Ian,
We are doing something similar to this, but are not getting consent
from the patient to use residual sample. We did have to get ethical
approval for this and the whole process took ages. Not sure whether
going through the LREC is authoritative enough for you.
Regards
Jeff
>>> IAN WATSON <[log in to unmask]> 03/05/2006 18:02 >>>
Does anyone have definitive insight as to the consent issues around
the
scenario below? Preferably quoting an authoritative UK source.
Yours in anticipation,
Ian Watson
Consultant Biochemist
In general a laboratory test is used to diagnose or monitor
treatment/prognosis. The effectiveness of that test is determined by
the
knowledge applied and the selected analyte. Different analytes may
reflect the disease being tested with different sensitivity
and specificity.
Thus to detect/monitor Disease A, test B is used. However if there is
a
body of research that indicates test C is as good/better, then good
service practice requires that we compare the performance of test B
versus test C in disease A in our population. Such an exercise
requires
the use of patient samples preferably with outcome.
I would suggest that this is not Research, but is Development i.e.
looking to change/improve testing [test C] to detect/monitor the same
condition as the original requested test B as a service improvement.
Test C would be done on residual material from samples collected for
test B.
It would be useful to know if conducting test C on residual material
from test B to diagnose/monitor the same disease is a permissible use
of
that material in an attempt to improve service.
Is it?
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