Asunto(s)
Investigación Biomédica/ética , Códigos de Ética , Ética en Investigación , Experimentación Humana/ética , Sujetos de Investigación , Comités Consultivos , Beneficencia , Comités de Ética en Investigación , Humanos , Consentimiento Informado , Obligaciones Morales , Motivación , Nacionalsocialismo , Negativa a Participar , Sujetos de Investigación/economía , Salarios y Beneficios , Naciones Unidas , Estados Unidos , Poblaciones VulnerablesRESUMEN
As the fifth national bioethics commission has concluded its work and a sixth is currently underway, it is time to step back and consider appropriate measures of success. This paper argues that standard measures of commissions' influence fail to fully assess their role as public forums. From the perspective of democratic theory, a critical dimension of this role is public engagement: the ability of a commission to address the concerns of the general public, to learn how average citizens resolve moral issues in healthcare, and to monitor public opinion on the topics addressed in the commission. Such a public forum role is supported by the critical literature within bioethics, which has deemed some commissions successful, supported more generally by the history of bioethics as a reform discourse that has brought socially important values into the medical domain, and supported more generally still by the example of the great social issues commissions of the 1960s.
Asunto(s)
Comités Consultivos/historia , Comités Consultivos/organización & administración , Comités Consultivos/normas , Discusiones Bioéticas , Bioética , Participación de la Comunidad , Eticistas , Rol Profesional , Evaluación de Programas y Proyectos de Salud , Política Pública , Bioética/historia , Miembro de Comité , Participación de la Comunidad/métodos , Democracia , Gobierno Federal , Historia del Siglo XX , Historia del Siglo XXI , Filosofía , Formulación de Políticas , Opinión Pública , Estados UnidosAsunto(s)
Experimentación Humana/ética , Comités Consultivos , Beneficencia , Revisión Ética/historia , Historia del Siglo XX , Experimentación Humana/historia , Experimentación Humana/legislación & jurisprudencia , Humanos , Autonomía Personal , Ética Basada en Principios/historia , Cambio Social , Justicia Social , Estados UnidosRESUMEN
There are approximately one million cases of type 1 diabetes in the US, and the incidence is increasing worldwide. Given that two-thirds of cases present in childhood, it is critical that prediction and prevention research involve children. In this article, I examine whether current research methodologies conform to the ethical guidelines enumerated by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, and adopted into the federal regulations that protect research subjects. I then offer two policy recommendations to help researchers design studies that conform to these ethical requirements.
Asunto(s)
Diabetes Mellitus Tipo 1/prevención & control , Ética en Investigación , Experimentación Humana/ética , Pediatría/ética , Niño , Guías como Asunto , Humanos , Formulación de Políticas , Medición de Riesgo , Estados UnidosRESUMEN
As we contemplate the emerging era of neuromodulation and imagine the utility of deep brain stimulation for disease entities in neurology and psychiatry, our enthusiasm is immediately tempered by history. Just a generation ago, other confident investigators were heralding invasive somatic therapies like prefrontal lobotomy to treat psychiatric illness. That era of psychosurgery ended with widespread condemnation, congressional calls for a ban, and avow that history should never repeat itself. Now, just 30 years later, neurologists, neurosurgeons, and psychiatrists are implanting deep brain stimulators for the treatment of Parkinson's disease and contemplating their use for severe psychiatric illnesses, such as obsessive-compulsive disorder and the modulation of consciousness in traumatic brain injury.
Asunto(s)
Investigación Biomédica/ética , Encéfalo/cirugía , Trastornos Mentales/historia , Cuidados Paliativos/historia , Psicocirugía/historia , Investigación Biomédica/historia , Historia del Siglo XX , Humanos , Trastornos Mentales/cirugía , Cuidados Paliativos/métodos , Psicocirugía/ética , Psicocirugía/instrumentación , Estados UnidosRESUMEN
The U.S. federal regulations require investigators conducting nonbeneficial research to obtain the assent of children who are capable of providing it. Unfortunately, there has been no analysis of which children are capable of assent or even what abilities ground the capacity to give assent. Why should investigators be required to obtain the positive agreement of some children, but not others, before enrolling them in research that does not offer a compensating potential for direct benefit? We argue that the scope of children's research decision making should be based on the principles of respect for autonomy and nonmaleficence. These principles imply that the threshold for assent should be fixed at 14 years of age, and a dissent requirement should be adopted for all children in the context of nonbeneficial research.
