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Fraud in clinical trials in terms of ethics and law
Jedličková, Anetta ; Haškovcová, Helena (advisor) ; Prudký, Libor (referee) ; Strnadová, Věra (referee)
The subject of my dissertation is fraud in clinical trials in terms of ethics and law. The aim of my research was to analyze the frequency of fraud in clinical trials of a given sample of data collected, identify the main fraudsters and to analyze the causes that led participants in clinical trials to commit fraud. In the theoretical part of my dissertation I defined the concepts of clinical trials, deception, ethical issues and the relevant legal framework. The practical part contains the results of the data analysis of the incidence and causes of fraud, the main actors of fraud and conception of recommendations, which appears to be essential for the prevention of fraud in clinical trials. The data analysis and participant observation show that during 107 GCP (Good Glinical Practice) audits conducted during the period of 2008-2013 in 22 countries, 14 revelations of fraud in clinical trials were identified, which represents 13.1 %. Most often fraud was committed by investigators, a total of 47.6 % of all observed groups of cheating clinical trial participants. The main causes that led investigators to commit fraud represent a lack of eligible patients, financial gain and personality traits. Based on the results obtained during my research I highlighted in the practical part of my dissertation the ethical...
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The topics of ethicin professional nurse behaviour in the care of psychiatric patients
Tošnarová, Hana ; Haškovcová, Helena (advisor) ; Tóthová, Valerie (referee) ; Soukupová, Tereza (referee)
5 Hana Tošnarová The topics of ethicin professional nurse behaviour in the care of psychiatric patients Abstract Presented dissertation theses are dedicated to the ethic aspects of the professional behaviour of nurses in their care of the mental patients. In the theroretical part are described thesis connected with the profession of psychiatric nurses, with the psychiatry as a medial branch, legislation in the psychiatry and with the questions of ethics in the connection of nursing. The practical part, that describes the qualitative research, is divided into two subsections and observing. The phenomenal study went through in the Mental home of Bohnice (Prague) and the output was the determination of defined notion "professional behaviour of a nurse in the care of mental patients in the scope of ethics". The second part of the observation was targeted on the access of the nurses to the mental patients in the special handpicked working places of the somatic medicine in Prague. The output of this research is a description of the behaviour style of nurses in the somatic working places in an interaction with mental patients. Keywords: ethics in nursery, ethics in psychiatry, ethics in medicíně, professional behaviour of a nurse, nursing, medical law
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Good Death and Euthanasia from Antiquity to 30th of 20th century
KRATOCHVÍLOVÁ HAVLOVÁ, Jitka
The thesis provides a comprehensive view of the "good death" and euthanasia from antiquity to the 1930s. It describes the attitudes of physicians and other scholars in different historical periods. The research is based on published sources and literature. The author examines the phenomenon in general, compares published sources and makes a comparison of the phenomenon from a historical perspective. The first part describes basic terminology related to the topic. Death and dying are viewed from the historical and ethical points of view. The second part describes the individual historical periods from antiquity to the 1930s in terms of social and cultural changes. The emphasis is placed on the opinions of philosophers, scholars and doctors about good death and euthanasia. The general view on death and euthanasia is even better illustrated by the medical care of a given period, the development of medical science and medicine. The thesis presents a theoretical base from which information for practical research of the phenomenon of death can be drawn. The examined phenomenon could be equally important and challenging for the present.
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Ethical issues of the predictive genetic diagnosis
ČAPKOVÁ, Jitka
This bachelor's thesis deals with ethical issues of the predictive genetic diagnosis. The goal of this thesis is to introduce ethical issues of the predictive genetic testing that is developing rapidly, and present possible questionable aspects that our society will have to deal with. This thesis is based on a hypothesis that the predictive testing must take place only within specialized genetic departments, on the basis of observing basic ethical and legal principles, to minimize moral dilemmas and maintain dignity of the human existence. The theoretic part focuses on introducing the issues of genetic testing. This thesis puts emphasis especially on ethical reflection of genetic testing issues such as genetic discrimination, genetic testing of children, and interpretation of the results of predictive genetic testing. Definition of the principle of human dignity as a moral basis of the predictive medicine, and analysis of selected documents, agreements, and programmes relating to human dignity and rights related to the field of genetic testing will be also included.
