The Ethical and Legal Regulation of Human Tissue and Biobank Research Across the 27 European Member States Plus Switzerland

Total Page:16

File Type:pdf, Size:1020Kb

The Ethical and Legal Regulation of Human Tissue and Biobank Research Across the 27 European Member States Plus Switzerland uman tissue and biobank research is of increasing importance for Katharina Beier, Hunderstanding the causes of widespread diseases and developing Silvia Schnorrer, effective therapies. However, while the success of biobank research depends Nils Hoppe, on the availability of a large number of samples and the consolidation of collections across country borders is very desirable from the perspective Christian Lenk (eds.) of researchers, the legal and ethical requirements for the procurement, storage and use of human tissue samples are rather heterogeneous across The Ethical and different countries. Moreover, the lack of comprehensive supranational Legal Regulation of regulation on human tissue and biobanking can be seen as posing a serious threat to transnational biomedical research. Against this background, it was Human Tissue and one of the aims of the EU-funded Tiss.EU project (“Evaluation of Legislation Biobank Research and Related Guidelines on the Procurement, Storage and Transfer of Human Tissues and Cells in the European Union – an Evidence-Based Impact Analysis”) in Europe to analyse the ethical and legal regulation of human tissue and biobank research across the 27 European Member States plus Switzerland. The Proceedings of the results of nine international workshops and three conferences are gathered in this volume. While the country reports evaluate the implementation of Tiss.EU Project ethical and legal guidelines at a national level, point out their strengths and deficits, and, where required, create an evidence base for the revision of said legislation, the conference reports address more general ethical and legal issues in this field. The volume is completed by a final presentation of project’s results. U4 Sichtbare Fläche 167 x 246 mm U1 Sichtbare Fläche 167 x 246 mm Bei Randabfallenden Farbflächen oder Bildern Bei Randabfallenden Farbflächen oder Bildern muss die Farbfläche oder die Bild Datei in den muss die Farbfläche oder die Bild Datei in den iobank Research in Europe in Research iobank Überklebungsbereich gehen. B Überklebungsbereich gehen. Bitte auch für den Buchrücken beachten. Bitte auch für den Buchrücken beachten. Buchrücken Muster Breite 10 x 246 mm Beier/Schnorrer/Hoppe/Lenk (eds.) The Ethical and Legal Regulation of Human Tissue and Tissue Human of Regulation Legal and Ethical The (eds.) Beier/Schnorrer/Hoppe/Lenk ISBN: 978-3-86395-031-6 Universitätsverlag Göttingen Universitätsverlag Göttingen Katharina Beier, Silvia Schnorrer, Nils Hoppe, Christian Lenk (eds.) The Ethical and Legal Regulation of Human Tissue and Biobank Research in Europe This work is licensed under the Creative Commons License 3.0 “by-nd”, allowing you to download, distribute and print the document in a few copies for private or educational use, given that the document stays unchanged and the creator is mentioned. You are not allowed to sell copies of the free version. erschienen im Universitätsverlag Göttingen 2011 Katharina Beier, Silvia Schnorrer, Nils Hoppe, Christian Lenk (eds.) The Ethical and Legal Regulation of Human Tissue and Biobank Research in Europe Proceedings of the Tiss.EU Project Universitätsverlag Göttingen 2011 Bibliographische Information der Deutschen Nationalbibliothek Die Deutsche Nationalbibliothek verzeichnet diese Publikation in der Deutschen Nationalbibliographie; detaillierte bibliographische Daten sind im Internet über <http://dnb.ddb.de> abrufbar. Address of the Editor Katharina Beier E-mail: [email protected] This work is protected by German Intellectual Property Right Law. It is also available as an Open Access version through the publisher’s homepage and the Online Catalogue of the State and University Library of Goettingen (http://www.sub.uni-goettingen.de). Users of the free online version are invited to read, download and distribute it. Users may also print a small number for educational or private use. However they may not sell print versions of the online book. Satz und Layout: Katharina Beier Umschlaggestaltung: Franziska Lorenz © 2011 Universitätsverlag Göttingen http://univerlag.uni-goettingen.de ISBN: 978-3-86395-031-6 Contents Introduction 1 Ethical and Legal Aspects of Research with Human Tissue in Europe 7 (First International Conference, Göttingen) Katharina