National Repository of Grey Literature 6 records found  Search took 0.01 seconds. 
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...
Ethical issues in connection with patient and physician involvement in clinical research
Norková, Olga ; Haškovcová, Helena (advisor) ; Holmerová, Iva (referee) ; Jedličková, Anetta (referee)
(in English): The subject of my dissertation is the decision of the subjects to participate in the early phase of clinical trial. The aim of this disseration is to detect and understand the ethical aspects of decision making of subjects with oncological diseases to participate in the early phase of clinical trial. In the theoretical part of my dissertation, I define the field of clinical research, describe the phases of clinical research and ethical codes important for clinical research. The current ethical dilemmas related to the participation of subjects in the early phase of clinical trial, which are being discussed by the professional public, are presented. The research part contains the results of interviews with seventeen respondents whose content correlates with the aim of the research part and it is to understand the decision- making of subjects to participate in the early phase of clinical trial in terms of subjectively constructed realities, which are different for individual respondents. The results of the research show that fourteen respondents identified one of the most important aspects of the decision-making to participate in the early phase of clinical trial of the recommendation of principal investigator and trust in a physician. Twelve respondents stated the most frequent reason...
Ethical context of resource allocation with regard to the possibilities and limits of chronic dialysis treatment
Dingová Šliková, Martina ; Jedličková, Anetta (advisor) ; Dusilová Sulková, Sylvie (referee) ; Rosina, Jozef (referee)
The main theme of the dissertation work are allocations of sources in regular dialysis treatment in ethical context. The aim of the work is detection, description and understanding to ethical problems forming in context with questionable allocation of sources in regular dialysis treatment. The theoretical part of the work is concentrated on mapping above mentioned problems from various point of view. By the help of analysis of pertinent literature it is referred to historical determination and social-economic context of difficult allocation of rare sources in health service, which subsequently caused development of specific ethical problems in clinical practice of dialysis treatment. Above mentioned ethical problems are discussed chronologically, namely from the first using of a dialysis device up to now, when this therapy is considered to be a standard clinical method. The practical part of the work contains results of high-quality research, the aim of which was to explore the experience of respondents with allocation of resources in regular dialysis treatment and so in ethical context. The dates for the research were obtained by the help of expert dialogues, the method of interpretative phenomenological analysis was used to the analysis of dates. The results of the research is the interpretation...
The Controversy about Childbirths outside Hospitals
Pultarová, Jana ; Haškovcová, Helena (advisor) ; Pinc, Zdeněk (referee) ; Jedličková, Anetta (referee)
1 ABSTRACT The issue of births outside a medical facility is currently a controversial topic between specialists as well as in the public sector. While the specialists concur in refusing home births, the society is divided. There are voices that refuse home births but there are also plenty of people who support the right of mothers to give birth outside of a medical facility. Very sensitive topic is the legal and ethical aspects of the protection of unborn children and the issue of a safely conducted delivery. In the last decades, the life value of an unborn child has been seen as an ethical problem. The right to life is one of the fundamental human rights, which is enshrined in the constitutional system of the Czech Republic and also in the international human rights conventions. Because there are different opinions regarding this issue, it is necessary to establish a view that is widely accepted so that legal standards can be approved provided that the opinions of minorities are being respected. The main objective of this presented dissertation was to ascertain why are people losing confidence in a doctor's role during delivery and what is the reason for some of the mothers being unsatisfied with current institutional system of obstetrics. On the basis of these factual findings, which emerged during the...
Ethical issues in connection with patient and physician involvement in clinical research
Norková, Olga ; Haškovcová, Helena (advisor) ; Holmerová, Iva (referee) ; Jedličková, Anetta (referee)
(in English): The subject of my dissertation is the decision of the subjects to participate in the early phase of clinical trial. The aim of this disseration is to detect and understand the ethical aspects of decision making of subjects with oncological diseases to participate in the early phase of clinical trial. In the theoretical part of my dissertation, I define the field of clinical research, describe the phases of clinical research and ethical codes important for clinical research. The current ethical dilemmas related to the participation of subjects in the early phase of clinical trial, which are being discussed by the professional public, are presented. The research part contains the results of interviews with seventeen respondents whose content correlates with the aim of the research part and it is to understand the decision- making of subjects to participate in the early phase of clinical trial in terms of subjectively constructed realities, which are different for individual respondents. The results of the research show that fourteen respondents identified one of the most important aspects of the decision-making to participate in the early phase of clinical trial of the recommendation of principal investigator and trust in a physician. Twelve respondents stated the most frequent reason...
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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