(FDA to release data on gene therapy trials.
in Science 291: 572-573,2001) に載っておりますので、こちらも併せご覧ください。また、バイオ研究者のための英語のその２３でも解説します。
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Office of Biotechnology
Activities; Recombinant DNA Research: Proposed
Actions Under the NIH Guidelines AGENCY:
National Institutes of Health (NIH), PHS,
ACTION: Notice of proposed actions under
the NIH Guidelines for Research Involving
Recombinant DNA Molecules (NIH Guidelines).
SUMMARY: The NIH is proposing changes to
the NIH Guidelines to enhance its oversight
of human gene transfer research by making
modifications to the reporting and analysis
of serious adverse events in human gene transfer
research studies. The purpose of this Notice
is to inform the public about the proposed
changes and to seek public comment on them.
The proposed changes involve four main issues:
(1) The scope and timing of serious adverse
event reporting; (2) public access to information
about serious adverse events; (3) protection
of individually identifiable patient information
as it relates to serious adverse event reporting;
and (4) a new mechanism for the review and
assessment of data on serious adverse events
and other relevant safety information.
The NIH currently requires all serious adverse
events to be reported immediately whether
or not they are expected or considered to
be associated with the gene transfer product.
The first proposed change would require expedited
reporting for those serious adverse events
that are unexpected and considered possibly
associated with the use of the gene transfer
product. The proposed change also provides
timeframes for expedited reporting and definitions
of serious, associated, and unexpected adverse
events. Under this proposal, other reportable
serious adverse events would be included
in annual reports.
The second proposed change would clarify
that serious adverse event reports submitted
to the NIH may not be classified as confidential
information and that trade secret or other
commercial confidential information should
not be included in serious adverse event
The third proposed change adds specific language
to the NIH Guidelines to prohibit the submission
of individually-identifiable patient information
in serious adverse event reports.
The fourth and final change is the establishment
of a working group of the NIH Recombinant
DNA Advisory Committee (RAC), to be known
as the NIH Gene Transfer Safety Assessment
Board, that will be responsible for the review
and analysis of serious adverse event reports
and other relevant safety information in
gene transfer research studies. The working
group will report safety information to the
RAC and information will, thereby, be disseminated
to the scientific and patient communities
and the public.