Analysis of the concept of informed consent concerning the use of genetic material according to the European Convention on Bioethics and in other solutionsm – Propositions for broad consent for future genetic research from the point of view of the activity of the Biobank
More details
Hide details
Department of Ethics and Human Philosophy, Medical University, Lublin, Poland
Corresponding author
Rafał Patryn   

Department of Ethics and Human Philosophy, Medical University, Lublin, Poland
Ann Agric Environ Med. 2017;24(3):383-386
The aim of the article is a critical presentation of the typology of consents included in the European Convention on Bioethics and in other formal solutions concerning the gathering of genetic material in institutions called Biobanks.

Material and Methods:
Existing types of Acts of Consent are inaccurate in their scope and possess insufficient information regarding the gathering of genetic material (application, usage, processing) and their final (future and diverse) use.

Lack of precise legal regulations on the broad future use of genetic material may result in various formal problems relating both to research participants as well as those commissioning the research. Ultimately, it may lead to various complications with the appropriate legal interpretation of consent and possible claims on behalf of the donors.

The presented proposition of consent with a terminal premise is to be applied eventually to legal and formal aspects of the collecting of genetic material. It is a possible solution which would clarify the issue of informed consent, and may be implemented in the regulations of the Convention as well as constitute a self-contained legislative solution to this matter. For example, Polish law in its current form, without the ratification of the Bioethical Convention, allows the collecting of material for genetic testing for determination of the risk of genetic defects in common genetic material from people who are planning to have a child.

Knoppers B. M, Glass K. Human genetic research, DNA banking and consent: A question of „form”?, Clinical Genetics 59 (2001).
Pawlikowski J. Sak J. Marczewski K. Problemy etyczne i prawne związane z działalnością biobanków. Diametros. 2009 (19):106–118.
Pawlikowski J. Sak J. Marczewski K. Biobank research and ethics: the problem of informed consent in Polish biobanks. Arch Med Sci. 2011;7(5):896–901.
Kauffman F. Cambon-Thomsen A. Tracing biological collections. Between books and clinical trials. JAMA (299), 2008.
Bankowski Z., Levine R.J. Ethics and Research on Human Subjects. International Guidelines,
Etchells E., Gilbert B.A. Bioethics for clinicians: 1. Consent. Canad. Med.Assoc.Jour. 1996.
Ahronhein J. Moreno J. Ethics in clinical practice. Little, Brown and Co. 1994 Boston.
Annas G.J. A National Bill of Patients’ Rights. Owned by the Massachusetts Medical Society. 1998; Vol. VI.
Stagmary B. Asplund K. Informed consent for genetic research on blood stored for more than a decade: A population based study. BMJ (325). 2002.
Armson B.A. Umbilical cord blood banking: implications for perinatal care providers, Journal of Obstetrics and Gynaecology Canada. 27(3). 2005.
Transplantation Act [Dz. U. z 2015 r. poz. 793. 1893, 1991]
Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells.
Williams G., Schroeder D. Human genetic banking: altruism, benefit and consent. New Genetics and Society. Volume 23, Issue 1, 2004.
Caulfield T. Upshur R. Daar A. DNA databanks and consent: A suggested policy option involving an authorization model. BMC Medical Ethics.(4:1)2003.
Hansson M.G. Combining efficiency and concerns about integrity when us-ing human biobanks. Studies in History and Philosophy of Biological and Biomedical Sciences. (37) 2006.
Madrid Declaration of the World Health Organization [Deklaracja Madrycka Światowej Organizacji Zdrowia 1987]
Convention for the protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (4.06.2013).
Resolution A2 – 327/88 on ethical and legal problems of genetic engineering, Official Journal C 96, 17/04/1989r., pg.1. (dostęp: 8.06.2013).
Corrigan O.P. Williams-Jones B. Pharmacogenetics: the bioethical problem of DNA investment banking. Studies in History and Philosophy of Biological and Biomedical Sciences. 37, 2006.
Flavio D’Abramo. Biobank research, informed consent and society. Towards a new alliance? J Epidemiol Community Health doi:10.1136/jech-2014–205215.
European Society of Human Genetics. Data storage and DNA banking for biomedical research: technical, social and ethical issues. Recommendations of the European Society of Human Genetics. European Journal of Human Genetics.11(2003),Suppl.2.
Włoszczak-Szubzda A. Jarosz M. Professional Communications competences of nurses. Ann Agric Environ Med 2012:19(3).
Journals System - logo
Scroll to top