[Memorandum to Acting Deputy Director for Intramural Research, NIH from F. William Dommel, Jr.]

NIff LIBRARY TRANSLATION

EMBASSY OF FRANCE Kinshasa, April 29, 1991
IN ZAIRE
CONFIDENTIAL
MISSION OF COOPERATION
AND CULTURAL ACTION
CERTIFICATE
Clinical trials of vaccination and immunotherapy were carried
out in Zaire, within the framework of a Franco-Zairian cooperation,
by Professor ZAGURY (Pierre and Marie Curie University - Paris VI),
Professor LURHUMA (University Clinic of Kinshasa), and Doctor
SALAUN (I.N.R.B.) [National Institute of Biomedical Research] in
accordance with the medical deontological regulations and French
and Zairian ethics.
Identical trials were carried out in France (at the Saint
Antoine Hospital).
Following a report of inquiry dated March 22, 1991 on these
clinical investigations, the Minister of Health of the French
Republic published a recent press release indicating that "the
texts in force, the procedures and recommendations of the Ethics
Committees were followed by the teams who carried out these
trials."
In Zaire, the Ethics Committee of the Institut de Recherche en
Sciences de la Sant6 (I.R.S.S.) [Institute of Research in the
Health Sciences] issued their approval. An informed consent form
from the volunteers, or for minors from their parents, was signed.
The medical acts were performed by physicians from Zaire. The
vaccinated individuals were volunteers and did not receive any
compensation.
These trials lie within the scope of Franco-Zairian (I.N.R.B.)
medical cooperation with the moral and material support of French
and Zairian authorities. The Mission de Cooperation et d'Action
Culturelle [Mission of Cooperation and Cultural Action) was
7 regularly informed by Doctor J.J. SALAUN.
No medical complication resulting from the treatments occurred
during the clinical trials.
Taking into consideration the medical results and in
particular the benefit to the patients treated since 1986, the
<0 French authority, represented by the Ambassador of France,
\ encourages the continuation of these trials within the same context
Sof respect of the medical deontology and French and Zairian ethics,
* in accordance with the Zairian authority, and specifies that the
Mission de Cooperation et d'Action Culturelle always be regularly
informed of the progress of these clinical trials.
(Signed)
Embassy of France in Zaire