RESUMO
STUDY DESIGN: Prospective experimental. OBJECTIVES: To compare sensory function as revealed by light touch and pin prick tests of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) and the electrical perceptual threshold (EPT) exams in individuals with chronic incomplete cervical spinal cord injury (SCI). SETTING: Pittsburgh, United States. METHODS: EPT was tested using cutaneous electrical stimulation (0.5 ms pulse width, 3 Hz) in 32 healthy controls and in 17 participants with SCI over key points on dermatomes C2 to T4 on each side of the body. Light touch and pin prick ISNCSCI scores were tested at the same key dermatomes in SCI participants. RESULTS: In controls, EPT values were higher in older males (1.26±0.2 mA, mean±s.d.) compared with younger males (1.0±0.2 mA) and older females (0.9±0.2 mA), regardless of the dermatome and side tested. Fifteen out of the seventeen SCI participants showed that the level of sensory impairment detected by the EPT was below the level detected by the ISNCSCI (mean=4.5±2.4, range 1-9). The frequency distribution of EPTs was similar to older male controls in dermatomes above but not below the ISNCSCI sensory level. The difference between EPT and ISNCSCI sensory level was negatively correlated with the time post injury. CONCLUSIONS: The results show that, in the chronic stage of cervical SCI, the EPT reveals spared sensory function at lower (~5) spinal segments compared with the ISNCSCI sensory exam. It is hence found that the EPT is a sensitive tool to assess recovery of sensory function after chronic SCI.
Assuntos
Limiar Sensorial/fisiologia , Traumatismos da Medula Espinal/fisiopatologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos de Casos e Controles , Medula Cervical/patologia , Doença Crônica , Estimulação Elétrica , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Exame Neurológico , Psicofísica , Índice de Gravidade de Doença , Pele/inervação , Estatística como Assunto , Tato/fisiologiaRESUMO
A decade of empirical work in brain imaging, genomics, and other areas of research has yielded new knowledge about the frequency of incidental findings, investigator responsibility, and risks and benefits of disclosure. Straightforward guidance for handling such findings of possible clinical significance, however, has been elusive. In early work focusing on imaging studies of the brain, we suggested that investigators and institutional review boards must anticipate and articulate plans for handling incidental findings. Here we provide a detailed analysis of different approaches to the problem and evaluate their merits in the context of the goals and setting of the research and the involvement of neurologists, radiologists, and other physicians. Protecting subject welfare and privacy, as well as ensuring scientific integrity, are the highest priorities in making choices about how to handle incidental findings. Forethought and clarity will enable these goals without overburdening research conducted within or outside the medical setting.
Assuntos
Encefalopatias/diagnóstico , Diagnóstico por Imagem/normas , Achados Incidentais , Relações Médico-Paciente/ética , Encéfalo/patologia , Encéfalo/fisiopatologia , Neoplasias Encefálicas/diagnóstico , Neoplasias Encefálicas/terapia , Protocolos Clínicos/normas , Ensaios Clínicos como Assunto/ética , Ensaios Clínicos como Assunto/normas , Confidencialidade/normas , Termos de Consentimento/normas , Diagnóstico por Imagem/ética , Revelação/normas , Hemangioma Cavernoso do Sistema Nervoso Central/diagnóstico , Hemangioma Cavernoso do Sistema Nervoso Central/terapia , Humanos , Malformações Arteriovenosas Intracranianas/diagnóstico , Malformações Arteriovenosas Intracranianas/terapia , Equipe de Assistência ao Paciente/ética , Equipe de Assistência ao Paciente/normas , Encaminhamento e Consulta/ética , Encaminhamento e Consulta/normasRESUMO
Ethical principles of beneficence and justice combined with international human rights norms and standards create certain obligations on researchers, sponsors and public health authorities. These include treatment provision for participants enrolled in clinical trials of vaccines, drugs and other new preventive and curative technologies and methods. However, these obligations are poorly defined in practical terms, inconsistently understood or inadequately applied. Vaccine clinical trial designs normally define standards of prevention applicable to the population where the trial is to take place. The present document addresses specifically the setting of standards applicable to care and treatment in vaccine trials. The lack of clear guidance on how to achieve the optimal synergy between the development of new health technologies, on the one hand, and the promotion and protection of ethical and human rights principles, on the other, is a barrier to the progress of health research and therefore to the advancement of public health. The World Health Organization and UNAIDS have engaged in a series of consultations in Africa, the Americas, Asia and Europe to reflect on how this aim could best be achieved. This document highlights the outcome of these consultations. It proposes a structured approach to consensual decision making in the context of the clinical trial of vaccines against such public health challenges as HIV and newly emerging or threatening epidemics. A structured approach involving investigators and sponsors in a consultative process with trial communities and other stakeholders in research will ensure that the needs and legitimate expectations of trial participants are appropriately met, obligations towards them are delivered and, as a result, ethical research is facilitated in the interest of public health.
