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1. Federated Analysis for Privacy-Preserving Data Sharing: A Technical and Legal Primer

Author

Casaletto, James, Bernier, Alexander, McDougall, Robyn, and Cline, Melissa S

Subjects
Biological Sciences, Genetics, Human Genome, Humans, Privacy, Fenbendazole, Health Facilities, Information Dissemination, Policy, federation, federated analysis, privacy protection, GDPR, genomics, Evolutionary Biology, Law, Genetics & Heredity
Abstract

Continued advances in precision medicine rely on the widespread sharing of data that relate human genetic variation to disease. However, data sharing is severely limited by legal, regulatory, and ethical restrictions that safeguard patient privacy. Federated analysis addresses this problem by transferring the code to the data-providing the technical and legal capability to analyze the data within their secure home environment rather than transferring the data to another institution for analysis. This allows researchers to gain new insights from data that cannot be moved, while respecting patient privacy and the data stewards' legal obligations. Because federated analysis is a technical solution to the legal challenges inherent in data sharing, the technology and policy implications must be evaluated together. Here, we summarize the technical approaches to federated analysis and provide a legal analysis of their policy implications.

Published
2023

2. Common conditions of use elements. Atomic concepts for consistent and effective information governance

Author

Sanchez Gonzalez, Maria del Carmen, Kamerling, Pim, Iermito, Mariapia, Casati, Sara, Riaz, Umar, Veal, Colin D., Maini, Monika, Jeanson, Francis, Benhamed, Oussama Mohammed, van Enckevort, Esther, Landi, Annalisa, Mimouni, Yanis, Le Cornec, Clèmence, Coviello, Domenico A., Franchin, Tiziana, Fusco, Francesca, Ramírez García, Jose Antonio, van der Zanden, Loes F. M., Bernier, Alexander, Wilkinson, Mark D., Mueller, Heimo, Gibson, Spencer J., and Brookes, Anthony J.

Published
2024
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3. Getting your DUCs in a row - standardising the representation of Digital Use Conditions

Author

Jeanson, Francis, Gibson, Spencer J., Alper, Pinar, Bernier, Alexander, Woolley, J. Patrick, Mietchen, Daniel, Strug, Andrzej, Becker, Regina, Kamerling, Pim, Sanchez Gonzalez, Maria del Carmen, Mah, Nancy, Novakowski, Ann, Wilkinson, Mark D., Benhamed, Oussama Mohammed, Landi, Annalisa, Krog, Georg Philip, Müller, Heimo, Riaz, Umar, Veal, Colin, Holub, Petr, van Enckevort, Esther, and Brookes, Anthony J.

Published
2024
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6. GA4GH: International policies and standards for data sharing across genomic research and healthcare

Author

Rehm, Heidi L, Page, Angela JH, Smith, Lindsay, Adams, Jeremy B, Alterovitz, Gil, Babb, Lawrence J, Barkley, Maxmillian P, Baudis, Michael, Beauvais, Michael JS, Beck, Tim, Beckmann, Jacques S, Beltran, Sergi, Bernick, David, Bernier, Alexander, Bonfield, James K, Boughtwood, Tiffany F, Bourque, Guillaume, Bowers, Sarion R, Brookes, Anthony J, Brudno, Michael, Brush, Matthew H, Bujold, David, Burdett, Tony, Buske, Orion J, Cabili, Moran N, Cameron, Daniel L, Carroll, Robert J, Casas-Silva, Esmeralda, Chakravarty, Debyani, Chaudhari, Bimal P, Chen, Shu Hui, Cherry, J Michael, Chung, Justina, Cline, Melissa, Clissold, Hayley L, Cook-Deegan, Robert M, Courtot, Mélanie, Cunningham, Fiona, Cupak, Miro, Davies, Robert M, Denisko, Danielle, Doerr, Megan J, Dolman, Lena I, Dove, Edward S, Dursi, L Jonathan, Dyke, Stephanie OM, Eddy, James A, Eilbeck, Karen, Ellrott, Kyle P, Fairley, Susan, Fakhro, Khalid A, Firth, Helen V, Fitzsimons, Michael S, Fiume, Marc, Flicek, Paul, Fore, Ian M, Freeberg, Mallory A, Freimuth, Robert R, Fromont, Lauren A, Fuerth, Jonathan, Gaff, Clara L, Gan, Weiniu, Ghanaim, Elena M, Glazer, David, Green, Robert C, Griffith, Malachi, Griffith, Obi L, Grossman, Robert L, Groza, Tudor, Auvil, Jaime M Guidry, Guigó, Roderic, Gupta, Dipayan, Haendel, Melissa A, Hamosh, Ada, Hansen, David P, Hart, Reece K, Hartley, Dean Mitchell, Haussler, David, Hendricks-Sturrup, Rachele M, Ho, Calvin WL, Hobb, Ashley E, Hoffman, Michael M, Hofmann, Oliver M, Holub, Petr, Hsu, Jacob Shujui, Hubaux, Jean-Pierre, Hunt, Sarah E, Husami, Ammar, Jacobsen, Julius O, Jamuar, Saumya S, Janes, Elizabeth L, Jeanson, Francis, Jené, Aina, Johns, Amber L, Joly, Yann, Jones, Steven JM, Kanitz, Alexander, Kato, Kazuto, Keane, Thomas M, and Kekesi-Lafrance, Kristina

Subjects
Biological Sciences, Genetics, Human Genome, Clinical Research, Health Services, Generic health relevance, Good Health and Well Being
Abstract

The Global Alliance for Genomics and Health (GA4GH) aims to accelerate biomedical advances by enabling the responsible sharing of clinical and genomic data through both harmonized data aggregation and federated approaches. The decreasing cost of genomic sequencing (along with other genome-wide molecular assays) and increasing evidence of its clinical utility will soon drive the generation of sequence data from tens of millions of humans, with increasing levels of diversity. In this perspective, we present the GA4GH strategies for addressing the major challenges of this data revolution. We describe the GA4GH organization, which is fueled by the development efforts of eight Work Streams and informed by the needs of 24 Driver Projects and other key stakeholders. We present the GA4GH suite of secure, interoperable technical standards and policy frameworks and review the current status of standards, their relevance to key domains of research and clinical care, and future plans of GA4GH. Broad international participation in building, adopting, and deploying GA4GH standards and frameworks will catalyze an unprecedented effort in data sharing that will be critical to advancing genomic medicine and ensuring that all populations can access its benefits.

