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nqoft ofthe Clinical Rzview Co nittee CONFIDENTIAL

3. The "whistle blower" policy extant at the University should be reviewed. At the

very least, such policy and procedure should be disseminated and implemented

throughout the lnstitution.


4. The Dean of the Medical School should alert New york presbtterian Hospital to

the need for a review of personnel, facilitjes and procedures relating to routine I

clinical and research intravenous fluid preparation.

5. The Dean should help the Department of Anesthesiology address the

Departmental management issues identified in the report as well as other issues

noted, but not investigated by this committee. Specificaljy, we refer to alleged

retaliation in response to complaints about protocol #92b6.

6. This study and a published abstract have been referred to at a meeting of the

FDA's Blood Products Advisory Committee (Appendix O). However, we

recommend against publication of the results because the true risks were not

fully outlined in the consent form. Hence, the data were not collected under

ffiepted ethical standards.


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May 27, 2OO2

Elliort Bennetr-Guerrero, M.D.

Ireing Assistant Professor
Departunent of Anesthesiologr
Box 46

Dear Dr. Bennett-Guerrero:

I trave asked Dr. Ha:wey R. Colten to chair a clinical study review

coqmittee to investigate issues raised regarding IRB protocol #9256.
l1le members are:
Warren M. Zapol, M.D,
Jane Pitt, M.D.
Robert Sladen, M.D.
Allan Schwartz, M.D.
Howard Jacobson
Henry Spomitz, M.D.
Richard J. Sohn, Ph. D., ex-officio

llds review has been prompted by alleged problems with inlormed

consent, reporting of adverse events and the findings on an initial audit.

The committee is charged wittr determining the lacts pertaining to

I'otocoi #9256 relevant to instittttional policies and procedures,
adherence to appropriate standards for humari studies, including
informed consent and execution of the study. Based on a comprihensive
review of the case, tl're committee v/ill recommend remedial action ro
assure improvements in policy, procedure and performance going

Fischbach, M.

Harvey R. Colten, M.D.

James H. Garvin, M.D.
Aadrew Wit, M.D.

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