Asunto(s)
Adolescente , Factores de Edad , Desarrollo Infantil , Niño , Comprensión , Consentimiento Informado/psicología , Experimentación Humana no Terapéutica , Altruismo , Beneficencia , Toma de Decisiones , Regulación Gubernamental , Humanos , Consentimiento Informado/ética , Consentimiento Informado/legislación & jurisprudencia , Competencia Mental , Experimentación Humana no Terapéutica/legislación & jurisprudencia , Autonomía Personal , Negativa a Participar/ética , Estados UnidosRESUMEN
From the time of Hippocrates, physicians have sworn to "abstain from all intentional wrongdoing and harm," (Lifton, 1986). They are guided by ethical principles and theories that are intended to help them in their practice of medicine and scientific research. The purpose of this paper was to define research and human subjects, to review cases of abuse, address benefits and risks of human experimentation, discuss regulations governing experiments on humans, and address ethical principles and theories regarding this type of research. Human experimentation is an important activity of great societal benefit that must be conducted in a manner consistent with basic societal beliefs and values about the rights and worth of an individual (Gray, 1975). Ethical issues in human experimentation defy definite solutions, and the problems involved in human experimentation will almost certainly continue to receive active attention in future years.
Asunto(s)
Discusiones Bioéticas , Experimentación Humana/legislación & jurisprudencia , Historia del Siglo XX , Experimentación Humana/historia , Humanos , Estados UnidosAsunto(s)
Revelación , Experimentación Humana , Consentimiento Informado/legislación & jurisprudencia , Revelación de la Verdad , Comités Consultivos , Canadá , Bases de Datos de Ácidos Nucleicos , Ética Médica , Medicina Familiar y Comunitaria/legislación & jurisprudencia , Medicina Familiar y Comunitaria/normas , Gobierno Federal , Investigación Genética , Regulación Gubernamental , Política de Salud/legislación & jurisprudencia , Humanos , Legislación Hospitalaria , Responsabilidad Legal , Mala Praxis/legislación & jurisprudencia , National Institutes of Health (U.S.)/legislación & jurisprudencia , Experimentación Humana no Terapéutica , Autonomía Personal , Relaciones Médico-Paciente , Sujetos de Investigación , Relaciones Investigador-Sujeto , Medición de Riesgo , Experimentación Humana Terapéutica , Estados Unidos , United States Food and Drug Administration/legislación & jurisprudenciaAsunto(s)
Regulación Gubernamental , Guías como Asunto , Experimentación Humana/ética , Experimentación Humana/legislación & jurisprudencia , National Institutes of Health (U.S.) , Comités Consultivos , Beneficencia , Coerción , Comprensión , Comités de Ética en Investigación , Declaración de Helsinki , Humanos , Consentimiento Informado/ética , Consentimiento Informado/normas , Selección de Paciente , Autonomía Personal , Sujetos de Investigación , Medición de Riesgo , Justicia Social , Estados UnidosRESUMEN
Current and coincident biomedical advances make this an opportune time to encourage research with individuals who have fluctuating periods of incapacity caused by psychotic disorders like schizophrenia. Effecting research with this heterogeneous population who may have impaired decision-making capacity that diminishes their autonomy, while honoring their liberty and safeguarding their well-being, may be difficult to achieve. Federal regulations and guidelines in regard to research with this population are insufficient and cause additional obstacles. Use of research advance directives that allow for the appointment of a surrogate decision maker, the designation of a research monitor, and delineation of specific safeguards for the research participants also may provide protection for investigators and foster and improve community trust in medical research.
