio.2019.0073. PMID: 31833812; PMCID: PMC6998048. Open Access
Mascalzoni D, Bentzen HB, Budin-Ljøsne I, Bygrave LA, Bell J, Dove ES, Fuchsberger C, Hveem K, Mayrhofer MT, Meraviglia V, O’Brien DR, Pattaro C, Pramstaller PP, Rakic V, Rossini A, Shabani M, Svantesson DJB, Tomasi M, Ursin L, Wjst M, Kaye J. Are Requirements to Deposit Data in Research Repositories Compatible With the European Union’s General Data Protection Regulation? Ann Intern Med. 2019 Mar 5;170(5):332-334. doi: 10.7326/M18-2854. Epub 2019 Feb 12. PMID: 30776795.
Simell BA, Törnwall OM, Hämäläinen I, Wichmann HE, Anton G, Brennan P, Bouvard L, Slimani N, Moskal A, Gunter M, Zatloukal K, Minion JT, Soini S, Mayrhofer MT, Murtagh MJ, van Ommen GJ, Johansson M, Perola M; BBMRI-LPC Consortium (FP7 GA no. 313010). Transnational access to large prospective cohorts in Europe: Current trends and unmet needs. N Biotechnol. 2019 Mar 25;49:98-103. doi: 10.1016/j.nbt.2018.10.001. Epub 2018 Oct 17. PMID: 30342241. Open Access
2018
Holub P, Kohlmayer F, Prasser F, Mayrhofer MT, Schlünder I, Martin GM, Casati S, Koumakis L, Wutte A, Kozera Ł, Strapagiel D, Anton G, Zanetti G, Sezerman OU, Mendy M, Valík D, Lavitrano M, Dagher G, Zatloukal K, van Ommen GB, Litton JE. Enhancing Reuse of Data and Biological Material in Medical Research: From FAIR to FAIR-Health. Biopreserv Biobank. 2018 Apr;16(2):97-105. doi: 10.1089/bio.2017.0110. Epub 2018 Jan 23. PMID: 29359962; PMCID: PMC5906729. Open Access
Mayrhofer MT, Schlünder I. Mind the Gap: From Tool to Knowledge Base. Biopreserv Biobank. 2018 Dec;16(6):458-462. doi: 10.1089/bio.2018.0018. Epub 2018 Aug 13. PMID: 30102551; PMCID: PMC6308279. Open Access
2016
Mayrhofer, Holub, Wutte, Litton: BBMRI-ERIC: the novel gateway to biobanks. From humans to humans, 1-6, 2016, DOI: 10.1007/s00103-015-2301-8
Research
2023
Akyüz, Kaya, Goisauf, Melanie, & Mayrhofer, Michaela Th. (2023). EUCAN-Connect Deliverable D7.3: Sustainability Plan. Zenodo. Open access
Mayrhofer, Michaela Th, Akyüz, Kaya, Goisauf, Melanie, Wilson, Becca, & Avraam, Devetris. (2023). Deliverable D7.1: Governance context appraisal. Zenodo. Open Access
Mayrhofer, Michaela Th, Goisauf, Melanie, Akyüz, Kaya, Avraam, Demetris, Wilson, Becca, Swertz, Morris, Burton, Paul, & Murtagh, Madeleine. (2023). Deliverable D7.2: ELSI Governance Model and Data Management Plan for Federated Cohort Analysis. Open Access
2022
Goisauf, Melanie, Feriol, Lisa, & Rial-Sebbag, Emmanuelle. (2022). CINECA First recommendations for implementation in IT Framework (Incl. a Data Management Plan) D7.3 (Version 1). Zenodo. Open Access
Álvarez, Eva García, Ohmann, Christian, Saunders, Gary, Wagener, Harald, Colussi, Ilaria, Boiten, Jan-Willem, Panagiotopoulou, Maria, Cano Abadía, Mónica, David, Romain, Schluender, Irene, Holub, Petr, & Mayrhofer, Michaela Th. (2022). EOSC-Life Requirements for hosting/ distributing and access control for sensitive data. Zenodo. Open Access
Irene Kesisoglou, Shona Cosgrove, Pascal Derycke, Petronille Bogaert, Annika Jacobsen, Marco Roos, Anna Niemeyer, Alicia Martinez Garcia, Adrian Thorogood, Petr Holub, Irene Schluender, Salvador Capella-Gutierrez, Juan Gonzalez Garcia, Celia Alvarez Romero, Teresa D’Altri, Amy Curwin, Laura Portell Silva, & Lidia López Cuesta. (2022). Glossary of commonly used terms in the field of health data research – developed by the EU project HealthyCloud (1.0). Zenodo. Open Access
