I do not think that any definitive position on this is possible, but I am
happy to share the advice I normally give when asked in my capacity as Trust
Director of Research.
If there is a sufficient body of published evidence to support the routine
use of a test in a particular clinical setting, then the introduction of
that test may require the legitimate use of residual clinical samples in
order to establish that assay characteristics are satisfactory; this can be
done without consent / ethics committee / research governance approval.
If, in contrast, the body of evidence supporting the introduction of a test
is not this strong, then the collection and evaluation of evidence about the
usefulness of the test should be viewed as research. This will require
ethics committee and research governance approval, although individual
informed consent from patients will not be required if all data is
anonymised. The judgement as to whether anonymisation is adequate will be
made by the ethics committee.
Best wishes
Ian Young
IS Young
Professor of Medicine, Queen's University Belfast
Consultant in Clinical Biochemistry, The Royal Group of Hospitals, Belfast
Wellcome Research Laboratories
Mulhouse Building
Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BJ
UK
tel: +44 2890 632743
fax: +44 2890 235900
email: [log in to unmask]
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