The cholecystectomy procedure is the most routinely performed intervention in general surgery. The current international gold standard is via the laparoscopic approach. It is a safe, minimally-invasive procedure; however, it is associated with complications in 1% of cases. The aim of the study was to analyze patient feedback, by means of a survey, to determine how much knowledge patients possessed about their disease state and proposed surgical intervention, based primarily on information contained within the informed consent form developed by the Association of Polish Surgeons. Material and methods. This study involved the participation of 51 patients who underwent laparoscopic cholecystectomy, indicated by a diagnosis of gallstones, in the years 2014 and 2015. Results. Despite having signed the informed consent form, there was considerable variation among the responses given to the survey by the 51 patients in this study. Some patients’ responses were tangential to the questions asked; many patients did not respond to any of the sub points. Conclusions. Given that this study is based on a small sample size of patients, it must be presumed that the process by which the patient declares his or her informed consent requires further consideration with respect to the means by which it is obtained. The authors of this study thus recommend that multimedia resources be harnessed as part of the process of obtaining the informed consent of patients prior to surgical intervention.
Rapid changes in different spheres of social life (especially the commercialization of science, the digitalization of data, and the explosion of social media) have recently influenced definitions of research situations and approaches to findings in the social sciences. While various new standards from the natural sciences have been implemented, research situations have also been shaped by circumstances related to wider cultural changes, that is, by a sort of a cultural shift, especially in the sphere of new media communication. All these phenomena have revived the discussion of ethical issues. This article analyzes the current methodological status of biographical research as part of a professional ethic construed as the systematic exploration of the methodology used bybiographical researchers and the need for constant reflection on the research process. The article is devoted to different areas that may be associated with ethical concerns: the relationship between a researcher and an interviewee; problems related to the consequences of digital archiving; the proper style of doing research when there are strong expectations that the results will be disseminated; the possible consequences of using informed consent with the illusory expectation that it removes ethical dilemmas; and the practices leading to a professionalization of ethics.
Objectives: In Poland, 95% of medical personnel had not received legal education before they completed their studies. Having been given these facts, we have started questioning legal awareness of people providing medical services. Aim of the study: The study aimed at evaluating the knowledge of allergists and pulmonologists. Material and Methods: The group consisting of 328 allergists and/or pulmonologist completed the questionnaire. Results: The participants possess the best knowledge in providing information to patients about their health status (CV1). Sixty nine % of responders replied correctly, and the difference was significant (p < 0.001) in comparison with next aspect referring to the principles of providing medical services following guidelines created by think-tanks and also possibilities to take autonomous decisions by physicians (CV2). The correct answers in relation to CV2 were given by 57% of responders. The third compared aspect was physicians' awareness of patients' right to giving a consent or refusal before undertaking the medical procedure CV3. Only 55% of physicians gave correct answers and the difference was significant compared to CV1 (p < 0.001) as well as CV2 (p < 0.05). Younger doctors showed to have better knowledge than their older colleagues (p < 0.05). Working in urban workplaces proved to be more associated with better knowledge than in rural ones (p < 0.05). Discussion: Insufficient knowledge results in a low quality of provided services and puts the doctors at risk of being liable. The rates indicate that doctors are not aware of the fact that only legal regulations are binding, while standards not published by the Minister of Health are not legally valid. Half of the respondents have the wrong belief that the opinions expressed by experts make the doctor feel exempt from liability. Probably there are specialities, like occupational medicine which are specially linked with awareness of valid legal rules.
Background: Empirical studies involving human participants need to follow procedures to avoid causing harm to the subjects. However, it is not always clear how researchers should report these procedures. Aim: This study investigates how researchers report ethical issues in the software engineering journal publications, particularly informed consent, confidentiality, and anonymity. Method: We conducted a literature review to understand the reporting of ethical issues in software engineering journals. In addition, in a workshop, we discussed the importance of reporting the different ethical issues. Results: The results indicate that 49 out of 95 studies reported some ethical issues. Only six studies discussed all three ethical issues. The subjects were mainly informed about the study purpose and procedure. There are limited discussions on how the subjects were informed about the risks involved in the study. Studies reported on how authors ensured confidentiality have also discussed anonymity in most cases. The results of the workshop discussion indicate that reporting ethical issues is important to improve the reliability of the research results. We propose a checklist based on the literature review, which we validated through a workshop. Conclusion: The checklist proposed in this paper is a step towards enhancing ethical reporting in software engineering research.
