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Klingström, T., Bongcam Rudloff, E. & Reichel, J. (2018). Legal & ethical compliance when sharing biospecimen. Briefings in Functional Genomics & Proteomics, 17(1), 1-7
Open this publication in new window or tab >>Legal & ethical compliance when sharing biospecimen
2018 (English)In: Briefings in Functional Genomics & Proteomics, ISSN 2041-2649, E-ISSN 2041-2657, Vol. 17, no 1, p. 1-7Article, review/survey (Refereed) Published
Abstract [en]

When obtaining samples from biobanks, resolving ethical and legal concerns is a time-consuming task where researchers need to balance the needs of privacy, trust and scientific progress. The Biobanking and Biomolecular Resources Research Infrastructure-large Prospective Cohorts project has resolved numerous such issues through intense ommunication between involved researchers and experts in its mission to unite large  rospective study sets in Europe. To facilitate efficient communication, it is useful for onexperts to have an at least basic understanding of the regulatory systemformanaging biological samples. Laws regulating research oversight are based on national law and normally share core principles founded on international charters. In interview studies among donors, chief concerns are privacy, efficient sample utilization and access to information generated fromtheir samples. Despite a lack of clear evidence regarding which concern takes precedence, scientific as well as public discourse has largely focused on privacy concerns and the right of donors to control the usage of their samples. It is therefore important to  roactively deal with ethical and legal issues to avoid complications that delay or prevent samples from being accessed. To help biobank professionals avoid making unnecessary mistakes, we have developed this basic primer covering the relationship between ethics and law, the concept of informed consent and considerations for returning findings to donors.

Place, publisher, year, edition, pages
Oxford: Oxford University Press, 2018
Keywords
Law, ethics, dataprotection, informed consent
National Category
Law and Society Medical Biotechnology (with a focus on Cell Biology (including Stem Cell Biology), Molecular Biology, Microbiology, Biochemistry or Biopharmacy) Medical Ethics
Identifiers
urn:nbn:se:uu:diva-346080 (URN)10.1093/bfgp/elx008 (DOI)000423309600001 ()28460118 (PubMedID)
Projects
B3Africa
Funder
EU, FP7, Seventh Framework Programme, 313010EU, Horizon 2020, 654404
Available from: 2018-03-14 Created: 2018-03-14 Last updated: 2018-05-16Bibliographically approved
Reichel, J. (2018). Offentlighet eller dataskydd som ledande princip i EU:s integrerade förvaltning?. Förvaltningsrättslig Tidskrift (1), 91-113
Open this publication in new window or tab >>Offentlighet eller dataskydd som ledande princip i EU:s integrerade förvaltning?
2018 (Swedish)In: Förvaltningsrättslig Tidskrift, ISSN 0015-8585, no 1, p. 91-113Article in journal (Refereed) Published
Abstract [sv]

Informationshantering har kommit att bli en central del i samarbetet mellan EU:s institutioner, myndigheter och organ och nationella myndigheter, vanligen benämnt den europeiska integrerade förvaltningen. En stor del av de kontakter som tas mellan de samarbetande myndigheterna rör insamling, delning och spridning av information, både i myndigheternas faktiska förvaltning och som underlag i enskilda ärenden. Reglering av informationshantering har utvecklats till ett viktigt policyområde för EU-lagstiftaren, med bl.a. en strategi för en inre digital marknad och en ny allmän dataskyddsförordning som träder i kraft i maj 2018. Därutöver har EU-domstolen utvecklat en progressiv praxis till skydd för den grundläggande rätten till skydd för personuppgifter. En viktig fråga ur svenskt perspektiv är hur utvecklingen påverkar den svenska offentlighetsprincipen, såsom den kommer till uttryck i tryckfrihetsförordningen. I artikeln analyseras rättsfall från EU-domstolen och Högsta förvaltningsdomstolen som väger intresset av offentlighet mot intresset av dataskydd, liksom förslaget om reglering av informationshantering i ReNEUALs  modellag för den europeiska förvaltningen. Kan Sverige fortsätta att ha offentlighetsprincipen som den ledande principen för sin förvaltning, när förvaltningen i en allt större utsträckning samverkar och delar information med europeiska och nationella organ inom EU:s integrerade förvaltning?

