Ian,
As a member of an LREC I would make the following observations.
1. Talk to the Chairman of your local LREC, he/she may be prepared to
say that it does not need ethical approval. Be prepared to send a
summary proposal highlighting what you intend to do, and what the
expected benefits will be, if there aren't any, then it's unethical!
2. Part 1 point 4 of the HTA reply would suggest that you may need
approval, as you will not just be measuring the two analytes, but
looking at the patient's records for outcome data.
3. Anything which asks for access to a patient's medical record for
anything other than general day to day queries (why do they want to do
that particularly expensive test), usually needs informed consent from
the patient.
Regards,
Gary
G. C. Mascall
Consultant in Clinical Biochemistry
Worcestershire Acute Hospitals NHS Trust.
[log in to unmask]
Tel: 01562 823424 extension 53465/53136
-----Original Message-----
From: Clinical biochemistry discussion list
[mailto:[log in to unmask]] On Behalf Of IAN WATSON
Sent: 04 May 2006 09:15
To: [log in to unmask]
Subject: Consent: HTA Reply
Thanks to those who have answered so far.
I attach the reply I received from the HTA.
Seems to me we need a definitive ruling on the kind of scenario I've
identified. I can't really believe that Ethics Committees want to be
burdened with service development scenarios on top of real research.
Further insights welcomed!
Ian Watson
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