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This article is focused on the examination of the law concerning medical treatment of minors, that is, persons under the age of 18. The first part of this article brings a short overview of the international documents regulating the rights of the child and specifically children’s rights within the area of health care provision. This article analyzes the issue of the maturity and competence of children and discusses whether persons under the age of 18 may be regarded as being capable of consenting to medical treatment. Furthermore this article brings a short comparative overview of the laws concerning medical treatment of minors in different countries and tries to extract the common features of the regulations in the different countries. Finally, the last and longest part of this article analyzes the issue of the capacity of minors to consent to medical treatment in the territory of the Czech Republic from the historical perspective and brings a structured overview of this issue under the current Czech laws.
The text examines the draft law on genetic testing for health purposes. Considerations are carried out in the context of the “right to ignorance” and the situation of family members of the patient. The author, in her analysis, concentrates on the principle of the informed consent and the right to respect for patient’s private life, in particular to protection of his or her personal data derived from a genetic test. There is no legal regulation of the genetic testing under the Polish law. However, it is an important issue that requires an intervention of the legislator. The author reflects that where the results of a genetic test undertaken on a person can be relevant to the health of other family members, the person tested shall be informed and these members should be informed as well.
Introduction: Patients’ rights must be respected at every stage of therapy, including during biological drug therapy. For clinicians, it is key to be involved in the decision-making process with regard to the choices of medication and possible drug substitution. In Poland, the law encourages automatic drug substitution and does not recognise disparities in biological drugs. Aim: The main aim of the paper is to describe the present legal situation depicting the scope of autonomy of a hospitalised patient. Methods: An analysis was conducted of the Polish regulations, the doctrine and administrative decisions and European Medicines Agency guidance documents. Results: In Poland, patients who require therapy with advanced technologies such as biopharmaceuticals, may obtain access to a medicine within a special drug reimbursement programme in a hospital. Hospitals are supplied with the drugs necessary for drug therapy programmes via public procurement. This means that hospital procurement procedures decide which drug a patient will receive. It is not the decision of the health care provider. In view of this, the Polish Patient Ombudsman, in a decision confirmed by the Provincial Administrative Courts, pointed out that the selection of a drug for therapy should depend on current medical knowledge rather than on the result of a tender carried out by a hospital. Conclusions: Polish solutions based on the lack of an obligatory requirement to consult a substitution with a treating physician deviate from the standard practices followed in numerous EU countries and the US.
A right to give a consent for a healthcare service is one of the most critical patients’ rights, but yet in relation to children it is limited. The principle is that the minor patient who turned 16 agrees for medical activities together with it’s legally designated representative; whereas for a patient who did not turn 16 decides exclusively the representative itself. For certain medical services Polish legislator introduced other rules. Differently regulated are rules concerning giving a consent by minor patients for participation in a medical experiment, for collection of the cells, tissues and organs for the purpose of transplantation, for taking blood or for a psychiatric examination. Excessive casuistry in accordance with the consent of a minor patient for a healthcare service undoubtedly make it’s understanding and applying more difficult.
PL
Prawo do wyrażenia zgody na udzielenie świadczenia zdrowotnego jest jednym z najistotniejszych praw pacjenta, jednakże w stosunku do dzieci, jest ono ograniczone. Zasadą jest, że pacjent małoletni, który ukończył 16 lat wyraża zgodę na działanie medyczne razem ze swoim przedstawicielem ustawowym, natomiast za pacjenta, który nie ukończył 16 lat, decyduje wyłącznie przedstawiciel ustawowy. Dla niektórych świadczeń zdrowotnych polski ustawodawca wprowadził jednak odmienne reguły. W sposób odmienny uregulował zasady wyrażania zgody przez pacjenta małoletniego na udział w eksperymencie medycznym, na pobranie komórek, tkanek i narządów w celu ich przeszczepienia, na pobranie krwi czy też na badanie psychiatryczne. Nadmierna kazuistyka przepisów w zakresie zgody pacjenta małoletniego na udzielenie świadczenia zdrowotnego niewątpliwie utrudnia ich poznanie i stosowanie.