Beier Rights and Entitlements in Human Tissue and Cells 19 (First International Workshop, Hannover) Katharina Beier Anonymisation and Pseudonymisation as Means of Privacy Protection 25 (Second International Workshop, Budapest) Petra Bárd, Judit Sándor Biobanks for Research Purposes 35 (Third International Workshop, Paris) Christine Noiville, Florence Bellivier, Virginie Commin Privacy, Confidentiality and Personality Rights in Biobanking and 51 Genetic Research with Human Tissue (Second International Conference, Göttingen) Katharina Beier Procurement, Storage and Transfer of Tissues and Cells for 61 Non-Clinical Purposes in a Legal and Ethical Perspective (Fourth International Workshop, Padova) Alessandra Bernardi, Luciana Caenazzo, Renzo Pegoraro Rights and Entitlements in Human Tissue and Cells: 77 the BENELUX Countries (Fifth International Workshop, Leiden) Jasper A. Bovenberg Anonymisation and Pseudonymisation as Means of Privacy Protection 89 (Sixth International Workshop, Stockholm) Claudio Tamburrini The Transfer, Storage and Procurement of Human Cells and Tissues 105 (Seventh International Workshop, Dublin) Elizabeth Yuko, Bert Gordijn Biobanking: Ethics, Governance and Regulation 119 (Eighth International Workshop, Birmingham) Sean Cordell Procurement, Storage and Transfer of Tissues and Cells for 131 Non-Clinical Research Purposes (Ninth International Workshop, Vilnius) Vilius Dranseika, Eugenijus Gefenas The Future of Biobanking in Europe: Searching for Answers 139 to the Ethical and Legal Challenges of Human Tissue Research (Final International Conference, Göttingen) Katharina Beier, Silvia Schnorrer Conclusions 161 Katharina Beier Introduction The Tiss.EU project – with full title “Evaluation of Legislation and Related Guide- lines on the Procurement, Storage and Transfer of Human Tissues and Cells in the European Union - an Evidence-Based Impact Analysis” – was funded by the Eu- ropean Commission in the 7th Framework Programme from April 2008 until March 2011. Within this project researchers from ten different European countries addressed questions of ethical and legal regulation regarding human tissue research. For this purpose, they analysed the respective legislation and guidelines in and across Europe, evaluating their implementation at a national level, their strengths and deficits, and, where required, created an evidence base for the revision of said legislation. This was made necessary by the lack of a comprehensive EU regulation on human tissue and biobanking, which poses a serious threat to transnational biomedical research. The legislation that exists so far covers mainly clinical applica- tion. In order to achieve its goal, the Tiss.EU project organized nine international workshops and three International Status Conferences during its three year project period, providing a platform for leading experts in the field of human tissue and biobank research. This allowed for the gathering of information on the current legislation in the 27 EU member states plus Switzerland. The present volume col- lects the revised reports on these events. Besides this, the documents, in their orig- inal form, can also be found at the project’s website, www.tisseu.org. One of the aims of the Tiss.EU project was the establishment of an information portal freely accessible to interested scientists as well as the broader public. The website also hosts an extensive database of legal documents, ethical guidelines and scientific articles on human tissue and biobanking to facilitate further research in the field. It will be maintained beyond the project period. During its term, the Tiss.EU project also set up a network of experts in the field of human tissue research, which connects about 150 representatives from a 2 Introduction multitude of disciplines, including ethicists, lawyers, physicians, policy makers and non-governmental institutions, from the whole of the European Union and Swit- zerland. The organizational structure of the Tiss.EU project was two-layered: on the one hand, there was a consortium consisting of the coordinating institution in Goettingen (Germany) and the nine academic partners from different EU Member States, namely France, Germany, Hungary, Ireland, Italy, Lithuania, Sweden, The Netherlands and the United Kingdom. Each partner was assigned a country group of two to five EU countries, which reported on the current regulation on human tissue and biobank research in their respective countries.1 On the other hand, the partners were teamed up in groups of two to