[Minutes, Clinical Research Subpanel Meeting]

2.. The memo fro Prs. erzofsky,. hearer, and 11o to Dr. S. Rroder
requesting approval of international collaboration with Dr. Daniel Zagury
for in vitro testing of peripheral blood from human volunteers previously
immunized against AIDS was discussed. Dr. Pass wanted to know what the
consent forms referred to were specifically pertaining to. Dr. Creekmore
noted that the issues are the safety of the virus, and the question of
doing research in a foreign country. We will probably need to see the
design of the study, etc. Dr. Mulshine asked whether it is satisfactory
to approve this on the basis of just this one sheet of paper that we
have. Dr. Wunderlich noted that we should exercise care when involving
collaborative research with other countries. Dr. Mulshine asked whether
assuming everything is in fact proper, and that if it is limited to the 15
patients referred, could the panel consider it okay. Could whatever has been
done already retrospectively be approved? Dr. Pass noted that since we
have not seen any of the material, maybe the panel should approve pending the
receipt of the approvals and the consent forms from Zaire. Dr. Mulshine added
that if the retrospective study was fine, before the panel could approve it for
any parts of the study that would be prospective, the panel would need to see the
approvals and consents. At this point Dr. Streicher came into the room and
presented a precis of the protocol. Dr. Creekmore asked whether or not this
study would be extended beyond just the 15 patients indicated in this letter
of request. The response was it could be if it is interesting and it probably
will be. Dr. Creekmore felt that this probably should be cause for some
review of anything in the future that is done. Dr. Mulshine noted that we
should see informed consents, etc. Dr. Creekmore noted that this should be
analogous to any other collaboration. Dr. Magrath then noted that this really
could be viewed as 2 pieces. The panel would be comfortable with what has
already been done, but they would need to see the materials with respect to

all future patients. Or. Mulshine agreed that permission for the 15 already
tested could be granted, but that this would be conditional on the provision
in writing that the WHO guidelines would he adheared to in this particular