Informed Consent and Research Involving Human Biological Material (in Polish)

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Published: Jun 19, 2015
DOI: https://doi.org/10.13153/diam.44.2015.765
Keywords:
research ethics, informed consent, blanket consent, broad consent, biobanks, human biological material

Main Article Content

Jakub Pawlikowski
Medical University of Lublin

Abstract

The development of research based on human biological material has contributed to a lively debate on the concept of informed consent in these studies, particularly its scope, form and length of validity. The biggest disputes and doubts concern the range of consent for research that will be conducted in the future, whose aim and place are unknown at the time of the sample collection, as are the future researchers and the ability to use the previously collected materials again. This situation raises the question of a just and prudent balance between the rights of participants in the research and the rights of researchers. New forms of consent have been proposed, which sometimes substantially diverge from the classical model (e.g. blanket consent or broad consent and its various kinds) in aiming towards responsible balancing between the necessity to protect the donors’ interests and the possibility of conducting research in medicine. These new concepts also find their application in legislative acts adopted internationally and in some European countries in the recent years.

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“Informed Consent and Research Involving Human Biological Material (in Polish)”. 2015. Diametros, no. 44 (June): 89-109. https://doi.org/10.13153/diam.44.2015.765.
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No. 44 (2015)
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Special Topic - New medical technologies and basic healthcare

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Author Biography

Jakub Pawlikowski, Medical University of Lublin

Jakub Pawlikowski, PhD Hab.
Medical University of Lublin
ul. Staszica 4/6,
20-240 Lublin

E-mail: jpawlikowski@wp.pl

How to Cite

“Informed Consent and Research Involving Human Biological Material (in Polish)”. 2015. Diametros, no. 44 (June): 89-109. https://doi.org/10.13153/diam.44.2015.765.
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References

Budimir [2011] – D. Budimir, O. Polasek, A. Marusic et al., Ethical aspects of human biobanks: a systematic review, „Croatian Medical Journal” (52) 2011, s. 262–279.

Caufield [2003] – T. Caulfield, R.E. Upshur, A. Daar, DNA databanks and consent: a suggested policy option involving an authorization model, „BMC Medical Ethics” 3 (4) 2003, E1.

Chih-Hsing Ho [2012] – Ho Chih-Hsing, Socio-legal perspectives on biobanking: the case of Taiwan, PhD thesis, The London School of Economics and Political Science, 2012.

CIOMS [2002] – Council for International Organizations of Medical Sciences, International ethical guidelines for biomedical research involving human subjects, CIOMS Geneva 2002; dostępne na: http://www.cioms.ch/publications/layout_guide2002.pdf [10.05.2014].

Corrigan [2006] – O.P. Corrigan, B. Williams-Jones, Pharmacogenetics: the bioethical problem of DNA investment banking, „Studies in History and Philosophy of Science” (37) 2006, s. 550–565.

Czarkowski [2009] – M. Czarkowski, Zasady prowadzenia badań na ludzkim materiale biologicznym, „Polski Merkuriusz Lekarski” (27) 2009, s. 349–352.

Decamp [2009] – M. Decamp, A. Buchanan, Pharmacogenomics: ethical and regulatory issues, [w:] The Oxford Handbook of Bioethics, Steinbock B (red.), Oxford University Press, 2009, s. 536–570.

Deschenes [2001] – C. Deschenes, G. Cardinal, B.M. Knoppers et al., Human genetic research, DNA banking and consent: A question of 'form'?, „Clinical Genetics” (59) 2001, s. 221–239.

Deutscher Ethikrat [2010] – Deutscher Ethikrat, Human biobanks for research, 2010, dostępne na: www.ethikrat.org/files/der_opinion_human-biobanks.pdf [10.05.2014].

Eriksson [2011] – C. Eriksson, H. Kokkonen, M. Johansson et al., Autoantibodies predate the onset of systemic lupus erythematosus in northern Sweden, „Arthritis Research & Ther-apy” 13 (1) 2011, R30.

Eriksson [2005] – S. Eriksson, G. Helgesson, Potential harms, anonymization, and the right to withdraw consent to biobank research, „European Journal of Human Genetics” 13 (9) 2005, s. 1071–1076.

EC [2012] – European Commission, Proposal for a Regulation of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation), 2012; dostępne na: http://ec.europa.eu/justice/data-protection/document/review2012 /com_2012_11_en.pdf [10.05.2014].

ESHG [2003a] – European Society of Human Genetics, Data storage and DNA banking for biomedical research: informed consent, confidentiality, quality issues, ownership, return of benefits. A professional perspective. Recommendations of the European Society of Human Genetics, „European Journal of Human Genetics” 11 (2) 2003, s. 88–122.

ESHG [2003b] – European Society of Human Genetics, Recommendations of the European Society of Human Genetics. Data storage and DNA banking for biomedical research: technical, social and ethical issues, „European Journal of Human Genetics” 11 (2) 2003, s. 8–10.