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Opinions of the students of the South Bohemia university about selected ethical problems of the health care
RAZIMOVÁ, Pavlína
This Bachelor thesis is focused on ethical issues in medicine, namely in communication between physician and patient, further on euthanasia, interruption and transplantation. This work is divided into two parts. The theoretical part introduces the theme of the thesis. It provides the basic information about ethics, about the relationship between physician and patient and their communication, about patient´s rights, about euthanasia, interruption and transplantation, too. The practical part reflects opinions of the students of the South Bohemia university in České Budějovice of these ethical matters. The analysis is based on quantitative research, which was performed by anonymous questionnaire in electronic form. The obtained data are processed in tabular and graphic forms.
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An ethical duty of the Hippocratic oath today
PETRŮ, Martina
The Hippocratic Oath probably comes from the 4th - 5th century BC. It is traditionally attributed to ancient physician Hippocrates or one of his disciples. It was created as a moral guide to behavior of physicians and it describes fundamental ethical principles of their profession in relation to the surroundings, family, teachers and the patient. In its time it represented a revolutionary rule.Text of the Hippocratic Oath has functioned as an oath sworn by inchoative physicians for centuries. Today it is replaced by a medical oath, which, in its different variants, is based on ethical Hippocratic requirements related to quality of contact between the physician and the patient. Changes in the Hippocratic Oath are mainly related to the development of surgery, transplantation, euthanasia, etc. The Hippocratic Oath refuses surgical interventions, because in times when it was created, these principles were in conflict with beneficence and intactness.This is the reason why it also rejects euthanasia and abortion.Nowadays, these interventions are already legalised in some countries to a certain extent and are applied according to relevant principles. Target of this Bachelor´s thesis was to find out what significance is attached to the Hippocratic Oath today. The thesis was conceived as a theoretical and historical comparative study aimed at the interpretation of content of the Hippocratic Oath, its further historical development and its today's validity or applicability. It was examined whether its text can compete in present times and which parts are still valid and which have been overcome. For this purpose, there was used a comparison of interpretation of content of the Hippocratic Oath with present moral codes in medicine, specifically with the Czech Medical Chamber Code and the Nurse Code of Ethics.In the introductory chapter of my Bachelor´s thesis, there are defined basic concepts related to the Hippocratic Oath, such as ethics, morality, medical ethics, relations between ethics and the law and basic medical principles. The next chapter deals with the author of the Oath, his teachings, times and circumstances of creation of the Hippocratic Oath, development of changes in the text of medical sponzes connected to changes in the society. The third chapter is dedicated to history of medicine from death of Hippocrates to present days.The last section is dedicated to the text analysis of the Hippocratic Oath in connection with current status of the medical field, and at the same time there was carried out a comparison of its text with applicable codes mentioned above. Aim of this thesis, in addition to interpretation and validity findings of the Hippocratic Oath, is to reveal identical and different elements referring to its text in the codes. Mutual comparison revealed that ethical issues of both codes are in accordance with the Hippocratic Oath. General ethical principles like decency, thoughtfulness and mutual respect are concepts, which have effect even today. I would say that in some points the Hippocratic Oath is obsolete and does not have anything to offer today. However, the opposite is true. Nowadays, medicine develops at an incredible pace and good relations between the physician and the patient slowly fade away. The patient is increasingly becoming some kind of material substance. Physicians often carry out their work under pressure of environment, insurance companies, pharmaceutical and other companies. Decency, empathy and good manners are disappearing. Nowadays, the Hippocratic Oath cannot fully encompass all complicated relationships and problems physicians face during their performance of their occupation, and according to these problems they should choose actual ethical practices. Despite its age, however, it is still accepted by laical and professional public for its unquestionable moral legacy.
