This thesis examines patient recruitment in clinical trials. It is a current and pressing issue, which is not sufficiently embedded in the thinking of doctors and patients, their patterns of communication, and more broadly in the traditional doctor-patient relationship, which continues to be burdened by post-socialist paternalism. The formal framework and ethics have been developed relatively recently, and their application causes confusion to all participants regarding how to proceed in specific situations. In addition, the choice of topic, and especially the form of dealing with the topic, was motivated by the relative lack of academic resources and publications in the field. The theoretical section of the thesis defines clinical research and its phases, and introduces basic terminology and documents closely linked to clinical research. In addition, it focuses on research ethics, thoroughly examining the issue of informed consent - a fundamental document necessary for recruiting a patient in a clinical trial. Finally, one chapter of the thesis focuses on the issue of medical literacy, the level of which is integral to the participants' understanding of the importance of clinical research, and directly affects participants' decision-making. The empirical section is divided into two parts. The...

In this dissertation I explore how the international law principle of free, prior and informed consent (FPIC) can enhance public participation, to promote environmental justice for communities affected by environmental decision-making in the mining sector in South Africa. Public participation required in terms of the mining sector environmental regulatory framework in South Africa is underscored by a requirement to ‘consult’. In chapter one, I describe how the requirement to consult differs from a requirement to secure consent in terms of FPIC. I describe public participation (i.e. consultation) requirements related to applications for rights, permits, licences and authorisations that must be in place prior to commencement of mining operations. I argue that where the level of public participation requires mere consultation, it can easily amount to a regulatory tick-box exercise given that the views of mining-affected communities can be manipulated or overlooked, with mining developments proceeding despite devastating effects on communities. In chapter two I describe how FPIC has become part of the regulatory framework governing mining activities through the court’s purposive interpretation of the Interim Protection of Informal Land Rights Act 31 of 1996 (IPILRA) in Baleni and Others v Minister of Mineral Resources and Others and Maledu and Others v Itereleng Bakgatla Mineral Resources (Pty) Limited and Another. In chapter three, I engage with scholarly literature on FPIC to analyse why and how environmental justice should and can be enhanced by embedding FPIC into legislative public participation requirements. I argue that FPIC, which now forms part of South Africa’s law through the IPILRA, should be a prominent feature in public participation processes for mining-affected communities generally, and not only for informal land right holders. / Mini Dissertation (LLM)--University of Pretoria, 2021. / Public Law / LLM / Unrestricted

The main topic of the master's thesis is protection of bodily integrity, which started to play an important role since the beginning of this millennium in the continental Europe in support of patient's individual rights. The thesis particularly undergoes research by which means is patient's bodily integrity guaranteed on the constitutional level. For that purpose, the thesis analyses informed consent in its various forms, namely in comparisons to foreign literature and judgements in USA and United Kingdom. Simultaneously the court decision became the centre of attention, because of its guarantee to protect bodily integrity to minors and incompatible people. These conclusions the thesis then follows up and applies on cases, in which is bodily integrity of patient is most vulnerable. The conclusion of this thesis is that the protection of bodily integrity is guaranteed on the constitutional level by art. 7 par. 1 Charter of fundamental rights and freedoms and art. 8 European Convention on human rights. Simultaneously the thesis comes to the conclusion that in some cases the protection of bodily integrity in not fully guaranteed. That's the case of sterilization of transsexual patients who are forced to undergo this surgery by statutory regulation. The thesis in the case of compulsory vaccination...

The aim of this thesis is to describe and evaluate legislation concerning the informed consent in the Czech legal system and propose its changes de lege ferenda. The thesis also comprises many comparisons between the Czech legislation and the foreign legislation. The first five chapters of this thesis deal with sources of legislation, informed consent as such along with information of patients as a necessary prerequisite for giving of the consent, other topics are refusal of medical care by patients and the so called advance decisions. Apart from this theoretical part the thesis also includes a practical part. The aim of this practical part is to explore implementation of legislation concerning informed consent in the everyday practice of hospitals and subsequently to compare this practice with the requirements of law. This survey was carried out by means of questionnaires, which were submitted to doctors relating theirs experience with using of informed consents in their medical practice. The purpose of this practical part is also to find out the experience and opinions of recipients of medical services, i. e. the patients, concerning different issues connected with the informed consent, also by means of the questionnaire method. Last but not least the thesis mentions many problems which are...

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Informed consent can be considered, without any doubt, as a central issue in current bioethics and in medical law. The modern relationship between physician and patient has completely changed. Informed consent has dominated the theoretical discussions since the 1970s. Its importance is essential for both medical research and clinical practice. This work focuses mainly on clinical practice, on the relationship between a doctor (or more generally a healthcare professional) and a patient. The institute of informed consent has evolved similarly in medical ethics as well as in the medical law, but there are some significant differences. One of the basic issues of this work is to distinguish both positions and point out differences between legal and ethical aspects of this institute. The thesis sees the fundamental differences in the different purposes of both two key normative systems, in their function, in the values they represented and in the principles they emphasized. While trust and mutuality are essential to informed consent in ethics, the legal institute reflects more the protection of the subjects, especially the protection against abuse, thus providing legal certainty especially for the patient. The ethical level is primarily to ensure respect for the other person so that he or she is...