Published
2021

12. Common conditions of use elements. Atomic concepts for consistent and effective information governance

Author

European Commission, Sanchez Gonzalez, Maria Del Carmen [0000-0002-8523-9218], Kamerling, Pim [0009-0007-3897-0466], Casati, Sara [0000-0002-5049-7321], Riaz, Umar [0009-0002-2265-8770], Veal, Colin [0000-0002-9840-2512], Jeanson, Francis [0000-0001-6085-2967], Benhamed, M. [0000-0002-2567-1914], van Enckevort, Esther [0000-0002-2440-3993], Landi, Annalisa [0000-0001-9368-6424], Mimouni, Yanis [0000-0002-7527-524X], Coviello, Domenico [0000-0001-8440-865X], Franchin, Tiziana [0000-0003-2745-0733], Fusco, Francesca [0000-0002-7578-6058], van der Zanden, Loes [0000-0003-3914-7491], Wilkinson, Mark D. [0000-0001-6960-357X], Mueller, Heimo [0000-0002-9691-4872], Gibson, Spencer [0000-0003-0768-1542], Brookes, Anthony [0000-0001-8686-0017], Sanchez Gonzalez, Maria Del Carmen, Kamerling, Pim, Iermito, Mariapia, Casati, Sara, Riaz, Umar, Veal, Colin, Maini, Monika, Jeanson, Francis, Benhamed, M., van Enckevort, Esther, Landi, Annalisa, Mimouni, Yanis, Le Cornec, Clémence M. A., Coviello, Domenico, Franchin, Tiziana, Fusco, Francesca, Ramírez García, Jose Antonio, van der Zanden, Loes, Bernier, Alexander, Wilkinson, Mark D., Mueller, Heimo, Gibson, Spencer, Brookes, Anthony, European Commission, Sanchez Gonzalez, Maria Del Carmen [0000-0002-8523-9218], Kamerling, Pim [0009-0007-3897-0466], Casati, Sara [0000-0002-5049-7321], Riaz, Umar [0009-0002-2265-8770], Veal, Colin [0000-0002-9840-2512], Jeanson, Francis [0000-0001-6085-2967], Benhamed, M. [0000-0002-2567-1914], van Enckevort, Esther [0000-0002-2440-3993], Landi, Annalisa [0000-0001-9368-6424], Mimouni, Yanis [0000-0002-7527-524X], Coviello, Domenico [0000-0001-8440-865X], Franchin, Tiziana [0000-0003-2745-0733], Fusco, Francesca [0000-0002-7578-6058], van der Zanden, Loes [0000-0003-3914-7491], Wilkinson, Mark D. [0000-0001-6960-357X], Mueller, Heimo [0000-0002-9691-4872], Gibson, Spencer [0000-0003-0768-1542], Brookes, Anthony [0000-0001-8686-0017], Sanchez Gonzalez, Maria Del Carmen, Kamerling, Pim, Iermito, Mariapia, Casati, Sara, Riaz, Umar, Veal, Colin, Maini, Monika, Jeanson, Francis, Benhamed, M., van Enckevort, Esther, Landi, Annalisa, Mimouni, Yanis, Le Cornec, Clémence M. A., Coviello, Domenico, Franchin, Tiziana, Fusco, Francesca, Ramírez García, Jose Antonio, van der Zanden, Loes, Bernier, Alexander, Wilkinson, Mark D., Mueller, Heimo, Gibson, Spencer, and Brookes, Anthony

Abstract

Myriad policy, ethical and legal considerations underpin the sharing of biological resources, implying the need for standardised and yet flexible ways to digitally represent diverse 'use conditions'. We report a core lexicon of terms that are atomic, non-directional 'concepts of use', called Common Conditions of use Elements. This work engaged biobanks and registries relevant to the European Joint Programme for Rare Diseases and aimed to produce a lexicon that would have generalised utility. Seventy-six concepts were initially identified from diverse real-world settings, and via iterative rounds of deliberation and user-testing these were optimised and condensed down to 20 items. To validate utility, support software and training information was provided to biobanks and registries who were asked to create Sharing Policy Profiles. This succeeded and involved adding standardised directionality and scope annotations to the employed terms. The addition of free-text parameters was also explored. The approach is now being adopted by several real-world projects, enabling this standard to evolve progressively into a universal basis for representing and managing conditions of use.

Published
2024

13. Getting your DUCs in a row - standardising the representation of Digital Use Conditions

Author

European Commission, Jeanson, Francis [0000-0001-6085-2967], Gibson, Spencer [0000-0003-0768-1542], Alper, Pinar [0000-0002-2224-0780], Woolley, J. Patrick [0000-0002-2829-8756], Mietchen, Daniel [0000-0001-9488-1870], Strug, Andrzej [0000-0003-1948-4597], Becker, Regina [0000-0002-6711-8375], Kamerling, Pim [0009-0007-3897-0466], Sánchez-González, M. [0000-0002-8523-9218], Mah, Nancy [0000-0002-1240-8076], Novakowski, Ann [0000-0002-1309-8356], Wilkinson, Mark D. [0000-0001-6960-357X], Benhamed, M. [0000-0002-2567-1914], Landi, Annalisa [0000-0001-9368-6424], Müller, Heimo [0000-0002-9691-4872], Riaz, Umar [0009-0002-2265-8770], Veal, Colin [0000-0002-9840-2512], Holub, Petr [0000-0002-5358-616X], van Enckevort, Esther [0000-0002-2440-3993], Brookes, Anthony [0000-0001-8686-0017], Jeanson, Francis, Gibson, Spencer, Alper, Pinar, Bernier, Alexander, Woolley, J. Patrick, Mietchen, Daniel, Strug, Andrzej, Becker, Regina, Kamerling, Pim, Sánchez-González, M., Mah, Nancy, Novakowski, Ann, Wilkinson, Mark D., Benhamed, M., Landi, Annalisa, Krog, Georg Philip, Müller, Heimo, Riaz, Umar, Veal, Colin, Holub, Petr, van Enckevort, Esther, Brookes, Anthony, European Commission, Jeanson, Francis [0000-0001-6085-2967], Gibson, Spencer [0000-0003-0768-1542], Alper, Pinar [0000-0002-2224-0780], Woolley, J. Patrick [0000-0002-2829-8756], Mietchen, Daniel [0000-0001-9488-1870], Strug, Andrzej [0000-0003-1948-4597], Becker, Regina [0000-0002-6711-8375], Kamerling, Pim [0009-0007-3897-0466], Sánchez-González, M. [0000-0002-8523-9218], Mah, Nancy [0000-0002-1240-8076], Novakowski, Ann [0000-0002-1309-8356], Wilkinson, Mark D. [0000-0001-6960-357X], Benhamed, M. [0000-0002-2567-1914], Landi, Annalisa [0000-0001-9368-6424], Müller, Heimo [0000-0002-9691-4872], Riaz, Umar [0009-0002-2265-8770], Veal, Colin [0000-0002-9840-2512], Holub, Petr [0000-0002-5358-616X], van Enckevort, Esther [0000-0002-2440-3993], Brookes, Anthony [0000-0001-8686-0017], Jeanson, Francis, Gibson, Spencer, Alper, Pinar, Bernier, Alexander, Woolley, J. Patrick, Mietchen, Daniel, Strug, Andrzej, Becker, Regina, Kamerling, Pim, Sánchez-González, M., Mah, Nancy, Novakowski, Ann, Wilkinson, Mark D., Benhamed, M., Landi, Annalisa, Krog, Georg Philip, Müller, Heimo, Riaz, Umar, Veal, Colin, Holub, Petr, van Enckevort, Esther, and Brookes, Anthony

