Ethical and Legal Dimensions

Objectives

To identify and investigate significant ethical and legal challenges raised by the work of all REBIRTH research groups; to contribute to scholarly debate and academic literature in appraising and resolving these challenges; to facilitate and support ethically and legally sound approaches within REBIRTH by providing guidance and dialogue to other research groups.

Research Focus

The project of Dietmar Hübner focuses on the ethical evaluation of the creation and use of human-animal chimeras and hybrids (HACHs). The subgroup has established a comprehensive systematic review of pertinent ethical arguments in this field (Kwisda, White, Hübner, under review). It has also developed a novel ethical account of HACHs, highlighting a paradoxical interplay of “individual species arguments” 

(ISAs), referring to the individual level of protection that HACHs might be accorded due to their partly human species membership, and “group species arguments” (GSAs), referring to the possibility of HACHs blurring normatively essential boundaries between species (Hübner 2018, Journal of Medicine and Philosophy). The group currently intensifies its research into concrete scenarios of HACH generation and use.

 

The research group of Daniel Strech within Unit 10.7 focuses on Public Involvement, Informed Consent, and Ethics Review in regenerative medicine. This group contributes to a professionalization of “consent management”, “risk‐benefit analysis” and “public involvement” in regenerative medicine and related topics in biomedical research and innovation. A more scientific and internationally consented approach to these three core elements of governance in regenerative medicine aims to protect patients’ and research participants’ rights and the freedom and feasibility of biomedical research and innovation. Results from the different studies performed by this group also aim to improve the reporting standards and editorial policies on research with biomaterials.

Collaborations

  • Centre for Health, Law and Emerging Technologies, University of Oxford
  • Indiana University Center for Bioethics, Indiana University, USA
  • Institute for Science, Innovation and Society, University of Oxford
  • Mason Institute for Medicine, Life Sciences and the Law, University of Edinburgh
  • European School of Molecular Medicine, Milan
  • Department of Social Science, Health & Medicine, King’s College London
  • Biomedical Ethics Unit, McGill University.

    Further Research Projects

    • DFG project ‘STRUCTURES – Structure and Transparency in Translational Research’ (Strech)
    • BMBF project ‘FairBBank – Fair Allocation of Scarce Sample in Biobank Research” (Strech)
    • BMBF project ‘EUREM – Ethics University for Regenerative Medicine’ (Strech)
    • SFB/TRR127 'Biology of xenogeneic cell and organ transplantation - from bench to bedside' (Hoppe)
    • EU Horizon2020 Project ARISE 'Aortic Valve Replacement using Individualised Regenerative Allografts: Bridging the Therapeutic Gap' (Hoppe)
    • IMI Project EBiSC ‘European Bank for induced pluripotent Stem Cells’ (Hoppe)
    • EU FP7 Project EUCELLEX ‘Cell-based regenerative medicine: new challenges for EU legislation and governance’ (Hoppe)
    • BMBF Programme IFB-Tx 'Integrated Research and Treatment Center Transplantation' (Core Facility) (Hoppe)
    • DFG Research Training Group 2073 'Ethics and Epistemology of Science' (Hoppe, Hübner)

    Teaching

    • Biotechnology Law (Faculty of Law, Leibniz Universität Hannover)
    • Biotechnology Law (European School of Molecular Medicine, Milan)
    • Ethics and Law in the Life Sciences Research Seminar (Leibniz Universität Hannover)
    • Medical and Public Health Ethics (Medizinische Hochschule Hannover)
    • Research Ethics (University of Zurich)
    • PhD Programme LAST-JD
    • PhD Programme IFB-Tx

    Further Information

    Centre for Ethics and Law in the Life Sciences:

    Publications

    2013 - ongoing

     2018

    Wieschowski S, Chin WWL, Federico C, Sievers S, Kimmelman J, Strech D. Preclinical efficacy studies in investigator brochures: Do they enable risk-benefit assessment? PLoS Biol. 2018;16(4):e2004879.

    Hübner D. Human-Animal Chimeras and Hybrids: An Ethical Paradox behind Moral Confusion? The Journal of Medicine and Philosophy: A Forum for Bioethics and Philosophy of Medicine. 2018;43(2):187-210.

