[Minutes, Clinical Research Subpanel Meeting]

NATIONAL CANCER INSTITUTE

CLINICAL RESEARCH SUBPANEL MEETING
Minutes
April 18, 1988

Members Present:
Members Absent:

Dr. Jim Mulshine (for Dr. Broder)
Dr. Ian Magrath
Dr. Neal Rosen
Dr. Dave Danforth
Dr. Andrew Raubitschek
Dr. John Wunderlich
Dr. Seth Steinberg
Rev. Kenneth MacLean
Dr. Jay Robbins
Dr. Paul Jarosinski
Dr. Harvey Pass
Ms. Annett Galassi (for Ms. Thaney)
Ms. Susan Hubbard
Dr. Samuel Broder (Chairman)
Dr. Stephen Creekmore
Ms. Kathy Thaney

Guests:

Dr.
Dr.
Dr.
Dr.
Dr.
Dr.

Tom Walsh
Michael Lotze
Barry Kramer
Mary Dearing
Robert Yarchoan
James Pluda

1. A. The minutes of the March 21 meeting were presented for discussion and
unanimously approved as written without stipulations or recommendations. Dr. Mulshine discussed a recent meeting with Dr. Broder at
which time concern was expressed regarding delay in the institution of
protocols caused by excessive requirements for non-substantive changes.
The changes in question are those requested by committees which reviev
the protocols after they have been evaluated by the IRB. This problem was
discussed at length, and the IRB strongly recommended that there be no
non-substantive changes made in the protocols after they have left the IRBto
avoid delay in getting promising new treatments to patients.
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