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.

• Klíčová slova
• Biobank, ELSI, informed consent, personalized medicine,
• MeSH
• banky biologického materiálu * MeSH
• informovaný souhlas pacienta * MeSH
• lidé MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• Geografické názvy
• Česká republika MeSH

Informed consent is necessary in good clinical practice. It is based on the patient´s ability to understand the information about the proposed procedure, the potential consequences and complications, and alternative options. The information is written in understandable language and is fortified by verbal discussion between physician and patient. The aim is to explain the problem, answer all questions and to ensure that the patient understands the problems and is able to make a decision. The theory is clear but what happens in daily practice?

• Klíčová slova
• Endoscopy, Informed consent, Uninformed consent, Written consent,
• Publikační typ
• časopisecké články MeSH

Rapid development of clinical genetics was enabled by the advances of molecular genetic laboratory diagnostics. Genetic laboratory testing has unique characteristics, and results of germinal genome testing has consequences not only for the patient but also for his relatives. Genetic laboratory testing in the Czech Republic is governed by the act no. 373/2011, which explicitly states that the testing requires the completion of a written informed consent. This article explains in detail the process of obtaining an informed consent within a broader framework of genetic counselling. An informed consent with genetic laboratory testing not only informs the patient (this being its primary purpose), but can also serve as a lead for physicians of other clinical specialties intending to order genetic laboratory tests.

• Klíčová slova
• clinical genetics, genetic counselling, genetic laboratory testing, informed consent,
• MeSH
• genetické poradenství * MeSH
• genetické testování * MeSH
• informovaný souhlas pacienta * MeSH
• lidé MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• Geografické názvy
• Česká republika MeSH

For centuries, people of various nationalities from various States have sought asylum for varied reasons. These people seeking asylum can need medical care in the host country. In this article I would like to discuss to what extent informed consent is needed, and to what extent informed consent must be sought. The problem is discussed from the perspective of European international documents, mainly on those of the Council of Europe.

• MeSH
• informovaný souhlas pacienta zákonodárství a právo   MeSH
• lidé MeSH
• uprchlíci zákonodárství a právo   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• Geografické názvy
• Evropa MeSH

Having the means to share research data openly is essential to modern science. For human research, a key aspect in this endeavor is obtaining consent from participants, not just to take part in a study, which is a basic ethical principle, but also to share their data with the scientific community. To ensure that the participants' privacy is respected, national and/or supranational regulations and laws are in place. It is, however, not always clear to researchers what the implications of those are, nor how to comply with them. The Open Brain Consent (https://open-brain-consent.readthedocs.io) is an international initiative that aims to provide researchers in the brain imaging community with information about data sharing options and tools. We present here a short history of this project and its latest developments, and share pointers to consent forms, including a template consent form that is compliant with the EU general data protection regulation. We also share pointers to an associated data user agreement that is not only useful in the EU context, but also for any researchers dealing with personal (clinical) data elsewhere.

• Klíčová slova
• brain imaging, general data protection regulation, informed consent,
• MeSH
• informovaný souhlas pacienta * etika   MeSH
• lidé MeSH
• mozek diagnostické zobrazování   MeSH
• neurozobrazování * etika   MeSH
• šíření informací * etika   MeSH
• subjekty výzkumu * MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• práce podpořená grantem MeSH
• Research Support, N.I.H., Extramural MeSH
• Research Support, U.S. Gov't, Non-P.H.S. MeSH
• úvodníky MeSH

The issue of a patient´s competence is often solved in practice without a major theoretical concept. Such an approach, focused only on the basis of intuitions and experiences of physicians, however, may lead in some cases to an inadequate assessment of competence of a particular patient. Ultimately, it can happen that the decision of an incompetent person will be respected or that the decision of the competent person will be disrespected. Both possibilities can have ethical as well as legal consequences. This article addresses both theoretical and practical issues of competence in adult patients.

• Klíčová slova
• Bioethics, autonomy, beneficence, competence, informed consent,
• MeSH
• dospělí MeSH
• informovaný souhlas pacienta * MeSH
• lékaři * MeSH
• lidé MeSH
• mravy MeSH
• Check Tag
• dospělí MeSH
• lidé MeSH
• Publikační typ
• časopisecké články MeSH