Assuntos
Ensaios Clínicos como Assunto/ética , Vacinas/uso terapêutico , Ensaios Clínicos como Assunto/normas , Atenção à Saúde , Guias como Assunto , HumanosRESUMO
Gillon is correct that the four principles provide a sound and useful way of analysing moral dilemmas. As he observes, the approach using these principles does not provide a unique solution to dilemmas. This can be illustrated by alternatives to Gillon's own analysis of the four case scenarios. In the first scenario, a different set of factual assumptions could yield a different conclusion about what is required by the principle of beneficence. In the second scenario, although Gillon's conclusion is correct, what is open to question is his claim that what society regards as the child's best interest determines what really is in the child's best interest. The third scenario shows how it may be reasonable for the principle of beneficence to take precedence over autonomy in certain circumstances, yet like the first scenario, the ethical conclusion relies on a set of empirical assumptions and predictions of what is likely to occur. The fourth scenario illustrates how one can draw different conclusions based on the importance given to the precautionary principle.
Assuntos
Temas Bioéticos , Ética Baseada em Princípios , Obtenção de Tecidos e Órgãos/ética , Recusa do Paciente ao Tratamento/ética , Adulto , Atitude Frente a Saúde , Beneficência , Transfusão de Sangue/ética , Criança , Comércio/ética , Ética Clínica , Humanos , Consentimento Livre e Esclarecido , Testemunhas de Jeová , Transplante de Rim/ética , Doadores Vivos/ética , Princípios Morais , Pais/psicologia , Autonomia Pessoal , Justiça Social/ética , Fatores de Tempo , Obtenção de Tecidos e Órgãos/economiaRESUMO
Research on the effectiveness of treatment programs in early stages of severe mental illness raise significant ethical questions when conducted in industrialized countries that have adequate protections for the human subjects of biomedical and behavioral research. Before embarking on similar trials in developing countries, researchers face formidable barriers that must first be addressed and overcome. The challenges to external sponsors of research in conducting ethically responsible clinical trials in developing countries include at least the following: the existence of alternative belief systems regarding the causes and treatment of mental illness; difficulty in implementing the results of successful research in resource-poor countries; providing for adequate prior ethical review in the host country of the proposed study; and problems in ensuring that voluntary, informed consent is properly obtained from research subjects or their legally authorized representatives. Global justice demands that we not adopt one ethical standard for rich countries and another for resource-poor countries.
Assuntos
Ensaios Clínicos como Assunto/legislação & jurisprudência , Países em Desenvolvimento , Ética Médica , Competência Mental/legislação & jurisprudência , Pessoas com Deficiência Mental/legislação & jurisprudência , Comparação Transcultural , Humanos , Consentimento Livre e Esclarecido/legislação & jurisprudência , Tutores LegaisRESUMO
Bolt and Mul argue persuasively against the "disease" approach and the "client" approach in addressing the question of whether growth hormone for short children properly belongs in the medical realm. Their own preferred approach, the "suffering" approach, is superior to the others but has practical problems that would arise in its application. An additional ethical issue, not addressed by Bolt and Mul, relates to justice in providing access for children from families of limited financial means to growth hormone treatment.
