Al-Sarraj, S

Arzberger, T

Bell, JE

Dexter, DT

Huitinga, I

Ironside, JW

Klioueva, NM

Rademaker, MC

Schmitz, P

Seilhean, D

Streichenberger, N

Journal of Neural Transmission

Research utilizing human tissue and its removal
at post-mortem has given rise to many controversies in the
media and posed many dilemmas in the fields of law and
ethics. The law often lacks clear instructions and unambiguous
guidelines. The absence of a harmonized international
legislation with regard to post-mortem medical
procedures and donation of tissue and organs contributes to
the complexity of the issue. Therefore, within the BrainNet
Europe (BNE) consortium, a consortium of 19 European
brain banks, we drafted an ethical Code of Conduct for
brain banking that covers basic legal rules and bioethical
principles involved in brain banking. Sources include laws,
regulations and guidelines (Declarations, Conventions,
Recommendations, Guidelines and Directives) issued by
international key organizations, such as the Council of
Europe, European Commission, World Medical Association
and World Health Organization. The Code of Conduct
addresses fundamental topics as the rights of the persons
donating their tissue, the obligations of the brain bank with
regard to respect and observance of such rights, informed
consent, confidentiality, protection of personal data, collections
of human biological material and their management,
and transparency and accountability within the
organization of a brain bank. The Code of Conduct for
brain banking is being adopted by the BNE network prior
to being enshrined in official legislation for brain banking
in Europe and beyond

