Research ethics committee auditing: the experience of a university hospital.
HEC Forum
; 25(3): 257-68, 2013 Sep.
Article
em En
| MEDLINE
| ID: mdl-23435968
ABSTRACT
The authors report the first Italian experience of a research ethics committee (REC) audit focused on the evaluation of the REC's compliance with standard operating procedures, requirements in insurance coverage, informed consent, protection of privacy and confidentiality, predictable risks/harms, selection of subjects, withdrawal criteria and other issues, such as advertisement details and justification of placebo. The internal audit was conducted over a two-year period (March 2009-February 2011) divided into quarters to better value the influence of the new insurance coverage regulation that came into effect in March 2010 (Ministerial Decree of 14 July, 2009) and expand the requirements to safeguard participants in clinical drug trials including other critical items as information and consent and the risks to benefits ratio. Out of a total of 639 REC's opinions and research studies, 316 were reviewed. Regarding the insurance policy requirements, Auditor/REC non-compliance occurred only in one case. The highest number of Auditor/REC non-compliance was in regard to information and consent, which should have incurred a suspended decision rather than a favorable opinion. This internal audit shows the importance and the difficulty of the review process. For this reason, specific courses for members of the research ethics committee and for those who aspire to become auditors will be provided. There may also be efforts to improve the standard operating procedures already in place.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Comitês de Ética Clínica
/
Ética em Pesquisa
/
Hospitais Universitários
/
Auditoria Administrativa
Tipo de estudo:
Clinical_trials
/
Prognostic_studies
País/Região como assunto:
Europa
Idioma:
En
Revista:
HEC Forum
Assunto da revista:
ETICA
/
HOSPITAIS
/
JURISPRUDENCIA
Ano de publicação:
2013
Tipo de documento:
Article