その１９ アメリカ遺伝子治療学会の見解 つづき
The Society also wishes to comment in general
terms regarding the increased regulatory
role OBA is proposing. ASGT is committed
to the ethical conduct of clinical trials
with an appropriate emphasis on patient safety.
Adherence to these general principles assures
that the field will maintain a necessary
level of credibility as it develops and advances.
The Society strongly supports an oversight
structure which assures that trials will
not proceed until all elements of the risk-benefit
ratio are addressed and approved. Nevertheless,
we are very concerned that investigators
in this field are faced with two distinct
systems of oversight. While some aspect of
the proposed Notice attempt to improve harmonization,
other proposed changes only solidify the
distinct features of the oversight organizations.
By default, investigators are forced to contend
with two varying sets of requirement and
it is not clear that this additional burden
proves any added value to enhancing patient
safety in human clinical trials.