Spiral - Imperial College Digital Repository

NEUROLOGY AND PRECLINICAL NEUROLOGICAL STUDIES - ORIGINAL ARTICLEBrainNet Europe’s Code of Conduct for brain bankingNatasja M. Klioueva • Marleen C. Rademaker • David T. Dexter •Safa Al-Sarraj • Danielle Seilhean • Nathalie Streichenberger • Peer Schmitz •Jeanne E. Bell • James W. Ironside • Thomas Arzberger • Inge HuitingaReceived: 22 September 2014 / Accepted: 16 December 2014 / Published online: 13 January 2015 The Author(s) 2015. This article is published with open access at Springerlink.comAbstract Research utilizing human tissue and its removalat post-mortem has given rise to many controversies in themedia and posed many dilemmas in the fields of law andethics. The law often lacks clear instructions and unam-biguous guidelines. The absence of a harmonized interna-tional legislation with regard to post-mortem medicalprocedures and donation of tissue and organs contributes tothe complexity of the issue. Therefore, within the BrainNetEurope (BNE) consortium, a consortium of 19 Europeanbrain banks, we drafted an ethical Code of Conduct forbrain banking that covers basic legal rules and bioethicalprinciples involved in brain banking. Sources include laws,regulations and guidelines (Declarations, Conventions,Recommendations, Guidelines and Directives) issued byinternational key organizations, such as the Council ofEurope, European Commission, World Medical Associa-tion and World Health Organization. The Code of Conductaddresses fundamental topics as the rights of the personsdonating their tissue, the obligations of the brain bank withregard to respect and observance of such rights, informedconsent, confidentiality, protection of personal data, col-lections of human biological material and their manage-ment, and transparency and accountability within theorganization of a brain bank. The Code of Conduct forbrain banking is being adopted by the BNE network priorto being enshrined in official legislation for brain bankingin Europe and beyond.Keywords Bioethics  Brain autopsy  Brain bank Informed consent  Biobanking  NeuropathologyAll the authors participated in the project BrainNet Europe II—aNetwork of Excellence, funded by the European Commission in the6th Framework Program ‘‘Life Science’’ (LSHM-CT-2004-503039):www.brainnet-europe.org.Electronic supplementary material The online version of thisarticle (doi:10.1007/s00702-014-1353-5) contains supplementarymaterial, which is available to authorized users.N. M. Klioueva  M. C. Rademaker  I. Huitinga (&)Netherlands Brain Bank, Netherlands Institute for Neuroscience,Meibergdreef 47, 1105 BA Amsterdam, The Netherlandse-mail: i.huitinga@nin.knaw.nlD. T. DexterDivision of Brain Sciences, Department of Medicine, Centre forNeuroinflammation and Neurodegeneration, Imperial CollegeLondon, London, UKS. Al-SarrajDepartment Clinical Neuropathology, London Institute ofPsychiatry, London, UKD. SeilheanLaboratoire de Neuropathologie, Raymond Escourolle,Université Pierre et Marie Curie and INSERM, Paris, FranceN. StreichenbergerService de Neuropathologie, Groupement Hospitalier Est,Hospices Civils de Lyon, Université Lyon 1, CNRS UMR5292,INSERM U1028, Lyon, FranceP. Schmitz  T. ArzbergerCentre for Neuropathology and Prion Research, Ludwig-Maximilians-University Munich, Munich, GermanyJ. E. Bell  J. W. IronsideDepartment of Pathology, University of Edinburgh, WesternGeneral Hospital, Edinburgh, UKT. ArzbergerDepartment of Psychiatry and Psychotherapy, Ludwig-Maximilians-University Munich, Munich, Germany123J Neural Transm (2015) 122:937–940DOI 10.1007/s00702-014-1353-5IntroductionNeurological and psychiatric diseases put a high toll onpublic and personal health and cause a heavy economicburden (Wittchen et al. 2011; Smith 2011). The patholog-ical processes involved in neurological diseases such asAlzheimer’s and Parkinson’s disease are now becomingbetter understood. However, effective treatments and pre-vention measures are yet to be identified (Montine et al.2012). In psychiatric diseases, the nature of molecular andcellular changes of the brain is still obscure (Deep-Sobo-slay et al. 2011). Notwithstanding recent impressive pro-gress in MRI, genetic and biomarker studies as well asexperimental animal research, validation by histological,cellular and molecular research of the human brain is stillrequired (Lin et al. 2011). State of the art imaging tech-niques, genomics and proteomics make human brain tissueresearch more compelling than ever. However, CNS tissuesamples can generally only be obtained after death and tofoster research in human brain diseases, brain banks havebeen established worldwide (Kretzschmar 2009, Samar-asekera et al. 2013).Post-mortem removal and storage of human organs,research with human brain tissue and genetic research haveoften been the centre of media attention (Burton et al.2003) and posed a great deal of questions in the fields oflaw and ethics (Andrews 2006; Case Law 1988; Greenfield2006). Due to the relative novelty of the Brain Bank as anentity, the law is often lacking in clear instructions