Blood taking is a medical procedure which requires a valid consent from patients. This problem may be considered in terms of many different aspects. The statement that the circumstances and aims of this medical procedure exert an influence on law serves as a good starting point. Blood donation is regulated by different rules than blood sampling. Moreover, yet another principles are applied when HIV test is performed. Additionally, blood taking is regulated in civil proceedings. To sum up, in each case a consent of blood taking is a necessary, yet not an exclusive component. It, however, ascertains that medical procedures are followed according to the law. In that way, the legislator protects patients’ fundamental rights.
Artykuł przedstawia kwestię świadomej zgody w badaniach z dziećmi w perspektywie etyki i metodologii badań. Bazując na własnych badaniach z udziałem dzieci, autorki przedstawiają rozważania na temat wagi takiej zgody, a następnie sposoby, w jakie dzieci mogą wyrazić zgodę lub jej nie udzielić. Udzielenie zgody na badanie przez dzieci zostało przedstawione jako proces, nie jednorazowy akt. Jednocześnie jednak autorki zwracają uwagę na to, że sam moment udzielenia zgody pełni ważną funkcję, wzmacniając pozycję dziecka w badaniu.
EN
The article explores the issue of informed consent in childhood studies from the ethical and methodological perspective. Based on their experience in research with children, the authors first elaborate on the importance of such consent in research with children and then show how children give (or not give) their consent to participate in social research. The article shows how giving assent to research by children is a process rather than a single occurrence. At the same time, however, the moment of giving assent is important and meaningful as it empowers the child as participant in the research.
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This article is focused on the examination of the legal nature of the informed consent and its consequences. The first part of this article discusses whether informed consent is juridicial act and the conditions of the validity such as competence, information and voluntariness. A special attention is given to the analysis of the scope of the medical disclosure and to the legal consequences of the failure to warn. Further this article analyses the scope of the civil liability in the cases of the improper medical disclosure.
CS
Tento článek se zabývá právní povahou informovaného souhlasu a následky neúplného poučení z hlediska civilního práva. První část článku se věnuje problematice právního jednání a jeho náležitostí a zasazuje je do problematiky informovaného souhlasu s poskytováním zdravotních služeb. Následně se článek zabývá problematikou vad právního jednání a jejich důsledků pro jeho platnost a vznik povinnosti k náhradě újmy. Existence povinnosti k náhradě újmy je pak podrobně analyzována s ohledem na odlišnost situací, kdy informovaný souhlas nebyl vůbec udělen nebo byl udělen po vadně provedeném poučení. Cílem tohoto článku je poskytnout ucelenější teoretickou analýzu povahy informovaného souhlasu a jeho zakotvení v systematice civilního práva.
Esej ten stanowi rozszerzoną wersję komentarza dotyczącego referatów zaprezentowanych w trakcie sesji pt. „Antropologie oparte na współpracy, zaangażowanie społeczne i epistemologie równości”, zorganizowanej i prowadzonej przez L.E. Lassitera na dorocznym spotkaniu American Anthropological Association w 2007 roku w Waszyngtonie.
EN
This essay expands upon a commentary on papers offered in the Presidential Session titled „Collaborative Anthropologies, Public Engagement, and Epistemologies of Equity”, chaired and organized by Luke Eric Lassiter, at the 2007 annual meeting of the AAA in Washington, DC.
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Biobanki populacyjne stwarzają nowe możliwości prowadzenia badań biomedycznych oraz rozwoju medycyny personalizowanej i genomiki zdrowia publicznego. Z drugiej strony niosą wyzwania w zakresie zagwarantowania praw dawców (świadoma zgoda, zachowanie prywatności i poufności, niedyskryminacja w oparciu o dziedzictwo genetyczne). Główne wymiary, w których realizować się może ochrona praw dawców, to: właściwa komunikacja zarówno na poziomie społecznym (konsultacje społeczne) jak i indywidualnym (proces uzyskiwania świadomej zgody od dawców), odpowiednia organizacja biobanku (bezpieczny system informatyczny, kodowanie i anonimizacja danych, reguły dostępu do danych), właściwy nadzór nad działalnością biobanku (zazwyczaj sprawowany przez komisję etyczną i komitet naukowy), a także stworzenie odpowiednich regulacji prawnych dotyczących pobierania, przechowywania i udostępniania ludzkiego materiału biologicznego oraz zapobiegających dyskryminacji ze względu na dziedzictwo genetyczne. W artykule opisane zostały również zasady organizacji i funkcjonowania biobanków populacyjnych w wybranych krajach europejskich (Estonia, Hiszpania, Wielka Brytania) w kontekście respektowania praw dawców.
