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AI is entering clinical care and the healthcare sector in a big way, at the same time, a growing number of scholars are concerned that this technology cannot adhere to current bioethical principles. In particular, there are increasing concerns that AI poses a threat to the autonomy of patients by being irreconcilable with the practice of informed consent. In this essay, I shall defend the thesis that some applications of AI can be reconciled with a revised version of informed consent – what I call AI Adapted Informed Consent. This solution shall not rest on the idea of making black box AI more transparent or explicable. Instead, I shall argue that black box AI does not necessarily withhold the kind of information necessary for informed consent. Rather, patients can be given epistemic access to the kind of information necessary to make an informed decision, as well as being informed as to how the AI is used in the medical decision-making and in the assessment of their medical situation. Hence, this solution offers a re-interpretation of informed consent as information about contextual functioning and role of AI in medical decision-making. Drawing on republican interpretations of freedom as nondomination, I argue that demands for informed consent can only be restrained if it preserves the voluntariness of our decisions. Hence, I shall conclude that my adapted informed consent thesis allows for the possibility that some applications of black box AI in clinical care can be reconciled with informed consent and due respect for patient autonomy – if three specific conditions can be met.

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Para avaliar a efetividade do processo de obtenção do termo de consentimento livre e esclarecido (TCLE) no contexto da pesquisa clínica em seres humanos, foram realizadas análises sistematizadas sobre os principais elementos de sustentação do TCLE (bioética na pesquisa em seres humanos, direitos humanos do sujeito da pesquisa, história da obtenção do TCLE, e regulamentações brasileiras na pesquisa em seres humanos), assim como também análises sistematizadas sobre a efetividade dos principais processos envolvidos na obtenção do TCLE (comunicação médico-paciente, tomada de decisão pelo sujeito da pesquisa, e interpretação das expressões de probabilidade no TCLE pelo sujeito da pesquisa). Ainda que estes três processos envolvidos na obtenção do TCLE apresentem, individualmente, alguns procedimentos efetivos, verificou-se que a obtenção de um TCLE verdadeiramente autônomo é utópica e, portanto, o processo de obtenção do TCLE é considerado não-efetivo / In order to evaluate the effectiveness of the process for obtaining the informed consent (IC) within the context of clinical research in human beings, systematic-like analysis were performed on the key elements supporting the IC (bioethics within the research in human beings, human rights for the research subject, history of the obtainment for the IC, and Brazilian regulation within research in human beings), as well as systematic-like analysis on the effectiveness of the major processes involved in the obtainment for the IC (physician-patient communication, decision-making for the research subject, and interpretation of the probability expressions in the IC by the research subject). Eventhough these three processes involved in the obtainment for the IC present, individually, a few effective procedures, the obtainment of a truly autonomous IC is utopia and thus the process for obtaining the IC is considered non-effective

This study was designed to evaluate the quality of informed consent practiced by healthcare professionals in South Africa using an empirical quantitative methodology combined with medicolegal analysis to produce an interdisciplinary thesis on bioethics and medical law. Informed consent is an ethical and legal doctrine derived from the principle of respect for autonomy, whereas the rights to bodily integrity, privacy and human dignity are constitutionally protected in South Africa. The National Health Act 61 of 2003 codified requirements for informed consent by stipulating that healthcare providers must inform healthcare users about diagnosis, risks, benefits, treatment options, and the right of refusal, while taking into consideration users language and literacy levels. However, African communities are inherently challenged by problems of poverty, poor education, power asymmetry, and unfamiliarity with libertarian rights-based autonomy, which could affect informed consent practice. An empirical study was conducted at randomly selected public hospitals in EThekwini metropolitan municipality involving 927 participants; comprising 168 medical doctors, 355 professional nurses, and 404 patients. The study showed that healthcare professionals had limited knowledge regarding ethical and legal requirements for informed consent, and were partially compliant with current informed consent regulations. Barriers to informed consent identified were language, poor education, workload, and lack of interpreters. Most patients attending public hospitals were indigent, but preferred full information disclosure, and a shift from informed to shared-healthcare decision-making. The study recommends that a corps of trained interpreters should be introduced at public hospitals. This will improve providerpatient communications and minimize workloads, increase job satisfaction, and the overall quality of healthcare service delivery. Analysis of recent South African case law on informed consent revealed vacillations between the “reasonable doctor” and “prudent patient” standards of information disclosure which are inconsistent with the jurisprudence from comparative foreign common law jurisdictions. Therefore, South African court judgments on informed consent ought to be re-evaluated to establish a uniform standard of information disclosure consistent with international jurisprudence, current legislation, and constitutional protections relating to human dignity and security of the person. / Jurisprudence / LL. D.

