[Memorandum to Jay Berzofsky from Jim Mulshine]

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DEPARTMENT OF H TH & HUMAN SERVICES National Institutes of Health
National Cancer Institute
REC E121D MAR 4 Memorandum

Date February 16, 1928
From Acting Chairman, Clinical Research Subpanel, NCI
Subject Action on Clinical Research Project
To Dr. J. Rerzofsky
Principal Investigator, MET, NCI
Your memo requesting approval of international collaboration with
Dr. Daniel Zagury for in vitro testing of peripheral blood from human
volunteers previously immunized against AIDS was circulated and reviewed
by the Clinical Research Subpanel on January 25, 1988, and was unanimously
approved with the following stipulations as stated in the attached minutes.
Please submit a covering letter specifically outlining your response to
the recommendations of the committee. Also, to simplify further review and
to enhance the clarity of communications please indicate on one copy of
the revised protocol the specific changes that have been made in response
to the recommendations of the Institutional Review Board. This may be
done by highlighting relevant sections in yellow or by underlining such
sections in ink. It is absolutely essential that you denote the specific
changes you have made. This is important in expediting the processing of
your protocol, and failure to do this may result in a delay of final
approval. In truly unusual circumstances you may seek the opportunity to
formally rebut one or more recommendations. Please telephone the Deputy
Clinical Director's office if such unusual circumstances apply to this
protocol. Otherwise you must respond to the Roard's recommendations
before the protocol can be forwarded to the Clinical Center for final
approval. Please send 12 copies of the revised annual reviews to this
office, Ruilding 10, Room 12N214.

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Acting Chairman
Clinical Research Subpanel, NCI
Approval
Acting Chairman
Clinical Research Subpanel, NCI

' Mulshine, M. D.

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Date

Mushine, M.D.

Date

Approval
Deputy Clinical

Director, NCI

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Date

John L. Decker, M.D.
Director, CC

DATP/ Project Number Assigned