Helping patients and their families prepare for the end of life is a privilege for physicians. Often these discussions are very sensitive; one must be able to navigate the complexities of dying while maintaining the strong, intimate relationship with a person who has entrusted the doctor with his or her final care. Many of the same principles of medical ethics still apply such as informed consent, acknowledging different degrees of health literacy, and cultural humility. With end-of-life care, physicians are responsible for providing their patients dignity in death. In doing so, it is important to decide how aggressive or intense medical treatment should be. There is evidence to suggest that early involvement of palliative care, foregoing invasive procedures or surgeries, and honest communication with families can improve the dying experience. The COVID-19 pandemic has only added more challenges to an already difficult art that physicians spend entire careers working on perfecting. Nevertheless, this provides even more reason to be proactive in determining what is most important for every individual in their final days. / Urban Bioethics

BACKGROUND: The Emergency Department is a quick-moving environment in which rapid identification of illness and prompt treatment is the mainstay of care. Obtaining informed consent from a patient for a high-risk or invasive procedure is required both legally and ethically regardless of the setting. However, informed consent in the Emergency Department is routinely inadequate. LITERATURE REVIEW: Research thus far has identified several of the barriers to obtaining proper informed consent; a few including language barriers, gaps in intellectual levels, fragmented care of different emergency providers, vulnerability of patients in the ED, and the complexity of the informed consent forms. Investigation into improving the informed consent discussion and patient comprehension has shown promise in implementing patient centered modalities that aid in communication. Such modalities include repeat-back mechanisms, easy-read documents, and implemented multimedia presentations. PROPOSED PROJECT: In this proposed study, we will focus on a pre-intervention (control) group and an intervention group. The intervention to be implemented will be a paracentesis informed consent video and a provider checklist including procedure, diagnosis/intervention, risks, benefits, and alternatives all to be checked off after being discussed with and repeated back by the patient. Patient understanding will be analyzed using a post-discussion questionnaire completed by all participants. We hypothesize that this intervention will improve overall comprehension of the informed consent discussion regarding the paracentesis procedure. CONCLUSION: Patient comprehension of the informed consent discussion in the Emergency Department is often lacking in meeting both legal and ethical standards. Reviewing the data for a significant change between the control and intervention group will allow us to determine if enhancing the informed consent discussion to a more patient-centered process will improve patient understanding of all aspects of the informed consent discussion. In the end, this will guarantee ED patients their lawful right to truly informed consent. SIGNIFICANCE: This informed consent video and checklist will allow for an informed consent process that remains standardized but is more patient focused to improve patient comprehension of the process and protect the rights of all parties involved.

Human cultures have used classic psychedelics for healing purposes for millennia, emphasizing their subjective effects. In the 21st century, research has been revived to investigate the therapeutic effects of these substances. These substances show promising results in the treatment of various mental-related disorders such as depression, post-traumatic stress disorder, and others, necessitating ethical considerations and guidelines for researchers, psychotherapists, and policymakers. The subjective effects of the psychedelic experience that these substances evoke, such as the feeling of oneness and interconnectedness, infallibility, the sense of reduced one's self-importance, the encounter with the "ultimate" reality or with God, radically distinguish them from typical psychiatric medications such as selective serotonin reuptake inhibitors (SSRIs). In their essay "Ethics and Ego Dissolution: the Case of Psilocybin", William R. Smith and Dominic Sisti argue that the special properties of psychedelics entail certain novel risks that warrant "enhanced" informed consent that is "one that is more comprehensive than what may be typical for other psychiatric medications". They emphasize the unique effects of these substances, including 1) the potential for significant personality changes, 2) the short duration of treatment, and 3) the potential for profound and transformative experiences. They highlight the importance of explicitly addressing these potential changes as part of the informed consent process to ensure patient understanding, autonomy, and well-being. This current paper substantially complements Smith and Sisti's work by discussing in more detail the differences between psychedelics and typical psychiatric medications with respect to informed consent. I first support their arguments and then further argue that there are three other critical reasons why psychedelics should not be treated like other psychiatric medications that should be considered when discussing the enhancement of informed consent and disclosure. 1) potential changes in ethical values, 2) set and setting, and 3) suggestibility. To clarify my argument, I propose a distinction between changes in worldview and ethical values induced by the psychedelic experience and emphasize their differential impact on individuals undergoing psychedelic therapy. I introduce the term "ethical limbo", characterized as a state of uncertainty or ambiguity regarding the ethical implications or consequences of a particular action, decision, or situation due to conflicting ethical values, to highlight a potential risk of the psychedelic experience that should be considered in informed consent. Finally, I address potential objections to my arguments before concluding the paper and addressing some limitations of the research.