Abstract

Improving patient care and advancing scientific discovery requires responsible sharing of research data, healthcare records, biosamples, and biomedical resources that must also respect applicable use conditions. Defining a standard to structure and manage these use conditions is a complex and challenging task. This is exemplified by a near unlimited range of asset types, a high variability of applicable conditions, and differing applications at the individual or collective level. Furthermore, the specifics and granularity required are likely to vary depending on the ultimate contexts of use. All these factors confound alignment of institutional missions, funding objectives, regulatory and technical requirements to facilitate effective sharing. The presented work highlights the complexity and diversity of the problem, reviews the current state of the art, and emphasises the need for a flexible and adaptable approach. We propose Digital Use Conditions (DUC) as a framework that addresses these needs by leveraging existing standards, striking a balance between expressiveness versus ambiguity, and considering the breadth of applicable information with their context of use.

Published
2024

16. Reconciling the biomedical data commons and the GDPR: three lessons from the EUCAN ELSI collaboratory

Author

Bernier, Alexander, primary, Molnár-Gábor, Fruzsina, additional, Knoppers, Bartha M., additional, Borry, Pascal, additional, Cesar, Priscilla M. D. G., additional, Devriendt, Thijs, additional, Goisauf, Melanie, additional, Murtagh, Madeleine, additional, Jiménez, Pilar Nicolás, additional, Recuero, Mikel, additional, Rial-Sebbag, Emmanuelle, additional, Shabani, Mahsa, additional, Wilson, Rebecca C., additional, Zaccagnini, Davide, additional, and Maxwell, Lauren, additional

Published
2023
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17. CONP Ethics Toolkit v1.0.4

Author

Beauvais, Michael J.S., Knoppers, Bartha Maria, Cavoukian, Ann, Clarkson, John, Green-Noble, Lindsay, Illes, Judy, Karamchandani, Jason, Nadler, Roland, Roskams-Edris, Dylan, Stewart, Walter, Bermudez, Patrick, Bernier, Alexander, Lemmens, Trudo, Farrés, Marcel, Royer, Jessica, and Zatorre, Robert

Subjects
neuroscience, neuroethics, open science, human subjects research regulation, privacy, law, ethics
Abstract

CONP Ethics Toolkit consisting of: Model prospective consent clauses Retrospective consent filter De-identification information and tools This consent toolkit is the product of extended discussions and careful drafting that considers bothCanadianandinternationalethical frameworks and research practice. In adapting this consent toolkit for your own research needs, we encourage you to mention to your research ethics board that your consent materials are modeled after those created by theCONP Ethics and Governance Committee. The Committee's members include internationally recognized experts in research ethics, neuroethics, data governance, and law: Trudo Lemmens (Chair), Alexander Bernier (Manager), Ann Cavoukian, John Clarkson, Jason Karamchandani, Roland Nadler, Dylan Roskams-Edris, and Walter Stewart. Further feedback was graciously provided from members of the CONP community, in particular Patrick Bermudez, Marcel Farrés Franch, Jessica Royer, Robert Zatorre, and past Committee Members Bartha Maria Knoppers, Lindsay Green Noble, and Judy Illes. GitHub source:https://github.com/CONP-PCNO/Ethics_and_Data_Governance

Published
2023
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19. The Canadian Open Neuroscience Platform—An open science framework for the neuroscience community

Author

Harding, Rachel, Bermudez, Patrick, Bernier, Alexander, Beauvais, Michael J.S., Bellec, Pierre, Hill, Sean, Karakuzu, Agah, Knoppers, Bartha Maria, Pavlidis, Paul, Poline, Jean-Baptiste, Roskams, Jane, Stikov, Nikola, Stone, Jessica, Strother, Stephen C., Evans, Alan C., Harding, Rachel, Bermudez, Patrick, Bernier, Alexander, Beauvais, Michael J.S., Bellec, Pierre, Hill, Sean, Karakuzu, Agah, Knoppers, Bartha Maria, Pavlidis, Paul, Poline, Jean-Baptiste, Roskams, Jane, Stikov, Nikola, Stone, Jessica, Strother, Stephen C., and Evans, Alan C.

Abstract

The Canadian Open Neuroscience Platform (CONP) takes a multifaceted approach to enabling open neuroscience, aiming to make research, data, and tools accessible to everyone, with the ultimate objective of accelerating discovery. Its core infrastructure is the CONP Portal, a repository with a decentralized design, where datasets and analysis tools across disparate platforms can be browsed, searched, accessed, and shared in accordance with FAIR principles. Another key piece of CONP infrastructure is NeuroLibre, a preprint server capable of creating and hosting executable and fully reproducible scientific publications that embed text, figures, and code. As part of its holistic approach, the CONP has also constructed frameworks and guidance for ethics and data governance, provided support and developed resources to help train the next generation of neuroscientists, and has fostered and grown an engaged community through outreach and communications. In this manuscript, we provide a high-level overview of this multipronged platform and its vision of lowering the barriers to the practice of open neuroscience and yielding the associated benefits for both individual researchers and the wider community.