Forsberg [2013] – J.S. Forsberg, M.G. Hansson, K. Evers, International guidelines on biobank research leave researchers in ambiguity: why is this so?, „European Journal of Epidemi-ology” 28 (6) 2013, s. 449–451.

Forsberg [2014] – J.S. Forsberg, S. Soini, A big step for Finnish Biobanking, „Nature Reviews Genetics” 15 (6) 2014.

Giesbertz [2012] – N.A. Giesbertz, A.L. Bredenoord, J.J. van Delden, Inclusion of residual tissue in biobanks: opt-in or opt-out?, „PLoS Biology” 10 (8) 2012.

Gottweis [2012] – H. Gottweis, J. Kaye, F. Bignami et al., Biobanks for Europe – A Challenge for Governance, EU, 2012; dostępne na: http://www.coe.int/t/dg3/healthbioethic /Activities/10_Biobanks/biobanks_for_Europe.pdf [10.05.2014].

Greely [2001] – H. Greely, Informed Consent and Other Ethical Issues in Human Population Genetics, „Annual Review of Genetics” (35) 2001, s. 785–800.

Grzymkowska [2009] – M. Grzymkowska, Standardy bioetyczne w prawie europejskim, Wolters Kluwer, Warszawa 2009.

Hansson [2014] – M. Hansson, Biobank and Registry Ethics Report, Uppsala University, 2014; dostępne na: http://www.crb.uu.se/downloads/BiobankEthicsReport CRB.pdf [10.05.2014].

Hansson et al. [2006] – M.G. Hansson, J. Dillner, C.R. Bartram et al., Should donors be allowed to give broad consent to future biobank research?, „The Lancet Oncology” 7 (3) 2006, s. 266–269.

Hansson [2006] – M.G. Hansson, Combining efficiency and concerns about integrity when using human bio-banks, „Studies in History and Philosophy of Science” 37 (3) 2006, s. 520–532.

Helgesson [2012] – G. Helgesson, In defense of broad consent, „Cambridge Quarterly of Healthcare Ethics” 21 (10) 2012, s. 40–50.

Hellman [2003] – D. Hellman, What makes genetic discrimination exceptional?, „American Journal of Law & Medicine” (29) 2003, s. 85–86.

HGC [2001] – Human Genetics Commission, Public attitudes to human genetic information, London 2001; dostępne na: http://www.ipsos-mori.com/Assets/Docs/Archive /Polls/hgcrep.pdf [10.05.2014].

Hirtzlin [2003] – I. Hirtzlin, C. Dubreuil, N. Preaubert et al., An empirical survey on biobanking of human genetic material and data in six EU countries, „European Journal of Human Genetics” (11) 2003, s. 475–488.

Hoeyer [2004] – K. Hoeyer, B.O. Olofsson, T. Mjorndall, N. Lynoe, Informed consent and biobanks: a population-based study of attitudes towards tissue donation for genetic research, „Scandinavian Journal of Public Health” 32 (3) 2004, s. 224–229.

Hoeyer [2008] – K. Hoeyer, The ethics of research biobanking: A critical review of the literature, „Biotechnology & Genetic Engineering Reviews” (25) 2008, s. 429–452.

Hofmann [2009] – B. Hofmann, Broadening consent – and diluting ethics?, „Journal of Medical Ethics” 35 (2) 2009, s. 125-129.

Human Genes Research Act [2000] – Human Genes Research Act passed 13.12.2000, dostępne na: https://www.riigiteataja.ee/en/eli/531102013003/consolide [23.05.2015].

Human Tissue Act [2004] – The UK Human Tissue Act passed 2004; dostępne na: http://www.legislation.gov.uk/ukpga/2004/30/contents [23.05.2015].

Karolinska Institutet [2014] – Karolinska Institutet, New EU Data Protection Regulation may have major consequences for patients in Europe; dostępne na: http://www.bbmri-eric.eu/documents/10181/126363/140925+-+JKL+-+Data+Protection+Regulation _V9+%282%29.pdf/ed511de1-d76d-4bf3-b3ab-f6665996e308 [10.05.2014].

Kaye [2004] – J. Kaye, H. Helgason, A. Nõmper et al., Population genetic databases: a comparative analysis of the law in Iceland, Sweden Estonia and the UK, „A Journal of the Humanities & Social Sciences” 8 (1/2) 2004, s. 15.

Lawrence [1998] – S.C. Lawrence, Beyond the grave, [w:] Stored Tissue Samples: Ethical, Legal, and Public Policy Implications, R.F. Weir (red.), University of Iowa Press, Iowa City 1998, s. 111–142.

Lloyd [2001] – A.J. Lloyd, The extent of patients' understanding of the risk of treatments, „International Journal for Quality in Health Care” 10 (1) 2001, s. 14–18.

McNelly, Combon-Thomsen [2004] – E. McNelly, A. Combon-Thomsen, 25 Recommendations on the ethical, legal and social implications of genetic testing, Brussels 2004; dostępne na: http://ec.europa.eu/research/conferences/2004/genetic pdf/ recommendations_en.pdf [10.05.2014].