The large-scale change of Czech society since 1989 has involved the democratic transformation of the health system. To empower the patient was one important goal of the healthcare reform launched immediately after the Velvet Revolution. The process has been enhanced by the accession of the Czech Republic to the European Union and the adoption of important European conventions regulating the area. The concept of informed consent and a culture of negotiation are being inserted into a traditionally paternalistic culture. Our article describes the current situation on the issue of the communication of information on state of health and treatment, and on the question of the participation of the patient in decisions on treatment. We present empirical results of a public opinion survey on this issue. The results show a still prevailing submissive attitude towards the physicians, despite the fact that the concept of informed consent has become more and more publicly familiar (42% of respondents gave the completely correct answer regarding informed consent). The impact of age, education and sex on answers to the questionnaire was analysed. Men, younger and more educated respondents were more likely to show the autonomous attitude, whereas women, older and less educated people tended to show the traditional submissive attitude. Further, our article raises the question of the cultural and historical background within which the current ethically and legally binding norms (products of western democracies, in fact) are interpreted. The question is how far cultural modifications are tolerable in the practical implementation of universal ethical constructs (informed consent).

• MeSH
• dospělí MeSH
• informovaný souhlas pacienta etika   zákonodárství a právo   MeSH
• lidé středního věku MeSH
• lidé MeSH
• moc (psychologie) MeSH
• osobní autonomie MeSH
• poskytování zdravotní péče MeSH
• postoj zdravotnického personálu MeSH
• průzkumy a dotazníky MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• vztahy mezi lékařem a pacientem etika   MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• Geografické názvy
• Česká republika MeSH

Unless it is necessary to provide immediate assistance to a patient who, due to his state of health, is unable to give consent, every medical treatment must be performed with an voluntary consent from the patient. The patient must be informed, in advance, about the purpose and nature of the treatment, its consequences and risks. If the patient refuses the proposed treatment he must be notified about the possible harmful effects of this decision for his health (life) and the patient must sign a written refusal of the medical treatment - commonly known as revers. In case the patient refuses both the treatment and the signature, then the refusal must be signed by a witness. Informed consent may be oral; its written form is obligatorily dictated by law only in exceptional cases. Every health service provider is solely responsible for deciding which treatments will require written consents. The refusal form, revers, must always be written. The European courts have been emphasising that the most significant thing is the dialogue between the doctor and the patient, not the signed document. The patient must be informed by a relevant doctor about the treatment he is about to undergo not by a nurse or a doctor who will not be performing it. It is questionable whether it would not be better to substitute a written consent for an audio or audio-visual recording showing the interaction between the doctor and the patient, or his family. Anyone is allowed to express a future wish for situations when he will not be able to agree or disagree with the offered health services (that means previously expressed wishes - living will). The law will determine the formalities of such a document. Previously expressed wish should be respected unequivocally, although, its fulfillment must not lead to active cause of death. The rule is that human free will gives way to the protection of his life.

• MeSH
• informovaný souhlas pacienta * MeSH
• lidé MeSH
• pacientova přání ohledně budoucí terapie MeSH
• vztahy mezi lékařem a pacientem MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH

In this work the author is trying to show some problems related to informed consent in psychiatry. It deals especially with problems of medical research, sterilisation, involuntary therapy, treatment of drug addition etc. In each of these areas there can come to a clash of interests between the society and the patient. The informed consent turns our attention to the patient.

• MeSH
• informovaný souhlas pacienta * MeSH
• lidé MeSH
• psychiatrie * MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• anglický abstrakt MeSH
• časopisecké články MeSH

OBJECTIVE: A systematic review of recent available literature on the topic of informed consent, evaluation of the terminus a quo and the creation of theoretical basis for execution of the process of informed consent in clinical practice with attention to specific aspects in gynecology and obstetrics. TYPE OF STUDY: Review of literature. SETTING: Mother and Child Care Institute Prague, Chair of Gynecology and Obstetrics, IPVZ, Prague. METHODS: Review of publications on the given topic and implementation of general principles of medical ethics in the area of gynecology and obstetrics. RESULTS: The branch of gynecology and obstetrics brings about various controversial clinical situations, which arise from specific features of the branch. The informed consent is an integral part of the diagnostic-therapeutic process and precondition of the correct (lege artis) procedure. The adequate agreement with the therapy should be informed, free and competent. It prevents ethical crisis in conditions of an ethical conflict. The paper defines the content and structure of the informed consent and draws attention to its technical prerequisites so as to fulfill the truthfulness and legal validity. CONCLUSION: The informed consent is an important part of communication between the physician and the patient. The physician provides a complex, qualified, truthful and complete information. A competent patient accepts this kind of information and decides, based on full understanding, when and in what form, undergoes the recommended procedure or refuses it.

• MeSH
• gynekologie * MeSH
• informovaný souhlas pacienta etika   MeSH
• lidé MeSH
• porodnictví * MeSH
• střet zájmů MeSH
• záznamy jako téma MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• přehledy MeSH
• systematický přehled MeSH