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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.
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.
>
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