Dear Nadia, The REC member should hold a meeting with the Researcher and discuss with him his research before giving the decision and try to negotiate about the suitable alternatives, and asking an expert to share in the meeting and if insists about his objectives or methods, this would be the full board decision
Best regards
Diaa Marzouk
Prof of Public Health
Faculty of Medicine
Ain Shams University
Cairo, Egypt
Certified trainer of
Health Research Ethics
University of Maryland USA
Mobile: 002-0101994689
--- On Thu, 4/23/09, nadia zaki <nadiazaki65@...> wrote:
From: nadia zaki <nadiazaki65@...> Subject: [EGYPTIAN_RECS] Protocol Disapproval To: "Egyptian RECs" <EGYPTIAN_RECS@yahoogroups.com> Date: Thursday, April 23, 2009, 11:25 PM
Dear All,
I have a question regarding REC disapproval of a study protocol . What if the investigator feels that there is no satisfactory justification for disapproval of his submitted protocol ?
In other words, is it obligatory for an REC to explain in detail why did they disapprove a protocol and could there be any action to be taken by the investigator in case he/ she feels that this disapproval is not fully justified ?
Again, can the PI re-submit his study protocol asking for further or second review by the REC and giving his/her reasons for willingness to conduct this study since it is considered of minimal risk and is having potential benefits to the participants ???
Can you , please, help me in resolving this issue and if it is stated in any regulations , can you provide me with this document ????
Best regards,,
Nadia Zaki, MD
A. Prof. of Hematology,
Clinical Director of AlexandriaClinical Research Center,
Dear All, Â Â Â Â Â Â Â Â Â Â I have a question regarding REC disapproval of a study protocol . What if the investigator feels that there is no satisfactory...
Dear Nadia, The REC member should hold a meeting with the Researcher and discuss with him his research before giving the decision and try to negotiate about...
Dear dr Nadia, the IRB or REC determination: approved, contingent, deferred or disapproved if your REC disapproved the study protocol according to: 1. protocol...
Nadia: could I use this question for my students in another class I am teaching? I will keep the origin secret. Henry ... Dear All, I have a question...
Dear Nadia: Regarding this question, I agree with the others who have answered. Every investigator has a right of appeal a decision. Such an appeal process...
Dear Dr. Nadia; Thanks for raising such issue which throw light on the importance of SOPs. ·        The SOPs make transparent the authority of the...
Dear all,, Â Â Â Â Â Â Â Thank you so much for your prompt & valuable responses. Up till now, we didn't receive the disapproval letter, so that I can provide...
Dear Nadia: the phase, in it of itself, should not be the determining factor, but rather the actual risks. One could say that by the time a drug reaches...
Dear Dr. Nadia, Today only, I have a part of time to check my e-mail. I really enjoyed with your raising question and enjoy with all responses. I have only a...
Dear Dr. Mervat, Â Â Â Â Â Â I really appreciate your valuable explanation and help. I'm also looking forward to meeting you & all the group in Ismailia on...
Dear friends I uploaded the (ICH-GCP-Guideline,E6) in our files ,may be some of us don't have it and may also it will help in answering some of our inquiries...
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