Dear All: Collaborative IRBs is a very interesting idea that should be given
serious attention for many reasons.

In the U.S. The Office for Human Research Protections (OHRP) in the U.S. is
seeking information so as to ENCOURAGE institutions to rely on other IRBs and
to encourage centralized IRBs. In other words, OHRP is encouraging more
institutions to make cooperative arrangements with other institutions so that
more institutions will rely on external IRBs for some research.

Essentially, OHRP is requesting public information to determine the feasibility
of making a rule change that will encourage the reliance on external IRBs.
Hence, the thinking is that two IRBs can review cooperatively one protocol, that
is, each IRB can lend their specific expertise to the review of a protocol.
For example, the local IRB can input their knowledge of their own investigators
in determining approval of the protocol, whereas the external IRB, due to its
experience, can review the ethical aspects of the protocol.

Can such cooperative arrangements work in Egypt?

Below is the full announcement.

Subject: March 5, 2009 Request for Information and Comments on IRB
Accountability.

The Office for Human Research Protections (OHRP), has issued a Federal
Register notice requesting information and comments from the public
about whether the office should pursue a notice of proposed rulemaking
to enable OHRP to hold IRBs and the institutions or organizations
operating the IRBs directly accountable for meeting certain regulatory
requirements of 45 CFR part 46. OHRP is contemplating this regulatory
change to encourage institutions to rely on IRBs that are operated by
another institution or organization, when appropriate. OHRP believes
that such a regulatory change in its enforcement authority may address
one of the main disincentives institutions have cited as inhibiting them
from exercising the regulatory flexibility that currently permits
institutions to implement a variety of cooperative review arrangements
and to rely on the review of an IRB operated by another institution or
organization. If institutions become more willing to rely on
cooperative review arrangements and on review of IRBs operated by other
institutions or organizations, OHRP believes that this will reduce
administrative burdens associated with implementing 45 CFR part 46
without diminishing human subject protections.

This request for information and comments stems from interest in this
issue from the Secretary's Advisory Committee on Human Research
Protections and others, as well as two meetings on alternative IRB
models that OHRP co-sponsored in November 2005 and November 2006 along
with the National Institutes of Health, the Association of American
Medical Colleges, and the American Society of Clinical Oncology.

Submit written or electronic information and comments by June 3, 2009.
Written comments may be sent to IRB ACCOUNTABILITY, Office for Human
Research Protections, The Tower Building, 1101 Wootton Parkway, Suite
200, Rockville, MD 20852. Comments also may be sent via e-mail to
IRBaccountability@..., or via facsimile at 301-402-2071.

Comments received within the comment period, including any personal
information provided, will be made available to the public upon request.


The notice can be accessed at:
http://edocket.access.gpo.gov/2009/E9-4628.htm or
http://edocket.access.gpo.gov/2009/pdf/E9-4628.pdf.


Henry Silverman, MD,MA
Professor of Medicine
Chair, Ethical Advisory Committee
Director, Middle East Research Ethics Training Initiative www.mereti.net

University of Maryland School of Medicine
10 S. Pine St/Suite 800
Baltimore, MD 21201
Cell: 443-562-5143



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>>> "Azza Saleh" <azzasaleh@...> 3/6/2009 3:07 AM >>>
Dear Samia , Isabelle and All

I am in some extent with the idea of (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. ),and this can be done through
cooperation of our RECs together , they have to know each other ,this can be
achieved through the ENREC , it facilitates exchanges of knowledge, harmonizes
practices, enhances communications, and disseminates teaching material among
members.
I agree with Samia and Isabelle in that (it might be still a bit early for
us)but WE need to start working on this cooperation .
Again Thank you for both of you for your replies and asking the other dear
friends to give their inputs
Best of wishes to all of us in the efforts we are doing in different issues to
enhance and ameliorate our researches.
Azza




--- In EGYPTIAN_RECS@yahoogroups.com, "inakhla1" <inakhla@...> wrote:
>
> 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.
> > >
> > >
> > >
> >
>



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