Dear Samia and Azza
Thank you so much for your prompt responses.
I agree with you, Samia, in what concerns the issue that Azza is raising, but at
the same time I do not disagree with Azza completely.
I agree with you that one REC should not replace the others, but in some
situations one REC can deligate another REC to review the study, if the first
REC feels comfortable about it, or these two RECs have an understanding of how
and what regulations they use for review.
But again, as Samia said, this might be still a bit early for us, but not an
impossible solution in the future for the advantages that Azzza mentioned.
As for the question of the collaborative research and the documents required by
the REC to be included in the initial application, I again agree with Samia, the
REC should see the original protocol as one document among some others to have
an answer to the questions you listed. We will also discuss different case
scenarios in the coming weeks about different types of samples and tests.
Dear all, what other documents in general do you wish to review to be able to
make an informed decision about this protocol.
Thank you, Samia, thank you, Azza, and thank you all,
Isabelle
--- In EGYPTIAN_RECS@yahoogroups.com, samia rizk <rizksh@...> wrote:
>
> Dear Ezabell
> As to your posted question, I think to give asound answer we need to know
> the nature of the research& what are the collected sample going to be used
> for and where.
> thanks
> Samia Rizk
> On Thu, Mar 5, 2009 at 7:00 AM, inakhla1 <inakhla@...> wrote:
>
> > Dear members of the group
> > Welcome back after the mid-year holiday! Hope you all enjoyed it and had
> > time to relax and be with your families.
> >
> > This week's question is arising from real life situation that some RECs are
> > confronted with. Below is the situation, and for the coming weeks there will
> > be one question to discuss about different points within this scenario!
> > "A foreign-national investigator writes an entire protocol and will sponsor
> > it. He approaches an Egyptian investigator for collaboration, where the
> > Egyptian collaborator's institute will be the site for participants'
> > enrollment. The study includes several sites and blood samples collected for
> > the study will be analyzed in one central laboratory."
> > Question 1: You as REC, what documnets would you like the application
> > package presented to you from your Egyptian investigator to include?
> >
> > Thank you and looking forward to hear from you,
> >
> > Isabelle
> >
> > P.S. As an act of kindness to all the members please keep the use of this
> > group and its discussions to topics related Reseach Ethics and RE
> > committees. Chain emails should not be circulated here. We appreciate your
> > help in this.
> >
> >
> >
>