Informed consent is an important document for every existing biobank or repository to obtain, store and use human biospecimens and associated data and information for current and future research. Biobanks have undergone great progress worldwide during the last three decades and have become an integral part of personalized medicine and health care systems and due to new scientific and social questions to be solved. Ethical, legal and social issues (ELSI) guarantee safe sample and data management, and informed consent is one of the key ELSI documents. The form and the consent given in biobank informed consent forms differs between biobank-related institutions, national biobanks, between EU states, and to find the optimal informed consent requires one to fulfil national and international laws and regulations. The Biobank in Pilsen, Czech Republic was officially opened on April the 20th 2017 as a hospital-integrated biobank, and the informed consent was one of the essential documents that had to be ready prior the opening. The process of formulating informed consent corresponding with institutional, national, and international rules and laws to share the experience, to present the challenges, and to demonstrate the national dissimilarity are tasks of the article.

Department of Medical Chemistry and Biochemistry Faculty of Medicine in Pilsen Charles University Karlovarská 48 30166 Pilsen Czech Republic

Laboratory of Immunoanalysis University Hospital in Pilsen E Beneše 13 30599 Pilsen Czech Republic

Zobrazit více v PubMed

Bledsoe M.J. Ethical Legal and Social Issues of Biobanking: Past, Present, and Future. Biopreserv. Biobank. 2017;15:142–147. doi: 10.1089/bio.2017.0030. PubMed DOI

World Health Organization (WHO) Code of Conduct for Responsible Research. WHO; Geneva, Switzerland: 2017. [(accessed on 25 August 2019)]. Available online: https://www.who.int/about/ethics/code-of-conduct-responsible-research.pdf.

Steinsbekk K.S., Myskja B.K., Solberg B. Broad consent versus dynamic consent in Biobank research: Is passive participation an ethical problem? Eur. J. Hum. Genet. 2013;21:897–902. doi: 10.1038/ejhg.2012.282. PubMed DOI PMC

ISBER Best Practices: Recommendations for Repositories Fourth Edition. [(accessed on 25 August 2019)]; Available online: www.isber.org/bestpractices.

Bunnik E.M., de Jong A., Nijsingh N., de Wert G.M. The new genetics and informed consent: Differentiating choice to preserve autonomy. Bioethics. 2013;27:348–355. doi: 10.1111/bioe.12030. PubMed DOI

Bunnik E.M., Janssens A.C., Schermer M. A tiered–layered- staged model of informed consent in personal genome testing. EJHG. 2013;21:596–601. doi: 10.1038/ejhg.2012.237. PubMed DOI PMC

Grady C., Eckstein L., Berkman B., Brock D., Cook-Deegan R., Fullerton S.M., Greely H., Hansson M.G., Hull S., Kim S., et al. Broad consent for research with biological samples: Workshop conclusions. Am. J. Biotech. 2015;15:34–42. doi: 10.1080/15265161.2015.1062162. PubMed DOI PMC

Salvaterra E., Lecchi L., Giovanelli S., Butti B., Bardella M.T., Bertazzi P.A., Bosari S., Coggi G., Coviello D.A., Lalatta F., et al. Banking together. A unified model of informed consent for biobanking. Embo. Rep. 2008;9:307–313. doi: 10.1038/embor.2008.41. PubMed DOI PMC

BBMRI-ERIC. [(accessed on 25 August 2019)]; Available online: http://www.bbmri-eric.eu/

Holub P., Greplova K., Knoflickova D., Nenutil R., Valik D. The Biobanking Research Infrastructure BBMRI_CZ: A Critical Tool to Enhance Translational Cancer Research. Klin. Onkol. 2012;25:2S78–2S81. PubMed

Valík D. Introducing Czech national node. Biobanks Eur. 2017;7:8–13.

World Medical Association . Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. World Medical Association; Seoul, Korea: 2008. [(accessed on 25 August 2019)]. Available online: https://www.wma.net/wp-content/uploads/2016/11/DoH-Oct2008.pdf.

