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In the current healthcare landscape, parents generally make decisions regarding whether or not their children are allowed to take part in clinical research, with the general assumption being that parents know what is best for children. Investigations have been conducted regarding what is likely to lead parents to consent or not consent to their child’s participation in a trial, but research plans seldom incorporate the consideration that not all parents come into the consent process with equal social, academic, and economic footing. Since the burden of the ultimate decision lies primarily on the parents, it is supremely important that they are capable of making a well-informed and thoughtful choice. Bioethical understanding of the influence of parental decisions in clinical research must consider demographic variables and how they may affect parents’ decisions to allow or disallow their child to participate in a clinical trial. Those differences could affect the consent process and have ramifications for the research findings, as research results are affected in numerous ways by which children do, and do not, participate in studies. This paper looks specifically at parents in the process of informed consent for pediatric research, taking into account several social determinants of health and how they affect who participates in research and how that affects research as a whole. / Urban Bioethics

The pediatric emergency department (PED) provides a unique environment to consider ethical issues faced in modern healthcare. Using a combination of personal reflections and a review of current literature, ethics within the PED is explored as it pertains to four categories: informed consent, health literacy, language barrier, and implicit bias. Parental consent is generally required for pediatric care, but there are exceptions encountered in the PED. Although children typically cannot provide consent, soliciting assent respects their autonomy and maturing cognitive development. Limited health literacy is a prominent issue in the U. S., yet healthcare information continues to be delivered in ways that do not adequately account for this. Change will necessitate creative solutions and reorientation to a focus on health equity and justice. Physician implicit bias may be related to a patient’s negative behaviors or inherent characteristics (e.g. race), and can result in adverse health outcomes for affected children. Physicians should confront their subconscious biases through introspection, open discussion, and implicit-bias training. Access to healthcare information in one’s native language is a basic human right protected by law. Use of qualified medical interpreters can alleviate disparities faced by patients with limited English proficiency, but may be underutilized in the PED. / Urban Bioethics

People with dementia account for a growing number of patients requiring end-of-life medical care each year in the United States. The clinical application of bioethical principles is rarely more important than in the context of end-of-life decision making, and determining the appropriate clinical treatment plan can be difficult and complex for clinicians, patients, and medical proxies. While the current bioethical literature offers a wealth of information on the principles underlying ethical medical practice, real-world clinical scenarios are often fraught with confusion, complexity, and conflicting understandings of best practices. There is a need for clinical decision-making tools that are both comprehensive yet simple, and broadly-applicable enough to be clinically useful. This thesis explores the cultural factors that necessitate further discussion and understanding of the issues surrounding end-of-life care for people with dementia, uses a clinical case to demonstrate a real-world approach to the ethical complexities surrounding such care, and proposes a basic ethical decision-making algorithm with the potential for broad application by students and clinicians encountering complex ethical scenarios. / Urban Bioethics

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Although current professional and public opinion support the right of the client to make an informed decision about entering and continuing in a psychotherapy or counseling relationship, research studying the effects of informed consent on client behaviors and attitudes in the medical, research, and mental health fields has resulted in equivocal findings. This study looked at the effects of an informed consent procedure on client behaviors and attitudes in a pro-life pregnancy counseling center where the center's primary goal is to reduce the number of abortion decisions among clients. Thirty of the center's clients (Experimental Group) were given an Informed Consent Sheet that explicitly stated the center's policies, procedures, and goals while another 30 clients {Control Group) were exposed to the center's regular procedures which did not include this Informed Consent Sheet. Results of subsequently administered questionnaires showed that there were no differences between groups regarding their stated intention to abort a potential pregnancy, nor were there any differences between groups on their attitudes toward their counselors and their counseling experience, in general.

The therapeutic privilege is a defence in terms of which a doctor may withhold information from a patient if disclosure of such information could harm the patient. This study explores the defence of therapeutic privilege and provides a critical evaluation. A comparative investigation is undertaken, while arguments springing from a variety of disciplines are also incorporated. A number of submissions are made for limiting the ambit of the defence. The main submission is that the therapeutic privilege should comply with all the requirements of the defence of necessity. In addition, it should contain some of the safeguards afforded to the patient by the requirements of the defence of negotiorum gestio so that therapeutic privilege is out of the question if medical treatment is administered against the patient's will, or the doctor has reason to believe (or knows) that the patient will refuse to undergo an intended intervention once properly informed. / Jurisprudence / L.L.M. (Jurisprudence)

O presente trabalho avaliou através de um questionário e entrevistas pessoais no período de maio a setembro de 2004, cinqüenta participantes voluntários sujeitos de pesquisas envolvendo seres humanos, nas unidades de saúde do âmbito da Secretaria Municipal de Saúde – SMS, espalhadas pelo município de São Paulo e na Faculdade de Odontologia da Universidade de São Paulo – FOUSP. Colheu a opinião destes, sobre a experiência da voluntariedade nos experimentos de que participaram nestes locais, abordando questões como: o motivo de terem contribuído, grau de conhecimento do Termo de Consentimento Livre e Esclarecido -TCLE e a importância dispensada a este documento, com que concordaram e autorizaram a participação, de acordo com a determinação da Resolução 196/96, diretriz nacional que regulamenta as pesquisas envolvendo seres humanos. O estudo observou que, passados oito anos da entrada em vigor da Resolução 196/96, o processo de obtenção do consentimento livre e esclarecido ainda carece de cuidados. Participantes efetivamente não são esclarecidos ou não entendem o que lhes foi proposto. Consideramos a necessidade de uma maior difusão, através de ações educativas, do assunto “experimentação com seres humanos", para um maior entendimento dos voluntários de pesquisas dos seus direitos e deveres, no sentido de manter as pesquisas num elevado padrão ético. O presente estudo pretende contribuir com a hermenêutica desta Resolução e suscitar maiores discussões e reflexões sobre o assunto / The present assignment evaluated through a questionnaire and personal interviews in the period within May and September 2004, fifty volunteered participants subjects of researches involving human beings, in the units of health SMS) in São Paulo city and at Odontology University of São Paulo - FOUSP. It collected the opinion of these volunteers about the experience of voluntariness in the experiments that took part in these locals, tackling matters as: their reason of having contributed, knowledge degree of free consent form – TCLE and the dispensed importance of this document, to which they agreed and authorized the participation, according to the determination of the Resolution 196/96, national guideline that regulates the researches involving human beings. The study observed that eight years after the Resolution 196/96 was put into effect, the obtainment process of the informed consent still lacks of cares. Participants are not clear or do not understand what they were proposed. We consider the need of a larger diffusion through educational actions, of the subject experimentation with human beings, for volunteers larger understanding of their right and duties, in the sense to maintaining the researches in an elevated ethical standard. The present study intends to contribute with the hermeneutics of this Resolution and to raise larger discussions and reflections on the subject