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The Ethics of the Clinical research from the perspective of a Clinical research associate
Norková, Olga ; Haškovcová, Helena (advisor) ; Rohanová, Eva (referee)
Monitoring is one of the most important methods of overseeing the pursuit of the clinical research. A monitoring person (Clinical research associate) is responsible for verifying correctness of the monitoring process in the trial site and checks that the respect for dignity and rights of individual subjects exposed to the clinical research are being abided by. The theoretical part of the MA thesis examines the issue of the clinical research of medicinal products and explains the basic terminology pertaining to the performance of the clinical research. The thesis further analyses the position of Clinical research associate and describes the monitoring process. Concurrently, the ethical problems, which Clinical research associate encounters in practice, are traced. The empirical section studies the outcomes of an investigation conducted via a questionnaire, which focused on how Clinical research associate perceive the ethical problems. As a result, the study identifies the most frequently observed ethical issues. Respondents of the questionnaire view the ethical issues as less significant. Clinical research associates are not united in tagging the most frequent occurrence of ethical problems (in the field of medicine and the catchment area). In the same section, the MA thesis rebuts a hypothesis...
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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...
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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...
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The Ethics of the Clinical research from the perspective of a Clinical research associate
Norková, Olga ; Haškovcová, Helena (advisor) ; Rohanová, Eva (referee)
Monitoring is one of the most important methods of overseeing the pursuit of the clinical research. A monitoring person (Clinical research associate) is responsible for verifying correctness of the monitoring process in the trial site and checks that the respect for dignity and rights of individual subjects exposed to the clinical research are being abided by. The theoretical part of the MA thesis examines the issue of the clinical research of medicinal products and explains the basic terminology pertaining to the performance of the clinical research. The thesis further analyses the position of Clinical research associate and describes the monitoring process. Concurrently, the ethical problems, which Clinical research associate encounters in practice, are traced. The empirical section studies the outcomes of an investigation conducted via a questionnaire, which focused on how Clinical research associate perceive the ethical problems. As a result, the study identifies the most frequently observed ethical issues. Respondents of the questionnaire view the ethical issues as less significant. Clinical research associates are not united in tagging the most frequent occurrence of ethical problems (in the field of medicine and the catchment area). In the same section, the MA thesis rebuts a hypothesis...
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