three to evaluate the leading ethical and legal issues for human tissue research that arose with regard to one of the project’s four focal themes. Identifica- Coordinator, Collection tion of partner and dissemi- external institutions nation at the experts for and country online data- all EU groups base and the Member project States plus website as a Recommenda- Switzerland comprehen- tions from the by the Analysis of sive infor- project project the four mation partners focal themes source (workshops & confer- ences) 1 The country reports refer to a range of legal documents and guidelines on human tissue and biobank research. Insofar an English translation is available, these documents are accessible via the Tiss.EU website www.tisseu.org (under the
Recommended publications
  • Review of Scientific Self-Experimentation: Ethics History, Regulation, Scenarios, and Views Among Ethics Committees and Prominent Scientists
    Rejuvenation Research Page 1 of 41 © Mary Ann Liebert, Inc. DOI: 10.1089/rej.2018.2059 1 Review of Scientific Self-experimentation: ethics history, regulation, scenarios, and views among ethics committees and prominent scientists. Brian Hanley, Butterfly Sciences, POBox 2363, Davis, CA 95616, USA. [email protected] William Bains, Rufus Scientific Ltd. 37 The Moor, Melbourn, Royston, Hertsfordshire, SG8 nt scientists. (DOI: 10.1089/rej.2018.2059) 10.1089/rej.2018.2059) scientists. nt (DOI: 6ED, UK. [email protected] nal published version may fromdiffer this proof. George Church, Department of Genetics, Harvard Medical School, Boston, MA 02115, USA. Word count: 5,969 Address for correspondence and reprints: [email protected] Keywords: ethics, research history, human research, medical ethics; self-experimentation, n-of-1 Abbreviated title: Review of Scientific Self-experimentation Rejuvenation Research lation, scenarios, and views among ethics committees and promine Downloaded by UNIVERSITY OF FLORIDA from www.liebertpub.com at 06/25/18. For personal use only. Review of Scientific Self-experimentation: regu ethics history, This paper has been peer-reviewed and accepted publication,for but has yet to copyediting undergo correction. and proof The fi Page 2 of 41 2 Abstract We examine self-experimentation ethics history and practice, related law, use scenarios in universities and industry, and attitudes. We show through analysis of the historical development of medical ethics and regulation, from Hippocrates through Good Clinical Practice that there are no ethical barriers to self-experimentation. When the self- experimenter is a true investigator, there is no other party to be protected from unethical behavior.
    [Show full text]
  • A DNA Database in the NHS: Your Freedom up for Sale?
    A DNA database in the NHS: Your freedom up for sale? May 2013 In April 2013, the Caldicott Committee, including Government Chief Scientist Sir Mark Walport, proposed new rules for data-sharing which would allow the Government to build a DNA database of the whole population of England in the NHS by stealth.1 The plan is to make NHS medical records and people’s genetic information available to commercial companies and to use public-private partnerships to build a system where all private information about every citizen is also accessible to the police, social workers, security services and Government. The Wellcome Trust, which was involved in the Human Genome Project and was led by Walport for ten years, has produced a plan which involves including a variant file, containing the whole genome of every person minus the reference genome, as an attachment to every medical record in the NHS in England.2 This data would be made available to ‘researchers’ (including commercial companies) for data-mining in the cloud and personalised risk assessments would be returned to individuals. The aim is to transform the NHS in line with proposals developed more than a decade ago by former GlaxoSmithKline Chairman Sir Richard Sykes. This is expected to massively expand the market for medicines, medical tests and other products, such as supplements and cholesterol-lowering margarines, by allowing products to be marketed to individuals based on personal risk assessments, created using statistical analysis of genetic data, medical records and other health information. The proposal to build a DNA database in the NHS was endorsed by the Human Genomics Strategy Group in 20123,4 and the Government (led by Prime Minister David Cameron) has quietly adopted this recommendation without telling members of the public.
