Patient consent to the use of genetic material in Poland and worldwide

Abstract

Currently developed and functioning models of so-called informed consent seem to be insufficient in case of the application, handling, or use of the genetic material, and may lead to over-interpretation or misinterpretation of the formal rules for using the stored genetic material. In medical practice, the aim is to obtain patient’s consent to any interventions not only therapeutic, but also other, having a diagnostic character. These interventions often lacking direct medicinal goal, are often associated with a high risk to the health of the patient, who should be informed about that. The most common form of consent is called informed consent, in which the emphasis is primarily put on the patient’s understanding of what needs to be signed on a specific form. The informed consent is a fundamental element of the subjective permission to submit to any intervention that interferes in bodily-mental realm of man. Currently valid provisions contained in a number of non-synchronized with each other regulatory acts selectively treat the concept of informed consent in the case of working with genetic material (the use, processing) and its terminal (temporary) use. The issue of storing genetic material in biobanks (both worldwide and in Poland) does not have a leading and promoting solution, and the present standards specifying the type and nature of consent are rather formal parts of different formal acts than a single standardized model. There is a need to have a new uniform interpretation of the law, which could be the basis for the concept of consent as a declaration of intent for the use of genetic material. The report presents a formal-legal approach to the issue of the concept and scope of consent as a declaration of intent, in the case of genetic material use. The currently existing in Poland and in the world legal solutions of the interpretations of the concept and scope of consent, as a declaration of intent for the use of genetic material, have been analyzed. The actual and hypothetical disputable and interpretation issues have been discussed. The paper presents original solution clarifying the issues of informed consent, which can be used in practice.