Institutional review board approaches to the incidental findings problem.
J Law Med Ethics
; 36(2): 352-5, 213, 2008.
Article
em En
| MEDLINE
| ID: mdl-18547204
ABSTRACT
Institutional Review Boards (IRBs) are confronted with new challenges in the face of expanding technologies while fulfilling their existing regulatory mandate to ensure that plans are in place to protect subjects and to inform them of risks and benefits of research participation. Existing regulations and guidance do not address the issue of incidental findings (IFs), thus leaving awareness of the issue and the application of ethical principles to IRB judgment alone. In order to assure that researchers are aware of the potential for IFs, IRBs must identify which studies are likely to identify IFs and establish what plans should be put into place prior to study initiation to assure the subjects are appropriately informed of the likelihood of IFs, how IFs will be communicated to subjects, and whether the burden of follow-up falls on the researchers or is the subject's responsibility.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Revelação
/
Comitês de Ética em Pesquisa
/
Achados Incidentais
/
Pesquisa Biomédica
Tipo de estudo:
Diagnostic_studies
/
Etiology_studies
/
Prognostic_studies
/
Risk_factors_studies
Limite:
Humans
Idioma:
En
Revista:
J Law Med Ethics
Assunto da revista:
ENFERMAGEM
/
ETICA
/
JURISPRUDENCIA
/
MEDICINA
/
PESQUISA EM SERVICOS DE SAUDE
Ano de publicação:
2008
Tipo de documento:
Article
País de afiliação:
Estados Unidos