Assuntos
Ética Médica , Transtornos do Crescimento/tratamento farmacológico , Hormônio do Crescimento Humano/uso terapêutico , Criança , Humanos , Modelos TeóricosAssuntos
Países Desenvolvidos , Países em Desenvolvimento , Acessibilidade aos Serviços de Saúde , Direitos Humanos , Internacionalidade , Saúde Pública , Política Pública , Justiça Social , Bioética , Pesquisa Biomédica , Ensaios Clínicos como Assunto , Feminino , Humanos , Masculino , Pessoas sem Cobertura de Seguro de Saúde , Preconceito , Alocação de Recursos , Estados Unidos , Saúde da MulherRESUMO
Following a long process of revision, a new version of the Declaration of Helsinki was approved by the World Medical Association in 2000. Two provisions of the Declaration address ongoing international controversies regarding research sponsored by industrialized countries and conducted in developing countries. Despite the issuance of the final version of the Declaration, opponents remain locked in debate. Moreover, the Declaration remained silent on other prominent controversies concerning international research. An analysis of these current controversies reveals reasons why they are not likely to be readily resolved, despite apparent agreement by opponents on overarching ethical principles.
Assuntos
Ensaios Clínicos como Assunto/normas , Países em Desenvolvimento , Análise Ética , Guias como Assunto , Declaração de Helsinki , Internacionalidade , Países Desenvolvidos , Dissidências e Disputas , Revisão Ética , Comitês de Ética em Pesquisa/organização & administração , Acessibilidade aos Serviços de Saúde , Experimentação Humana , Humanos , Placebos , Projetos de Pesquisa , Justiça Social , Populações VulneráveisRESUMO
Four key guidance points in the UNAIDS guidance document, Ethical Considerations in HIV Preventive Vaccine Research, are compared with analogous statements in three other recently issued documents dealing with international research. Those documents are: the Declaration of Helsinki, as revised in 2000; the report of the U.S. National Bioethics Advisory Commission, issued in 2001; and a current (2001) draft revision of the 1993 CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects. The four guidance points compared with statements on similar issues on the other three documents are Guidance Point 2, which deals with making available a safe and effective vaccine after trials are completed; the second half of Guidance Point 4, which requires that the desired outcome should benefit the population from which research participants are drawn; Guidance Point 11, which discusses what should be provided to a control group in a vaccine trial; and Guidance Point 16, which addresses the care and treatment to be provided for trial participants who become infected with HIV during the trial. The analysis and comparison concludes that the UNAIDS guidance points are at least as ethically sound as analogous points in these other documents, and for the most part are ethically superior in providing greater benefits to research participants and to others. Nevertheless, they are subject to the criticism that they are too 'aspirational' and not sufficiently 'pragmatic'.
Assuntos
Vacinas contra a AIDS , Guias como Assunto , Declaração de Helsinki , Experimentação Humana/ética , Experimentação Humana/normas , Projetos de Pesquisa , Comitês Consultivos , Ensaios Clínicos como Assunto/ética , Ensaios Clínicos como Assunto/normas , Países em Desenvolvimento , Comitês de Ética em Pesquisa , Humanos , Internacionalidade , Placebos , Responsabilidade SocialRESUMO
Problems in obtaining and documenting informed consent are especially difficult to resolve in countries whose cultures differ considerably from those of most Western nations. Confusion between the research and therapeutic contexts are widespread. Two departures from widely accepted ethical standards are discussed: withholding information about the research and requiring a husband's permission for his wife to participate. Supporters of such departures claim that they are justified by the cultural context of the country in which the research is carried out. One program at the World Health Organization has developed guidelines stating that requiring partner agreement or authorization for an individual to participate in research violates the autonomy of research subjects and their right to confidentiality. A study carried out at one reproductive health clinic in Chile describes a process of obtaining informed consent to research that could serve as a model for US investigators interested in making informed consent a meaningful and ethically respectable aspect of their research activities. Research involving human subjects should adhere to a single, universally applicable standard of informed decision making by participants.
Assuntos
Países em Desenvolvimento , Experimentação Humana , Consentimento Livre e Esclarecido/legislação & jurisprudência , Organização Mundial da Saúde , Adulto , Chile , Ensaios Clínicos como Assunto , Características Culturais , Tomada de Decisões , Ética Médica , Feminino , Humanos , Masculino , Participação do Paciente , CônjugesRESUMO
Three reports on ethical aspects of research involving human embryonic stem cells were issued in the final months of 1999. Two were from governmental agencies or commissions: the National Institutes of Health and the National Bioethics Advisory Commission. The third report was issued by the American Association for the Advancement of Science and the Institute for Civil Society. All three reports endorse the use of federal funds for embryonic stem cell research, but other differences distinguish these reports. This article describes the differences and provides an ethical analysis of the main arguments.