National Category
Law (excluding Law and Society)
Research subject
Administrative Law; Administrative Law
Identifiers
urn:nbn:se:uu:diva-346023 (URN)
Available from: 2018-03-14 Created: 2018-03-14 Last updated: 2018-05-16Bibliographically approved
Reichel, J. (2017). Europeiska principer för god förvaltning (3ed.). In: Lena Marcusson (Ed.), Offentligrättsliga principer: . Iustus förlag
Open this publication in new window or tab >>Europeiska principer för god förvaltning
2017 (Swedish)In: Offentligrättsliga principer / [ed] Lena Marcusson, Iustus förlag, 2017, 3Chapter in book (Other academic)
Place, publisher, year, edition, pages
Iustus förlag, 2017 Edition: 3
National Category
Law (excluding Law and Society)
Research subject
Administrative Law
Identifiers
urn:nbn:se:uu:diva-346081 (URN)978-91-7678-993-3 (ISBN)
Available from: 2018-03-14 Created: 2018-03-14 Last updated: 2018-05-16Bibliographically approved
Slokenberga, S., Merino Martinez, R. & Reichel, J. (2017). Legal and ethical governance of intercontinental biobanking: Some experiences from a H2020 project. Förvaltningsrättslig Tidskrift (1), 169-192
Open this publication in new window or tab >>Legal and ethical governance of intercontinental biobanking: Some experiences from a H2020 project
2017 (English)In: Förvaltningsrättslig Tidskrift, ISSN 0015-8585, no 1, p. 169-192Article in journal (Refereed) Published
Abstract [en]

Biobanks exist today on every continental though they have evolved differently in different parts of the world. The African States have been involved in biobank research for a considerable time but for decades large volumes of data and samples have been transferred outside the continent to developed countries for their storage and eventual further use, thus affecting the capacity-building and development for researchers in Africa. Currently, there are ongoing projects to build biobank research capacity within the regions where they are at an early developmental stage and collaborate transnationally in that regard. One of them is B3Africa, an EU-funded project that aims to facilitate collaboration between selected EU Member States and the African States and enhance mutual data and sample exchange between the EU and African States. Within the project, an informatics platform, the eB3Kit, is being developed. The platform integrates available open-source software, services and tools for biobanking and bioinformatics. Further, an ethical and legal framework for collaboration is being drafted that may bridge biobank research activities in the EU Member States and the African States. This article focuses on the latter, the ethical and legal framework.

Keywords
intercontinental biobanking data protection transfer
National Category
Law (excluding Law and Society)
Research subject
Administrative Law
Identifiers
urn:nbn:se:uu:diva-323944 (URN)
Projects
B3Africa
Funder
EU, Horizon 2020, 654404
Available from: 2017-06-11 Created: 2017-06-11 Last updated: 2018-05-16Bibliographically approved
Reichel, J. (2017). Oversight of EU medical data transfers: An administrative law perspective on cross-border biomedical research administration. Health and Technology, 7(4), 389-400
Open this publication in new window or tab >>Oversight of EU medical data transfers: An administrative law perspective on cross-border biomedical research administration
2017 (English)In: Health and Technology, ISSN 2190-7188, E-ISSN 2190-7196, Vol. 7, no 4, p. 389-400Article in journal (Refereed) Published
Abstract [en]

The notionof privacy has longhad a central rolein human rights law, not least in connection to health and medicine.International, regional and national bodies have enacted a number of binding and non-binding document for physicians and researchers to adhere to, in order to protect the autonomy, dignity and privacy of patients and research subjects. With the development of new technologies, the right to privacy has gained a new perspective; the right to protection of personal data with in information and communication technologies. The right to data protection has been attributed an increasing  importance within EU law. Accordingly, the use of health data in medical research in general and in biobankrelated medical research in particular, has made data protection law highly relevant. In medical research involving biobanks, transferring human biological samples and/or individual health data is taking place on a daily basis.These transfers involve several oversight bodies, institutional review boards (IRBs), research ethics committees, or even data protection authorities. This article investigates the role of these national oversight bodies in the transfer of health data in cross border research, from an EU law point of view. A special focus is laid on transfer of health data for research purposes from the EU to the US, in the light of the recently enacted EU US Privacy Shield.The main question posed is how American oversight bodies for medical research can be expected to handle the increasingly strict EU requirements for the processing of health data in medical research review.

Keywords
privacy, data protection, health, data transfer, EU, US, ethical review
National Category
Law (excluding Law and Society)
Research subject
Administrative Law
Identifiers
urn:nbn:se:uu:diva-323943 (URN)10.1007/s12553-017-0182-6 (DOI)000424076200009 ()29308345 (PubMedID)
Projects
B3Africa
Funder
EU, Horizon 2020, 654404
Available from: 2017-06-11 Created: 2017-06-11 Last updated: 2018-05-16Bibliographically approved
Persson, M., Giertz, M., Hellstadius, Å., Nilsson, M., Reichel, J., Sjödin, E., . . . Åhman, K. (2017). Svensk juridik. Stockholm: Wolters Kluwer
Open this publication in new window or tab >>Svensk juridik
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2017 (Swedish)Book (Other academic)
Abstract [sv]

Svensk juridik är en grundläggande lärobok i juridik där författarna på ett modernt, pedagogiskt och överskådligt sätt beskriver stora delar av det svenska rättssystemet. Boken går förhållandevis djupt för att vara en grundläggande lärobok, samtidigt som författarna lagt ner mycket arbete på att anpassa texten till modernt språkbruk. En mängd exempel och förklarande skisser gör det komplicerade mer lättillgängligt. Författarnas ambition är inte endast att läsaren ska få förståelse för juridiken utan även vinna insikt om hur juridiken används och fungerar i praktiken.

