HEC Forum 25 (3):257-268 (2013)

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
Keywords Internal auditing  Research ethics committee  Insurance policies  Standard operating procedures
Categories (categorize this paper)
DOI 10.1007/s10730-013-9210-8
Edit this record
Mark as duplicate
Export citation
Find it on Scholar
Request removal from index
Revision history

Download options

PhilArchive copy

Upload a copy of this paper     Check publisher's policy     Papers currently archived: 52,768
Through your library

References found in this work BETA

Add more references

Citations of this work BETA

No citations found.

Add more citations

Similar books and articles

Internal Auditing's International Contribution to Governance.Kenneth D'Silva & Jeffrey Ridley - 2007 - International Journal of Business Governance and Ethics 3 (2):113-126.
Reassessing the Role of the Biomedical Research Ethics Committee.Merryn Ekberg - 2012 - Journal of Academic Ethics 10 (4):335-352.
The Protection of Patients' Rights in Clinical Trials.Marek Czarkowski - 2006 - Science and Engineering Ethics 12 (1):131-138.
Enhancing Perceptions of Auditor Independence.Michael A. Pearson - 1985 - Journal of Business Ethics 4 (1):53 - 56.


Added to PP index

Total views
29 ( #340,165 of 2,341,547 )

Recent downloads (6 months)
1 ( #514,645 of 2,341,547 )

How can I increase my downloads?


My notes