Assuntos
Bioética , Características Culturais , Relações Interpessoais , África , Ásia , Temas Bioéticos , Europa (Continente) , Humanos , América Latina , Oriente Médio , Estados UnidosAssuntos
Atitude , DNA Recombinante , Regulamentação Governamental , Pesquisadores , Controle Social Formal , Controles Informais da Sociedade , Governo Federal , Liberdade , Governo , Substâncias Perigosas , História , Humanos , Legislação como Assunto , Governo Local , Risco , Medição de Risco , Ciência , UniversidadesRESUMO
The period from the end of World War II to the early 1960s has been characterized as the "golden years" of patient-oriented clinical research in the United States, a period catalyzed and fostered by advances in biology and medicine, changes in the organization and financing of research units, and strong moral and political convictions growing out of the war about the importance and possibilities of the scientific enterprise. This account of some of the salient themes, phenomena, and issues in clinical research during that era draws primarily on the proceedings of an oral history conference whose core participants were a number of emeritus physician-investigators who had played major roles in shaping patient-oriented research. The topics that they and the other conferees discussed included the factors that had led the emeritus physician-investigators into clinical research; the organizational attributes of the units where they had trained and worked, focusing particularly on Boston's Peter Bent Brigham Hospital; the vital role played by private and federal funding for research and training; and some of the changes in the nature of clinical research, research training, and their relationships to the care of the sick in the decades since the golden years.
Assuntos
Pesquisa Biomédica/história , Pesquisa Biomédica/organização & administração , Escolha da Profissão , História do Século XX , Humanos , Cultura Organizacional , Apoio à Pesquisa como Assunto , Estados UnidosRESUMO
The clinical trial of the AbioCor artificial heart, initiated in July 2001 and still in process, has taken place within a matrix of social and cultural patterns that are both "old" and new. The old patterns--those that have accompanied previous clinical trials of other vital artificial organs and transplantation in the United States--include "experiment perilous," and courage, heroism, and pioneering themes; "right stuff" motifs; "Americana" symbols; allusions to the meaning of the human heart; connections with a for-profit corporation; and the occurrence of moratoriums. New patterns--those more particular and distinctive to the AbioCor trial--involve the restrictions imposed on releasing information about the post-operative clinical status of the implant recipients; the quasi-institutionalization of a patient advocacy system to represent patient-subjects and their families; and the "crises of success" that were encountered when several of the AbioCor recipients survived longer than expected. In certain instances, old and new patterns have been combined--for example, in some of the idiosyncratic features of the AbioCor-associated lawsuit that has resulted in part from the problem of the "therapeutic misconception," the belief that an experimental intervention is actually intended to be a treatment.