HEC Forum

, Volume 25, Issue 3, pp 257–268 | Cite as

Research Ethics Committee Auditing: The Experience of a University Hospital

  • Daniela MarchettiEmail author
  • Angelico Spagnolo
  • Marina Cicerone
  • Fidelia Cascini
  • Giuseppe La Monaca
  • Antonio G. Spagnolo


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.


Internal auditing Research ethics committee Insurance policies Standard operating procedures 



The authors thank the anonymous referees for their very useful comments on a previous draft.


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Copyright information

© Springer Science+Business Media Dordrecht 2013

Authors and Affiliations

  • Daniela Marchetti
    • 1
    Email author
  • Angelico Spagnolo
    • 1
  • Marina Cicerone
    • 2
  • Fidelia Cascini
    • 1
  • Giuseppe La Monaca
    • 3
  • Antonio G. Spagnolo
    • 4
  1. 1.Istituto di Medicina LegaleUniversity Hospital “Agostino Gemelli” 1RomeItaly
  2. 2.University Hospital “Agostino Gemelli”RomeItaly
  3. 3.Istituto di Filosofia dell’Agire Scientifico e TecnologicoUniversità Campus Bio-MedicoRomeItaly
  4. 4.University Hospital “Agostino Gemelli” 1RomeItaly

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