Published
2023

23. The Canadian Open Neuroscience Platform—An open science framework for the neuroscience community.

Author

Harding, Rachel J., Bermudez, Patrick, Bernier, Alexander, Beauvais, Michael, Bellec, Pierre, Hill, Sean, Karakuzu, Agâh, Knoppers, Bartha M., Pavlidis, Paul, Poline, Jean-Baptiste, Roskams, Jane, Stikov, Nikola, Stone, Jessica, Strother, Stephen, and Evans, Alan C.

Subjects
NEUROSCIENCES, COMMUNITY gardens, NEUROSCIENTISTS
Abstract

The Canadian Open Neuroscience Platform (CONP) takes a multifaceted approach to enabling open neuroscience, aiming to make research, data, and tools accessible to everyone, with the ultimate objective of accelerating discovery. Its core infrastructure is the CONP Portal, a repository with a decentralized design, where datasets and analysis tools across disparate platforms can be browsed, searched, accessed, and shared in accordance with FAIR principles. Another key piece of CONP infrastructure is NeuroLibre, a preprint server capable of creating and hosting executable and fully reproducible scientific publications that embed text, figures, and code. As part of its holistic approach, the CONP has also constructed frameworks and guidance for ethics and data governance, provided support and developed resources to help train the next generation of neuroscientists, and has fostered and grown an engaged community through outreach and communications. In this manuscript, we provide a high-level overview of this multipronged platform and its vision of lowering the barriers to the practice of open neuroscience and yielding the associated benefits for both individual researchers and the wider community. [ABSTRACT FROM AUTHOR]

Published
2023
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25. Public Biological Databases and the Sui GenerisDatabase Right

Author

Bernier, Alexander, Busse, Christian, and Bubela, Tania

Abstract

The sui generisdatabase right is an intellectual property right created in the European Union to stimulate investment in the curation of databases. Since its inception, communities engaged in research and development efforts have questioned its potential to incentivise database production, and posit that it stifles productive downstream uses of existing datasets. European courts have restricted the right’s ambit through a restrictive interpretation of the circumstances in which it applies, which we argue, enables downstream use of biological databases. Nonetheless, residual ambiguities about potential infringement of the right exist. The prospect of unintentional infringement can frustrate downstream innovation. These ambiguities are compounded because the criteria that determine whether or not the right applies are reliant on information that is not available to the prospective downstream users of public datasets. Repealing the sui generisdatabase right is recommended. Legislatures are advised to refrain from the implementation of broad novel intellectual property rights in the future, without first adopting safeguards that mitigate the potential for such rights to frustrate the reuse of available intangibles to the detriment of pro-social innovation.

Published
2023
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26. Bridging the European Data Sharing Divide in Genomic Science

Author

Derecho publico, Zuzenbide publikoa, Molnár Gábor, Fruzsina, Beauvais, Michael J. S., Bernier, Alexander, Nicolás Jiménez, María Pilar, Recuero Linares, Mikel, Derecho publico, Zuzenbide publikoa, Molnár Gábor, Fruzsina, Beauvais, Michael J. S., Bernier, Alexander, Nicolás Jiménez, María Pilar, and Recuero Linares, Mikel

Abstract

In this viewpoint, we argue for the importance of creating data spaces for genomic research that are detached from contexts in which fundamental rights concerns related to surveillance measures override a purpose-specific balancing of fundamental rights. Genomic research relies on molecular and phenotypic data, on comparing findings within large data sets, on searchable metadata, and on translating research results into a clinical setting. These methods require sensitive genetic and health data to be shared across borders. International data sharing between the European Union (EU) or the European Economic Area and third countries has accordingly become a cornerstone of genomics. The EU General Data Protection Regulation contains rules that accord privileged status to data processing for research purposes to ensure that strict data protection requirements do not impede biomedical research. However, the General Data Protection Regulation rules applicable to international transfers of data accord no such preferential treatment to international data transfers made in the research context. The rules that govern the international transfer of data create considerable barriers to international data sharing because of the cost-intensive procedural and substantive compliance burdens that they impose. For certain jurisdictions and select use cases, there exist practically no lawful mechanisms to enable the international transfer of data because of concerns about the protection of fundamental rights. The proposed solutions further fail to address the need to share large data sets of local and regional cohorts across national borders to enable joint analyses. The European Health Data Space is an emerging federated, EU-wide data infrastructure that is intended to function as an infrastructure bringing together EU health data to improve patient care and enable the secondary use of health-related data for research purposes. Such infrastructure is implementing new institutions to su

Published
2022

29. An agenda-setting paper on data sharing platforms: euCanSHare workshop

Author

Devriendt, Thijs, primary, Ammann, Clemens, additional, W. Asselbergs, Folkert, additional, Bernier, Alexander, additional, Costas, Rodrigo, additional, Friedrich, Matthias G., additional, Gelpi, Josep L., additional, Jarvelin, Marjo-Riitta, additional, Kuulasmaa, Kari, additional, Lekadir, Karim, additional, Mayrhofer, Michaela Th., additional, Papez, Vaclav, additional, Pasterkamp, Gerard, additional, Petersen, Steffen E., additional, Schmidt, Carsten Oliver, additional, Schulz-Menger, Jeanette, additional, Söderberg, Stefan, additional, Shabani, Mahsa, additional, Veronesi, Giovanni, additional, Viezzer, Darian Steven, additional, and Borry, Pascal, additional

Published
2021
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34. Radical collaboration during a global health emergency: development of the RDA COVID-19 data sharing recommendations and guidelines

Author

Pickering, Brian, primary, Biro, Timea, additional, Austin, Claire C., additional, Bernier, Alexander, additional, Bezuidenhout, Louise, additional, Casorrán, Carlos, additional, Crawley, Francis P., additional, David, Romain, additional, Engelhardt, Claudia, additional, Mitrea, Geta, additional, Mochmann, Ingvill Constanze, additional, Nagrani, Rajini, additional, O'Brien-Uhlmansiek, Mary, additional, Parker, Simon, additional, Wang, Minglu, additional, Castro, Leyla Jael, additional, Cournia, Zoe, additional, Dharmawardena, Kheeran, additional, Diallo, Gayo, additional, Dillo, Ingrid, additional, Gonzalez-Beltran, Alejandra, additional, Gururaj, Anupama, additional, Gutam, Sridhar, additional, Harrower, Natalie, additional, Jonnagaddala, Jitendra, additional, McNeill, Katherine, additional, Mietchen, Daniel, additional, Pienta, Amy, additional, Polydoratou, Panayiota, additional, and Tovani-Palone, Marcos Roberto, additional