EN
Population biobanks offer new opportunities for biomedical research, and are fundamental for the development of personalized medicine and public health genomics. On the other hand they demand new rules in order to guarantee donor rights (informed consent, privacy, confidentiality, non-discrimination). The main dimensions of respecting donor rights are: good communication skills with society (public consultation) and with individual donors (informed consent), appropriate biobanks organization (secure IT system, encoding and data anonymization, access to data), supervisory systems (Ethics Committees and Research Committees) and legal norms concerning the storage, management and transfer of samples and data, and non-discrimination rules. The article presents population biobanks in selected European countries (UK, Spain, Estonia) in the context of donor rights in the process of biobanking.
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In the contemporary bioethics, patient's autonomy is often recognized as the most important issue. This autonomy is interpreted as the right to self-determination regarding all medical-related decisions. An essential condition of autonomous decisions is the adequate knowledge of the issues involved. The "informed consent" has become a gold standard of bioethics. All this leads to focusing on the problems related to communication, and, in consequence, on the language as a fundamental tool of communication. The aim of the article was to reveal the meaning of "breath(e)/breathing" and in that way to contribute to a better communication between doctors and patients. An analysis was performed using a method of non-analytical philosophy of language. English, Italian, and Polish were chosen as subjects of this study. The results clearly show the multiplicity and variety of meanings that assume breathing-related linguistic expressions. All of them are classified in four main groups. In conclusion, the author submits that an improvement in the understanding of different meanings of words used in the doctor-patient relationship can contribute to maintaining ethical standards in medical practice.
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Respect for patientʼs autonomy is a key requirement of every ethical and legal codes. But what does it mean, autonomy? What concept of autonomy shall we choose? In modern bioethics, two concepts of autonomy dominate. The first is the so-called default theory created by Tom Beauchamp and James Childress, the second is the so-called split-level autonomy theory, sometimes referred to as the theory of authenticity. The first concept is derived from the concept of negative autonomy, the second is the idea of a positive interpretation of this word. The proven thesis of this article is that respect for that patient default autonomy is a necessary but not sufficient condition for an ethical relationship between the doctor and the patient. Respect for patient authenticity on the other hand cannot be a necessary condition for this ethical relationship, but it should be the ideal that a physician should seek to achieve, the moral of aspiration. Choosing one of these two concepts of autonomy has also key impact on the theory of informed consent, which will be proved as well.
CS
Respekt k autonomii pacienta je klíčovým požadavkem plynoucí ze současných etických i právních kodexů. Není však zcela jisté, jaký koncept autonomie má být zvolen. Z toho plyne řada nejasností i pro teorii informovaného souhlasu. V současné moderní bioetice dominují dvě koncepce autonomie. První je tzv. defaultní teorie vytvořená Beauchampem a Childressem, druhá je tzv. teorie stupňovité autonomie, někdy nazývaná jako teorie autenticity. První koncepce je odvozena od koncepce tzv. negativní autonomie, druhá naopak předpokládá pozitivní výklad tohoto slova. Prokazovaná teze tohoto článku je ta, že respekt k tzv. defaultní autonomii pacienta je nutnou, nikoliv však postačující podmínkou pro etický vztah lékaře a pacienta. Respekt k stupňovité autonomii pacienta naopak nemůže být nutnou podmínkou pro etický vztah lékaře a pacienta, nicméně je klíčem pro dosažení tzv. morálky aspirace, ideálu, který by se měl lékař snažit dosáhnout. Výběr konceptu autonomie má pak zásadní dopady i na teorii informovaného souhlasu.
This paper analyses some specific problems under article 200 § 1 of the Penal Code. The basic aim of my research was to give a relatively clear answer to the question about penalising an offender when he/she is just several years older than his/her victim or when the victim initiates sexual activities. Taking into consideration the decrease of age in which youths begin sexual initiation, it is important to know what the consequences of it in their emotional sphere are. By referring such observations to the problem of child sexual abuse, there is a dissonance between child’s acceptance of incursion in his/her intimacy and legal regulations. Therefore, child sexual abuse is not only a legal problem, but it also has influence on sexuality and the society, morality etc.
PL
Opracowanie dotyczy przedmiotu ochrony z art. 200 § 1 kodeksu karnego, jakim jest wolność seksualna osób poniżej 15. roku życia. Podstawowym jego celem jest udzielenie względnie jednoznacznej odpowiedzi na pytanie, czy w sytuacji, kiedy sprawca jest zaledwie kilka lat starszy od pokrzywdzonego oraz w momencie, gdy ofiara sama inicjuje czynności seksualne dorosły młodociany powinien być karany zgodnie z sankcją z ww. przepisu. Mając na uwadze stale obniżający się wiek inicjacji seksualnej młodzieży, gdy osoba, która nie ukończyła 15. roku życia, dobrowolnie poddała się czynności seksualnej z osobą nieznacznie starszą (powyżej 17. roku życia, ponieważ taką granicę wieku wprowadza kodeks karny, by móc sprawcy przypisać popełnienie czynu zabronionego), powstaje dysonans prawny, moralny i obyczajowy. Z jednej bowiem strony są przepisy penalizujące takie zachowanie, z drugiej to nieletni sam przekroczył granicę ingerencji w swoją sferę intymną. W sytuacji, gdy ofiara zgadza się na kontakty seksualne albo sama zachęca czy inicjuje obcowanie płciowe lub inną czynność seksualną, neguje to cel, który przyświecał ustawodawcy kryminalizującemu takie zachowania. Tym niemniej przepisy obowiązują, w związku z czym warto przybliżyć tę tematykę w odniesieniu nie tylko do zachowania nagannego w kontekście prawnym, ale także z punktu widzenia socjologii czy obyczajności.
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Informed consent is the fundamental ethical and legal doctrine that protects the patient's rights. Philosophers and lawyers have created an enormous literature addressing the themes of personal autonomy, self-determination, and informed consent. Firstly, this article makes a historical research based on some empirical studies, searching for historical sources of doctor – patient relationship. Informed consent is a little bit hybrid concept which speaks both to physicians´ disclosure obligations and patients´ willingness to undergo a particular treatment. Both elements and their historical background shall be analysed in this article. The brief history of doctor-patient communication seems to be based on paternalistic approach. Throughout the ages physicians believed that they should make treatment decisions for their patients. This conviction inheres in the Hippocratic Oath. The patient is not mentioned as a person whose ability and judgment deserve consideration, at least in the antique and medieval ages. We can find slide different opinions on communication between doctor and patient in modern era. Two recently framed and competitive historical analyses illustrate the difficulty of amassing historical evidence about informed consent and its historical justifications. The two theses have been ably defended by historian Martin S. Pernick and psychiatrist Jay Katz. Katz speaks about “the silent world of doctor and patient”, which persists at least till the second half of 20th century. By contrast, Pernick concludes, after a thorough examination of a wide variety of nineteenth-century sources, that "truth-telling” and “consent-seeking” have long been part of an indigenous medical tradition, based on medical theories that taught that knowledge and autonomy had demonstrably beneficial effects on most patients' health.
CS
Informovaný souhlas je fundamentální etická i právní doktrína, která má ochraňovat práva pacienta. Filosofové a právníci vytvořili množství odborné literatury, která se zabývá otázkou autonomie, sebe-určení v kontextu informovaného souhlasu. Primárním cílem tohoto článku je provést historickou analýzu, vycházející z empirických studií, přičemž předmětem zkoumání budou historické prameny popisující vztah mezi pacientem a lékaře. Při tomto historickém zkoumání je třeba mít stále na vědomí, že informovaný souhlas je hybridní koncept – skládá se totiž z prvku lékařovy povinnosti sdělovat informace pacientovi a z pacientovy vůle podstoupit léčbu. V tomto článku se pokusím analyzovat oba tyto koncepty. Historická analýza pak poodkrývá, že vztah lékaře a pacienta byl založen na „paternalistickém“ konceptu, doktoři chtěli činit dobro pro své pacienty, aniž by se jich ptali na názor a přenášeli na ně rozhodovací pravomoc. Historie medicínské etiky se odvíjela od Hippokratovské přísahy. V starověké i středověké medicíně není pacient přizván do procesu rozhodování o jeho léčbě. V moderní éře by tomu mělo být jinak. Má však jít o radikální změnu? V článku jsou zkoumany dvě odlišné interpretace vztahu lékaře a pacienta v historickém kontextu, teze obhajovaná Martinem Pernickem a druhá zastávaná psychiatrem Jay Katzem. Katz mluví o „tichém světu lékaře a pacienta“, který přetrvával minimálně do druhé poloviny 20. století. Pernick nesouhlasí. Podle ně koncepty pravdomluvnosti vůči pacientovi, s čímž souvisí i snaha dosáhnout souhlasu pacienta s navrženou léčbou, jsou přítomny již minimálně v 18. století. Článek srovnává obě teze a vyvozuje etické závěry.