orspecific guidelines. Frequently, brain banks do not fit intowell-defined and harmonized legal regimes while existinglocal legal regimes applicable to donation and use ofhuman organs and tissues for research purposes differsignificantly between countries. Therefore, many uncer-tainties arise pertaining to initiation and governance of thebrain banks, informed consent, donor confidentiality ortissue commercialization, which hampers the establishmentof the valuable resources (Bell et al. 2008).The development of the Code of Conduct for brainbanking and its foundationsThe partners of the Brain Net Europe (BNE) consortium, aconsortium of 19 European brain banks, belong to a varietyof academic and/or health institutions, established in ele-ven different European countries. All of the BNE BrainBanks are either affiliated with or are part of(neuro)pathology departments or neuroscience institutes.Considerable variations in practice, policies and legalrequirements are inevitable. The lack of harmonization inEuropean legislation with regard to post-mortem medicalprocedures and donations of tissue to a biobank forresearch purposes contributes to the complexity of the field.Although a set of uniform exhaustive operating require-ments was deemed unfeasible to formulate and perhaps inmany cases undesirable to impose, we reasoned that acertain set of minimum ethical standards had to be main-tained at all times, regardless of the differences among thebrain banks. To formulate these standards, we systemati-cally surveyed various authoritative sources in the disci-plines of law and ethics. These include Declarations,Conventions, Recommendations, Guidelines and Direc-tives issued by the international governmental and non-governmental organizations, such as the Council of Eur-ope, European Commission, World Medical Associationand World Health Organization (documents used in thepreparation of the Code of Conduct see: http://www.brainnet-europe.org/index.php?option=com_content&view=article&id=104&Itemid=104%29, http://www.brainbank.nl).Specifically, the Recommendation on Research onBiological Materials of Human origin adopted by theCommittee of Ministers of the Council of Europe wasimportant in the design of the Code of Conduct and func-tioned as a template for its first draft. To establish acommon ground as well as fundamental differences in thepractices and the legal frameworks under which brainbanks operate, and to involve more BNE members in thedevelopment of the first drafts of the code of conduct, ameeting in Amsterdam was organized in November 2006.During this meeting, attendees from different BNE brainbanks have deliberated on principal points to be included inthe code of conduct, thereby setting a certain course. Thefirst draft of the Code of Conduct was presented during aBNE meeting in Stockholm, in June 2007. The discussionsduring this meeting had mainly revolved around therequirement for informed consent. Although it had beenestablished that informed consent of the donor or the nextof kin is not always prescribed by law for conducting anautopsy and retaining whole organs or tissue samples forexamination or research purposes, the BNE membersagreed that a brain bank should strive to implement theinformation and consent procedure in their daily practice(Lunetta et al. 2007; Sakr et al. 1989). By this ‘‘declarationof intention’’ in the code of conduct, an aim for a futurestandard had been set. Following this meeting, the finaldraft of the Code of Conduct has been circulated among allBNE members with a possibility to comment on its con-tents and suggest textual amendments. During the nextmeeting in Barcelona in June 2008, the final version of theCode of Conduct was ratified by all BNE brain banks.Subsequently, at an International Conference on BrainBanking, organized by the BNE network, in Munich inDecember 2008 (http://www.brainnet-europe.org/index.php?option=com_content&view=article&id=125&Itemid=141), a workshop on legal and ethical issues in Brain938 N. M. Klioueva et al.123Banking was held where the applicability of the Code ofConduct was discussed. This workshop was attended by thedirectors of Brain Banks, scientists as well as representa-tives of patient organizations from many different coun-tries. Practical examples of Code of Conduct application indaily practice were discussed.The contents of the Code of Conduct and its purposeThe Code of Conduct consists of four Chapters (for the textof BNE’s Code of Conduct for brain banking see supple-mentary material). The first Chapter sets out the objectives,general principles and the scope of the Code of Conduct, aswell as defining key terminology (indicated in the text byCapital Letters). The second Chapter deals with differentaspects of Material procurement (e.g. Informed Consent,Authorization, Incompetent persons, Autopsy). The thirdChapter states the principles that should govern the pro-cessing of the Material (e.g. financial aspects, confidenti-ality, data protection measures). The fourth Chapter isconcerned with distribution and the use of the Material