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

(Page 2 -- Director, NIH)

Since we have never tested these materials with blood samples from
any individuals, either here or abroad, we never did apply for ICRS
approval. Dr. William C. Eby, another outside consultant committee
member also stated "...Dr. Papas denies any collaborative
experiments involving human subjects. He (Dr. Papas) states that
his only contribution was the provision of materials for animal
studies. No ICRS approval for research was obtained, nor is it
clear that human subjects were involved in any work with Dr.
Papas...." These then constitute the verbatim report of the two
consultants that commented on my project that was sent forward to
the OPRR.
3) The OPRR report may have confused the Dr. Klebanoff's statement,
that if I or Dr. Zagury, need to test the materials sent to him
with human sera, we "may" require ICRS approval or informed
consent. It should be apparent that since the research materials I
sent to our Division's Vaccine Task Force were only used in animals
and never used with individual human sera, we were not required to
obtain ICRS approval or informed consent; therefore we have not in
anY way violated,. Or failed to comply with, the rules and
regulations of HHS or the NIH. In addition we have no publications
or communications emanating from this project; we simply were
providing research materials as requested, and for which funding
was approved by our Division's AIDS Vaccine Task Force. I can
understand however, from the vastness of the research projects
reviewed by the OPRR at the NIH, how this inaccuracy pertaining to
my project occurred. I agree, in fact, with the report's general
conclusion that the NIH guidelines and directives need to be
clarified regarding such Intramural collaborations, and indeed the
steps towards this are being implemented; however since I did not
do anything to disregard those guidelines, I feel I should not be
subject to any greater restrictions than any other NIH Intramural
scientist.
I would seek your assistance and hope that the final report be
corrected to faithfully reflect the statements of the outside
consultant's investigative findings by including the statement
that there is no evidence that my materials were used in humans.
Also the OPRR inaccuracy should be corrected in the final report to
reflect that no human HIV-positive sera was obtained from Dr.
Zagury or his collaborators, or was ever tested by us for this
project.
I would also seek your assistance with another matter, indirectly
related to this issue. Over the past few months, my requests for
outside activities have been held up or rejected by the NIH
administration, in spite of the fact that they have nothing to do
with this matter and are entirely unrelated to this project.
Despite efforts by my Division Director to assist me, this matter
still remains unresolved. It appears then, that this outside
activity issue is being further compounded with the matters