If you go here:
http://www.hta.gov.uk/aboutus/htact/
and look at Part 2 of Schedule 1
and then read the first paragraph under "Tissue from the Living"
I would interpret this to mean that Ian's scenario does not require consent.
Is this research? Maybe in a broad sense if you are asking a question to acquire new knowledege or test a hypothesis. But I would tend to agree with Ian that this is closer to quality improvement.
We at UK NEQAS have correspondence from the DH HTA team that says that we can use residual material from test A to use for quality assurance of test B without consent
Hope this helps
J
Dr Jonathan Middle
Deputy Director, UK NEQAS Birmingham
0121 414 7300, fax 0121 414 1179
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-----Original Message-----
From: Clinical biochemistry discussion list on behalf of IAN WATSON
Sent: Wed 03/05/2006 18:02
To: [log in to unmask]
Subject: Consent
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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