forresearch. It also contains articles on research results andguidelines on how to deal with information on hereditarydiseases.The Code of Conduct for brain banking states theprinciples that should govern brain banking in general.Detailed regulations concerning the local governance of aBrain Bank are to be laid down in a different documentsuch as a Brain Bank Regulations, which should be inconcordance with the principles described in the code ofconduct. Furthermore to support the daily practice of theBrain Bank documents such as a Material TransferAgreements, Confidentiality Agreements, Tissue applica-tion forms and Personal Data Protection measures shouldbe in place. Examples of these documents are provided onthe BNE website (http://www.brainnet-europe.org/index.php?option=com_content&view=article&id=103&Itemid=103). The scope of the Code of Conduct could be widenedto cover all post-mortem tissue donations for researchpurposes, whether of CNS origin or not (for instanceperipheral lymph nodes or dorsal root ganglia), since thesame principles apply.ConclusionBNE’s Code of Conduct is being adopted by the BNEnetwork prior to being enshrined in official legislation.BNE has no legal power to enforce it. However, this Codeof Conduct is a first common European attempt to defineethical standards in Brain Banking in one document. Incase of BNE, the Code of Conduct has stimulated the BNEbrain banks to reflect on their daily practice and on thegovernance of their brain banks. We hope that brainbanking will receive more attention in future legislation,locally and internationally, and that this Code of Conductmay lay in part a foundation for more official legislation forbrain banking in Europe and beyond.Acknowledgments We are highly indebted to the late ProfessorHans Kretzschmar, leader of the BNE Consortium, who advised andsupported us throughout the development and evolution of the Codeof Conduct between 2006 until the ratification in 2008 by all BNEmembers. We remember him as an inspiring and wise guide and misshim.BNE II received research funding from the European Community’sSixth Framework Programme (LSHM-CT-2004-503039).The authors thank the valuable discussions about the Code ofConduct with other BNE consortium project leaders: Dr. DavidMeyronet, Hospices Civils de Lyon, Pinel, France; Prof. Tamas Re-vesz, Queen Square Brain Bank, Institute of Neurology, UniversityCollege London, London, UK; Dr. Giorgio Giaccone, Istituto Naz-ionale Neurologico Carlo Besta, Milan, Italy; Prof. Peter Falkai,Munich LMU Neurobiobank, Dept. of Psychiatry and Psychotherapy,LMU Munich, Germany; Prof. Herbert Budka, Institute of Neurology,Medical University of Vienna, Austria; Prof. Peter Riederer, ClinicalNeuroschemistry, University of Wuerzburg, Wuerzburg, Germany;Prof. Richard Reynolds, The UK multiple sclerosis tissue bank,Imperial College of Science, Technology and Medicine, London, UK;Prof. Irina Alafuzoff, Uppsala University, Sweden; Prof. Dr. E. Pat-souris, Dept. of Pathology, School of Medicine, Athens, Greece; Prof.Isidro Ferrer, Institut de Neuropatologia, Barcelona, Spain; Dr. PieroParchi, Dept. of Neurological Sciences, Università de Bologna,Bologna, Italia; Prof. Miklós Palkovits, Human Brain Tissue BankBudapest, Budapest, Hongary; Dr. Nenad Bogdanovic, The BrainBank at Karolinska Institutet, Stockholm, Sweden. See also http://www.brainnet-europe.org/.This publication reflects only the authors’ views and the Commu-nity is not liable for any use that may be made of the informationcontained therein.Open Access This article is distributed under the terms of theCreative Commons Attribution License which permits any use, dis-tribution, and reproduction in any medium, provided the originalauthor(s) and the source are credited.ReferencesAndrews L (2006) Who owns your body? A patient’s perspective onWashington University v. Catalona. J Law Med Ethics34:398–407Bell JE, Alafuzoff I, Al-Sarraj S, Arzberger T, Bogdanovic N, BudkaH, Dexter DT, Falkai P, Ferrer I, Gelpi E, Gentleman SM,Giaccone G, Huitinga I, Ironside JW, Klioueva N, Kovacs GG,Meyronet D, Palkovits M, Parchi P, Patsouris E, Reynolds R,Riederer P, Roggendorf W, Seilhean D, Schmitt A, Schmitz P,Streichenberger N, Schwalber A, Kretzschmar H (2008) Man-agement of a twenty-first century brain bank: experience in theBrainNet Europe consortium. Acta Neuropathol 115:497–507Burtun JL, Underwood JC (2003) Necropsy practice after the ‘‘organretention scandal’’: requests, performance, and tissue retention.J Clin Pathol 56:537–541Deep-Soboslay A, Benes FM, Haroutunian V, Ellis JK, Kleinman JE,Hyde TM (2011) Psychiatric brain banking: three perspectivesBrainNet Europe’s Code of Conduct for brain banking 939123on current trends and future directions. Biol Psychiatry69:104–112Greenfield DL (2006) Greenberg v. 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BrainNet Europe's Code of Conduct for brain banking

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BrainNet Europe's Code of Conduct for brain banking

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