The question asked by Ian Watson raises a number of issues. The first is
exactly what is the purpose behind the study. Clearly this is 'service
development/evaluation' rather than research and as such does not require REC
approval. Of course it is not always easy to separate service development from
research and guidance may need to be taken from the local REC chairman if there
is any doubt.
Secondly I am pretty sure that under the new Human Tissue Act you do not need
consent to use legitimately obtained excess tissue for service development or
for quality issues. No doubt someone will quote chapter and verse if I am wrong
but this act will be the definitive UK authority on the use of tissue including
blood.
The third question is why does each lab have to re-evaluate the new test against
the old if there is sufficient evidence in the literature to show that this is
so? If you follow this train of thought to its' logical conclusion it would be
almost impossible to set up a new lab as you would have to evaluate every test
before you could use it. Does CPA require us to do this or are we just being
over cautious?
Mike Addison
Retired Consultant Chemical Pathologist
Locum Consultant Scientist
Chairman Salford and Trafford LREC
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