Assuntos
Embrião de Mamíferos , Ética Médica , Política , Apoio à Pesquisa como Assunto/legislação & jurisprudência , Células-Tronco , Financiamento Governamental , Humanos , National Institutes of Health (U.S.) , Estados UnidosRESUMO
Research that is initiated, designed or funded by sponsor agencies based in countries with relatively high social and economic development, and conducted in countries that are relatively less developed, gives rise to many important ethical challenges. Although clinical trials of HIV vaccines began ten years ago in the US and Europe, an increasing number of trials are now being conducted or planned in other countries, including several that are considered "developing" countries. Safeguarding the rights and welfare of individuals participating as research subjects in developing countries is a priority. In September, 1997, the Joint United Nations Programme on HIV/AIDS (UNAIDS) embarked on a process of international consultation; its purpose was further to define the important ethical issues and to formulate guidance that might facilitate the ethical design and conduct of HIV vaccine trials in international contexts. This paper summarises the major outcomes of the UNAIDS consultative process.
Assuntos
Ensaios Clínicos como Assunto/normas , Diversidade Cultural , Países Desenvolvidos , Países em Desenvolvimento , Ética Médica , Cooperação Internacional , Internacionalidade , Guias de Prática Clínica como Assunto , Nações Unidas , Vacinas contra a AIDS , Atitude Frente a Saúde , Temas Bioéticos , Consenso , Grupos Controle , Revisão Ética , Ética , Ética em Pesquisa , Saúde Global , Prioridades em Saúde , Humanos , Obrigações Morais , Avaliação das Necessidades , Experimentação Humana não Terapêutica , Defesa do Paciente , Projetos de Pesquisa/normas , Sujeitos da Pesquisa , Justiça Social , Valores Sociais , Fatores Socioeconômicos , Experimentação Humana TerapêuticaRESUMO
Ethical questions surrounding the administration of synthetic growth hormone (GH) to short normal children can be grouped into the following four categories: 1) appropriateness of medical treatment when no disease or biological deficiency is present; 2) how to proceed in the face of ambiguity or uncertainty of research results; 3) difficulty in weighing the risks and benefits of treatment; and 4) who should decide? This article seeks to determine whether GH administration to normal short children is properly considered an 'enhancement', and, if so, whether such treatment would be ethically wrong.
Assuntos
Estatura , Endocrinologia , Ética Médica , Hormônio do Crescimento Humano/uso terapêutico , Pediatria , Criança , Hormônio do Crescimento Humano/efeitos adversos , Humanos , Medição de RiscoAssuntos
Grupos Controle , Ética Médica , Doença de Parkinson/cirurgia , Placebos , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Medição de Risco , Procedimentos Cirúrgicos Operatórios , Experimentação Humana Terapêutica , Revelação , Revisão Ética , Comitês de Ética em Pesquisa , Transplante de Tecido Fetal , Humanos , Consentimento Livre e Esclarecido , Sujeitos da Pesquisa , Risco , Procedimentos Cirúrgicos Operatórios/efeitos adversosAssuntos
Implantes de Mama/efeitos adversos , Métodos Epidemiológicos , Ética Médica , Imperícia/legislação & jurisprudência , Géis de Silicone/efeitos adversos , Incerteza , Comitês Consultivos , Pesquisa Biomédica , Compensação e Reparação , Medicina Baseada em Evidências/legislação & jurisprudência , Feminino , Humanos , Justiça Social , Estados UnidosRESUMO
Properly understood, informed consent is a process of communication between researcher and subject. The purpose of the informed consent form is to document the informed consent discussion. The place of informed consent in leading international codes of research ethics is reviewed. Some prominent examples of past violations of informed consent are discussed. Even when properly understood, informed consent presents an array of ongoing problems and unanswered questions. These include the question of how much information must be given to research subjects, and how much is too much; and how to ensure the full voluntariness of subjects' consent, especially when the researcher is also the patient's physician. An ongoing problem is the 'therapeutic misconception'--the belief that proposed research is a promising treatment intended to benefit the subjects. The complexity of the technical language in which consent forms are written remains a problem, though this can easily be remedied.