Informed Consent Without Autonomy

This Essay explains why and how the Roman Catholic basis for informed consent is different from the secular basis. It argues that the Catholic basis, which is rooted in natural law, is the better model for society to adopt. The author explains that the secular view is rooted in the belief that patient autonomy must never be violated but the Catholic view is based on human dignity, which simply requires doctors to allow patients to exercise their free will within moral limits. This view allows doctors to override patients\u27 decisions if those decisions are morally wrong or irrational

An Empirical Analysis of the Medical Informed Consent Doctrine: Search for a Standard of Disclosure

Informed consent and its conceptual equivalents, e.g., right-to-know, are increasingly important. The author discusses the development of the informed consent doctrine in tort cases and attempts to evaluate the consistency of its application. He concludes that it is difficult to separate that which must be disclosed from that which need not be. He also argues that much remains to be done in achieving the objectives of the informed consent doctrine

Informed consent, or, consent on a form : an ethical or legal dilemma? : a thesis presented in partial fulfillment of the requirements for the degree of Master of Arts in Social Anthropology at Massey University

Informed consent is a worthwhile concept but in my view it does not work within the hospital institution in New Zealand. Why? • Because the continued emphasis in theory and in practice is still on consent rather than choice and so the focus of the healthcare professional continues to be a signed consent form rather than the process of informing leading to choice? • Because, to 'fully' inform and to ensure a person 'fully' understands is impossible...fully should be replaced with 'substantially' to make informed consent possible. • Because the underlying principle of the present model of informed consent is autonomy, a Western concept centered on individualism, a view that is not held by all healthcare professionals or all healthcare consumers. A combination of autonomy, cross-cultural approach, 'ethics of care', and feminist perspective needs to be incorporated within moral theory that informs bioethics - ensuring the patient is viewed as autonomous and relational. • And lastly, to accommodate true informed consent/choice a different approach to the relationship within the clinical encounter needs to happen; one of effective communication, collaboration and shared decision-making

Informed consent to HIV cure research

Trials with highly unfavourable risk–benefit ratios for participants, like HIV cure trials, raise questions about the quality of the consent of research participants. Why, it may be asked, would a person with HIV who is doing well on antiretroviral therapy be willing to jeopardise his health by enrolling in such a trial? We distinguish three concerns: first, how information is communicated to potential participants; second, participants’ motivations for enrolling in potentially high risk research with no prospect of direct benefit; and third, participants’ understanding of the details of the trials in which they enrol. We argue that the communication concern is relevant to the validity of informed consent and the quality of decision making, that the motivation concern does not identify a genuine problem with either the validity of consent or the quality of decision making and that the understanding concern may not be relevant to the validity of consent but is relevant to the quality of decision making. In doing so, we derive guidance points for researchers recruiting and enrolling participants into their HIV cure trials, as well as the research ethics committees reviewing proposed studies

Informed Consent Without Autonomy

This Essay explains why and how the Roman Catholic basis for informed consent is different from the secular basis. It argues that the Catholic basis, which is rooted in natural law, is the better model for society to adopt. The author explains that the secular view is rooted in the belief that patient autonomy must never be violated but the Catholic view is based on human dignity, which simply requires doctors to allow patients to exercise their free will within moral limits. This view allows doctors to override patients\u27 decisions if those decisions are morally wrong or irrational

Informed Consent and the Research Process: Following Rules or Striking Balances?

Gaining informed consent from people being researched is central to ethical research practice. There are, however, several factors that make the issue of informed consent problematic, especially in research involving members of groups that are commonly characterised as \'vulnerable\' such as children and people with learning disabilities. This paper reports on a project funded by the UK Economic and Social Research Council (ESRC) which was concerned to identify and disseminate best practice in relation to informed consent in research with six such groups. The context for the study is the increased attention that is being paid to the issue of informed consent in research, not least because of the broad changes taking place in research governance and regulation in the UK. The project involved the analysis of researchers\' views and experiences of informed consent. The paper focuses on two particular difficulties inherent in the processes of gaining and maintaining informed consent. The first of these is that there is no consensus amongst researchers concerning what comprises \'informed consent\'. The second is that there is no consensus about whether the same sets of principles and procedures are equally applicable to research among different groups and to research conducted within different methodological frameworks. In exploring both these difficulties we draw on our findings to highlight the nature of these issues and some of our participants\' responses to them. These issues have relevance to wider debates about the role of guidelines and regulation for ethical practice. We found that study participants were generally less in favour of guidelines that regulate the way research is conducted and more in favour of guidelines that help researchers to strike balances between the conflicting pressures that inevitably occur in research.Informed Consent; Research Ethics; Regulation of Research; Research Governance; Professional Guidelines

Informed consent comprehension

BACKGROUND: Informed consent is compulsory in professional practice and research studies involving human beings. It represents respect to autonomy. This study aims at identifying the degree of understanding displayed by individuals who participate in research studies or treatment. METHODS: An informed concent form was prepared and written in a clear and comprehensible language, with a Flesch Reading Ease Score of 95, and thus classified as very easy. Age, schooling, readership frequency, access to information and to the Internet, and family income were analyzed as factors bearing on comprehension of free and informed consent. RESULTS: Even though the form was prepared to result in a comprehension score of 9 and 10, the score observed was 7.5 ± 1.62 and was not related to age or gender. Schooling level was seen to affect comprehension (p=0.0013) as well as readership frequency (p=0.0001) and access to the Internet (p=0.0070). The income level analysis revealed that individuals who earn more than 10 times the minimum wage showed better comprehension (p=0.0041). CONCLUSION: It can be concluded that individuals participating in research studies should be chosen among those with better schooling, frequent readership, easy access to the Internet, and within a higher income bracket. In medical practice, each patient's condition should be observed, their comprehension limitations understood, and the informed consent form should be read on a one-to-one basis, and all the details and implications should be clearly explained.OBJETIVO: O termo de consentimento informado é uma obrigação para o exercício profissional e para a pesquisa envolvendo seres humanos. Representa o respeito à autonomia. Este estudo teve por objetivo reconhecer o grau de entendimento dos indivíduos que participam de uma pesquisa ou de um tratamento. MÉTODOS: Um termo de consentimento foi preparado com linguagem potencialmente clara e acessível, com índice de facilidade de leitura de Flesch igual a 95, o que o classificou como muito fácil. Foram analisados dados como idade, grau de escolaridade, hábito de leitura, meios de acesso à informação e internet e renda familiar, como fatores que modificam o entendimento do consentimento livre e esclarecido. RESULTADOS: Apesar do termo ter sido preparado para atingir pontuação de acerto entre 9 e 10, observou-se que ele atingiu 7,5 ± 1,62 e não esteve relacionado à idade ou ao sexo. O nível de escolaridade influenciou a capacidade de entendimento (p=0,0013), bem como o hábito de leitura (p=0,0001) e o acesso à Internet (p=0,0070). A análise de ganho mostrou que os que ganham mais de dez salários mínimos são os que compreendem melhor (p=0,0041). CONCLUSÃO: Pode-se admitir que os sujeitos para pesquisa devem ser aqueles com melhor nível de escolaridade, com habitualidade para a leitura, com facilidade de acesso à internet e os que têm melhor faixa salarial. Na prática médica, observar a condição de cada um dos doentes, entender as suas limitações de compreensão, ler junto com eles, um à um, explicando todos os pontos.UNIFESPPUCPRUniversidade Federal do Paraná Departamento de CirurgiaUNIFESPSciEL