RESUMEN
The use of whole-genome sequencing in biomedical research is expected to produce dramatic advances in human health. The increasing use of this powerful, data-rich new technology in research, however, will inevitably give rise to incidental findings (IFs)-findings with individual health or reproductive significance that are beyond the aims of the particular research-and the related questions of whether and to what extent researchers have an ethical obligation to return IFs. Many have concluded that researchers have an ethical obligation to return some findings in some circumstances but have provided vague or context-dependent approaches to determining which IFs must be returned and when. As a result, researchers have started returning IFs inconsistently, giving rise to concerns about legal liability in circumstances in which notification could have potentially prevented injury. Although it is clear that ethical guidance should not be automatically codified as law and that crafting ethical obligations around legal duties can be inappropriate, the ethical debate should not proceed unaware of the potential legal ramifications of advancing and implementing an ethical obligation to return IFs. This Article assesses the legal claims that could be brought for a researcher's failure to return IFs. The potential for researchers to be held liable in tort is still uncertain and turns largely on a number of factors-including customary practice and guidance documents-that are still in flux. Unlike medical care, which has a well-defined duty into which evolving scientific knowledge about genetics and genomics can readily be incorporated, a researcher's duty to return IFs is less well defined, making it difficult to determine at the outset whether and when legal liability will attach. This Article advocates for a clearer, ethically sound standard of requiring that researchers disclose in the informed consent document which approach to offering IFs will be taken. This approach enables participants to know at the outset which findings, if any, will be returned, allows researchers to ascertain when their failure to appropriately return incidental findings will give rise to liability, and enables courts to make determinations that will produce more consistent legal guidance.
RESUMEN
For more than 20 years, the Ethical, Legal, and Social Implications (ELSI) Program of the National Human Genome Research Institute has supported empirical and conceptual research to anticipate and address the ethical, legal, and social implications of genomics. As a component of the agency that funds much of the underlying science, the program has always been an experiment. The ever-expanding number of issues the program addresses and the relatively low level of commitment on the part of other funding agencies to support such research make setting priorities especially challenging. Program-supported studies have had a significant impact on the conduct of genomics research, the implementation of genomic medicine, and broader public policies. The program's influence is likely to grow as ELSI research, genomics research, and policy development activities become increasingly integrated. Achieving the benefits of increased integration while preserving the autonomy, objectivity, and intellectual independence of ELSI investigators presents ongoing challenges and new opportunities.
Asunto(s)
Genoma Humano/genética , National Human Genome Research Institute (U.S.)/ética , National Human Genome Research Institute (U.S.)/legislación & jurisprudencia , Política Pública , Pruebas Genéticas , Humanos , National Human Genome Research Institute (U.S.)/tendencias , Estados UnidosRESUMEN
Ethical complexities surround the promise of genomic technology and the power of genetic information as they alter conceptions of identity and dynamics within personal and professional relationships. Creative approaches such as dramatic vignettes offer a unique analytical stage for imagining the bioethical past and future. Dramatic narratives can bring to life images of differing perspectives and values when experiencing innovations in medicine. Although the scientific landscape shifts, concerns expressed in theatre from 50 years ago parallel many contemporary ELSI (ethical, legal, and social implications) issues, highlighting the ongoing struggle to appreciate the impact of emerging genetic technologies on relationships. To illuminate these enduring concerns, we explore how perceptions and relationships have influenced-and been influenced by-genetics as portrayed through dramatic vignettes. We build on the legacy of using case vignettes as a clinical teaching modality, and believe similar value exists within the research ethics domain. The selection of dialogue discussed encompasses abbreviated excerpts from two existing and one original vignette that we staged at the ELSI 2011 Congress and various academic and health institutions.
Asunto(s)
Drama , Investigación Genética/ética , Investigadores/psicología , Ética en Investigación , Investigación Genética/legislación & jurisprudencia , Técnicas Genéticas/ética , Humanos , Consentimiento Informado , Investigadores/ética , Valores SocialesRESUMEN
During the past two decades, the use of DNA tests has revolutionized court proceedings in criminal and paternity cases. On the horizon is a new challenge for judges--whether to admit or compel genetic tests to confirm or predict genetic diseases and conditions in many more judicial contexts, e.g., decisions regarding culpability, sentencing, liability, causation, and damages. This Policy Forum reports on an empirical study of how judges would analyze these issues. The authors discuss the challenges these types of cases will bring to the court-room and suggest a series of questions that judges should consider in evaluating the need for genetic information in legal cases.
