Meeting the Challenge: The National Cancer Institute's Central Institutional Review Board for Multi-Site Research.
J Clin Oncol
; 36(8): 819-824, 2018 03 10.
Article
em En
| MEDLINE
| ID: mdl-29384720
ABSTRACT
The National Institutes of Health (NIH) issued a new policy that requires a single institutional review board (IRB) of record be used for all protocols funded by the NIH that are carried out at more than one site in the United States, effective January 2018. This policy affects several hundred clinical trials opened annually across the NIH. Limited data exist to compare the use of a single IRB to that of multiple local IRBs, so some institutions are resistant to or distrustful of single IRBs. Since 2001, the National Cancer Institute (NCI) has funded a central IRB (CIRB) that provides human patient reviews for its extensive national cancer clinical trials program. This paper presents data to show the adoption, efficiencies gained, and satisfaction of the CIRB among NCI trial networks and reviews key lessons gleaned from 16 years of experience that may be informative for others charged with implementation of the new NIH single-IRB policy.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Pesquisa Biomédica
Tipo de estudo:
Guideline
Limite:
Humans
País/Região como assunto:
America do norte
Idioma:
En
Revista:
J Clin Oncol
Ano de publicação:
2018
Tipo de documento:
Article
País de afiliação:
Moldávia