Para avaliar a efetividade do processo de obtenção do termo de consentimento livre e esclarecido (TCLE) no contexto da pesquisa clínica em seres humanos, foram realizadas análises sistematizadas sobre os principais elementos de sustentação do TCLE (bioética na pesquisa em seres humanos, direitos humanos do sujeito da pesquisa, história da obtenção do TCLE, e regulamentações brasileiras na pesquisa em seres humanos), assim como também análises sistematizadas sobre a efetividade dos principais processos envolvidos na obtenção do TCLE (comunicação médico-paciente, tomada de decisão pelo sujeito da pesquisa, e interpretação das expressões de probabilidade no TCLE pelo sujeito da pesquisa). Ainda que estes três processos envolvidos na obtenção do TCLE apresentem, individualmente, alguns procedimentos efetivos, verificou-se que a obtenção de um TCLE verdadeiramente autônomo é utópica e, portanto, o processo de obtenção do TCLE é considerado não-efetivo / In order to evaluate the effectiveness of the process for obtaining the informed consent (IC) within the context of clinical research in human beings, systematic-like analysis were performed on the key elements supporting the IC (bioethics within the research in human beings, human rights for the research subject, history of the obtainment for the IC, and Brazilian regulation within research in human beings), as well as systematic-like analysis on the effectiveness of the major processes involved in the obtainment for the IC (physician-patient communication, decision-making for the research subject, and interpretation of the probability expressions in the IC by the research subject). Eventhough these three processes involved in the obtainment for the IC present, individually, a few effective procedures, the obtainment of a truly autonomous IC is utopia and thus the process for obtaining the IC is considered non-effective

Thesis (LLD (Public Law))--University of Stellenbosch, 2010. / ENGLISH ABSTRACT: The unique and intimate relationship that exists between a medical practitioner and his/her client is possibly one of the most important relationships that can come into being between any two people. This relationship is characterised and influenced by the qualities and attributes specific to the nature and historical development of medical care, as well as medical science in general. The doctor-patient relationship is also influenced by the social dynamics of a particular community, environmental factors, technological advances and the general social and commercial evolution of the human race. With regard to medical care and health service delivery, the doctor-patient relationship is furthermore vital to the quality of the care provided, as well as to the outcomes and relative success of the specific medical intervention or treatment. One of the distinct characteristics of the doctor-patient relationship is the power imbalance inherent in this relationship. The medical practitioner has expert knowledge and skill, while the patient finds himself or herself in an unusually dependent and vulnerable position. It is because of this important role that the doctor-patient relationship still plays in health service delivery today; the susceptibility of the relationship to a variety of influences, and the characteristic power imbalances inherent in this relationship, that a study of the doctor-patient relationship in South African medical- and health law is necessary. The characteristic power imbalances will be considered from a legal perspective in this dissertation. This study provides a comprehensive source of the doctor-patient relationship from a legal perspective. Where relevant, references are made to theories and principles from other disciplines, including sociology, economy and medical ethnomethodology. The prevalence and consequences of power imbalances in the doctor-patient relationship are identified and discussed with the aim of bringing these to the attention of both the legal fraternity, and medical practitioners. Specific problem areas are identified and solutions are offered, including the following: • The adverse consequences of power imbalances inherent in the doctor-patient relationship on the medical decision-making process are considered from various perspectives. With regard to these adverse consequences, the doctrine of informed consent is analysed and evaluated in great detail. • The influence of paternalistic notions in health service delivery; the business model