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  • Columbia Drug Study: Clinical Review Committee Recommendations

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    huffpostfund
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    A confidential report of the Clinical Review Committee convened by Dean Gerald Fischbach recommends that Bennett-Guerrero “should be subjected to appropriate sanctions based on his failure to comply with good clinical practice and the resulting lack of adherence to ethical and regulatory standards for the conduct of clinical research.” Source: Court Documents RELATED STORY: http://huffpostfund.org/stories/2009/10/government-orders-columbia-tell-patients-true-nature-drug-study

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    A confidential report of the Clinical Review Committee convened by Dean Gerald Fischbach recommends that Bennett-Guerrero “should be subjected to appropriate sanctions based on his failure to comply with good clinical practice and the resulting lack of adherence to ethical and regulatory standards for the conduct of clinical research.” Source: Court Documents RELATED STORY: http://huffpostfund.org/stories/2009/10/government-orders-columbia-tell-patients-true-nature-drug-study

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    Attribution Non-Commercial (BY-NC)
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    212 tayangan3 halaman

    Columbia Drug Study: Clinical Review Committee Recommendations

    Diunggah oleh

    huffpostfund
    A confidential report of the Clinical Review Committee convened by Dean Gerald Fischbach recommends that Bennett-Guerrero “should be subjected to appropriate sanctions based on his failure to comply with good clinical practice and the resulting lack of adherence to ethical and regulatory standards for the conduct of clinical research.” Source: Court Documents RELATED STORY: http://huffpostfund.org/stories/2009/10/government-orders-columbia-tell-patients-true-nature-drug-study

    Hak Cipta:

    Attribution Non-Commercial (BY-NC)
    Unduh sebagai PDF, TXT atau baca online dari Scribd
    Tandai sebagai konten tidak pantas
    dari 3

    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.


    E

    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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    ^ND 'HI

    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
    fuward.

    dJ-
    DK
    Fischbach, M.

    Harvey R. Colten, M.D.


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

    R 000021

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