RESUMO
Biomedical and behavioral research may affect strongly held social values and thereby create significant controversy over whether such research should be permitted in the first place. Institutional review boards (IRBs) responsible for protecting the rights and welfare of participants in research are sometimes faced with review of protocols that have significant implications for social policy and the potential for negative social consequences. Although IRB members often raise concerns about potential long-term social implications in protocol review, federal regulations strongly discourage IRBs from considering them in their decisions. Yet IRBs often do consider the social implications of research protocols and sometimes create significant delays in initiating or even prevent such research. The social implications of research are important topics for public scrutiny and professional discussion. This article examines the reasons that the federal regulations preclude IRBs from assessing the social risks of research, and examines alternative approaches that have been used with varying success by national advisory groups to provide such guidance. The article concludes with recommendations for characteristics of a national advisory group that could successfully fulfill this need, including sustainability, independence, diverse and relevant expertise, and public transparency.
Assuntos
Comitês Consultivos , Ensaios Clínicos como Assunto/ética , Comitês de Ética em Pesquisa , Experimentação Humana/ética , Consentimento Livre e Esclarecido/ética , Valores Sociais , Adolescente , Comportamento do Adolescente , Alcoolismo/terapia , Transtorno da Personalidade Antissocial/terapia , Ética em Pesquisa , Melhoramento Genético/ética , Genética Comportamental/ética , Redução do Dano/ética , Humanos , Transtornos Mentais/terapia , Opinião Pública , Política Pública/tendências , Estados Unidos , Violência/prevenção & controleRESUMO
The unique historical aspects of Pelger and Huet's discovery of the Pelger-Huet cell highlight the diagnostic challenge that this morphologic finding presents to the physician. Making the diagnosis of the benign autosomal dominant anomaly is complicated by the morphologically similar pseudo-Pelger-Huet cell, which can signify underlying myeloid dsyplasia. This article relates the history of the Pelger-Huet anomaly as well as describes the clinical significance and diagnostic workup for the finding of a Pelger-Huet cell on peripheral smear.
Assuntos
Neutrófilos/patologia , Anomalia de Pelger-Huët , Animais , Núcleo Celular/ultraestrutura , Criança , Diagnóstico Diferencial , Eosinófilos/patologia , Feminino , Morte Fetal/genética , Genes Dominantes , História do Século XX , Humanos , Infecções/sangue , Leucemia Mieloide/sangue , Leucemia Mieloide/diagnóstico , Síndromes Mielodisplásicas/sangue , Síndromes Mielodisplásicas/diagnóstico , Países Baixos , Linhagem , Anomalia de Pelger-Huët/sangue , Anomalia de Pelger-Huët/diagnóstico , Anomalia de Pelger-Huët/genética , Anomalia de Pelger-Huët/história , Receptores Citoplasmáticos e Nucleares/deficiência , Receptores Citoplasmáticos e Nucleares/genética , Receptor de Lamina BRESUMO
Leprosy is uncommon in North America. Because it has a prolonged incubation period and can masquerade with a variety of manifestations, many patients with leprosy experience a significant delay in diagnosis and treatment. Lepra reactions are of 2 types: reversal (type 1) and erythema nodosum leprosum (ENL) (type 2). Type 1 or reversal reactions represent an increase in cell-mediated immunity, whereas type 2 or ENL is caused by antigen-antibody complex formation and deposition after antigen release from dying lepra bacilli. This article describes the diagnostic challenges presented by a Minnesota patient eventually found to have lepromatous leprosy. That challenge was compounded by the fact that the clinical scenario closely mimicked connective tissue/immune complex disease and by the fact that the patient presented in a location where the incidence and prevalence of leprosy is extremely low.
Assuntos
Hanseníase Virchowiana/diagnóstico , Sarcoidose/diagnóstico , Doença Aguda , Adulto , Biópsia , Diagnóstico Diferencial , Eritema Nodoso/diagnóstico , Eritema Nodoso/patologia , Humanos , Hanseníase Virchowiana/patologia , Linfonodos/patologia , Masculino , Sarcoidose/patologia , Pele/patologiaAssuntos
Viés , Ensaios Clínicos como Assunto/ética , Conflito de Interesses , Indústria Farmacêutica/ética , Viés de Publicação , Apoio à Pesquisa como Assunto/ética , Ensaios Clínicos como Assunto/estatística & dados numéricos , Humanos , Minnesota , Projetos de Pesquisa/estatística & dados numéricos , Resultado do Tratamento , Estados UnidosRESUMO
No consensus yet exists on how to handle incidental findings (IFs) in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are findings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. This paper reports recommendations of a two-year project group funded by NIH to study how to manage IFs in genetic and genomic research, as well as imaging research. We conclude that researchers have an obligation to address the possibility of discovering IFs in their protocol and communications with the IRB, and in their consent forms and communications with research participants. Researchers should establish a pathway for handling IFs and communicate that to the IRB and research participants. We recommend a pathway and categorize IFs into those that must be disclosed to research participants, those that may be disclosed, and those that should not be disclosed.
Assuntos
Pesquisa Biomédica/ética , Genômica/tendências , Achados Incidentais , Encaminhamento e Consulta/ética , Sujeitos da Pesquisa , Revelação da Verdade/ética , Pesquisa Biomédica/legislação & jurisprudência , HumanosAssuntos
Ética Médica , Revisão por Pares/ética , Poder Psicológico , Má Conduta Científica/ética , Humanos , MinnesotaRESUMO
Complications related to liver hemangioma are rare. We herein describe the case of a patient with three giant cavernous hemangiomas of the liver, of which two were resected for symptoms. A significant microangiopathic hemolytic anemia occurred in the early postoperative period, leading to acute renal failure and necessitating blood transfusions. The systematic evaluation of hemolytic processes in the postoperative patient is described. Surgeons should be aware of the potential for hemolytic complications after major surgery when giant hepatic hemangiomas are present.