Asunto(s)
Directivas Anticipadas , Experimentación Humana , Enfermos Mentales , Sujetos de Investigación , Esquizofrenia , Comités Consultivos , Ética en Investigación , Guías como Asunto , Declaración de Helsinki , Experimentación Humana/ética , Experimentación Humana/legislación & jurisprudencia , Humanos , Consentimiento Informado , Competencia Mental , Apoderado , Riesgo , Estados UnidosAsunto(s)
Experimentación Humana/historia , Experimentación Humana/normas , Competencia Mental , Trastornos Mentales , Control Social Formal , Comités Consultivos , Comités de Ética en Investigación , Europa (Continente) , Gobierno Federal , Regulación Gubernamental , Guías como Asunto , Historia del Siglo XX , Experimentación Humana/legislación & jurisprudencia , Humanos , Consentimiento Informado , Enfermos Mentales , Experimentación Humana no Terapéutica/ética , Experimentación Humana no Terapéutica/historia , Personas con Discapacidades Mentales , Sujetos de Investigación , Mala Conducta Científica/historia , Experimentación Humana Terapéutica/historia , Estados UnidosAsunto(s)
Comités de Ética en Investigación , Regulación Gubernamental , Experimentación Humana/legislación & jurisprudencia , Experimentación Humana/normas , Competencia Mental , Trastornos Mentales , Comités Consultivos , Experimentación Humana/ética , Humanos , Consentimiento Informado , Enfermos Mentales , Experimentación Humana no Terapéutica , Personas con Discapacidades Mentales , Sujetos de Investigación , Estados UnidosAsunto(s)
Comités Consultivos , Experimentación Humana/ética , Experimentación Humana/normas , Política Pública , Comités Consultivos/organización & administración , Compensación y Reparación , Comités de Ética en Investigación , Gobierno Federal , Regulación Gubernamental , Humanos , Sujetos de Investigación , Estados UnidosAsunto(s)
Adolescente , Catolicismo , Experimentación Humana , Menores , Medición de Riesgo , Riesgo , Comités Consultivos , Factores de Edad , Comités de Ética , Comités de Ética en Investigación , Gobierno Federal , Terapia Genética , Gobierno , Regulación Gubernamental , Guías como Asunto , Humanos , Consentimiento Informado , Distrofia Muscular de Duchenne , Experimentación Humana no Terapéutica , Consentimiento Paterno , Política Pública , Religión , Investigación , Control Social Formal , Teología , Experimentación Humana Terapéutica , Consentimiento por Terceros , Estados UnidosAsunto(s)
Discusiones Bioéticas , Bioética , Historia , Feto Abortado , Comités Consultivos , Investigación Biomédica , Tecnología Biomédica , Catolicismo , Participación de la Comunidad , Ética Médica , Investigación Fetal , Feto , Financiación Gubernamental , Historia del Siglo XX , Experimentación Humana , Humanos , Filosofía , Médicos , Política Pública , Religión , Investigación , Mala Conducta Científica , Teología , Estados UnidosRESUMEN
In 1978, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research issued an important report that addressed the difficult ethical issues arising in research involving subjects with mental disabilities. However, because of irreconcilable conflicts between the scientific community and rights-oriented advocacy groups, the federal government never issued the special regulations pertaining to these issues that had been envisioned by the National Commission. Because these important ethical issues have not yet been adequately addressed by policy-making bodies, protection of cognitively impaired subjects depends too heavily on the diverse ethical sensitivities of individual investigators and on ad hoc responses of particular institutional review boards. Researchers should support a credible and authoritative process for reexamining and resolving ethical issues relating to research with cognitively impaired subjects. This can be accomplished without leading to the stalemate that doomed the National Commission's proposals. The challenge is to forge a consensus on ethical guidelines and safeguards that will most reasonably accommodate the goals of protecting the dignity and well-being of research subjects while avoiding undue impediments to valuable scientific inquiry.