The law of incidental findings in human subjects research: establishing researchers' duties.
J Law Med Ethics
; 36(2): 361-83, 214, 2008.
Article
en En
| MEDLINE
| ID: mdl-18547206
ABSTRACT
Research technologies can now produce so much information that there is significant potential for incidental findings (IFs). These are findings generated in research that are beyond the aims of the study. Current law and federal regulations offer no direct guidance on how to deal with IFs in research, nor is there adequate professional or institutional guidance. We advocate a defined set of researcher duties based on law and ethics and recommend a pathway to be followed in handling IFs in research. This article traces the underlying ethical and legal theories supporting researcher duties to manage IFs, including duties to develop a plan for management in the research protocol, to discuss the possibility of and management plan for IFs in the informed consent process, and to address, evaluate, and ultimately offer to disclose IFs of potential clinical or reproductive significance to research participants when they arise.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Investigadores
/
Tecnología Biomédica
/
Revelación
/
Hallazgos Incidentales
/
Relaciones Investigador-Sujeto
/
Investigación Biomédica
Tipo de estudio:
Diagnostic_studies
/
Guideline
/
Prognostic_studies
Aspecto:
Ethics
Límite:
Humans
Idioma:
En
Revista:
J Law Med Ethics
Asunto de la revista:
ENFERMAGEM
/
ETICA
/
JURISPRUDENCIA
/
MEDICINA
/
PESQUISA EM SERVICOS DE SAUDE
Año:
2008
Tipo del documento:
Article
País de afiliación:
Estados Unidos