Published
2021
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35. GA4GH: International policies and standards for data sharing across genomic research and healthcare

Author

Abigail Wexner Research Institute, Academy of Finland, Medical Research Future Fund, BioBank Japan, Canada Foundation for Innovation, Canadian Institutes of Health Research, European Commission, German Research Foundation, Genome Canada, Google, Howard Hughes Medical Institute, Instituto de Salud Carlos III, Japan Agency for Medical Research and Development, Mayo Clinic, Fundación la Caixa, Ministère de l'Économie et de l'Innovation (Québec), Monarch Initiative, National Human Genome Research Institute (US), National University of Singapore, Agency for Science, Technology and Research A*STAR (Singapore), National Health and Medical Research Council (Australia), National Institutes of Health (US), National Institute of General Medical Sciences (US), Swiss Institute of Bioinformatics, State Secretariat for Education, Research and Innovation (Switzerland), Terry Fox Research Institute, Canada Research Chairs, European Molecular Biology Laboratory, Ministry of Research, Innovation and Science (Ontario), Ontario Genomics Institute, Natural Sciences and Engineering Research Council of Canada, Wellcome Trust, National Taiwan University, Rehm, Heidi L., Page, Angela, Smith, Lindsay, Adams, Jeremy B., Alterovitz, Gil, Babb, Lawrence J., Barkley, Maxmillian P., Baudis, Michael, Beauvais, Michael J. S., Beck, Tim, Beckmann, Jacques S., Varma, Susheel, Vears, Danya F., Viner, Coby, Voisin, Craig, Wagner, Alex H., Wallace, Susan E., Walsh, Brian P., Williams, Marc S., Winkler, Eva C., Brudno, Michael, Kelleher, Jerome, Wold, Barbara J., Wood, Grant M., Woolley, J. Patrick, Yamasaki, Chisato, Yates, Andrew D., Yung, Christina K., Zass, Lyndon J., Zaytseva, Ksenia, Zhang, Junjun, Goodhand, Peter, Kerry, Giselle, Brush,Matthew H., North, Kathryn, Birney, Ewan, Bujold, David, Burdett, Tony, Buske, Orion J., Cabili, Moran N., Cameron, Daniel L., Carroll, Robert J., Casas-Silva, Esmeralda, Khor, Seik-Soon, Chakravarty, Debyani, Chaudhari, Bimal P., Chen, Shu Hui, Cherry, J. Michael, Chung, Justina, Cline, Melissa, Clissold, Hayley L., Cook-Deegan, Robert M., Courtot, Melanie, Cunningham, Fiona, Knoppers, Bartha M., Cupak, Miro, Davies, Robert M., Denisko, Danielle, Doerr, Megan J., Dolman, Lena I., Dove, Edward S., Dursi, Lewis Jonathan, Dyke, Stephanie O. M., Eddy, James A., Eilbeck, Karen, Konopko, Melissa A., Ellrott, Kyle P., Fairley, Susan, Fakhro, Khalid A., Firth, Helen V., Fitzsimons, Michael S., Fiume, Marc, Flicek, Paul, Fore, Ian M., Freeberg, Mallory A., Freimuth, Robert R., Kosaki, Kenjiro, Fromont, Lauren A., Fuerth, Jonathan, Gaff, Clara L., Gan, Weiniu, Ghanaim, Elena M., Glazer, David, Green, Robert C., Griffith, Malachi, Griffith, Obi L., Grossman, Robert L., Kuba, Martin, Groza, Tudor, Guidry Auvil, Jaime M., Guigó, Roderic, Gupta, Dipayan, Haendel, Melissa A., Hamosh, Ada, Hansen, David P., Hart, Reece K., Hartley, Dean Mitchell, Haussler, David, Lawson, Jonathan, Hendricks-Sturrup, Rachele M., Ho, Calvin W. L., Hobb, Ashley E., Hoffman, Michael M., Hofmann, Oliver M., Holub, Petr, Shujui Hsu, Jacob, Hubaux, Jean-Pierre, Hunt, Sarah E., Husami, Ammar, Leinonen, Rasko, Jacobsen, Julius O., Jamuar, Saumya S., Janes, Elizabeth L., Jeanson, Francis, Jene, Aina, Johns, Amber L., Joly, Yann, Jones, Steven J. M., Kanitz, Alexander, Kato, Kazuto, Li, Stephanie, Keane, Thomas M., Kekesi-Lafrance, Kristina, Beltran, Sergi, Lin, Michael F., Linden, Mikael, Liu, Xianglin, Udara Liyanage, Isuru, López, Javier, Lucassen, Anneke M., Lukowski, Michael, Mann, Alice L., Marshall, John, Mattioni, Michele, Bernick, David, Metke-Jiménez, Alejandro, Middleton, Anna, Milne, Richard J., Molnár-Gábor, Fruzsina, Mulder, Nicola, Muñoz-Torres, Mónica C., Nag, Rishi, Nakagawa, Hidewaki, Nasir, Jamal, Navarro, Arcadi, Bernier, Alexander, Nelson, Tristan H., Niewielska, Ania, Nisselle, Amy, Niu, Jeffrey, Nyrönen, Tommi H., O’Connor, Brian D., Oesterle, Sabine, Ogishima, Soichi, Wang, Vivian Ota, Paglione, Laura A. D., Bonfield, James K., Palumbo, Emilio, Parkinson, Helen E., Philippakis, Anthony A., Pizarro, Angel D., Prlic, Andreas, Rambla, Jordi, Rendon, Augusto, Rider, Renee A., Robinson, Peter N., Rodarmer, Kurt W., Boughtwood, Tiffany F., Lyman Rodríguez, Laura, Rubin, Alan F., Rueda, Manuel, Rushton, Gregory A., Ryan, Rosalyn S., Saunders, Gary I., Schuilenburg, Helen, Schwede, Torsten, Scollen, Serena, Senf, Alexander, Bourque, Guillaume, Sheffield, Nathan C., Skantharajah, Neerjah, Smith, Albert V., Sofia, Heidi J., Spalding, Dylan, Spurdle, Amanda B., Stark, Zornitza, Stein, Lincoln D., Suematsu, Makoto, Tan, Patrick, Bowers, Sarion R., Tedds, Jonathan A., Thomson, Alastair A., Thorogood, Adrian, Tickle, Timothy L., Tokunaga, Katsushi, Törnroos,Juha, Torrents, David, Upchurch, Sean, Valencia, Alfonso, Valls