From: Panageas, Helen [HPanagea@Winthrop.org]
Sent: Thursday, March 28, 2002 9:43 AM
To: 'fdadockets@oc.fda.gov'
Subject: Docket No. 01N-0322


I am writing to you on behalf of the Institutional Review Board Committee at
Winthrop University Hospital in Mineola, New York.  Upon reading the
announcement in the federal register, we were relieved that the FDA is
recognizing and addressing this very important problem.  As part of a
smaller institution, our IRB is often perplexed by how some protocols
actually receive approval by other IRBs without significant changes to the
Informed Consent and/or the protocol.  Upon requesting changes (sometimes
rather substantive changes), our IRB is often told by sponsors that changes
will not be made because other institutions participating have already
approved the protocol and consent forms.  The sponsor explains although they
agree, it would be a problem to make changes at this time.  As you may
gather, the IRB is left in a rather awkward position.  The IRB then has to
deny approval of a protocol that would otherwise be approved if specific
issues could be addressed by the sponsor.  In addition, our Investigators
are displeased and feel the IRB is acting unreasonably by withholding
approval on a protocol that everyone else is doing. 

However, one concern that may be important to consider is the possibility of
an IRB making decisions based upon a decision made by another IRB at a
larger, more active research Institute.  This potential loss of objectivity,
that is expected of all IRBs, may be problematic.  

Nevertheless, overall it would be very helpful to have information from
previous IRB reviews.  It is not only important because of IRB shopping
(although this may be a growing area of concern due to increasing number of
commercial IRBs) but also for the reasons stated above.  It would be
constructive for IRBs to know that other IRBs share similar concerns.
Therefore, allowing Investigators to work together in approaching sponsors
regarding safety concerns and important other changes.  By not having this
information, IRBs and Investigators are operating in a vacuum. 

We agree it is important to revise FDA IRB regulations to require
disclosures and that disclosure should be required by the person who sought
the prior review, whether a sponsor, investigator, or both a sponsor and
investigator.  OHRP should also consider adopting such a policy. Thank you.


Helen Panageas
Associate Director
Institutional Review Board
Winthrop University Hospital
Telephone: (516) 663-2552
Facsimile: (516) 663-8590