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  • 1.  Ethics Committee Aproval

    Posted 11-Nov-2011 11:06
    Is there a requirement for Ethics Committee approval prior to initiating a postmarket study in Italy? If so, where is this cited?

    Thank you.


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    Melissa Traylor
    Manager, Regulatory Affairs
    FzioMed, Inc.
    San Luis Obispo CA
    United States
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  • 2.  RE:Ethics Committee Aproval

    Posted 12-Nov-2011 10:47
    Hello Melissa,

    In paragraph 1.1 of a Ministry Circular dated 2 August 2011 (Circolare 2 agosto 2011), the Italian Ministry of Health states that Ethics Committee approval is requested before initiating a postmarket device clinical study. The document is in Italian and here is the link: www.normativasanitaria.it/jsp/dettaglio.jsp?id=39558

    A Circular does not have the same legal status of a Decree and the language of the Circular includes "request" rather than "require"; however, it is a document that provides the Ministry's interpretation of what should be done and should therefore be followed.

    Furthermore, the Ministry also requests that it be notified of the initiation of a postmarket clinical study. The guide on the compilation of the relevant form also includes Ethics Committee approval as a prerequisite of submitting the form. The link to the guide, also in Italian, is www.salute.gov.it/dispositivi/documenti/moduli/ManualeUtente-ResponsabileDellaComunicazione_V1_0.pdf

    While some information on Ministry website is in English, I was  unable to find the documents mentioned here in English.
     
    Hope this helps and let me know if you need additional information,

    Maria
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    Maria Donawa MD
    President
    Donawa Lifescience Consulting Srl
    Rome
    Italy
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    Original Message


  • 3.  RE:Ethics Committee Aproval

    Posted 13-Nov-2011 15:33
    Greetings all!

    I agree with Maria. I believe it is possible to submit concurrently to the Ethics Committee and Ministry of Health - perhaps Maria could confirm or put me right on this?

    Melissa, Giovanni Monopoli from ClinTec presented on this subject (changes to clinical trial requirements in Italy) at last month's TOPRA Medical Device Symposium in Rome ... you might want to have a look at the TOPRA website to see if there is a report?

    Neil

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    Neil Armstrong
    CEO
    MeddiQuest Ltd.
    Welwyn Garden City
    United Kingdom
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    Original Message


  • 4.  RE:Ethics Committee Aproval

    Posted 14-Nov-2011 12:05
    Hello everyone,

    I need to add something important to the response provided previously, which does not change the conclusion, but does provide a legal reference. Daniela Karrer, Director, Clinical Affairs of our company, reminds me that there is legal text that requires Ethics Committee approval of postmarket studies, which is found in paragraph 8 of Article 14 of the Italian Decree, which implements the amendments made by Directive 2007/47/EC, "Attuazione della Direttive 93/42/CEE Concernente i Dispositivi Medici" - can be downloaded from: www.salute.gov.it/imgs/C_17_pagineAree_1636_listaFile_itemName_1_file.pdf

    That is, the first sentence of paragraph 8 specifies that paragraphs 1, 2 and 5 of Article 14, Indagini Cliniche (Clinical investigations) do not apply to clinical studies conducted with CE marked devices, except for the need to obtain a favorable opinion from the relevant Ethics Committee and the need to send a communication to the Ministry of Health regarding the start of the postmarket study. 

    With regard to Neil's comments: "I believe it is possible to submit concurrently to the Ethics Committee and Ministry of Health - perhaps Maria could confirm or put me right on this?" This concurrent process applies to notifying the Ministry of Health of a premarket clinical study and submitting a request for approval of the study to the Ethics Committee. This can be done in parallel in Italy. For postmarket studies, there is no notification, just a communication to the Ministry before the start of the study, which needs to be made after obtaining a favorable opinion from the Ethics Committee.

    Sorry for not providing the legal reference initially!!

    Maria

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    Maria Donawa MD
    President
    Donawa Lifescience Consulting Srl
    Rome
    Italy
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    Original Message