Organisation for Economic Co-Operation and Develoment (OECD) Guidelines on Human Biobanks and Genetic Research Databases. OECD; Paris, France: 2009. [(accessed on 25 August 2019)]. Available online: http://www.oecd.org/sti/emerging-tech/44054609.pdf.

Gottweis J.H., Kaye J. Biobanks for Europe: A Challenge for Governance. Report of the Expert Group on Dealing with Ethical and Regulatory Challenges of International Biobank Research. European Commission; Luxembourg: 2012. [(accessed on 25 August 2019)]. Available online: https://publications.europa.eu/en/publication-detail/-/publication/629eae10-53fc-4a52-adc2-210d4fcad8f2.

Ayuso C., Millan J.M., Mancheno Dal-Re R. Informed consent for whole-genome sequencing studies in the clinical setting. Proposed recommendations on essential content and process. Eur. J. Hum. Genet. 2013;21:1054–1059. doi: 10.1038/ejhg.2012.297. PubMed DOI PMC

Mascalzoni D., Janssens A.C.J., Stewart A., Pramstaller P., Gyllensten U., Rudan I., Van Duijn C.M., Wilson J.F., Campbell H., Mc Quillan R. Comparison of participant information and informed consent forms of five European studies in genetic isolated populations. Eur. J. Hum. Genet. 2010;18:296–302. doi: 10.1038/ejhg.2009.155. PubMed DOI PMC

Informed Consent at University Hospital in Pilsen. [(accessed on 15 October 2019)]; Available online: https://www.fnplzen.cz/ fn_plzen/informovane_souhlasy.

Beskow L.M., Friedman J.Y., Hardy N.C., Lin L., Weinfurt K.P. Developing a Simplified Consent Form for Biobanking. PLoS ONE. 2010;5:e13302. doi: 10.1371/journal.pone.0013302. PubMed DOI PMC

Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the Protection of Natural Persons with Regard to the Processing of Personal Data and on the Free Movement of Such Data, and Repealing Directive 95/46/EC (General Data Protection Regulation) [(accessed on 25 August 2019)]; Available online: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L:2016:119:FULL&from=EN.

Kaye J., Whitley E.A., Lund D., Morrison M., Teare H., Melham K. Dynamic consent: A patient interface for twenty-first century research networks. Eur. J. Hum. Genet. 2015;23:141–146. doi: 10.1038/ejhg.2014.71. PubMed DOI PMC

Nijhawan L.P., Janodia M.D., Muddukrishna B.S., Bhat K.M., Bairy K.L., Udupa N., Musmade P.B. Informed consent: Issues and challenges. J. Adv. Pharm. Technol. Res. 2013;4:134–140. PubMed PMC

Pawlikowski J., Sak J., Mercyewski K. The analysis of the ethical, organizational and legal aspects of Polish biobanks activity. Eur. J. Public Health. 2009;20:707–710. doi: 10.1093/eurpub/ckp202. PubMed DOI

Calzolari A., Napolitrano M., Bravo E. Review of the Italian Current Legislation on Research Biobanking Activities on the Eve of the Participation of National Biobanks’ Network in the Legal Consortium BBMRI-ERIC. Biopreserv. Biobank. 2013;11:124–128. doi: 10.1089/bio.2012.0058. PubMed DOI PMC

Schickle D., Griffin M., El-Arifi K. Inter- and Intra- Biobank Networks Classification of Biobanks. Pathobiology. 2010;77:181–190. doi: 10.1159/000292651. PubMed DOI

Lin J.C., Hsiao W.W., Fan C.T. Managing “incidental findings” in biobank research: Recommendations of the Taiwan biobank. Comput. Struct. Biotechnol. J. 2019;17:1135–1142. doi: 10.1016/j.csbj.2019.07.006. PubMed DOI PMC

Xiao Y., Qian K., Zheng L., Cao X., Zhu Y., Xiao Y. Challenges of Ethical Reviews in China’s Biobanks. MJ Urol. 2017;1:4.