Panagiotopoulou, Maria, Yaïche, Sarhan, Michon, Amélie, Ohmann, Christian, Demotes, Jacques, Matei, Mihaela, Canham, Steve, Hjelle, Sigrun Margrethe, Klusek, Patrycja, Batuca, Joana, Schmid, Caecilia, Buoncervello, Maria, Toschi, Elena, Minghetti, Luisa, Chiusano, Maria Luisa, Vives Vilatersana, Adriana, Calvo I Orteu, María, Szabó, Zsolt, Součková, Lenka, Mayrhofer, Michaela Th.… Sonderlichová, Simona. (2022). EOSC-Life Public database inventorying the national health databases and registries and describing their access procedures for reuse for research purposes. Zenodo. Open Access
Ortega, Eva, María Berdasco, Carmen Guerra, Melanie Goisauf, and Martín-Arribas. Mª Concepción (2022). “Organoides Humanos. Aspectos Éticos, Legales y Sociales.” ANCEI V (4). Open Access
Christian Ohmann, Romain David, Mónica Cano Abadia, Florence Bietrix, Jan-Willem Boiten, Steve Canham, Maria Luisa Chiusano, Walter Dastrù, Arnaud Laroquette, Dario Longo, Michaela Theresia Mayrhofer, Maria Panagiotopoulou, Audrey Richard, Pablo Emilio Verde; Pilot Study on the Intercalibration of a Categorisation System for FAIRer Digital Objects Related to Sensitive Data in the Life Sciences. Data Intelligence 2022; 4 (2): 196–211. Open Access
2021
Cano Abadía, Mónica, Adeniran, Ayodeji, Ahern, Caitlin, Akyüz, Kaya, Casati, Sara, Colussi, Ilaria, Mayrhofer, Michaela Th., & Schlünder, Irene. (2021). BBMRI-ERIC ELSI Knowledge Base. Europe Biobank Week 2021. Zenodo. Open Access
EOSC-LIFE WP4 TOOLBOX: Toolbox for sharing of sensitive data — a concept description, Open Access
Devriendt T, Ammann C, W. Asselbergs F et al. An agenda-setting paper on data sharing platforms: euCanSHare workshop [version 2; peer review: 2 approved]. Open Res Europe 2021, 1:80. Open Access
Muller, M. T. Mayrhofer, E. -B. Van Veen and A. Holzinger, “The Ten Commandments of Ethical Medical AI,” in Computer, vol. 54, no. 7, pp. 119-123, July 2021, doi: 10.1109/MC.2021.3074263. Open Access
2020
Jahns, Roland, Lavitrano, Marialuisa, Chassang, Gauthier, Mayrhofer, Michaela Th., Goisauf, Melanie, Adeniran, Ayodeji, Akyüz, Kaya, Cano Abadía, Mónica, & Casati, Sara. (2020). BBMRI-ERIC ELSI Services & Research Q&A on COVID-19 & ELSI (Version V1). Zenodo. https://doi.org/10.5281/zenodo.3839273
Reports
Report, Biobanks and the Public, compiled by the ELSI WP of BBMRI-PP GA212111 & public writer, 2013
BBMRI ELSI WORKSHOP REPORT Sharing and access to data and human biospecimens for the benefit of patients – Towards a BBMRI-ERIC Policy, 2016
Report, Ethics Review of European Biobank Research: Towards Mutual RECognition? Organised and hosted by BBMRI ERIC Common Services ELSI
in joint collaboration with BBMRI Large Prospective Cohorts and B3Africa 12 September 2016, Messe Wien
Responses to Public Consultations
Response by BBMRI-ERIC to European Health Data Space Questionnaire, 2021
Statement by BBMRI-ERIC on “A European Health Data Space”, 2021
BBMRI-ERIC joint comments to the Article 29 Working Party Guidelines on Consent under Regulation 2016/679 (wp259) and Transparency under Regulation 2016/679 (wp260), 2018
BBMRI-ERIC contribution to the public consultation on the wma declaration on ethical considerations regarding health data- bases and biobanks, 2015,
BBMRI-ERIC Position Paper on the GDPR, 2015
Comments to the public consultation on the Council of Europe Recommendation (2006)4 on research on biological materials of human origin, 2014/08/14