MRC [2001] – Medical Research Council, Human tissue and biological samples for use in research. Operational and ethical guidelines, London 2001; dostępne na: http://www.mrc.ac.uk/Utilities/Docu-mentrecord/index.htm?d=MRC002420 [10.05.2014].

OECD [2009] – Rekomendacje OECD w zakresie biobankowania materiału ludzkiego i tworzenia baz danych genetycznych dla celów badań naukowych z 2009 roku (Guidelines on Human Biobanks and Genetic Research Databases); dostępne na: http://www.oecd.org/science/biotech/44054609.pdf [10.05.2014].

Palsson [2007] – G. Palsson, Anthropology and the New Genetics, Cambridge University Press, Edinburgh 2007.

Pawlikowski [2012] – J. Pawlikowski, Ochrona praw dawców w wybranych europejskich biobankach populacyjnych, „Diametros” (32) 2012, s. 91–109.

Pawlikowski [2013] – J. Pawlikowski, Biobankowanie ludzkiego materiału biologicznego dla celów badań naukowych – aspekty organizacyjne, etyczne, prawne i społeczne, Uniwersytet Medyczny w Lublinie, 2013.

Reichel [2014] – J. Reichel, A.S. Lind, Updated analysis of the EU Data Protection Regulation, Biobank perspectives. Current issues on biobank ethics and law, 2014.

Sellaroli [2007] – V. Sellaroli, F. Cucca, A. Santosuosso, Shared genetic data and the rights of involved people, „Law and the Human Genome Review” (26) 2007, s. 198.

Siegrist [2000] – M. Siegrist, The influence of trust and perception of risks and benefits on the acceptance of gene technology, „Risk Analysis” (20) 2000, s. 195–203.

Skene [2002] – L. Skene, Ownership of human tissue and the law, „Nature Reviews Genetics” (3) 2002, s. 145–148.

Stegmayr [2002] – G. Stegmayr, K. Asplund, Informed consent for genetic research on blood stored for more than a decade: a population based study, „BMJ” (325) 2002, s. 634–635.

Steinsbekk [2013] – K.S. Steinsbekk, B.K. Myskja, B. Solberg, Broad consent versus dynamic consent in biobank research: Is passive participation an ethical problem?, „European Journal of Human Genetics” 2013.

Stenbeck [2004] – M. Stenbeck, J. Askling, S. Ernestam, A. Carlsson, New EU Data Protection Regulation may have major consequences for patients in Europe; dostępne na: http://bbmri-eric.eu/documents/10181/126363/140925+-+JKL+-+Data+Protecti on+Regulation_V9+%282%29.pdf/ed511de1-d76d-4bf3-b3ab-f6665996e308 [23.05.2014].

Taupitz [2012] – J. Taupitz, J. Weigel, The Necessity of Broad Consent and Complementary Regulations for the Protection of Personal Data in Biobanks: What Can We Learn from the German Case?, „Public Health Genomics” 15 (5) 2012, s. 263–271.

The Gallup Organization [2000] – The Gallup Organization, Public attitudes toward medical privacy, 2000; dostępne na: http://forhealthfree-dom.org/Gallupsurvey/IHF-Gallup.html [10.05.2014].

Wang [2001] – S.S. Wang, F. Fridinger, K.M. Sheedy, M.J. Khoury, Public attitudes regarding the donation and storage of blood samples for genetic research, „Community Genet” 4 (1) 2001, s. 18–26.

Weldon [2004] – S. Weldon, 'Public Consent' or 'Scientific Citizenship'? What counts as Public Participation, [w:] Population-Based DNA Collections? In Genetic Databases: Socio-Ethical Issues in the Collection and Use of DNA, R. Tutton, O. Corrigan (red.), Routledge, London 2004, s. 161–180.

Wendler [2002] – D. Wendler, E. Emanuel, The debate over research on stored biological samples: what do sources think?, „Archives of Internal Medicine” (162) 2002, s. 1457–1462.

Whitley [2012] – E.A. Whitley, Kanellopoulou, J. Kaye, Consent and Research Governance in Biobanks: Evidence from Focus Groups with Medical Researchers, „Public Health Genomics” (15) 2012, s. 232–242.

WMA [2008] – World Medical Assiociation, Declaration of Helsinki. Ethical Principles for Medical research in volving Human Subjects. 59th WMA General Assembly, Seoul, Korea 2008; dostępne na: http://www.wma.net/en/30publications/10policies /b3/index.html.pdf?print-media-type&footer-right=[page] [10.05.2014].

Womack [2006] – C. Womack, J. Pope, A. Jack, C. Semple, Cadaveric Tissue Retrieval Service for Research: One-year Review and Options for the Future, „Cell and Tissue Banking” (7) 2006, s. 211–214.

Wood [2002] – J. Wood, The role, duties, and responsibilities of technologists in the clinical laboratory, „Clinica Chimica Acta” (319) 2002, s. 127–132.

Zika [2010] – E. Zika, D. Paci, T. Schulte et al., Biobanks in Europe: Prospects for harmonization and Networking, Directorate-General for Research and Innovation of European Commission, 2010.