of health service delivery and the effects of managed care and consumer-directed health care on the doctor-patient relationship and health service delivery in general are also analysed from a legal perspective, and specifically with regard to the power imbalances inherent in this relationship. • The role of autonomy, self-determination and dignity, as well as the principles of beneficence in medical practice, are reconsidered in an attempt to provide a solution for redressing the power imbalances inherent in the doctor-patient relationship. • The fiduciary nature of the doctor-patient relationship and the special role of trust in the relationship are emphasised throughout the dissertation as the focal point of departure in the doctor-patient relationship and the main constituent in any legal endeavor to redress the power imbalances inherent in it. / AFRIKAANS OPSOMMING: Die unieke en intieme verhouding wat bestaan tussen ‘n mediese praktisyn en ‘n pasiënt is wêreldwyd waarskynlik een van die belangrikste verhoudings wat tussen twee persone tot stand kan kom. Hierdie verhouding word gekenmerk en beïnvloed deur kwaliteite en eienskappe eie aan die besonderse aard en historiese ontwikkeling van gesondheidsorg, sowel as die mediese wetenskap in die algemeen. Die dokter-pasiënt verhouding word verder beïnvloed deur die sosiale dinamika van ‘n bepaalde gemeenskap, omgewingsfaktore, tegnologiese vooruitgang en die algemene sosiale en kommersiële ontwikkeling van die mensdom. Op die terrein van gesondheidsorg en mediese dienslewering is die dokter-pasiënt verhouding voorts ook sentraal tot die kwaliteit van die mediese sorg wat verskaf word, sowel as die uitkomste en relatiewe sukses van die spesifieke mediese behandeling. Een van die kenmerkende eienskappe van die dokter-pasiënt verhouding is die magswanbalans wat daar tussen dokter en pasiënt bestaan. Die mediese praktisyn beskik oor deskundige kennis en vaardighede, terwyl die pasiënt hom- of haarself in ‘n ongewone, afhanklike en kwesbare posisie bevind. Dit is dan veral weens die besondere rol wat hierdie verhouding steeds in hedendaagse gesondheidsorg speel, die beïnvloedbaarheid van hierdie verhouding deur ‘n verskeidenheid faktore, sowel as die kenmerkende magswanbalans inherent in die verhouding, dat ‘n ondersoek na die dokter-pasiënt verhouding in die Suid-Afrikaanse mediese reg noodsaaklik is. Hierdie kenmerkende magswanbalans sal vanuit ‘n regsperspektief verder in hierdie proefskrif ondersoek word. Hierdie studie bied ‘n omvattende bron van die dokter-pasiënt verhouding benader vanuit ‘n regsperspektief, terwyl verwysings na teorieë en beginsels van ander dissiplines soos die sosiologie, ekonomie en mediese etnometodologie ook waar nodig ingesluit word. Die voorkoms en gevolge van ‘n magswanbalans in die dokter-pasiënt verhouding word verder geïdentifiseer en bespreek ten einde dit onder die aandag te bring van beide regslui en medici. Spesifieke probleemareas wat geïdentifiseer is en die oplossings wat daarvoor aan die hand gedoen is sluit die volgende in: • Die nadelige gevolge van die bestaan van ‘n magswanbalans in die dokter-pasiënt verhouding op die mediese-besluitnemingsproses word bespreek vanuit verskillende persepktiewe. Met betrekking tot hierdie nadelige gevolge, word die leerstuk van ingeligte toestemming in besonder geanaliseer en geëvalueer. • Die invloed van ‘n paternalistiese benadering tot gesondheidsorg, die besigheids-model van gesondheidsorg, en die effek van bestuurde- en verbruikersgedrewe gesondheidsorg inisiatiewe op die dokter-pasiënt verhouding en die verskaffing van gesondheidsdienste in die algemeen word ook vanuit ‘n regsperspektief ge-analiseer. Spesifieke aandag word in dié verband gegee aan die invloede van hierdie benaderings en perspektiewe op die magswanbalans inherent aan die dokter-pasiënt verhouding. • Die besondere rol van autonomie, selfbeskikking en menswaardigheid, asook die beginsels van weldadigheid in gesondheidsorg, word heroorweeg in ‘n poging om ‘n meer gelyke distribusie van mag in die dokter-pasiënt verhouding te verseker. • Die fidusiêre aard van die dokter-pasiënt verhouding en die besondere rol wat vertroue in hierdie verhouding speel, word in hierdie proefskrif beklemtoon en word voorts as die basis van die dokter-pasiënt verhouding beskou. Vertroue, as ‘n kenmerk van die dokter-pasiënt verhouding, behoort ook die fokuspunt te wees van enige poging om die magswanbalans in die dokter-pasiënt verhouding aan te spreek.