    [Show full text]
  • Mycode®: Engineering the Perfect Biobank
    Linking the Research Community • Spring 2015 A message from MyCode®: Engineering the David H. Ledbetter, PhD Perfect Biobank Geisinger’s biobank and the MyCode® Community Health This issue of Research Initiative began in 2004 with a phone call from Glenn D. Connections is devoted to the Steele Jr., MD, PhD, Geisinger’s former president and CEO, to MyCode® Community Health David H. Ledbetter, PhD, then at Emory University’s School Initiative, a project with the of Medicine. Speaking genetically, not meteorologically, Steele potential to change significantly described Geisinger’s Pennsylvania footprint and resources to health and healthcare. MyCode Ledbetter as being, “as close to Iceland as you’ll ever find in the will uncover new connections United States.”* between genes and disease, inform and improve the health Ledbetter, now Geisinger’s Chief Scientific Officer, found many of Geisinger’s patients and re- similarities between Iceland and Geisinger’s central Pennsylvania envision how we approach our own well-being and that of location. Like Iceland, Geisinger’s regional population was stable, our families. often with three generations in the area. In addition, Geisinger‘s healthcare was centralized with a robust electronic health record This project is possible because of Geisinger’s specific (EHR) in place since 1996. combination of assets: an established biobank; an extensive and robust electronic health record (EHR); and According to Ledbetter, the qualities listed above, along with international expertise in bioethics, medical genetics, Geisinger’s tradition of innovation, creates, “a healthcare genetic counseling and genomics. Our partnership with laboratory and an ideal model to learn when and how genetic Regeneron, an innovative biotechnology company with information can improve health.” Ledbetter described Geisinger’s extensive resources for whole exome sequencing, is key service area as, “the ideal place in the United States to do to positioning this project to make groundbreaking longitudinal, large scale, genomic medicine research.” discoveries.
    [Show full text]
  • Faqs on Applying and Accessing UK Biobank Data
    FAQs on applying and accessing UK Biobank data This document contains answers to FAQs from researchers. Please read our UK Biobank Access Policy and Procedures before registering via the UK Biobank Access Management System (AMS). For assistance you can send us a Message via AMS after you have signed up. For queries pre-registration you can email [email protected]. Registration What do I do if I am affiliated with more than one institute? You can add all your current affiliations to a single registration in AMS, listing your personal institute email address for each of them. Who can register for access to the UK Biobank Resource? The Resource is available to all bona fide researchers for all types of health-related research which is in the public interest. What is the cost of Registration? There is no cost to register. I am trying to register but the system will not let me progress. What should I do? If the mandatory fields have been completed please contact the Access Management Team for assistance. Can I register on behalf of someone else? No. The email address used to register must be your personal institute email address. I have submitted my Registration. What happens next? We aim to review all registrations within 10 working days, but this may be longer if additional information is required. My account is locked, what do I do? Follow the process for “What happens if I forget my password?” below. What happens if I forget my password? Click the ‘Forgot your password?’ link on the AMS Log in Page.