Asunto(s)
Pruebas Genéticas/legislación & jurisprudencia , Recolección de Datos , Humanos , JurisprudenciaAsunto(s)
Predisposición Genética a la Enfermedad , Privacidad Genética , Pruebas Genéticas , Seguro de Salud , Empleo/legislación & jurisprudencia , Miedo , Privacidad Genética/legislación & jurisprudencia , Proyecto Genoma Humano , Humanos , Selección Tendenciosa de Seguro , Seguro de Salud/legislación & jurisprudencia , Prejuicio , Opinión Pública , Política Pública , Estados UnidosAsunto(s)
Niño , Revelación/legislación & jurisprudencia , Intoxicación por Plomo/prevención & control , Responsabilidad Legal , Experimentación Humana no Terapéutica/legislación & jurisprudencia , Investigadores/legislación & jurisprudencia , Riesgo , Baltimore , Deber de Advertencia , Exposición a Riesgos Ambientales , Vivienda/normas , Humanos , Rol Judicial , Experimentación Humana no Terapéutica/ética , Consentimiento Paterno/legislación & jurisprudencia , Salud Pública , Relaciones Investigador-SujetoAsunto(s)
Predisposición Genética a la Enfermedad , Investigación Genética , Genética , Judíos , Prejuicio , Neoplasias de la Mama , Empleo , Femenino , Pruebas Genéticas , Experimentación Humana , Humanos , Consentimiento Informado , Seguro , Neoplasias , Sujetos de Investigación , Riesgo , Medición de Riesgo , Estereotipo , Enfermedad de Tay-Sachs , Confianza , Estados Unidos , MujeresAsunto(s)
Comités de Ética en Investigación , Comités de Ética , Experimentación Humana , Grupos Minoritarios , National Institutes of Health (U.S.) , Selección de Paciente , Sujetos de Investigación , Mujeres , Participación de la Comunidad , Gobierno Federal , Femenino , Gobierno , Regulación Gubernamental , Guías como Asunto , Humanos , Embarazo , Mujeres Embarazadas , Control Social Formal , Estadística como Asunto , Estados UnidosAsunto(s)
Experimentación Humana , Selección de Paciente , Embarazo , Mujeres Embarazadas , Sujetos de Investigación , Mujeres , Factores de Edad , Revelación , Comités de Ética , Comités de Ética en Investigación , Gobierno Federal , Femenino , Gobierno , Regulación Gubernamental , Guías como Asunto , Humanos , Consentimiento Informado , Competencia Mental , National Academies of Science, Engineering, and Medicine, U.S., Health and Medicine Division , National Institutes of Health (U.S.) , Paternalismo , Personas , Control Social Formal , Justicia Social , Esposos , Consentimiento por Terceros , Estados Unidos , United States Dept. of Health and Human Services , Poblaciones Vulnerables , Salud de la MujerAsunto(s)
Guías como Asunto , Experimentación Humana , Responsabilidad Legal , National Institutes of Health (U.S.) , Selección de Paciente , Efectos Tardíos de la Exposición Prenatal , Política Pública , Sujetos de Investigación , Salud de la Mujer , Mujeres , Factores de Edad , Investigación Conductal , Niño , Revelación , Femenino , Feto , Humanos , Consentimiento Informado , Grupos Minoritarios , Revisión por Pares , Embarazo , Mujeres Embarazadas , Investigación , Proyectos de Investigación , Investigadores , Riesgo , Experimentación Humana Terapéutica , Estados UnidosAsunto(s)
Regulación Gubernamental , Experimentación Humana , Selección de Paciente , Prejuicio , Política Pública , Sujetos de Investigación , Control Social Formal , Mujeres , Investigación Biomédica , Derechos Civiles , Comunicación , Confidencialidad , Toma de Decisiones , Gobierno Federal , Femenino , Feto , Financiación Gubernamental , Libertad , Gobierno , Humanos , Jurisprudencia , Responsabilidad Legal , Hombres , National Institutes of Health (U.S.) , Autonomía Personal , Preparaciones Farmacéuticas , Relaciones Médico-Paciente , Embarazo , Mujeres Embarazadas , Efectos Tardíos de la Exposición Prenatal , Reproducción , Investigación , Justicia Social , Esposos , Gobierno Estatal , Decisiones de la Corte Suprema , Consentimiento por Terceros , Estados Unidos , United States Food and Drug Administration , Salud de la MujerAsunto(s)
Coerción , Enfermedades Transmisibles , Jurisprudencia , Programas Obligatorios , Cooperación del Paciente , Salud Pública , Política Pública , Cuarentena , Tuberculosis , Derechos Civiles , Internamiento Obligatorio del Enfermo Mental , Personas con Discapacidad , Economía , Gobierno Federal , Gobierno , Seropositividad para VIH , Asignación de Recursos para la Atención de Salud , Personas con Mala Vivienda , Humanos , Grupos Minoritarios , Motivación , Atención al Paciente , Preparaciones Farmacéuticas , Prejuicio , Prevalencia , Asignación de Recursos , Factores Socioeconómicos , Gobierno Estatal , Negativa del Paciente al Tratamiento , Estados Unidos , Poblaciones VulnerablesRESUMEN
The law's response to reproductive genetic testing depends on a number of assumptions about choice, causation and control which need to be questioned. From the preconception stage forward, the illusion of choice may raise such fundamental questions as the woman's choice not to be tested, limits on genetic information, and the availability of reproductive options. In turn, assumptions about choice raise questions about the responsibility for results and the connection between choice and causation in the context of wrongful birth and life actions. Assumptions made about control over reproductive choice and over causing 'harm', will impact on the development of future law.