Guimera, Roman, Brookes, Anthony J., Vamathevan, Jessica, Abigail Wexner Research Institute, Academy of Finland, Medical Research Future Fund, BioBank Japan, Canada Foundation for Innovation, Canadian Institutes of Health Research, European Commission, German Research Foundation, Genome Canada, Google, Howard Hughes Medical Institute, Instituto de Salud Carlos III, Japan Agency for Medical Research and Development, Mayo Clinic, Fundación la Caixa, Ministère de l'Économie et de l'Innovation (Québec), Monarch Initiative, National Human Genome Research Institute (US), National University of Singapore, Agency for Science, Technology and Research A*STAR (Singapore), National Health and Medical Research Council (Australia), National Institutes of Health (US), National Institute of General Medical Sciences (US), Swiss Institute of Bioinformatics, State Secretariat for Education, Research and Innovation (Switzerland), Terry Fox Research Institute, Canada Research Chairs, European Molecular Biology Laboratory, Ministry of Research, Innovation and Science (Ontario), Ontario Genomics Institute, Natural Sciences and Engineering Research Council of Canada, Wellcome Trust, National Taiwan University, Rehm, Heidi L., Page, Angela, Smith, Lindsay, Adams, Jeremy B., Alterovitz, Gil, Babb, Lawrence J., Barkley, Maxmillian P., Baudis, Michael, Beauvais, Michael J. S., Beck, Tim, Beckmann, Jacques S., Varma, Susheel, Vears, Danya F., Viner, Coby, Voisin, Craig, Wagner, Alex H., Wallace, Susan E., Walsh, Brian P., Williams, Marc S., Winkler, Eva C., Brudno, Michael, Kelleher, Jerome, Wold, Barbara J., Wood, Grant M., Woolley, J. Patrick, Yamasaki, Chisato, Yates, Andrew D., Yung, Christina K., Zass, Lyndon J., Zaytseva, Ksenia, Zhang, Junjun, Goodhand, Peter, Kerry, Giselle, Brush,Matthew H., North, Kathryn, Birney, Ewan, Bujold, David, Burdett, Tony, Buske, Orion J., Cabili, Moran N., Cameron, Daniel L., Carroll, Robert J., Casas-Silva, Esmeralda, Khor, Seik-Soon, Chakravarty, Debyani, Chaudhari, Bimal P., Chen, Shu Hui, Cherry, J. Michael, Chung, Justina, Cline, Melissa, Clissold, Hayley L., Cook-Deegan, Robert M., Courtot, Melanie, Cunningham, Fiona, Knoppers, Bartha M., Cupak, Miro, Davies, Robert M., Denisko, Danielle, Doerr, Megan J., Dolman, Lena I., Dove, Edward S., Dursi, Lewis Jonathan, Dyke, Stephanie O. M., Eddy, James A., Eilbeck, Karen, Konopko, Melissa A., Ellrott, Kyle P., Fairley, Susan, Fakhro, Khalid A., Firth, Helen V., Fitzsimons, Michael S., Fiume, Marc, Flicek, Paul, Fore, Ian M., Freeberg, Mallory A., Freimuth, Robert R., Kosaki, Kenjiro, Fromont, Lauren A., Fuerth, Jonathan, Gaff, Clara L., Gan, Weiniu, Ghanaim, Elena M., Glazer, David, Green, Robert C., Griffith, Malachi, Griffith, Obi L., Grossman, Robert L., Kuba, Martin, Groza, Tudor, Guidry Auvil, Jaime M., Guigó, Roderic, Gupta, Dipayan, Haendel, Melissa A., Hamosh, Ada, Hansen, David P., Hart, Reece K., Hartley, Dean Mitchell, Haussler, David, Lawson, Jonathan, Hendricks-Sturrup, Rachele M., Ho, Calvin W. L., Hobb, Ashley E., Hoffman, Michael M., Hofmann, Oliver M., Holub, Petr, Shujui Hsu, Jacob, Hubaux, Jean-Pierre, Hunt, Sarah E., Husami, Ammar, Leinonen, Rasko, Jacobsen, Julius O., Jamuar, Saumya S., Janes, Elizabeth L., Jeanson, Francis, Jene, Aina, Johns, Amber L., Joly, Yann, Jones, Steven J. M., Kanitz, Alexander, Kato, Kazuto, Li, Stephanie, Keane, Thomas M., Kekesi-Lafrance, Kristina, Beltran, Sergi, Lin, Michael F., Linden, Mikael, Liu, Xianglin, Udara Liyanage, Isuru, López, Javier, Lucassen, Anneke M., Lukowski, Michael, Mann, Alice L., Marshall, John, Mattioni, Michele, Bernick, David, Metke-Jiménez, Alejandro, Middleton, Anna, Milne, Richard J., Molnár-Gábor, Fruzsina, Mulder, Nicola, Muñoz-Torres, Mónica C., Nag, Rishi, Nakagawa, Hidewaki, Nasir, Jamal, Navarro, Arcadi, Bernier, Alexander, Nelson, Tristan H., Niewielska, Ania, Nisselle, Amy, Niu, Jeffrey, Nyrönen, Tommi H., O’Connor, Brian D., Oesterle, Sabine, Ogishima, Soichi, Wang, Vivian Ota, Paglione, Laura A. D., Bonfield, James K., Palumbo, Emilio, Parkinson, Helen E., Philippakis, Anthony A., Pizarro, Angel D., Prlic, Andreas, Rambla, Jordi, Rendon, Augusto, Rider, Renee A., Robinson, Peter N., Rodarmer, Kurt W., Boughtwood, Tiffany F., Lyman Rodríguez, Laura, Rubin, Alan F., Rueda, Manuel, Rushton, Gregory A., Ryan, Rosalyn S., Saunders, Gary I., Schuilenburg, Helen, Schwede, Torsten, Scollen, Serena, Senf, Alexander, Bourque, Guillaume, Sheffield, Nathan C., Skantharajah, Neerjah, Smith, Albert V., Sofia, Heidi J., Spalding, Dylan, Spurdle, Amanda B., Stark, Zornitza, Stein, Lincoln D., Suematsu, Makoto, Tan, Patrick, Bowers, Sarion R., Tedds, Jonathan A., Thomson, Alastair A., Thorogood, Adrian, Tickle, Timothy L., Tokunaga, Katsushi, Törnroos,Juha, Torrents, David, Upchurch, Sean, Valencia, Alfonso, Valls Guimera, Roman, Brookes, Anthony J., and Vamathevan, Jessica

