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

NIH 91-135 2
- First approval of the National Ethics Committee on May 20,
1987.
- Second approval of the Ethics Committee of the C.H.U.
[University Hospital Center) of SAINT ANTOINE, following a request
of the continuation and development of treatment, on May 29, 1990.
We noticed an ambiguity on the formulation of the latter. It is
approval with the express reservation that "the recommendations
declared by the National Ethics Committee continue to be
scrupulously respected". The recommendations of May 20, 1987 of the
National Committee list four points:
- treatment reserved for patients... whose life expectancy
beyond the next twelve months is practically null...";
- patients whose leukoneutropenia contraindicates any
treatment with AZT;
- sufficient time interval to judge the effect of treatment";
- the Committee wishes to be kept informed of each case".
The approval of the Local Committee on May 29, 1990 is aimed at
patients with AIDS of ARC and, therefore, a life expectancy greater
than twelve months - and who can also receive AZT, the approval
motivated by the encouraging preliminary results.
According to Dr. PICARD, the recommendations that the Local
Committee wanted to see applied concern only the regular
information of the Ethics Committee (fourth recommendation).
3. The legislation concerning the protection of individuals was
followed (HURIET Law of December 20, 1988):
- Oral and written information is given before inclusion in
the research protocol.
- The certificates of consent that we consulted are signed:
between March 7, 1989 and April 27, 1990, there are twenty-four in
number for the immunotherapy in patients; between December 28, 1988
and December 20, 1989, there are thirty-six in number for the
vaccine trial.
- A special insurance was taken out on March 26, 1990 for,
eventual compensations.
- The clinical departments where these trials are being
performed have not requested nor obtained any payment for these
studies.
- Healthy volunteers - most often physicians of the SAINT
ANTOINE Hospital - are not paid or compensated.