    [Show full text]
  • Bioethics and Large-Scale Biobanking: Individualistic Ethics and Collective Projects*
    Genomics, Society and Policy 2005, Vol.1, No.2, pp.50–66. Bioethics and large-scale biobanking: individualistic ethics and collective projects* GARRATH WILLIAMS Abstract Like most bioethical discussion, examination of human biobanks has been largely framed in terms of research subjects’ rights, principally informed consent, with some gestures toward public benefits. However, informed consent is for the competent, rights-bearing individual: focussing on the individual, it thus neglects social, economic and even political matters; focussing on the competent rights-bearer, it does not serve situations where consent is plainly inappropriate (eg, the young child) or where coercion can obviously be justified (the criminal). Using the British experience of large-scale biobanking, I argue that the focus on consenting individuals distorts our ways of thinking about biobanks and has serious practical ramifications. This becomes clear if we contrast the case of adult biobanks intended for medical research with two other forms of biobanking. Thus child cohort studies – vital for sound scientific investigation of the interplay of genetics and environment in health – have been very badly funded next to adult studies. On the other hand, forensic databases have attracted massive investment, but little debate – partly owing to a sense that here, at least, is a case where consent is not relevant. Contrasting these central types of biobanking, I will suggest that there are powerful factors at work in limiting ‘ethics’ to individual rights. Projects of this size should direct our attention to more overtly political questions concerning priority setting and organisation of medical research. Introduction In this paper I wish to cast a critical eye at the way in which we – meaning both bioethicists and practitioners – frame ethical and bioethical discussion.
    [Show full text]
  • Genetic Data Aren't So Special: Causes and Implications of Re
    Genetic Data Aren’t So Special: Causes and Implications of Re-identification T.J. Kasperbauer & Peter H. Schwartz Indiana University Center for Bioethics Indiana University School of Medicine This is the pre-peer-reviewed version of the article published here: https://doi.org/10.1002/hast.1183 Full citation: Kasperbauer, T.J. & Schwartz, P.H. (2020). Genetic data aren’t so special: Causes and implications of re-identification. Hastings Center Report, 50, 30-39. Abstract: Genetic information is widely thought to pose unique risks of re-identifying individuals. Genetic data reveals a great deal about who we are, and, the standard view holds, should consequently be treated differently from other types of data. Contrary to this view, we argue that the dangers of re-identification for genetic and non-genetic data—including health, financial, and consumer information—are more similar than has been recognized. Before we impose different requirements on sharing genetic information, proponents of the standard view must show that they are in fact necessary. We further argue that the similarities between genetic and non-genetic information have important implications for communicating risks during consent for healthcare and research. While patients and research participants need to be more aware of pervasive data sharing practices, consent forms are the wrong place to provide this education. Instead, health systems should engage with patients throughout patient care to educate about data sharing practices. Introduction Genetic data and biological samples containing genetic material are widely thought to differ from other sorts of health data due to the impossibility of truly “de-identifying” genetic information.
    [Show full text]
  • Occupational Therapy Code of Ethics and Ethics Standards (2010)
    Occupational Therapy Code of Ethics and Ethics Standards (2010) PREAMBLE The American Occupational Therapy Association (AOTA) Occupational Therapy Code of Ethics and Ethics Standards (2010) ("Code and Ethics Standards") is a public statement of principles used to promote and maintain high standards of conduct within the profession. Members of AOTA are committed to promoting inclusion, diversity, independence, and safety for all recipients in various stages of life, health, and illness and to empower all beneficiaries of occupational therapy. This commitment extends beyond service recipients to include professional colleagues, students, educators, businesses, and the community. Fundamental to the mission of the occupational therapy profession is the therapeutic use of everyday life activities (occupations) with individuals or groups for the purpose of participation in roles and situations in home, school, workplace, community, and other settings. "Occupational therapy addresses the physical, cognitive, psychosocial, sensory, and other aspects of performance in a variety of contexts to support engagement in everyday life activities that affect health, well being, and quality of life" AOTA, 2004). Occupational therapy personnel have an ethical responsibility primarily to recipients of service and secondarily to society. The Occupational Therapy Code of Ethics and Ethics Standards (2010) was tailored to address the most prevalent ethical concerns of the profession in education, research, and practice. The concerns of stakeholders including the public, consumers, students, colleagues, employers, research participants, researchers, educators, and practitioners were addressed in the creation of this document. A review of issues raised in ethics cases, member questions related to ethics, and content of other professional codes of ethics were utilized to ensure that the revised document is applicable to occupational therapists, occupational therapy assistants, and students in all roles.
