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

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

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

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
• systematický přehled MeSH

Coequalitisation of the relation between the physician and his patient, which respects the professional dominancy of the first one, has promoted the full guidance before any serious diagnostic or therapeutic intervention. Patient has the right to be informed of his health status and of the therapeutic plan. He has also the right to refuse such information. Only after the full information, the patients can express his approval with the plan for therapy. Before any intervention, the patient's approval is necessary; exceptional are only by the law implicated situations. To get the lawful and therefore the qualified or informed approval, the patient should be able to accept the information, to consider its significance, to make decision, and the express his will. Incapable of doing that is not only the person with permanently decreased ability to resolve, but also those who are not able to accept the information because of language problem and those, whose psychical state is influenced by the actual state of the disease, therapy etc. For a child, the person who has the right to be informed and to give the consent is his protector (usually his parent), however, within the limits of his comprehension an older child has also the right to express his opinion. For the common treatment the written form of approval is not necessary, it is enough to get the oral consent. For intervention of a higher significance and risks, the written form is recommended. It should be connected with a possibility to discuss and get explained any questions. The information should include not only what is to be done, but also how it will be done and what are the benefits of the treatment. It is essential to inform the patient also about the after-effects, side effects and possible complications, all that considering their significance and incidence. Information about the intervention and its risks does not limit the patient's right for compensatory damages, but it frequently improves communication and mutual collaboration between the patient and health care workers.

• MeSH
• dítě MeSH
• duševní schopnost MeSH
• informovaný souhlas pacienta * zákonodárství a právo   MeSH
• lidé MeSH
• zákonný zástupce MeSH
• Check Tag
• dítě MeSH
• lidé MeSH
• Publikační typ
• anglický abstrakt MeSH
• časopisecké články MeSH
• Geografické názvy
• Česká republika MeSH

• MeSH
• formuláře a záznamy - kontrola a vedení MeSH
• genetické testování * MeSH
• informovaný souhlas pacienta normy   MeSH
• lidé MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• Geografické názvy
• Česká republika MeSH

The European Union (EU) General Data Protection Regulation (GDPR) imposes legal responsibilities concerning the collection and processing of personal information from individuals who live in the EU. It has particular implications for the remote monitoring of cardiac implantable electronic devices (CIEDs). This report from a joint Task Force of the European Heart Rhythm Association and the Regulatory Affairs Committee of the European Society of Cardiology (ESC) recommends a common legal interpretation of the GDPR. Manufacturers and hospitals should be designated as joint controllers of the data collected by remote monitoring (depending upon the system architecture) and they should have a mutual contract in place that defines their respective roles; a generic template is proposed. Alternatively, they may be two independent controllers. Self-employed cardiologists also are data controllers. Third-party providers of monitoring platforms may act as data processors. Manufacturers should always collect and process the minimum amount of identifiable data necessary, and wherever feasible have access only to pseudonymized data. Cybersecurity vulnerabilities have been reported concerning the security of transmission of data between a patient's device and the transceiver, so manufacturers should use secure communication protocols. Patients need to be informed how their remotely monitored data will be handled and used, and their informed consent should be sought before their device is implanted. Review of consent forms in current use revealed great variability in length and content, and sometimes very technical language; therefore, a standard information sheet and generic consent form are proposed. Cardiologists who care for patients with CIEDs that are remotely monitored should be aware of these issues.

• Klíčová slova
• Cardiac implantable electronic device, Cybersecurity, Data controller, Data processor, EHRA, ESC Regulatory Affairs Committee, General Data Protection Regulation, Informed consent, Informed consent form, Joint data controller, Remote monitoring,
• MeSH
• elektronika MeSH
• kardiologie * MeSH
• lidé MeSH
• monitorování fyziologických funkcí MeSH
• poradní výbory MeSH
• zabezpečení počítačových systémů MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH

BACKGROUND: Obtaining informed consent from research study participants continues to meet difficulties. New ways to connect with potential participants are necessary to address barriers, expand enrollment and offer more services to underserved populations. OBJECTIVES: Electronic consent is designed to complete consenting sessions remotely and may help combat the obstacles inherent in the traditional informed consent process. We investigate the implementation of an electronic consent platform, Teleconsent, to broaden and diversify recruitment for clinical research. METHODS: Semi-structured interviews were conducted with community members to assess their perceptions regarding the acceptability and usability of Teleconsent, a form of electronic consent. Interviews were structured to determine the main benefits, challenges and concerns as detailed by each participant. Participants were divided into rural and urban groupings. RESULTS: We interviewed 40 participants to gather first-time perceptions of Teleconsent. We found overall positive results. Predominately in urban communities, participants possessed the technological skills and amenities to support smooth implementation of this technology. However, many participants reflect on the challenges regarding logistics, privacy and reliability of utilizing Teleconsent in underserved, rural areas. 5 of 19 participants, more than a quarter for the rural group, experienced Teleconsent software problems. During these sessions, an alternative process with paper templates was employed to complete interviews. CONCLUSION: Perceptions regarding Teleconsent demonstrate current challenges along with potential acceptance within different communities. This is despite the fact that on its own it will not be able to overcome the barriers currently found in the informed consent process. Still, investment in electronic consent, including the development of enhanced and interactive content, can potentially revolutionize this process. Our findings offer a preliminary step towards determining the feasibility and acceptance of Teleconsent, a form of electronic consent, in different communities. More research surrounding the logistics of adoption is necessary in order to determine success.