Place, publisher, year, edition, pages
Stockholm: Wolters Kluwer, 2017. p. 710
National Category
Law (excluding Law and Society)
Identifiers
urn:nbn:se:uu:diva-346028 (URN)978-91-39-20790-0 (ISBN)
Available from: 2018-03-14 Created: 2018-03-14 Last updated: 2018-06-04Bibliographically approved
Reichel, J. (2017). The Swedish Right to Freedom of Speech, EU Data Protection Law and the Question of Territoriality. In: Anna-Sara Lind, Jane Reichel & Inger Österdahl (Ed.), Transparency in the future: Swedish openess 250 years (pp. 201-224). Tallin: Ragulka
Open this publication in new window or tab >>The Swedish Right to Freedom of Speech, EU Data Protection Law and the Question of Territoriality
2017 (English)In: Transparency in the future: Swedish openess 250 years / [ed] Anna-Sara Lind, Jane Reichel & Inger Österdahl, Tallin: Ragulka , 2017, p. 201-224Chapter in book (Other academic)
Abstract [en]

Sweden and the EU have quite different traditions when it comes to freedom of the press, freedom of expression and transparency on the one hand, and the protection on privacy and data protection on the other. One way these differences manifest themselves is in the choice of territorial scope of the respective legal framework.  The two Swedish basic acts, the Freedom of the Press Act (FPA) and the Fundamental Law on Freedom of Expression (FLFE),have a rather strict national approach; they aim at protecting Swedish freedom of press, including the right to public documents, and freedom of expression within the borders of Sweden. For examples, according to the FPA, all limitations of the right to access to documents must be set out clearly in a Swedish law, the Public Access to Information and Secrecy Act. Any other interest that might deserve an exception from the right to access to documents held by Swedish authorities that is not listed in this act will therefore not be protected. The Swedish freedom of the press act can be contrasted to the EU data protection law,  which has a wide scope of application, which may even be described as extraterritorial.  EU data protection law also directs itself to processors outside the sphere of application of the specific EU acts, by only permitting transfer of personal data if one of the mechanisms in the acts are followed; under an adequacy decision of the Commission, with the availability of adequate safeguard, or, if none of the above, closely defined exceptions to the rules. From the Safe Harbor verdict of the Court of Justice of the European Union, and the aftermath of the EU-US privacy shield, it is clear that the EU has high demands on those wanting to process EU data in third countries.

In this chapter I will contrast the nationally ­based approach on regulating the Swedish FPA and FLFE to the far­reaching protection law, where the main goal seems to be the protection of EU personal data according to an EU standard wherever it is processed in the world. The question posed is how to understand the territorial restrictions of a legal order, and lawmakers wishes to protect the individuals within this territory.

Place, publisher, year, edition, pages
Tallin: Ragulka, 2017
Keywords
Transperency, data protection, territoriality
National Category
Law (excluding Law and Society)
Research subject
Administrative Law
Identifiers
urn:nbn:se:uu:diva-323940 (URN)
Available from: 2017-06-11 Created: 2017-06-11 Last updated: 2018-05-16Bibliographically approved
Bessani, A., Brandt, J., Bux, M., Cogo, V., Dimitrova, L., Dowling, J., . . . Zimmermann, K. (2016). BiobankCloud: A Platform for the Secure Storage, Sharing, and Processing of Large Biomedical Data Sets. In: BIOMEDICAL DATA MANAGEMENT AND GRAPH ONLINE QUERYING: . Paper presented at 1st International Workshop on Data Management and Analytics for Medicine and Healthcare (DMAH) / Workshop on Big-Graphs Online Querying (Big-O (Q)), AUG 31-SEP 04, 2015, Waikoloa, HI (pp. 89-105).
Open this publication in new window or tab >>BiobankCloud: A Platform for the Secure Storage, Sharing, and Processing of Large Biomedical Data Sets
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2016 (English)In: BIOMEDICAL DATA MANAGEMENT AND GRAPH ONLINE QUERYING, 2016, p. 89-105Conference paper, Published paper (Refereed)
Abstract [en]

