groups » Research Ethics » Multiple ethics application

Dear Colleagues
We are sending a protocol to several ethics committee as we have overseas sponsor and for local requirements. We are sending the protocol at the same time to the committees. What do we do if one had a comment that the other do not make, or if one approves and the others do not or if comments do not agree. Thank you

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  • mkumal mkumal 29 Sep 2010

    Dear Colleagues
    We are sending a protocol to several ethics committee as we have overseas sponsor and for local requirements. We are sending the protocol at the same time to the committees. What do we do if one had a comment that the other do not make, or if one approves and the others do not or if comments do not agree. Thank you

  • Jef_Verellen Jef Verellen 11 Oct 2010

    Dear Mkumal,
    That is a problem that many mulicenter studies will face and I'm afraid there is no clear cut answer.

    What is important is whether it concerns a multinational study or not (in which each EC is competent over the site(s) in its own country. In this case you may opt for finalizing different protocols for each country incorporating the comments of the respective EC's. It is more difficult to monitor this way, but it takes everyones desires into account.

    In case you are doing a multicenter study in 1 country, things are a bit more difficult. I live in Belgium, and here, we have one Leading EC to which all EC's send their comments. The Leading EC then has the final opinion on what to do with all the comments and their own off course. If your country does not have any regulation or guidance on this you may go for the diplomatic approach and nofify all the EC of the other comments made and propose a modified protocol (in your own best judgement and with explanations on why you made the changes - a synthetic explanation letter is important) based on all the input you received.
    I hope this helps.
    Kind regards,
    Jef

  • aawasthi amina awasthi 19 Sep 2011

    I have just come across this post. We have this issue, what happens if you place applications into several committees for review and they come back with different comments? Do you tell the others? Do you implement them all? What if they contradict - is there a heirarchy?

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