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

NIH LIBRARY TRANSLATION NIH 91-130
Letters in
French
THE FRENCH REPUBLIC
MINISTRY OF SOCIAL AFFAIRS AND SOLIDARITY
STATE MINISTER OF HEALTH
PRESS RELEASE
Mr. Frangois STASSE, Director General of the Assistance
Publique [National Assistance Board) of Paris forwarded to Mr.
Bruno DURIEUX, State Minister of Health, the results of the inquiry
which he had been authorized to carry out, of the conditions under
which clinical trials on the prevention and treatment of AIDS were
begun at the St. Antoine Hospital by Pr. ZAGURY of the Pierre and
Marie Curie University.
These investigations were the subject of allegations in the
French and foreign press that all the prescribed authorizations
were not requested from the Ethics Committee.
The results of this inquiry showed that the texts in force,
the procedures, and the recommendations of the Ethics Committees
were respected by the teams that carried out these trials.
1) With respect to the vaccine trials using healthy
volunteers:
This investigation was approved by the National Ethics
Committee on June 22, 1988 for 30 subjects, many of whom were
members of the medical and nursing personnel.
This approval was renewed on September 19, 1990 for an
extension of the trial. The conditions imposed by the /Law of
December 20, 1988, termed the HURIET Law, were fulfilled:
- oral and written information given to the volunteers before
the initiation of the study
- informed consent signed by the volunteer individuals
- subscription by the organizer of the investigation for
insurance for eventual compensation,
Furthermore, the participants did not receive any compensation
or payment.