• Klíčová slova
• Informatics, Informed Consent, Telemedicine, Videoconference,
• Publikační typ
• časopisecké články MeSH

BACKGROUND: This article is a joint statement of the Czech Pneumological and Physiological Society and the Czech Society for Radiation Oncology, Biology and Physics, and reviews current opinions on radiotherapy in patients with idiopathic pulmonary fibrosis (IPF). In general, radiotherapy of lung tumours is associated with risk of radiation pneumonitis (RP); moreover, IPF may be complicated by acute exacerbations (AE-IPF). Both complications may immediately threaten patients lives. MATERIAL AND METHODS: Assessment of individual radiotherapy modalities has shown that conventional radiotherapy is not appropriate, especially in large tumours. Up to 30% of patients are at risk of developing AE-IPF. As a result, as many as 83% of patients die within 3 months of initiation of lung cancer treatment. Fatal RP is most commonly observed within 2 months of radiotherapy. In IPF accompanied by early-stage non-small cell lung cancer (NSCLC), stereotactic body radiation therapy (SBRT) may be considered. NSCLC should be treated with chemotherapy. Several cases report severe exacerbations of subclinical IPF after SBRT even with minimal signs of previous interstitial involvement. Grade 2 RP has been reported in up to 50% of cases with any level of interstitial change detected by lung CT prior to radiotherapy. In palliative radiotherapy, external radiation may be considered as an exception if the main bronchi are involved. Similarly, brachytherapy may be indicated for certain cases of bronchial stenosis. RESULTS: The presence of any level of interstitial change suggests a risk for fatal RP and AE-IPF. This is also supported by the fact that, at the present time, there are no dose limitations for radiation therapy of lung cancer in IPF, irrespective of whether conventional fractionated radiotherapy or SBRT is used. Moreover, there are no reliable predictive factors for lung involvement. In some studies, RP was more frequently associated with high CRP and LDH levels, PS 2 and interstitial changes of 10% or more. Treatment depends on the severity of the involvement. In more severe forms, corticosteroids, antibiotics and oxygen therapy should be administered. Ventilation support is often needed. CONCLUSION: Radiotherapy for patients with IPF and lung cancer or other chest tumours requires an individual approach depending on the local findings, the patients lung function and general condition, and the prognosis of the primary disease. Decision-making should take into consideration potential benefits and risks, and be carried out by a multidisciplinary team comprising a pulmonologist and clinical and radiation oncologists. Treatment should always be thoroughly discussed with the patient signing an informed consent form.Key words: idiopathic pulmonary fibrosis - chest radiotherapy - indications - radiation pneumonitis - acute exacerbation of idiopathic pulmonary fibrosis - treatment This work was supported by grant AZV 16-32-318 A. The authors declare they have no potential conflicts of interest concerning drugs, products, or services used in the study. The Editorial Board declares that the manuscript met the ICMJE recommendation for biomedical papers.Submitted: 4. 5. 2017Accepted: 18. 5. 2017.

• MeSH
• akutní nemoc MeSH
• idiopatická plicní fibróza etiologie   patofyziologie   MeSH
• lidé MeSH
• nádory plic patofyziologie   radioterapie   MeSH
• nemalobuněčný karcinom plic farmakoterapie   radioterapie   MeSH
• progrese nemoci MeSH
• radiační pneumonitida etiologie   patofyziologie   MeSH
• radiochirurgie škodlivé účinky   MeSH
• radioterapie škodlivé účinky   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• přehledy MeSH

Although drug compliance is a crucial component of treatment effectiveness in chronic diseases, it has never been evaluated in patients with systemic scleroderma. Therefore, the aim of this descriptive study was to determine the drug compliance rate in systemic scleroderma patients and to identify risk factors for noncompliance in these patients. A cross-sectional observational study was conducted. All patients with systemic scleroderma (n = 41) who visited a rheumatic center and signed an informed consent form were included. Data were obtained during structured interviews with patients and from medical records. The Compliance Questionnaire Rheumatology (CQR) was used to determine patient compliance. The relationships between compliance rate and demographic and clinical characteristics were examined. The mean CQR score was 75 %. Based on a dichotomous rating, only 42 % of the patients achieved a satisfactory compliance rate (≥80 %). No relationships between various demographic and clinical characteristics and CQR score expressed as continuous or dichotomous variables were found. This study represents the first evaluation of drug compliance in patients with systemic scleroderma. Many noncompliant patients were identified, but no common risk factors for noncompliance were discovered. The reasons for noncompliance seem to depend on the personal features of the patients.

• MeSH
• adherence k farmakoterapii * MeSH
• adherence pacienta MeSH
• chronická nemoc MeSH
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• průřezové studie MeSH
• průzkumy a dotazníky MeSH
• revmatologie metody   normy   MeSH
• senioři MeSH
• systémová sklerodermie farmakoterapie   MeSH
• výsledek terapie MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH