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EN
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.
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Content available remote Informed consent of minors with a special focus on the Czech legal regulation
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EN
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.
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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.
EN
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.
EN
There is a high demand for egg donors in the Czech Republic, driven by international couples’ interest in assisted reproductive procedures due to affordable treatment, no waiting list, and an extended age limit for recipients up to 49 years. For a population of 10.5 million, the country has 48 reproductive clinics. This study aims to evaluate Czech egg donor recruitment campaigns through the lens of free, informed, and specific consent requirements. A quantitative-qualitative analysis of recruitment strategies from 29 unique clinic websites in Czechia was conducted, with 12 sites specifically designed for marketing purposes. The analysis was based on 14 criteria. Of the 29 clinic websites, only three did not indicate compensation amounts, ranging from 800 to 1400 EUR. Thirteen clinics did not provide information on risks associated with oocyte donation, with one falsely stating no risks exist. Twenty-two websites used emotionally evocative quotes and images. Thirteen clinics did not disclose time commitments, and one provided misleading information. Seventeen clinics omitted conditions for donor refusal and the number of allowable donations. Eighteen clinics did not offer post-donation referrals. Conversely, 15 clinics highlighted psychological benefits, and 23 emphasized health benefits. None fully complied with international guidelines on oocyte donation. Analysed websites lack sufficient information for responsible egg donation decisions. The emphasis on compensation, benefits, and suggestive graphics creates an image of safe, community-oriented donation, potentially leading to inadequate understanding of health risks and commodification of the female body.
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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.
EN
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.
EN
The article discusses the issue of the necessity of obtaining informed consent from an individual who is to be a participant in an experiment. Codes of ethics concerning the behaviour of a psychologist fundamentally do not permit conducting experiments without informing their participants in advance that they will be conducted. Meanwhile, the act of obtaining prior consent (and thus of informing the study participant that they will be taking part in an experiment) can have a significant impact on results. The article describes an experiment in the field of social influence psychology during which one group was asked for their informed consent to participate in a study, while the second was simply presented with the main request (to sign a letter to the mayor about reducing the number of parking spaces for the disabled). The results demonstrate the strong influence of awareness that a study is being conducted on the decisions taken in the course of the experiment.
EN
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.
EN
It has been for several years now that physicians use medical devices based on artificial intelligence (AI) in their professional practice. The use of these tools makes health services more personalized, tailored to the individual characteristics and needs of the patient. There is also a technological possibility for AI systems to provide patients with information regarding their health condition and treatment methods. The use of medical devices equipped with AI creates new types of risk, including the risk of algorithmic error, the risk of cyber-attack, and the risk of algorithmic mismatch (false-positive or false-negative results). Most patients do not know these tools, so not everyone will trust them. Obtaining informed consent from the patient is a necessary condition for any medical intervention. This study attempts to answer the following questions: (1) Is there a legal possibility to provide AI with the ability to inform the patient about their health condition and proposed treatment methods?; (2) Does the unpredictability and opacity of AI behavior affect the scope of information that should be provided to the patient before medical intervention?; (3) What information should the physician provide to the patient for this consent to be considered informed?; (4) Should the patient always be informed that AI was involved in the diagnosis or therapeutic process? The presented study uses comparative law methodology. American, Belgian and German law are analysed. Is there a legal possibility to provide AI with the ability to inform the patient about his health condition and proposed treatment methods? Does the unpredictability and opacity of AI behavior, affect the scope of information that should be provided to the patient before medical intervention? What information should the physician provide to the patient for this consent to be considered informed? Should the patient always be informed that an AI was involved in the diagnosis or therapeutic process? The comparative law methodology was used in this study. American, Belgian and German law were analyzed.
EN
Individuals with profound intellectual and multiple disabilities (PIMD) present considerable research challenges due to their psycho-physical condition and their functioning as research subjects. Using two research projects as examples, one Polish (Kopeć, 2013, The (Non)-educational Reality of Indivi- dual with Profound Intellectual Disabilities) and the other Finnish (Vehmas, Mietola, 2021, Narrowed Lives: Meaning, Moral Value, and Profound Intellectual Disability), difficulties encountered during research involving individuals with PIMD were identified. The challenges related to the methodology of the conducted research projects were discussed, such as the choice of research paradigm, selection of research method, and their execution. Attention was also drawn to concerns associated with obtaining informed consent from individuals with PIMD who are subjects of the study. Referring to the research projects conducted, the researchers presented their approach to resolving the difficulties encountered during the research process.
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EN
As human medicine is developing at a galloping pace, continuously offering new medical products, diagnostic methods and preventive programmes, there is almost no time gap between their creation and application in medical practice. All these biomedical achievements are primarily intended to improve public health and the patient’s quality of life and health. Hence, it is important to define potential risks, side effects, and unwanted outcomes when applying a medical product/treatment before integrating it into healthcare. Unlike any other product/treatment intended for human use, medical products/treatments require prior clinical testing on human subjects (sick or sound). The authors of this paper have restricted their scientific interest to the participant (human subject) of a clinical study as one of the core elements of a clinical investigation, representing at the same time its means and its aim. By analyzing relevant international as well as national legal rules and ethical principles of the Republic of Srpska related to the participation of humans in clinical studies, it will be concluded that the participants’ safety and right to self-determination, integrity, and autonomy manifested through their independent right to either consent or refuse to participate in a clinical study supersedes the interests of science or society. However, clinical trial-related statistical data obtained from randomly chosen healthcare institutions in the Republic of Srpska will show certain derogations from prescribed ethical policies. Considering this fact, the authors have paid special attention to thematising the ethicality of recruiting participants for a clinical study based on partial or no information related to the purpose, methods, potential risks and side effects of the investigation in the name of the greater good for humanity. Such practice has accentuated the discretionary powers of ethical review committees on the one side and the uncertainty of the right to informed consent on the other.
EN
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.
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Content available Prawne aspekty zgody na pobranie krwi
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EN
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.
PL
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.
PL
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.
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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.
EN
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.
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Content available remote Ochrona praw dawców w wybranych europejskich biobankach populacyjnych
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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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Content available remote Language and thinking: analysis of breathing-related phraseology
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EN
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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