Abstract

The Global Alliance for Genomics and Health (GA4GH) aims to accelerate biomedical advances by enabling the responsible sharing of clinical and genomic data through both harmonized data aggregation and federated approaches. The decreasing cost of genomic sequencing (along with other genome-wide molecular assays) and increasing evidence of its clinical utility will soon drive the generation of sequence data from tens of millions of humans, with increasing levels of diversity. In this perspective, we present the GA4GH strategies for addressing the major challenges of this data revolution. We describe the GA4GH organization, which is fueled by the development efforts of eight Work Streams and informed by the needs of 24 Driver Projects and other key stakeholders. We present the GA4GH suite of secure, interoperable technical standards and policy frameworks and review the current status of standards, their relevance to key domains of research and clinical care, and future plans of GA4GH. Broad international participation in building, adopting, and deploying GA4GH standards and frameworks will catalyze an unprecedented effort in data sharing that will be critical to advancing genomic medicine and ensuring that all populations can access its benefits.

Published
2021

36. GA4GH: International policies and standards for data sharing across genomic research and healthcare

Author

Rehm, Heidi L; https://orcid.org/0000-0002-6025-0015, Page, Angela J H; https://orcid.org/0000-0002-4185-7268, Smith, Lindsay; https://orcid.org/0000-0002-0603-4178, Adams, Jeremy B; https://orcid.org/0000-0003-1215-8123, Alterovitz, Gil, Babb, Lawrence J; https://orcid.org/0000-0002-2455-2227, Barkley, Maxmillian P, Baudis, Michael; https://orcid.org/0000-0002-9903-4248, Beauvais, Michael J S; https://orcid.org/0000-0002-8371-3836, Beck, Tim; https://orcid.org/0000-0002-0292-7972, Beckmann, Jacques S; https://orcid.org/0000-0002-9741-1900, Beltran, Sergi; https://orcid.org/0000-0002-2810-3445, Bernick, David, Bernier, Alexander, Bonfield, James K; https://orcid.org/0000-0002-6447-4112, Boughtwood, Tiffany F; https://orcid.org/0000-0002-9634-3731, Bourque, Guillaume; https://orcid.org/0000-0002-3933-9656, Bowers, Sarion R; https://orcid.org/0000-0002-5687-5397, Brookes, Anthony J, Brudno, Michael; https://orcid.org/0000-0001-7947-2243, Brush, Matthew H; https://orcid.org/0000-0002-1048-5019, Bujold, David; https://orcid.org/0000-0001-7860-3264, Burdett, Tony; https://orcid.org/0000-0002-2513-5396, Buske, Orion J; https://orcid.org/0000-0002-9064-092X, Cabili, Moran N; https://orcid.org/0000-0002-0488-1349, Cameron, Daniel L; https://orcid.org/0000-0002-0951-7116, Carroll, Robert J; https://orcid.org/0000-0003-3802-8183, Casas-Silva, Esmeralda; https://orcid.org/0000-0002-9704-0812, Chakravarty, Debyani; https://orcid.org/0000-0001-8629-5732, Chaudhari, Bimal P; https://orcid.org/0000-0002-0115-949X, et al, Rehm, Heidi L; https://orcid.org/0000-0002-6025-0015, Page, Angela J H; https://orcid.org/0000-0002-4185-7268, Smith, Lindsay; https://orcid.org/0000-0002-0603-4178, Adams, Jeremy B; https://orcid.org/0000-0003-1215-8123, Alterovitz, Gil, Babb, Lawrence J; https://orcid.org/0000-0002-2455-2227, Barkley, Maxmillian P, Baudis, Michael; https://orcid.org/0000-0002-9903-4248, Beauvais, Michael J S; https://orcid.org/0000-0002-8371-3836, Beck, Tim; https://orcid.org/0000-0002-0292-7972, Beckmann, Jacques S; https://orcid.org/0000-0002-9741-1900, Beltran, Sergi; https://orcid.org/0000-0002-2810-3445, Bernick, David, Bernier, Alexander, Bonfield, James K; https://orcid.org/0000-0002-6447-4112, Boughtwood, Tiffany F; https://orcid.org/0000-0002-9634-3731, Bourque, Guillaume; https://orcid.org/0000-0002-3933-9656, Bowers, Sarion R; https://orcid.org/0000-0002-5687-5397, Brookes, Anthony J, Brudno, Michael; https://orcid.org/0000-0001-7947-2243, Brush, Matthew H; https://orcid.org/0000-0002-1048-5019, Bujold, David; https://orcid.org/0000-0001-7860-3264, Burdett, Tony; https://orcid.org/0000-0002-2513-5396, Buske, Orion J; https://orcid.org/0000-0002-9064-092X, Cabili, Moran N; https://orcid.org/0000-0002-0488-1349, Cameron, Daniel L; https://orcid.org/0000-0002-0951-7116, Carroll, Robert J; https://orcid.org/0000-0003-3802-8183, Casas-Silva, Esmeralda; https://orcid.org/0000-0002-9704-0812, Chakravarty, Debyani; https://orcid.org/0000-0001-8629-5732, Chaudhari, Bimal P; https://orcid.org/0000-0002-0115-949X, and et al

Abstract

The Global Alliance for Genomics and Health (GA4GH) aims to accelerate biomedical advances by enabling the responsible sharing of clinical and genomic data through both harmonized data aggregation and federated approaches. The decreasing cost of genomic sequencing (along with other genome-wide molecular assays) and increasing evidence of its clinical utility will soon drive the generation of sequence data from tens of millions of humans, with increasing levels of diversity. In this perspective, we present the GA4GH strategies for addressing the major challenges of this data revolution. We describe the GA4GH organization, which is fueled by the development efforts of eight Work Streams and informed by the needs of 24 Driver Projects and other key stakeholders. We present the GA4GH suite of secure, interoperable technical standards and policy frameworks and review the current status of standards, their relevance to key domains of research and clinical care, and future plans of GA4GH. Broad international participation in building, adopting, and deploying GA4GH standards and frameworks will catalyze an unprecedented effort in data sharing that will be critical to advancing genomic medicine and ensuring that all populations can access its benefits.

