From: Ehleben, Carole [Carole.Ehleben@tenethealth.com]
Sent: Thursday, March 28, 2002 12:02 PM
To: fdadockets@oc.fda.gov
Subject: Docket No. 01N-0322


Institutional Review Boards:  Regulations regarding prior IRB reviews.

I am making these comments as the senior partner of a company specializing
in developing research programs, and IRB's, for "community" hospitals.

1)  The issue is not limited to IRB "shopping;" it is an issue arising with
     multiple IRB reviews.

2)  Even with no intent to obfuscate on the part of the investigator, the
     following scenarios routinely occur:

     a.  An investigator is covered by a 'commercial' IRB for a single study as
          conducted in his private clinic, and for that same study also by a hospital
          IRB for patients for whom the procedure is done at that hospital (the
          Mentor and McGhan silicone implant trials are a good example).

     b.  An investigator with admitting privileges at more than one hospital can
         have the same study covered by more than one IRB, 'commercial' or
         otherwise.

     c.  An investigator may move his study from a hospital-based setting to a
          private practice by allowing approval of the study to terminate at the
          hospital and then having a 'commercial' IRB review for the practice
          setting.  (Problems associated with this practice were highlighted by
          the Medical College of Georgia psychiatric study incident about three
          years ago.)

     In each of the above cases, unless the investigator provides the information,
     there is no realistic way for the multiple IRB's to be aware of each other.
    
     This is especially a problem in studies in which the investigator is participating
     primarily for access to a drug or device, and does not 'buy into' the concept that
     this is a research study.

    For this reason, I would recommend that it be the responsibility of the sponsor,
    to provide all reviewing IRB's with at least a listing of all other IRB's who have
    reviewed the study for that investigator.  It might be even more helpful for the
    sponsor, as the only entity in a position to collect the material, to provide a
    listing (as is already done with some Compassionate Use studies and some
    Registries) of all involved IRB's.  It could be then left up to any one IRB to
    request further information.

3)  The issues are not only "negative" prior reviews.  Even more relevant is the
     concern that with more than one IRB per investigator, often adverse events,
     changes to the consent or protocol, or DSMB reports do not reach each 
     IRB.  Again, the sponsor is the only entity to be able to ensure complete
     distribution.

Thank you for your attention.

Carole M. Ehleben, Ed.D.
Senior Partner, CEAR