Research Ethics Committee Auditing: The Experience of a University Hospital
- 300 Downloads
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.
KeywordsInternal auditing Research ethics committee Insurance policies Standard operating procedures
The authors thank the anonymous referees for their very useful comments on a previous draft.
- Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research. Strasbourg, 25.1.2005. Available at: htpp://conventions.coe.int/treaty/en/reports/html/195.htm. Accessed 9 July 2012.
- Carpenter, D. (2004). Gatekeeping and the FDA’s role in human subjects protection. Virtual Mentor, 6(11). Available at: http://virtualmentor.ama-assn.org/2004/11/msoc1-0411.html.
- CIOMS (2002). International ethical guidelines for biomedical research involving human subjects. Geneva: CIOMS. Available at: http://www.cioms.ch/frame_guidelines_nov_2002.htm. Accessed 9 July 2012.
- Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine. Oviedo, 04.04.1997. Available at: http://www.iss.it/binary/coet/cont/ConvenzioneOviedo.pdf. Accessed 9 July 2012.
- Guidance for auditing quality systems of independent ethics committees in Europe (2008). Available at: http://www.efgcp.be/downloads/efgcp%20iec%20audit%20guidance%2014%20october2008.pdf. Accessed 9 July 2012.
- La Monaca, G., Schiralli, I., & Marchetti, D. (2010). Criteri di valutazione della copertura assicurativa delle sperimentazioni cliniche alla luce del Decreto del Ministero del Lavoro, della Salute e delle Politiche Sociali del 14 luglio 2009. Rivista Italiana di Medicina Legale, 6, 885–903.Google Scholar
- Legislative Decree n. 158 of September 13, 2012. Urgent measures to promote the development of the country through a higher level of healthcare. Available in Italian at: http://www.gazzettaufficiale.it/guridb/dispatcher?service=1&datagu=2012-09-13&task=sommario&numgu=214&tmstp=1349348785114.
- Legislative Decree n. 211 of June 24, 2003, Transposition of Directive 2001/20/CE relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for clinical use. Available at: http://www.camera.it/parlam/leggi/deleghe/03211dl.htm. Accessed 9 July 2012.
- Legislative Decree n.196 of June 30, 2003, Personal data protection code. Available at: http://www.garanteprivacy.it/garante/document?ID=311066. Accessed 9 July 2012.
- Ministerial Decree November 6, 2007, Transposition of Directive 2005/28/EC relating to principles and guidelines for good clinical practice for medicines in experimental phase for human use, and requirements for the authorization to produce and to import these medicines. Available at: http://oss-sper-clin.agenziafarmaco.it/normativa/DM_CRO_English.pdf. Accessed 9 July 2012.
- Ministerial Decree of December 17, 2004, Prescriptions and conditions of a general nature referring to the conduct of clinical trials of medicines with special reference to those designed to enhance clinical practice as an integral part of health and medical care. Available at: http://oss-sper-clin.agenziafarmaco.it/normativa/decreto_noprofit_inglese.pdf. Accessed 9 July 2012.
- Ministerial Decree of May 12, 2006, Minimum requirements for the institution, organization and functioning of Ethical Committee for clinical trials with medicines. Available at: http://www.normativasanitaria.it/jsp/dettaglio.jsp?aggiornamenti=&attoCompleto=si&id=674. Accessed 9 July 2012.
- Ministerial Decree of May 30, 2001: Inspection findings on compliance with the standards of good clinical practice. Google Scholar
- Ministry of labor, health and social policies decree July 14, 2009, Minimum requirements for insurance policies which safeguard participants to clinical trials of medicinal products. Available at: http://www.oss-sper-clin.agenziafarmaco.it/normativa/ministerial_decree_14_july_2009.pdf. Accessed 9 July 2012.
- Spagnolo, A. G., Sacchini, D., Torlone, G., et al. (1999). Il laboratorio del Comitato Etico: istituzione e procedure operative standard. Medicina e morale, 2, 221–263.Google Scholar
- Steering Committee on Bioethics (CDBI). Guide for Research Ethics Committee Members. Available at: http://www.coe.int/t/dg3/healthbioethic/source/INF(2011)_en.pdf.
- The EFGCP Report on The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe, 2011. Available at: http://www.efgcp.eu/Downloads/EFGCPReportFiles/Italy%20definitive.pdf. Accessed 9 July 2012.