Biomedical Engineering Reference
In-Depth Information
tually all public oversight responsibility for human gene transfer research
to the FDA.
Between June and August 1996, substantial opposition to the NIH
plans for RAC was expressed by four members of Congress and a major-
ity of letters written in response to the
Federal Register
notice, includ-
ing several authored by prominent figures in the field of bioethics.
8
Meanwhile, RAC skipped its March, June, and September 1996 meet-
ings—in part, it was said, because there was an insufficient number of
novel protocols requiring review. The director of the Office of Recom-
binant DNA Activities, which supported RAC's activities, departed the
NIH for an academic position at the end of June 1996, thus further com-
plicating RAC's situation.
In November 1996, February 1997, and October 1997, three further
proposals for the new public oversight system were published in the
Federal Register
. The upshot of this long process was the following
compromise:
•
RAC would continue to discuss, at its quarterly meetings, gene trans-
fer protocols that raised novel issues, used new vectors, or aimed to treat
new diseases.
•
There would, however, no longer be RAC approval or disapproval of
human gene transfer protocols; approval or disapproval (more techni-
cally, permission to proceed) belonged solely to the FDA.
•
The size of RAC was reduced from twenty-five to fifteen members.
•
A new type of forum, the Gene Therapy Policy Conferences, would be
associated with RAC's work and would discuss a theme—for example,
in utero gene transfer—rather than a particular protocol. This innova-
tion was, in my view, an excellent addition to RAC's role.
The most immediate and obvious effects of the 1996-97 changes were
the loss of transparency in the oversight system, and the weakening of
RAC's role in reviewing research protocols and monitoring the state of
the art in the field. A University of Pennsylvania proposal to study gene
transfer in subjects who had ornithine transcarbamylase (OTC) defi-
ciency can perhaps serve as a paradigm case for the new situation that
emerged in early 1996. RAC had discussed this protocol in detail at its
December 1995 meeting and had provided the researchers with several
suggestions for changes that might, in the committee's view, improve the
study. Yet with RAC's missed meetings in March, June, and September