A quantitative descriptive study was conducted to establish professional nurses’ and patients’ knowledge and understanding of laparoscopic surgery and to determine whether nurses are sufficiently knowledgeable to disseminate adequate information about laparoscopic surgery to patients. Two state hospitals based in KwaZulu-Natal where laparoscopic surgery is done were selected and the respondents were selected through convenience sampling. Data were collected by administering questionnaires to theatre nurses (n=39), ward nurses (n=87) and patients (n=42) scheduled for laparoscopic surgery. The SPSS version 15 for Windows was used to compute the results. The findings revealed that the professional nurses were not sufficiently knowledgeable about laparoscopic surgery to give adequate information to patients and the patients themselves were not fully informed about all aspects of laparoscopic surgery including the possibility of conversion to open surgery, complications and advantages and after care. There is therefore a dire need for improvement of patient education to assist patients gaining optimal recovery / Health Studies / M.A. (Health Studies)

Background: Direct-to-consumer (DTC) genetic tests are tests sold directly to consumers, normally without the involvement of healthcare professionals, which aim to provide consumers with their relative genetic risk for various complex diseases. Providers claim that this information will enable and encourage consumers to improve their health behaviour in order to reduce their likelihood of contracting diseases for which they are at an increased genetic risk. However, there are many criticisms and concerns about DTC genetic tests in the literature. Two common concerns are the lack of positive effects, and possible negative effects, that the information generated by the tests may have on consumers health behaviour and health anxiety, and the identified poor quality of information provision on the websites of providers of DTC genetic tests. Although the literature contains some research in these areas it is noticeably limited and occasionally contradictory. Aim and Methods: The aim of the research was to investigate the informational aspects of direct-to-consumer genetic tests, including the provision of information by the companies, consumers information needs and information-seeking behaviour and the effect of the information generated by the tests on health behaviour and health anxiety. The research consisted of three studies: a survey of 275 consumers and potential consumers of DTC genetic tests, in-depth email interviews with 36 consumers of DTC genetic tests and a content analysis of the information provided on all identified providers websites. Results: Positive or neutral changes in health behaviour were identified in a large minority of respondents who had been exposed to genetic risk information, along with the mechanisms by which the information prompted or contributed to change. A minority reported a change in health anxiety, mainly but not exclusively a decrease, with mechanisms again identified. Consumers reported a wide variety of information needs, the most common of which were information to do with the coverage and accuracy of the tests. The provision of information on providers websites varied considerably, both between and within providers, but was generally poor. However, most consumers used other sources alongside these websites, the most common of which was blogs. Conclusions: The results suggest that concerns about possible negative effects of the information generated by the tests are unfounded and that a large minority of consumers have improved health behaviour and decreased health anxiety after purchase. The results also suggest that concern about information provision on providers websites is justified; although this is mitigated by consumers general use of other sources alongside the websites, it is likely that a substantial number of consumers do not have access to enough information to give fully informed consent to the test.