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Re: New Discussion point: Material Transfer Agreement   Message List  
Reply | Forward Message #47 of 190 |
Re: [EGYPTIAN_RECS] Re: New Discussion point: Material Transfer Agreement

Dear All,
 
     Thanks Heba for raising this discussion point. I'll tell you about our limited experience in Alexandria CRC.
 
     Actually , in most of the phase III international multicenter clinical trials, the sponsor requests samples ( blood, tissues, pathology slides--etc) to be sent to a central lab. ( from all sites involved in the clinical trial ) . Although all investigations are done in the local lab. which should be an accredited certified one and although we rely on our local results to decide on treatment of our research subjects, yet those investigations are to be done at the same time in the cental lab. and results are sent to our site once they are available either by fax or email to be filed in the source documents of the participants and documented in the CRFs. Moreover, any discrepancies between both results have to be explained by the PI and this explanation is to be documented also on the source documents and in the CRFs.
 
    This material transfer is written in the study protocol from the start ( which is of course reviewed and approved by the REC and then by the MOH) and also in the ICFs and is explained to the subjects by the PI before signing the consent because this will require extra blood sampling and -to your knowledge -some subjects refuse to participate for this reason. The protocol and the ICF also should include a statement that these samples will not be used except for the purpose which is written in the protocol.
 
    This issue is also encountered in studies including pharmacokinetic and / or pharmacogenomic substudies in which the samples have to be shipped outside Egypt. Our REC usually approves the former but disapproves the latter part of the study and some subjects agree to participate in the main research but refuse to participate in the pharmacokinetic substudy because of concerns of extra risk of frequent blood samplinig especially that this will not offer any direct benefit to the subject.
 
    Of course shippment of these samples requires official letters issued from the CRC and signed by the Dean of our Faculty and stamped each time samples are taken by the Courrier . These letters include the title of the Study, the name of the PI and the research site , the number of tubes sent and  the purpose of sending such samples. Biological samples could never be sent outside the country without such official letters.
 
    Best wishes to all of you !!!!
 
 
       Nadia Zaki


--- On Sun, 3/8/09, inakhla1 <inakhla@...> wrote:
From: inakhla1 <inakhla@...>
Subject: [EGYPTIAN_RECS] Re: New Discussion point: Material Transfer Agreement
To: EGYPTIAN_RECS@yahoogroups.com
Date: Sunday, March 8, 2009, 11:23 PM


Dear Heba and all

Thank you Heba for your response and the document you mentioned, Material Transfer Agreement, is very important. I encourage all members to respond to this discussion; it is one of the most important documents to be included.

Does anyone have a copy of such a document? Has anyone used one before? An example will be useful to explain what the purpose of this document is and what its contents are?

Best regards to all,

Isabelle

--- 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.
> >
>




Mon Mar 9, 2009 11:49 am

nadiazaki65
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Message #47 of 190 |
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Dear Colleagues, Thanks for this fruitful discussion,   I totally agree with Dr Samia's comment and recommendation, collaboration between RECs does not...
Heba Kassem
hkassem67
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Mar 8, 2009
9:26 pm

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...
Azza Saleh
azzasaleh187
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Mar 9, 2009
4:21 am

Dear Heba and all Thank you Heba for your response and the document you mentioned, Material Transfer Agreement, is very important. I encourage all members to...
inakhla1
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Mar 9, 2009
6:23 am

Dear All,        Thanks Heba for raising this discussion point. I'll tell you about our limited experience in Alexandria CRC.        Actually , in...
nadia zaki
nadiazaki65
Offline Send Email
Mar 9, 2009
11:49 am
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