Columbia Drug Study: Clinical Review Committee Recommendations
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nqoft ofthe
3.
Clinical Rzview
Co nittee
CONFIDENTIAL
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 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.
't7 R 000018
I
Qor-urr,tn
rn LjNrvE
H EALTH Scte
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rry
NcE5 DrvtstoN
fxtcuTtvt vrc! pRt5rDINT foR H!^LrH 6lO&rD]C^t SClrNc!5 D'^N Of FACUITY ^ND OF MTO]C]N! ^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
3.
Clinical Rzview
Co nittee
CONFIDENTIAL
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 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.
't7 R 000018
I
Qor-urr,tn
rn LjNrvE
H EALTH Scte
Rs
rry
NcE5 DrvtstoN
fxtcuTtvt vrc! pRt5rDINT foR H!^LrH 6lO&rD]C^t SClrNc!5 D'^N Of FACUITY ^ND OF MTO]C]N! ^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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