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Pharmacy World and Science

, Volume 27, Issue 1, pp 2–3 | Cite as

Heterogeneity in the evaluation of observational studies by Italian ethics committees

  • Benedetta Santarlasci
  • Andrea MessoriEmail author
  • Filippo Pelagotti
  • Sabrina Trippoli
  • Monica Vaiani
Article
  • 35 Downloads

Abstract

Objective and method

In Italy, observational research is rarely brought to the attention of ethics committees (ECs). This study assessed to what extent the observational studies conducted within the Careggi Hospital (2000 beds) and retrieved from MEDLINE after their publication could be traced back from the registries of our EC. Another aim was to compare the different opinions expressed by 28 ECs throughout Italy about the same multi-centre clinical protocol (an oncologic observational study).

Results

Our analysis shows that, in this sample of observational studies, the rate of submission to the EC is 0%. In the second part of our study, the evaluations of the same protocol by the different ECs were extremely different and ranged from unconditioned approval to rejection.

Conclusion

Our proposal is that clinicians should always notify their observational studies to ECs. On the other hand, ECs should simply accept the observational protocols (without introducing any modifications except cases of macroscopic errors). The heterogeneity in the evaluation of a single protocol by different ECs raises the need to develop some forms of intervention to solve this source of inconsistency.

Keywords

Ethics committee Ethical approval Italy Multi-centre observational studies 

References

  1. Italian Ministry of Health. Attività dei comitati etici istituiti con DM 18 Marzo 1998, Circolare No. 6, 2 September 2002.Google Scholar
  2. Careggi Hospital Coordination Study Group. Observational study to evaluate seven off-label uses of three anti-cancer agents. http://www.wwwlabsifo.org/careggi-study.html (15 May 2004).Google Scholar
  3. Concato, J, Shah, N, Horwitz, RI. 2000Randomized, controlled trials, observational studies, and the hierarchy of research designsN Engl J Med342188792CrossRefPubMedGoogle Scholar
  4. Benson, K, Hartz, AJ. 2000A comparison of observational studies and randomized, controlled trialsN Engl J Med342187886CrossRefPubMedGoogle Scholar
  5. Ballatori, E, Roila, F. 2002Comitati etici è ora di riformare la riforma? [Ethical committees: is it time to reform the reform?]Texne41713Google Scholar

Copyright information

© Springer 2005

Authors and Affiliations

  • Benedetta Santarlasci
    • 1
  • Andrea Messori
    • 2
    Email author
  • Filippo Pelagotti
    • 2
  • Sabrina Trippoli
    • 2
  • Monica Vaiani
    • 2
  1. 1.Azienda Ospedaliera CareggiLaboratorio SIFO di Farmacoeconomia, c/o Pharmaceutical ServiceFlorenceItaly
  2. 2.Azienda Ospedaliera CareggiPharmaceutical ServiceFlorenceItaly

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