Biobanks store and catalog human biological material that is increasingly being digitized using next-generation sequencing (NGS). There is, however, a computational bottleneck, as existing software systems are not scalable and secure enough to store and process the incoming wave of genomic data from NGS machines. In the BiobankCloud project, we are building a Hadoop-based platform for the secure storage, sharing, and parallel processing of genomic data. We extended Hadoop to include support for multi-tenant studies, reduced storage requirements with erasure coding, and added support for extensible and consistent metadata. On top of Hadoop, we built a scalable scientific workflow engine featuring a proper workflow definition language focusing on simple integration and chaining of existing tools, adaptive scheduling on Apache Yarn, and support for iterative dataflows. Our platform also supports the secure sharing of data across different, distributed Hadoop clusters. The software is easily installed and comes with a user-friendly web interface for running, managing, and accessing data sets behind a secure 2-factor authentication. Initial tests have shown that the engine scales well to dozens of nodes. The entire system is open-source and includes pre-defined workflows for popular tasks in biomedical data analysis, such as variant identification, differential transcriptome analysis using RNA-Seq, and analysis of miRNA-Seq and ChIP-Seq data.

Series
Lecture Notes in Computer Science, ISSN 0302-9743 ; 9579
National Category
Medical Ethics
Identifiers
urn:nbn:se:uu:diva-311409 (URN)10.1007/978-3-319-41576-5_7 (DOI)000387957300007 ()9783319415765; 9783319415758 (ISBN)
Conference
1st International Workshop on Data Management and Analytics for Medicine and Healthcare (DMAH) / Workshop on Big-Graphs Online Querying (Big-O (Q)), AUG 31-SEP 04, 2015, Waikoloa, HI
Available from: 2016-12-27 Created: 2016-12-27 Last updated: 2018-05-16Bibliographically approved
Reichel, J. (2016). Den svenska förvaltningsmodellen i det europeiska samarbetsprojektet. In: Ingvar Mattson (Ed.), Statskontoret och Sieps, Statsförvaltningen efter 20 år i EU, om offentlig sektor, 2016: (pp. 57-81). Stockholm: Statskontoret
Open this publication in new window or tab >>Den svenska förvaltningsmodellen i det europeiska samarbetsprojektet
2016 (Swedish)In: Statskontoret och Sieps, Statsförvaltningen efter 20 år i EU, om offentlig sektor, 2016 / [ed] Ingvar Mattson, Stockholm: Statskontoret , 2016, p. 57-81Chapter in book (Other (popular science, discussion, etc.))
Place, publisher, year, edition, pages
Stockholm: Statskontoret, 2016
Keywords
EU förvaltning IMI dataskydd offentlighet
National Category
Law and Society
Research subject
Administrative Law
Identifiers
urn:nbn:se:uu:diva-291378 (URN)978-91-7220-912-1 (ISBN)
Available from: 2016-05-02 Created: 2016-05-02 Last updated: 2016-06-22Bibliographically approved
Gholami, A., Lind, A.-S., Reichel, J., Litton, J.-E., Edlund, Å. & Laure, E. (2016). Design and Implementation of the advanced cloud privacy threat modeling. International Journal of Network Security & Its Applications, 8(2), 103-122
Open this publication in new window or tab >>Design and Implementation of the advanced cloud privacy threat modeling
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2016 (English)In: International Journal of Network Security & Its Applications, ISSN 0975-2307, E-ISSN 0974-9330, Vol. 8, no 2, p. 103-122Article in journal (Refereed) Published
Abstract [en]

Privacy-preservation for sensitive data has become a challenging issue in cloud computing. Threat modeling as a part of requirements engineering in secure software development provides a structured approach for identifying attacks and proposing countermeasures against the exploitation of vulnerabilities in a system. This paper describes an extension of Cloud Privacy Threat Modeling (CPTM) methodology for privacy threat modeling in relation to processing sensitive data in cloud computing environments. It describes the modeling methodology that involved applying Method Engineering to specify characteristics of a cloud privacy threat modeling methodology, different steps in the proposed methodology and corresponding products. In addition, a case study has been implemented as a proof of concept to demonstrate the usability of the proposed methodology. We believe that the extended methodology facilitates the application of a privacy-preserving cloud software development approach from requirements engineering to design.

Keywords
Threat Modeling, Privacy, Method Engineering, Cloud Software Development
National Category
Law (excluding Law and Society)
Research subject
Public Law
Identifiers
urn:nbn:se:uu:diva-286414 (URN)
Projects
bbmri.se
Funder
Swedish Research Council
Available from: 2016-05-06 Created: 2016-04-20 Last updated: 2017-05-04Bibliographically approved
Organisations
Identifiers
ORCID iD: ORCID iD iconorcid.org/0000-0001-7509-4804

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