Dear Heba and All
what Heba mentioned is of utmost importance regarding (Material Transfer),to my
knowledge : no material has to be trasnferred abroad EXCEPT if the test done
there is NOT available in Egypt,can any body correct me if I am wrong???,
Other issue what to do if the international cooperation includes comparaison of
the results between 2 sites :for example as in external quality control
tests,re-reading of pathology slides...etc (don't forget I am a clinical
pathologist!!!! :)
Again I see that the network of the RECs will (strengthen performance and
potentials and exchange of ideas and reports)as Heba said, anyway generally ALL
of US agree that cooperation ,listening to each other, exchange of experience
are beneficial and are our way to raise our capacity and experience and to reach
the point of speaking a common language between our investigators and our RECs,
Waiting for the input of others in:
1-rules of material transfer outside Egypt and
2-what Heba mentioned :
(what should be included or addressed in the Material Transfer agreement)
Best
Azza
--- In EGYPTIAN_RECS@yahoogroups.com, Heba Kassem <hkassem67@...> wrote:
>
> Dear Colleagues,
> Thanks for this fruitful discussion,
>
> I totally agree with Dr Samia's comment and recommendation, collaboration
between RECs does not replace individual RECs. However NRECs is expected to
strengthen performance and potentials and exchange of ideas and reports should
be encouraged!
>
> In respect to Isabelle's question of documents requested: It should be as
usual: application form, research proposal. If the researcher is from a foreign
country then Material Transfer Agreement Should be also involved.
>
> It would be essential for us in the coming up weeks to discuss and circulate
amongst us what should be included or addressed in the Material Transfer
agreement particularly in international research. Please consider this a
new topic open for
>
> Kindest regards,
> Heba
>
>
>
> --- On Thu, 3/5/09, samia rizk <rizksh@...> wrote:
>
>
> From: samia rizk <rizksh@...>
> Subject: Re: [EGYPTIAN_RECS] Re: Collaborative research
> To: EGYPTIAN_RECS@yahoogroups.com
> Date: Thursday, March 5, 2009, 1:19 PM
>
>
>
>
>
>
>
>
> Dear Aza& all
> In response to Dr Azza posting;
> It is good to have a discussion forum, that allows the interchange of ideas
and experiences,
> But I totally disagree for having a common IRB to replace individual
institutional approvals, where the patient is actually treated. Local IRBs are
more in direct contact with the circumstances and internal environment in each
institution which may affect patients differently. Also the work of the IRB
doesn't end with the initial approval, they are still responsible for patient
protection through out the project, which is difficult to achieve except by a
local institutional board.
> Moreover, although we trust all our scientists, yet a single approval source,
will give more chance for backdoor approval of less ethical research protocols,
by bypassing their institutes. Since some ethical points are still vague, the
difference in opinion is the right environment for getting to the best ideas, we
cann't assume that only a small group of people, what ever good they are could
replace a whole scientific society, especially that we are all still new in a
field in which long real work experience far outweigh academic training& by long
I mean decades of experience.
> But what we can agree about, is that we have to persistently enhance raising
the capacity and experience of both RECs as well as researches, to the same
degree, to speak a common language. Most researchers are not really aware of the
ethical concepts and regulations.
> I don't think that it will be fair to please the researches at the expense of
our patient's welfare. We all know how disadvantaged our patients in public
hospitals are and how biased an informed consent from these patients will be, so
our environment now is not ready for loosening our regulations, we have already
enough bias.
>
>
> On Thu, Mar 5, 2009 at 7:52 AM, Azza Saleh <azzasaleh@hotmail. com> wrote:
>
>
>
>
>
>
> Thanks to Dear Isabelle for raising this real life issue in our RECs and I
want to add: as REC ,
>
> - Do you agree that having the ENREC as a forum , platform for such discussion
between these RECs involved in this project is a true beneficial idea and
>
> - May be also submitting to one of these RECs (member of ENREC) will be enough
and not to submit to all RECs collaborating in the project?
>
> - Also Standardization of the application package between these RECs will
effectively facilitate their work as well as the load faced by the investigators
teams in these different sites.
>
> Let us think in the issue globally and try to find a solution to help
investigators and RECs to enhace and not hinder research,
>
> Best and waiting for your valuable helpful replies,suggestions as we are
facing this issue right now :),
>
> again thanks to Isabelle
>
> Azza
>
>
> --- In EGYPTIAN_RECS@ yahoogroups. com, "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.
> >
>