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Transplatantion and ethics - general awareness (preliminary survey)
FARKAŠOVÁ, Markéta
This bachelor's thesis deals with the ethical issues of transplantation and its awareness by the general public. The theoretical part of the thesis is focused on the description of the most common ethical issues of transplantation. In modern era the transplantation of tissues and organs is generally seen as positive and emphasized clinical method, but still there are some certain ethical dilemmas. The very problem is the fact that this topic is only few communicated in the public and the citizens, speaking about the specific situation in the Czech Republic, have in certain parts the mistaken awareness of the function of the transplantation system "Opting out" which presumes the posthumous agreement with taking of tissues and organs after the death of the patient. The aim of the bachelor's thesis is to find out first what ethical aspects of transplantations are identified by the experts and whether according to their awareness the general publics have the interest in transplantations. Subsequently, the pre-research survey questions collect whether the answers from the citizens correspond with the answers of the expert representatives and also whether the respondents consider the current system in the Czech Republic as functional and ethically acceptable. Based on the described objectives the primarily qualitative research was chosen, managed by interviewing technique and semi-structured interviews with medical transplantologist, medical lawyer and bioethicist. From these interviews the important ethical aspects were analyzed from which further survey questions that have been tested on a sample of 130 respondents were prepared. The processed survey is the result of the bachelor's thesis and serves only as a pre-research of the pilot study. The results of interviews point to an existence of certain ethical issues connected with transplantations. Subsequently created and validated survey reflects the awareness of Czech Republic citizens of selected topic. Despite the fact that collected data from survey answers are considered as a guide and in fact indicative, some of the registered data is surprising. Among these belongs also e.g. the absolute majority of most respondent conviction of the possibility of illegal trade with organs in the Czech Republic. Other points of interest include the slightest awareness of such citizens who do not want to be donors upon their death. The positive result can be the fact that most of the surveyed respondents wish and agree with posthumous collection of their tissues and organs. Immediately we do learn that about the half of respondents is not well familiarized with currently working system of transplantations in the Czech Republic that assumes the agreement with posthumous collection of tissues and organs. Based on these findings, this created survey with specific slight changes, can be used in the future for quantitative more detailed investigation focused on the mentioned respondents according to pre-research results.
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Consent in hospital - theory and practice
SÝKOROVÁ, Marta
The diploma thesis is divided into a theoretical and a practical part. The first part describes the current state of the issue of informed consent in a general context and related topics. To obtain the data, I used the qualitative research, the method of questioning, and the data collection technique of a semi-structures interview. The research sample group consisted of 11 patients and two doctors. The objective of the thesis was to identify and describe the differences between the theory and the practice of informed consent in the hospital, and to find out whether there has been any shift in the mistakes and errors associated with informed consent as stated by Haškovcová (2007). The research results have shown that the interviewed patients are not familiar with the concept of informed consent. The knowledge of the informed consent concept was more accurate by doctors as presumed. On the issue of viewed benefits of informed consent, it is clear from respondents? answers that informed consent is viewed primarily as doctors? legal protection against any complaints or lawsuits made by the patients in the performance of their profession by making the patient familiar with any complications that may occur during the performance. This benefit is perceived by both patients and doctors. Doctors see its benefit also as the protection of patients. Another benefit viewed by doctors is the written informed consent form. Six of the interviewed patients stated that informed consent was submitted to them to sign by the nurse/male nurse without proper instructions. Furthermore, doctors? answers show that the timing of instructions depends on the nature of the surgery, whether it is planned or acute. However, some patients said that they were not even instructed with the sufficient time after giving informed consent even when related to a planned procedure. The most stated form was the combination of written and oral instructions, so the patient was first instructed orally and then he was also handed a detailed description of the particular procedure in the written form. There was no uniformity about the question of the amount of submitted information among the interviewed patients as well as doctors ? some of them prefer just basic information, some of them want to know all the information. One of the interviewed doctors favored just the adequate informed consent and saw the detailed informed consent as problematic, another doctor preferred introduction of all the details, although in the written form, mainly because of legal protection. In terms of quality of the provided information, it is clear from the statements of the patients that two most important facts for them are that the performance is in their benefit and the duration of hospitalization. All patients have agreed on the fact that it is very good that they are informed about the procedure which will be performed on them. However, they were not united regarding the issue of participation in the decision ? two patients stated that not even the properly informed patient should participate in the decision about their treatment. Only one doctor expressed his stance to the patient?s participation in the decision stating that he tries to persuade his patients that his proposed solution is the optimal. The standard for the patients is to ask questions when they are concerned about something or interested in it. However, the statements showed that they do not always get the answer they are satisfied with. When the patients stated that they do not ask their doctors about anything, their reasons were enough information, lack of staff and a feeling of unwillingness on the part of doctors. If the patients did not receive enough information from the medical staff, they looked for it in other sources of information. This thesis points to the broader psychosocial context of informed consent, so its results may help during the training of staff in the assisting professions.
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