     2017

    Bossert S, Kahrass H, Heinemeyer U, Prokein J, Strech D. Participatory improvement of a template for informed consent documents in biobank research - study results and methodological reflections. BMC Med Ethics. 2017;18(1):78.

    Bossert S, Strech D. An integrated conceptual framework for evaluating and improving 'understanding' in informed consent. Trials. 2017;18(1):482.

    Hübner D. Three Remarks on “Reflective Equilibrium“: On the Use and Misuse of Rawls’ Balancing Concept in Contemporary Ethics2017. 11-40 p.

    2016

    Langhof H, Lander J, Strech D. Input analysis for two public consultations on the EU Clinical Trials Regulation. Health Res Policy Syst. 2016;14(1):69.

    Wieschowski S, Silva DS, Strech D. Animal Study Registries: Results from a Stakeholder Analysis on Potential Strengths, Weaknesses, Facilitators, and Barriers. PLoS Biol. 2016;14(11):e2000391.

    Hübner D, White L. Neurosurgery for Psychopaths? An Ethical Analysis. AJOB Neuroscience. 2016;7(3):140-9.

    Lander J, Hainz T, Hirschberg I, Bossert S, Strech D. Do Public Involvement Activities in Biomedical Research and Innovation Recruit Representatively? A Systematic Qualitative Review. Public Health Genomics. 2016;19(4):193-202.

    Kaye J, Briceno Moraia L, Curren L, Bell J, Mitchell C, Soini S, Hoppe N, Oien M, Rial-Sebbag E. Consent for Biobanking: The Legal Frameworks of Countries in the BioSHaRE-EU Project. Biopreserv Biobank. 2016;14(3):195-200.

    Hoppe N. Privacy Laws and Biobanking in Germany. J Law Med Ethics. 2016;44(1):35-44.

    Hainz T, Bossert S, Strech D. Collective agency and the concept of 'public' in public involvement: A practice-oriented analysis. BMC Med Ethics. 2016;17:1.

    Chin WW, Wieschowski S, Prokein J, Illig T, Strech D. Ethics Reporting in Biospecimen and Genetic Research: Current Practice and Suggestions for Changes. PLoS Biol. 2016;14(8):e1002521.

    2015

    Webborn N, Williams A, McNamee M, Bouchard C, Pitsiladis Y, Ahmetov I, Ashley E, Byrne N, Camporesi S, Collins M, Dijkstra P, Eynon N, Fuku N, Garton FC, Hoppe N, Holm S, Kaye J, Klissouras V, Lucia A, Maase K, Moran C, North KN, Pigozzi F, Wang G. Direct-to-consumer genetic testing for predicting sports performance and talent identification: Consensus statement. Br J Sports Med. 2015;49(23):1486-91.

    Strech D, Deh U, Schmitz S, et al. Workshop - Ökonomische Steuerungsmechanismen: Beispiel Hämatologie und Onkologie. Oncology Research and Treatment 2015;38 Suppl 1:3-22.

    Medical care for older people – what evidence do we need? German National Academy of Sciences Leopoldina, acatech – National Academy of Science and Engineering and Union of the German Academies of Sciences and Humanities. 2015.

    Strech D, Kahrass H, Hirschberg I. Research Guideline Recommendations for Broad Consent Forms in Biobank Research and How They Are Currently Addressed in Practice. Am J Bioeth. 2015;15(9):60-3. Epub 2015/08/26.

    Strech D. Ethical Review of Biobank Research: Should Recs Review Each Release of Material from Biobanks Operating under an Already-Approved Broad Consent and Data Protection Model? Eur J Med Genet. 2015;58(10):545-9. Epub 2015/09/24.

    Seitzer F, Kahrass H, Neitzke G, Strech D. The Full Spectrum of Ethical Issues in the Care of Patients with Als: A Systematic Qualitative Review. J Neurol. 2015.

    Moraia LB, Kaye J, Tasse AM, Knoppers BM, Mitchell C, Soini S, Hoppe N, Wallace SE, Øien M. A Comparative Analysis of the Requirements for the Use of Data in Biobanks Based in Finland, Germany, the Netherlands, Norway and the United Kingdom. Medical Law International. 2015.

