[Memorandum to Director, NIH from Takis S. Papas]

DEPARTMENT OF HEALTH & HUMAN SERVICES National Institutes of Health
National Cancer Institute
Memorandum
Date July 3, 1991
From Chief, Laboratory of Molecular Oncology (LMO), NCI-FCRDC
Subject Reply to memo re: Human Research Subjects
To Director, NIH
Deputy Director for Intramural Research, NIH
I am responding to your memo dated June 21, 1991 concerning the
preliminary report being issued by the Office for Protection from
Research Risks (OPRR) regarding. allegations of noncompliance for
the protection of human research subjects. I believe that I must
correct and clarify several inaccuracies in the OPRR report as
quoted in your memo. Specifically your memo states that there has
been "... identified specific instances where I and my staff have
failed to comply with Health and Human Services7 regulations for the
protection of human subjects.... " I believe this statement was
unjustified, for the following reasons:
1) The OPRR report states: "... Project Eight initiated in early
1989 involved collaboration between NCI Scientist Dr. T.S. Papas
and Dr. Zagury in the production and purification of specific
recombinant vector expressed HIV-encoded polypeptides. According
to Dr. Papas the project included a limited series of in vitro
studies involving HIV-positive sera...." This latter statement is
incorrect; We never olJlaborated with Dr. Zaaury in any studies
tthat involved, him or us, using any human HIV positive sera. I
have examined the OPRR report thoroughly, which was based upon the
written investigative findings of a committee of outside
consultants, chaired by Dr. Seymour Klebanoff. I have read the
consultant's report very carefully as well. The OPRR report fails
to say that the outside investigative consultants came to the
conclusion that there was no evidence that our materials was used
for research -in Human subjects; this was quite clearly stated in
their written report.
2) The OPRR further asserted that we failed to submit to them the
proper ICRS notification, for using HIV-positive sera in this
project with Dr. Zagury as required by the Departments directive,
45 CFR 46. This OPRR statement is unsupported by the written
findings of the outside consultant's investigations; I have gone
thoroughly through the separate reports of the Chairman and the
individual consultants; Dr. Klebanoff states that t"...we can detect
no evidence in the material available to us, or in our meetings
with NIH Intramural scientists that Dr. Papas' vector expressed

polypeptides were used ij, huan subjects. D. Papas needs to be
aware if his materials needs to be tested with blood from human
subjects. ICRS approval and informed consent mayv be needed...."

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