    [Show full text]
  • Informed Consent and Refusal
    CHAPTER 3 Informed Consent and Refusal Evolution of the doctrine of informed consent Elements of informed consent and refusal The nature of informed consent Exceptions to the consent requirement Mrs. Stack is a 67- year- old woman admitted with rectal bleeding, chronic renal in- sufficiency, diabetes, and blindness. On admission, she was alert and capacitated. Two weeks later, she suffered a cardiopulmonary arrest, was resuscitated and intu- bated, and was transferred to the medical intensive care unit (MICU) in an unrespon- sive and unstable state. Consent for emergency dialysis was obtained from her son, who is also her health care agent. Dialysis was repeated two days later. During the past several years, Mrs. Stack has consistently stated to her family and her primary care doctor that she would never want to be on chronic dialysis and she has refused it numerous times when it was recommended. The physician, who has known and treated Mrs. Stack for many years, also treated her daughter who had been on chronic dialysis for some time and had died after suffering a heart attack. According to the physician and the patient’s family, Mrs. Stack’s refusal of dialysis has been based on her conviction that her daughter died as a result of the dialysis treatments. Mrs. Stack’s mental status has cleared considerably and, despite the ventilator, she is able to communicate nonverbally. Although she appears to understand the benefits of dialysis and the consequences of refusing it, including deterioration and eventual death, she has consistently and vehemently refused further treatments. Her capacity to make this decision is not now in question.
    [Show full text]
  • Sample Data Sharing Consent Form
    PREAMBLE: NINDS has the expectation that investigators will use broad consent language that allows for the storing, sharing, and use of human subjects data and specimens for future research, even if such future research may be unrelated to the original study or disorder for which the data and/or specimens were collected. NINDS expects investigators to consider including such language (or similar language as mandated by your IRB) in your consent forms in order to ensure that samples and data are available for storing, sharing and use in future, unspecified research. This language should be included in the draft consent submitted with your application and submitted to NINDS in preparation for your start-up meeting if your application is funded (EXHIBIT 1). If genetic sample collection is a component of the study, then consent language is expected to include the sharing of large-scale genomic data and associated phenotypic data in the NIH Database of Genotypes and Phenotypes (dbGaP: http://www.ncbi.nlm.nih.gov/gap). If another database is chosen, this would require pre-approval by NINDS program staff. A final, IRB-approved consent that includes this or similar language (or an explanation for why it was not included) should be submitted to NINDS program staff prior to study activation. If you have questions or need assistance developing your consent language, please feel free to contact NINDS Clinical Research Liaison (any consents) and/or Ran Zhang (consents with genetic/genomic data language). *Please note that all studies that generate large-scale human genomic data , regardless of cost, should refer to the the NIH Genomic Data Sharing (GDS) Policy for additional requirements.
    [Show full text]
  • The Views of Participants in DNA Biobanks
    The Views of Participants in DNA Biobanks Kelly E. Ormond,I Maureen E. Smith,II & Wendy A. WolfIII Abstract Biobanks are generally created with the long-term goal of establishing genotype-phenotype correlations. These resources collect and link DNA with health information for use in future genetic research studies. The biobanking process can vary with regard to specific characteristics in study design. Biobanks may extract DNA by using DNA from leftover samples or obtaining new DNA samples specifically for the biobank. Biobanks also vary in whether they use an opt- in or opt-out informed consent process. Some biobanks collect health information at a single point in time, while others “re-access” such information at designated points in the future to categorize subjects accurately into affected/unaffected status. These study design differences can influence the perception of participants and affect their willingness to participate. This paper will address the following three key issues: (1) why people decide to participate in DNA biobanks, (2) what enrollees understand about their participation in DNA biobanks, and (3) how participants feel about the possibility that biobanks will re-contact them, either to obtain new information for future studies or to share potential study results. Finally, we will suggest how information related to these three key issues ought to inform future study design for biobanks. I. INTRODUCTION.................................................................................................................81 II. WHY DO PEOPLE DECIDE TO PARTICIPATE IN DNA BIOBANKS?...........................82 III. WHAT DO ENROLLEES UNDERSTAND ABOUT THEIR PARTICIPATION IN A DNA BIOBANK? ..............................................................................................................................83 IV. HOW DO PARTICIPANTS FEEL ABOUT BIOBANK RE-CONTACT, AND HOW SHOULD THIS INFORMATION INFORM STUDY DESIGN?..............................................84 V.