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The development of research based on human biological material has contributed to a lively debate on the concept of informed consent in these studies, particularly its scope, form and length of validity. The biggest disputes and doubts concern the range of consent for research that will be conducted in the future, whose aim and place are unknown at the time of the sample collection, as are the future researchers and the ability to use the previously collected materials again. This situation raises the question of a just and prudent balance between the rights of participants in the research and the rights of researchers. New forms of consent have been proposed, which sometimes substantially diverge from the classical model (e.g. blanket consent or broad consent and its various kinds) in aiming towards responsible balancing between the necessity to protect the donors’ interests and the possibility of conducting research in medicine. These new concepts also find their application in legislative acts adopted internationally and in some European countries in the recent years.
PL
Rozwój badań naukowych opartych na wykorzystaniu ludzkiego materiału biologicznego przyczynił się do poważnej dyskusji wokół koncepcji świadomej zgody w tych badaniach, szczególnie jej zakresu, formy i długości obowiązywania. Największe spory i wątpliwości budzi zakres zgody na badania naukowe, które będą prowadzone w przyszłości, a konkretny cel badań, miejsce i badacze są nieznani w chwili pobrania materiału, a także możliwość ponownego wykorzystania wcześniej zgromadzonego materiału. Taka sytuacja rodzi pytanie o sprawiedliwe oraz roztropne zrównoważenie godności i praw uczestników badań, a także obowiązków i praw badaczy. Proponuje się nowe formy zgody, niekiedy odbiegające znacznie od jej klasycznego modelu (np. zgoda blankietowa, zgoda rozszerzona i jej odmiany), mające na celu odpowiedzialne zrównoważenie konieczności ochrony interesów dawców oraz możliwości prowadzenia badań naukowych w medycynie. Znajdują one również zastosowanie w aktach legislacyjnych przyjętych w ostatnich latach na forum międzynarodowym i w niektórych krajach europejskich.
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Vaccination has been presented as a probable solution to the ongoing pandemic of covid-19 and as such has been applied in the domestic context, and at the moment as a voluntary vaccination. However, there are a number of legal issues and implications associated with vaccination, and the present article seeks to bring at least some of these into focus. Attention is given to the nature of vaccination as a public administration and health service measure, prioritisation in the selection of persons for vaccination, the phenomenon of refusal to vaccinate, the public administration's vaccination campaign, the issue of distinguishing between vaccinated and unvaccinated in the imposition of various restrictions (and the related issue of discrimination on this basis), the legal possibility of compulsory vaccination, the related issue of conscientious objection and, finally, liability for harm caused by covid-19 vaccination. However, given its scope, the text is certainly not in any sense comprehensive.
CS
Očkování je označováno jako pravděpodobné řešení stále aktuální pandemie onemocnění covid-19 a jako takové je uplatňováno také v domácím kontextu, a to v současnosti jako očkování dobrovolné. S tímto očkováním však souvisí řada právních otázek a souvislostí, přičemž předložený článek usiluje o přiblížení alespoň některých z nich. Pozornost je věnována otázkám povahy očkování jako opatření veřejné správy a zdravotní služby, prioritizace při výběru osob k očkování, fenoménu odmítání očkování, očkovací kampaně veřejné správy, problematiky rozlišování mezi očkovanými a neočkovanými při ukládání různých omezení (a související otázce diskriminace na tomto základu), právní možnosti povinného očkování, navazující problematiky výhrady svědomí a konečně odpovědnosti za újmu způsobenou očkováním proti covidu-19. S ohledem na svou šíři však text jistě není jakkoli vyčerpávající.
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