    Meerpohl JJ, Schell LK, Bassler D, Gallus S, Kleijnen J, Kulig M, La Vecchia C, Marusic A, Ravaud P, Reis A, Schmucker C, Strech D, Urrutia G, Wager E, Antes G, consortium Op. Evidence-Informed Recommendations to Reduce Dissemination Bias in Clinical Research: Conclusions from the Open (Overcome Failure to Publish Negative Findings) Project Based on an International Consensus Meeting. BMJ Open. 2015;5(5):e006666.

    Marckmann G, Schmidt H, Sofaer N, Strech D. Putting Public Health Ethics into Practice: A Systematic Framework. Front Public Health. 2015;3:23. Epub 2015/02/24.

    Grewal J, Hoppe N. Don't Forget the Orphans. Eur J Health Law. 2015;22(2):107-11.

    Hoppe N. (in print) Privacy Laws and Biobanking in Germany. The Journal of Law, Medicine & Ethics.

    Webborn N, et al. (in print) Direct-to-Consumer Genetic Testing for Predicting Sports Performance and Talent Identification. British Journal of Sports Medicine.

    Hübner D. Gerechtigkeit. In: Sturma D, Heinrichs B, editors. Handbuch Bioethik: Stuttgart/Weimar. JB Metzler. 2015; p. 44-50.

    Hübner D. Some Remarks Concerning Free Will and Evolutionary Theory. American Journal of Bioethics - Neuroscience. 2015;6(2):24-26. doi: 10.1080/21507740.2015.1025998

    Lohse S, Grewal J. Book review: Governing Biobanks: Understanding the Interplay between Law and Practice. SCRIPTed. 2015; 12(1):70-74. doi: 10.2966/scrip.120115.70

    2014

    Strech D, Metz C, Knuppel H. Do Editorial Policies Support Ethical Research? A Thematic Text Analysis of Author Instructions in Psychiatry Journals. PLoS One. 2014;9(6):e97492. Epub 2014/06/06.

    Strech D. Patienten-/Probandenrekrutierung Und Kontaktaufnahme. In: Lenk C, Duttge G, Fangerau H, editors. Handbuch Ethik Und Recht Der Forschung Am Menschen: Springer Berlin Heidelberg; 2014. p. 213-6.

    Strech D. Wissenschaftlicher Und Sozialer Wert. In: Lenk C, Duttge G, Fangerau H, editors. Handbuch Ethik Und Recht Der Forschung Am Menschen: Springer Berlin Heidelberg; 2014. p. 299-303.

    Schrem H, Platsakis AL, Kaltenborn A, Koch A, Metz C, Barthold M, Krauth C, Amelung V, Braun F, Becker T, Klempnauer J, Reichert B. Value and Limitations of the Bar-Score for Donor Allocation in Liver Transplantation. Langenbecks Arch Surg. 2014;399(8):1011-9.

    Mueller KF, Briel M, Strech D, Meerpohl JJ, Lang B, Motschall E, Gloy V, Lamontagne F, Bassler D. Dissemination Bias in Systematic Reviews of Animal Research: A Systematic Review. PLoS One. 2014;9(12):e116016.

    Mertz M, Strech D. Systematic and Transparent Inclusion of Ethical Issues and Recommendations in Clinical Practice Guidelines: A Six-Step Approach. Implement Sci. 2014;9:184.

    Lenk C, Hoppe N. Research Governance in Placebo-Controlled Trials: Is the Ema/Ich Position Consistent in Itself and in Accordance with the Declaration of Helsinki? Medical Law International. 2014;14(3):115-32.

    Lander J, Hainz T, Hirschberg I, Strech D. Current Practice of Public Involvement Activities in Biomedical Research and Innovation: A Systematic Qualitative Review. PLoS One. 2014;9(12):e113274.

    Klose J, Klose MA, Metz C, Lehner F, Manns MP, Klempnauer J, Hoppe N, Schrem H, Kaltenborn A. Outcome Stagnation of Liver Transplantation for Primary Sclerosing Cholangitis in the Model for End-Stage Liver Disease Era. Langenbecks Arch Surg. 2014;399(8):1021-9.

