RESUMO
The welfare of research participants must be guaranteed by international ethical standards. This article communicates the procedures of the Research Ethics Committee of the School of Medicine, University of Chile (CEISH). The new Chilean legislation on research in human beings is also discussed. Law 20.120: "On scientific research in human beings, its genome and forbidding human cloning" establishes the ethical principles that must be accomplished in every research involving human beings. Article 28 of the Law 20.584 "Regulation of the rights and duties of health care users", forbids the participation of handicapped people who cannot express their will in scientific research. Article 13 states that people not related directly with patient care cannot have access to his clinical records (with the exception of people with notarial authorization by the patient). CEISH proposes that, in case of people with intellectual deficiency, the decision to approve a scientific research should be analyzed on an individual basis. If the person is capable of expressing his or her will or has stated his or her consent beforehand, the research can be authorized. If the person cannot express his or her will, the scientific research cannot take place. In prospective studies, a consent from the patient and an authorization of the health authority should be required to access clinical records. In retrospective studies, consent should be obtained from the patient when personal information is going to be used. If the information is nameless, the consent can be disregarded.
Assuntos
Comitês de Ética em Pesquisa , Regulamentação Governamental , Experimentação Humana/ética , Experimentação Humana/legislação & jurisprudência , Consentimento Livre e Esclarecido/ética , Consentimento Livre e Esclarecido/legislação & jurisprudência , Chile , HumanosRESUMO
BACKGROUND: The relationship between patients and health professionals emphasizes deliberation and joint decision making, that derives in the informed consent. AIM: To evaluate decision making of patients in health care and to identify the notion of capacity for decision making, according to lawyers and physicians. MATERIAL AND METHODS: A semi-structured interview about procedures to assess decision making capacity was applied to 27 selected physicians and lawyers, considering their experience in this area. A qualitative analysis of answers was performed. RESULTS: Several differences were observed between physicians and lawyers, probably originated in their respective disciplines as well as the context of their professional practice. For physicians the notion of capacity is associated to comprehension of the information, it is not absolute, and it must consider the intellectual maturity of the teenager and the autonomy of the elderly. This evaluation is frequently performed in the clinical interview and standardized protocols do not exist. For lawyers, capacity is established by age and is associated to rights and obligations, as determined by law. When it is assessed by experts, including physicians, it becomes evidence. These professionals assume that experts will use standardized assessment instruments. Capacity has significance in the legal system. CONCLUSIONS: Since there are substantial consequences when a person is deemed incompetent, it is necessary to distinguish between health capacity and legal capacity, and to inverted exclamation markink the informed consent with the fundamental rights of citizens, such as taking decisions about our own health.
Assuntos
Tomada de Decisões , Consentimento Livre e Esclarecido , Advogados , Competência Mental , Médicos , Prática Profissional , Adolescente , Adulto , Fatores Etários , Idoso , Criança , Chile , Compreensão , Direitos Humanos , Humanos , Entrevistas como Assunto , Pessoa de Meia-Idade , Pesquisa Qualitativa , Responsabilidade SocialRESUMO
Background: The relationship between patients and health professionals emphasizes deliberation and joint decision making, that derives in the informed consent. Aim: To evaluate decision making of patients in health care and to identify the notion of capacity for decision making, according to lawyers and physicians. Material and methods: A semi-structured interview about procedures to assess decision making capacity was applied to 27 selected physicians and lawyers, considering their experience in this area. A qualitative analysis of answers was performed. Results: Several differences were observed between physicians and lawyers, probably originated in their respective disciplines as well as the context of their professional practice. For physicians the notion of capacity is associated to comprehension of the information, it is not absolute, and it must consider the intellectual maturity of the teenager and the autonomy of the elderly. This evaluation is frequently performed in the clinical interview and standardized protocols do not exist. For lawyers, capacity is established by age and is associated to rights and obligations, as determined by law. When it is assessed by experts, including physicians, it becomes evidence. These professionals assume that experts will use standardized assessment instruments. Capacity has significance in the legal system. Conclusions: Since there are substantial consequences when a person is deemed incompetent, it is necessary to distinguish between health capacity and legal capacity, and to ¡ink the informed consent with the fundamental rights of citizens, such as taking decisions about our own health.
Assuntos
Adolescente , Adulto , Idoso , Criança , Humanos , Pessoa de Meia-Idade , Tomada de Decisões , Consentimento Livre e Esclarecido , Advogados , Competência Mental , Médicos , Prática Profissional , Fatores Etários , Chile , Compreensão , Direitos Humanos , Entrevistas como Assunto , Pesquisa Qualitativa , Responsabilidade SocialRESUMO
The decision making capacity of patients will acquire special relevance with the introduction of informed consent in clinical practice and the new normative that will appear in the future when the bills about health services are approved in the Congress. This paper reviews the concept of decision making capacity in the context of health care and its legal background in Chile. The main problems that arise from the comprehension, use and assessment of decision making capacity, are analyzed. The assessment of this capacity is, in most cases, subjective since there are no criteria, protocols or standards to be used. In courts of justice, the exercise capacity assessment is requested to experts. These specilized physicians will evaluate the mental health of the subject and its implications in the capacity to make decisions. In practice, it is difficult to integrate the concept of capacity from the law or health care perspective. It is concluded that the elaboration of criteria, standards and procedures to evaluate the decision capacity of patients, is mandatory.