Published
2021

37. Fostering global data sharing: highlighting the recommendations of the Research Data Alliance COVID-19 working group [version 1; peer review: awaiting peer review]

Author

Austin, Claire, Bernier, Alexander, Bezuidenhout, Louise, and Pickering, Brian

Abstract

The systemic challenges of the COVID-19 pandemic require cross-disciplinary collaboration in a global and timely fashion. Such collaboration needs open research practices and the sharing of research outputs, such as data and code, thereby facilitating research and research reproducibility and timely collaboration beyond borders. The Research Data Alliance COVID-19 Working Group recently published a set of recommendations and guidelines on data sharing and related best practices for COVID-19 research. These guidelines include recommendations for researchers, policymakers, funders, publishers and infrastructure providers from the perspective of different domains (Clinical Medicine, Omics, Epidemiology, Social Sciences, Community Participation, Indigenous Peoples, Research Software, Legal and Ethical Considerations). Several overarching themes have emerged from this document such as the need to balance the creation of data adherent to FAIR principles (findable, accessible, interoperable and reusable), with the need for quick data release; the use of trustworthy research data repositories; the use of well-annotated data with meaningful metadata; and practices of documenting methods and software. The resulting document marks an unprecedented cross-disciplinary, cross-sectoral, and cross-jurisdictional effort authored by over 160 experts from around the globe. This letter summarises key points of the Recommendations and Guidelines, highlights the relevant findings, shines a spotlight on the process, and suggests how these developments can be leveraged by the wider scientific community.

Published
2020

38. Fostering global data sharing: Highlighting the recommendations of the Research Data Alliance COVID-19 working group

Author

Austin, Claire C., Bernier, Alexander, Bezuidenhout, Louise, Bicarregui, Juan, Biro, Timea, Cambon-Thomsen, Anne, Carroll, Stephanie Russo, Cournia, Zoe, Dabrowski, Piotr Wojciech, Diallo, Gayo, Duflot, Thomas, Garcia, Leyla, Gesing, Sandra, Gonzalez-Beltran, Alejandra, Gururaj, Anupama, Harrower, Natalie, Lin, Dawei, Medeiros, Claudia, Meyers, Natalie, Mietchen, Daniel, Nagrani, Rajini, Nilsonne, Gustav, Parker, Simon, Pickering, Brian, Pienta, Amy, Polydoratou, Panayiota, Psomopoulos, Fotis, Rennes, Stephanie, Rowe, Robyn, Sansone, Susanna-Assunta, Shanahan, Hugh, Sitz, Lina, Stocks, Joanne, Tovani-Palone, Marcos Roberto, and Uhlmansiek, Mary

Subjects
Open science, Sharing research outputs in pandemics caused by infectious diseases, FAIR and CARE principles, Omics, Epidemiology, Social Science, Clinical Research, COVID-19
Abstract

© 2020 Austin CC et al. The systemic challenges of the COVID-19 pandemic require cross-disciplinary collaboration in a global and timely fashion. Such collaboration needs open research practices and the sharing of research outputs, such as data and code, thereby facilitating research and research reproducibility and timely collaboration beyond borders. The Research Data Alliance COVID-19 Working Group recently published a set of recommendations and guidelines on data sharing and related best practices for COVID-19 research. These guidelines include recommendations for researchers, policymakers, funders, publishers and infrastructure providers from the perspective of different domains (Clinical Medicine, Omics, Epidemiology, Social Sciences, Community Participation, Indigenous Peoples, Research Software, Legal and Ethical Considerations). Several overarching themes have emerged from this document such as the need to balance the creation of data adherent to FAIR principles (findable, accessible, interoperable and reusable), with the need for quick data release; the use of trustworthy research data repositories; the use of well-annotated data with meaningful metadata; and practices of documenting methods and software. The resulting document marks an unprecedented cross-disciplinary, cross-sectoral, and cross-jurisdictional effort authored by over 160 experts from around the globe. This letter summarises key points of the Recommendations and Guidelines, highlights the relevant findings, shines a spotlight on the process, and suggests how these developments can be leveraged by the wider scientific community.

Published
2020

39. International transfers of health research data following Schrems II: A problem in need of a solution

Author

Hallinan, Dara, Bernier, Alexander, Cambon-Thomsen, Anne, Crawley, Francis P., Dimitrova, Diana, Medeiros, Claudia Bauzer, Nilsonne, Gustav, Parker, Simon, Pickering, Brian, and Rennes, Stéphanie

Subjects
0303 health sciences, 03 medical and health sciences, Adequacy decisions, Health Research, 030305 genetics & heredity, EU Law, Schrems II, Third Country DataTransfers, 030304 developmental biology, General Data Protection Regulation
Abstract

On July 16th, 2020, the Court of Justice of the European Union issued a landmark decision in the case of Data Protection Commissioner v. Facebook Ireland Ltd, Maximillian Schrems (Schrems II) concerning the legality of Facebook’s transfers of personal data from the EU to the US. The decision has potentially significant effects on the ability of researchers to legitimately transfer personal data for health research purposes from countries inside the EU, to third countries outside the EU.[1] This article aims: i) to outline the consequences of the Schrems II decision for the legitimate sharing of personal data for health research between the EU and third countries, particularly in the context of the COVID-19 pandemic; and, in light of this elaboration, ii) to consider the avenues that might be pursued to remedy challenges posed by the decision and to facilitate international data exchange for health research moving forward. &nbsp

Published
2020
Full Text
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44. international data governance landscape.

Author

Bernier, Alexander, Molnár-Gábor, Fruzsina, and Knoppers, Bartha Maria

Subjects
DATA protection, BIOETHICS, CONSORTIA, PUBLIC law, CIVIL law, BIG data
Abstract

As the adoption of digital health accelerates health research increasingly relies on large quantities of biomedical data. Research institutions scattered across a large number of jurisdictions collaborate in producing and analyzing biomedical big data. National data protection legislation, for its part, grows increasingly complex and localized. To respond to heterogeneous legal requirements arising in numerous jurisdictions, decentralized health consortia must develop scalable organizational and 6 technological arrangements that enable data flows across jurisdictional boundaries. In this article, proposals are made to enable health sector organisations to align established biomedical ethics process and data analysis practices to shifting data protection norms through both public law co-regulation, private law tools, and design-oriented approaches. [ABSTRACT FROM AUTHOR]

Published
2022
Full Text
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