RESUMO
Background: In respect of the principle of autonomy and the right of self-determination, obtaining an informed consent of potential participants before their inclusion in a study is a fundamental ethical obligation. The variations in national laws, regulations, and cultures contribute to complex informed consent documents for patients participating in clinical trials. Currently, only few ethics committees seem willing to address the complexity and the length of these documents and to request investigators and sponsors to revise them in a way to make them understandable for potential participants. The purpose of this work is to focus on the written information in the informed consent documentation for drug development clinical trials and suggests (i) to distinguish between necessary and not essential information, (ii) to define the optimal format allowing the best legibility of those documents. Methods: The Aide et Recherche en Cancérologie Digestive (ARCAD) Group, an international scientific committee involving oncologists from all over the world, addressed these issues and developed and uniformly accepted a simplified informed consent documentation for future clinical research. Results: A simplified form of informed consent with the leading part of 1200-1800 words containing all of the key information necessary to meet ethical and regulatory requirements and 'relevant supportive information appendix' of 2000-3000 words is provided. Conclusions: This position paper, on the basis of the ARCAD Group experts discussions, proposes our informed consent model and the rationale for its content.
Assuntos
Termos de Consentimento , Neoplasias/tratamento farmacológico , Ensaios Clínicos como Assunto , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Consentimento Livre e Esclarecido , Participação do Paciente , Guias de Prática Clínica como AssuntoRESUMO
The extent of medicines sales and consumption in the informal market in Togo raises many ethical and public health issues. In order to report on the situation of public action in the fight against this practice, we conducted a qualitative survey from 15 to 25 February 2016 in the commune of Lomé and in the Maritime Region among the actors of control system and resource people in the general population. This was supplemented by an analysis of Togo's pharmaceutical and health policy documents and a literature review on the illicit drug market issues relating to public health, political science, the social sciences applied to health. In spite of the existence of national and international tools, household poverty, cultural self-medication, ignorance of the population concerning the health risks of informal market medicines, weak political commitment, weakness regulation and enforcement, corruption, constitute obstacles to the success of actions to combat this practice.
Assuntos
Indústria Farmacêutica , Setor Informal , Automedicação , Indústria Farmacêutica/legislação & jurisprudência , Humanos , Automedicação/efeitos adversos , TogoAssuntos
Emigrantes e Imigrantes , Nutrição Enteral , Fome , Médicos/legislação & jurisprudência , Prisioneiros/legislação & jurisprudência , Greve , Emigrantes e Imigrantes/legislação & jurisprudência , Nutrição Enteral/ética , Evolução Fatal , Direitos Humanos , Humanos , Masculino , Nigéria , Médicos/ética , Prisões , Suíça , Tortura/legislação & jurisprudência , Adulto JovemRESUMO
The main goal of the Canada Health Act is to guarantee that Canadian residents have reasonable access to a comprehensive and universal health care plan. However, reduced federal funding for health care and increases in health care costs due to technical and scientific developments have created unprecedented financial pressures on provincial health care systems. The right to health care, once perceived as one of the pillars of Canadian society, may be imperiled. This article will provide a detailed analysis of the nature and scope of the right to health care from mainly a legal, but also from a political, perspective. Based on the premises that the Canada Health Act is basically a financial agreement between the Federal and provincial governments and that it does not enshrine a substantive right on which individuals may claim services, the author explores the nature and scope of this right under Québec legislation. Indeed, the Québec Health and Social Services Act has, since the 1960s, included various provisions that establish a right of access to health care services. This right, however, is fraught with regulatory, organizational and financial limits. The first part of this paper examines relevant regulation from an historical perspective, highlighting the relationships between federal and Québec provincial legislation. In the second part, the author explores exhaustively the principal provisions relevant to the right to health care. This entails the analysis of administrative regulations as well as of the responsibilities of the various provincial, regional, institutional and professional authorities involved. Ultimately, as this study will demonstrate, the availability of health care services depends more on a vague process than on a legal right to health care. This conclusion is further confirmed by the analysis of the adjudication process of patient complaints provided under the Québec Health and Social Services Act and by the limited case law on the right of access to services. Even though judges are generally favorable to patients claims, court interventions remain ad hoc and a posteriori. But if the right of access to health care seems limited, its scope is nonetheless important. The right to health care acts as an obstacle to the current dismantling of health care services and to government withdrawal from this field. It also places limits on abusive, arbitrary and discriminatory decision-making and obliges public authorities to take into closer consideration patients' rights in formulating its health care policy and budgets. This protective role of the right to health care is currently illustrated by the politicians' insistence that the ongoing health care reform is not affecting the quality or quantity of available services.