Notes from the field: jumpstarting the IRB approval process in multicenter studies.
Health Serv Res
; 42(4): 1773-82, 2007 Aug.
Article
em En
| MEDLINE
| ID: mdl-17610447
ABSTRACT
OBJECTIVE:
To identify strategies that facilitate readiness for local Institutional Review Board (IRB) review, in multicenter studies. STUDYSETTING:
Eleven acute care hospitals, as they applied to participate in a foundation-sponsored quality improvement collaborative. STUDYDESIGN:
Case series. DATA COLLECTION/EXTRACTION Participant observation, supplemented with review of written and oral communications. PRINCIPALFINDINGS:
Applicant hospitals responded positively to efforts to engage them in early planning for the IRB review process. Strategies that were particularly effective were the provisions of application templates, a modular approach to study description, and reliance on conference calls to collectively engage prospective investigators, local IRB members, and the evaluation/national program office teams. Together, these strategies allowed early identification of problems, clarification of intent, and relatively timely completion of the local IRB review process, once hospitals were selected to participate in the learning collaborative.CONCLUSIONS:
Engaging potential collaborators in planning for IRB review may help expedite and facilitate review, without compromising the fairness of the grant-making process or the integrity of human subjects protection.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Estudos Multicêntricos como Assunto
/
Comitês de Ética em Pesquisa
/
Administração Hospitalar
/
Auditoria Administrativa
Tipo de estudo:
Clinical_trials
/
Prognostic_studies
Limite:
Humans
Idioma:
En
Ano de publicação:
2007
Tipo de documento:
Article