    [Show full text]
  • Biobanks for Europe
    KI-NA-25-302-EN-C This expert group report on the ethical and regulatory challenges of international biobank research has been authored by an interdisciplinary group with experts from science, law, governance and ethics. Biobanks for Biobank research is rapidly evolving, and in close interaction with developments in informatics and genomics. The size and breath of the collections of biological samples and associated data that can be Europe assembled has increased exponentially. This opens up a vast range of new options for research and diagnosis, but at the same time also holds an important challenge for the governance of these activities. In this report, the expert group makes speci c recommendations for good A Challenge for Governance governance of Biobanks Research and Innovation policy Research and Innovation ed205134cover_BAT.indd 1-3 11/06/12 09:14 How to obtain EU publications Free publications: • via EU Bookshop (http://bookshop.europa.eu); • at the European Union’s representations or delegations. You can obtain their contact details on the Internet (http://ec.europa.eu) or by sending a fax to +352 2929-42758. Priced publications: • via EU Bookshop (http://bookshop.europa.eu). Priced subscriptions (e.g. annual series of the O cial Journal of the European Union and reports of cases before the Court of Justice of the European Union): • via one of the sales agents of the Publications O ce of the European Union (http://publications.europa.eu/others/agents/index_en.htm). EUROPEAN COMMISSION Directorate-General for Research and Innovation Directorate B — European Research Area Unit B6 — Ethics and gender Contact: Lino PAULA European Commission B-1049 Brussels E-mail: [email protected] ed205134cover_BAT.indd 4-6 11/06/12 09:14 EUROPEAN COMMISSION Biobanks for Europe A challenge for governance Report of the Expert Group on Dealing with Ethical and Regulatory Challenges of International Biobank Research Chair: Herbert Gottweis Rapporteur: Jane Kaye Members: Fabrizia Bignami, Emmanuelle Rial-Sebbag, Roberto Lattanzi, Milan Macek Jr.
    [Show full text]
  • Summary De-Identification Protocol V2 1. Introduction 1.1 This Note Sets
    Summary de-identification protocol V2 1. Introduction 1.1 This note sets out the UK Biobank policy for the de-identification of participant data (Participants and Participant Data) prior to its release to researchers. At the outset, two clear distinctions should be made: 1.1.1 This note does not specifically address the simple fact of an individual being identified as a Participant in UK Biobank, as many Participants choose (quite reasonably) to volunteer this information about themselves. However, UK Biobank does not itself release the identity or confirm the identity of any Participant. 1.1.2 This note does specifically address the release of Participant Data by UK Biobank to researchers where the manner in which the Participant Data is released could inadvertently identify a Participant (bearing in mind other information about the Participant which may already be in the public domain). 1.2 To illustrate: the fact that Mr Jones is a participant in UK Biobank is significant but not, of itself, an overtly significant item of information. Nevertheless, releasing information about the state of Mr Jones health to researchers in such a way that a) Mr Jones is (or can be) identified and then b) cross-referenced directly to the UK Biobank phenotypical or genotypical information which UK Biobank holds on him, would be highly problematic. The purpose of this note is to set out the steps that UK Biobank takes to, as far as UK Biobank possibly can, ensure that this does not happen. 1.3 This note also sets out certain details about the nature of the Participant Data which UK Biobank holds on Participants, UK Biobank's legal obligations, considerations around health-record linkage, practical considerations about identification and finally the actual de-identification protocols.
    [Show full text]