    Kaye J, Hurles M, Griffin H, Grewal J, Bobrow M, Timpson N, Smee C, Bolton P, Durbin R, Dyke S, Fitzpatrick D, Kennedy K, Kent A, Muddyman D, Muntoni F, Raymond LF, Semple R, Spector T, Uk K. Managing Clinically Significant Findings in Research: The Uk10k Example. Eur J Hum Genet. 2014;22(9):1100-4.

    Hübner D. Kultürlichkeit Statt Natürlichkeit: Ein Vernachlässigtes Argument in Der Bioethischen Debatte Um Enhancement Und Anthropotechnik. Jahrbuch für Wissenschaft und Ethik2014. p. 25.

    Hoppe N, Miola J. Innovation in Medicine through Degeneration in Law? A Critical Perspective on the Medical Innovation Bill. Medical Law International. 2014.

    Hoppe N, Kwisda K. Geistiges Eigentum. In: Lenk C, Duttge G, Fangerau H, editors. Handbuch Ethik Und Recht Der Forschung Am Menschen: Springer Berlin Heidelberg; 2014. p. 159-62.

    Hirschberg I, Kahrass H, Strech D. International Requirements for Consent in Biobank Research: Qualitative Review of Research Guidelines. J Med Genet. 2014;51(12):773-81.

    Hainz T, Strech D. Which Public to Involve? More Reflection on Collective Agency and Sufficient Representativeness Is Needed. The American Journal of Bioethics. 2014;14(6):31-3.

    Hoppe N, Kwisda K. Oviedo Konvention. In: Lenk C, Duttge G, Fangerau H, editors. Handbuch Ethik Und Recht Der Forschung Am Menschen: Springer Berlin Heidelberg; 2014.

    Hoppe N, Miola J. Medical Law and Medical Ethics. 2014. Cambridge University Press. ISBN: 9781107612372

    2013

    Robienski J, Hoppe N. Aktuelle Medizinrechtliche Und -Ethische Herausforderungen Der Pathologie. Der Pathologe. 2013;34(1):9-15.

    Knüppel H, Metz C, Meerpohl JJ, Strech D. How Psychiatry Journals Support the Unbiased Translation of Clinical Research. A Cross-Sectional Study of Editorial Policies. PLoS ONE. 2013;8(10):e75995.

    Knuppel H, Mertz M, Schmidhuber M, Neitzke G, Strech D. Inclusion of Ethical Issues in Dementia Guidelines: A Thematic Text Analysis. PLoS Med. 2013;10(8):e1001498.

    Hoppe N. From Omics and Etics to Policy and Ethics: Regulating Evolution. Front Genet. 2013;4:172.

    Hoppe N. The Issue with Tissue: Why Making Human Biomaterials Available for Research Purposes Is Still Controversial. Diagnostic Histopathology. 2013;19(9):315-21.

    Hirschberg I, Knuppel H, Strech D. Practice Variation across Consent Templates for Biobank Research. A Survey of German Biobanks. Front Genet. 2013;4:240. Epub 2013/12/03.

    Fuchs M, Heinemann T, Heinrichs B, Hübner D, Kipper J, Rottländer K, Runkel T, Spranger TM, Vermeulen V, Völker-Albert M. Kagakugijutsukenkyuno- rinri-nyomon (Research Ethics – An Introduction), Tokio, Chisen Verl. 2013. XXXVII, 405 S.

    2006 - 2012

    2012

    Strech D. Normative Arguments and New Solutions for the Unbiased Registration and Publication of Clinical Trials. J Clin Epidemiol. 2012;65(3):276-81.

    Kaye J, Meslin EM, Knoppers BM, Juengst ET, Deschenes M, Cambon-Thomsen A, Chalmers D, De Vries J, Edwards K, Hoppe N, Kent A, Adebamowo C, Marshall P, Kato K. Research Priorities. Elsi 2.0 for Genomics and Society. Science. 2012;336(6082):673-4. Epub 2012/05/15.

    Raspe H, Hüppe A, Strech D, Taupitz J. Empfehlungen zur Begutachtung klinischer Studien durch Ethik-Kommissionen. Vol 2, Deutscher Ärzteverlag, 2012, ISBN 978-3-7691-1305-1.