This issue affects the EQA community greatly and has been a
cause of considerable concern and even 'drying up' of some
sources of material without which some schemes will cease to
exist or have to get by on inadequate material.
As stated, the guidance is that for QA, education and research
uses, you don't need a specific signed consent form for these
uses, but you do need to actively inform patients that their material
may be used in these ways. The problem is how you do the latter.
Is it practical to ask staff to give each patient from which a blood
or urine sample is being taken, a guidance leaflet and something
for them to sign to opt in or out, to counsel them on its meaning
and then manage the forms appropriately in conjunction with the
laboratory information and sample storage systems? Probably no.
Is it sufficient just to have a notice up in the phlebotomy room or
clinics? Probably no - you can't know whether a patient has
absorbed the information and really consents.
Can you assume consent unless the patient specifically says 'No'?
Definitely not!
Or do we have to wait until a 'permission flag' associated with an
eletronic patient record is in place? But should this be a one-off
generic permission or would it have to be re-stated at each sample
collection event?
My guess is we need something like the organ donor card which
GPs and clinics can give out to patients with an explantory leaflet
which they can read at their leisure and/or visit a website for further
information. They can then decide to carry a YES card which gives
permission or a NO card which does not. When a sample is taken
they are asked what card they carry and an appropriate box is then
checked on the request card (or electronic test request equivalent).
This information is recorded at sample accession and is then used
to rule in or out individual samples (which would have to be
anonymised if included) for the QA/education programme. This
could still be cumbersome, but is there an alternative at the
moment?
We at UK NEQAS would very much like to develop generic written
guidance for participants (and their patients) who kindly help us by
collecting residual serum and urine that has been analysed, and
promote this valuable contribution to quality that patients can
make. We would also be interested to see what is already out
there.
The problem is that everyone is much more concerned about
whole/part organs and tissue blocks, but this issue is affecting use
of relatively non-contentious residual serum and urine, which most
people feel should be used wherever it can be of assistance,
providing effective anonymisation is undertaken. (Before anyone
reminds me - yes I do know that you can't really anonymise
anything which contains DNA!)
best wishes
Jonathan Middle
UK NEQAS Birmingham
On 19 Dec 2002, at 11:21, Griffiths Paul (RQ3) BCH wrote:
> Dear Colleague,
>
> Further to the DoH Model Consent Policy how are other labs dealing
> with the issue of consent for tissue samples to be taken for
> diagnostic purposes? The policy states that,
> 'The legal position regarding the use of human tissue
> (including
> blood samples and other bodily fluids provided for testing) raises
> some difficult issues and is currently under review. Such tissue can
> be very valuable in education and research, and it's use may lead to
> developments in healthcare for all. .... Tissue samples may be
> used for quality assurance purposes without requiring specific patient
> consent provided there is an active policy of informing patients of
> such use.
>
> This raises a number of issues.
>
> 1. Given that the definition of tissue is a sample containing nucleic
> acids, do we need written consent for any blood samples or other
> fluids containing nucleated cells if they are likely to be stored and
> used for education, researc or audit purposes?
>
> 2. For solid tissue samples presumably we have to keep records of
> whether consent has been given for storage, use in audit, education
> and research or whether the patient (or carer) wants the specimen
> destroyed or returned.
>
> 3. Is a separate consent form required from the general 'consent to
> treatment' form?
>
> I would be grateful for any comments regarding experience with this
> issue, and examples of any consent forms currently in use.
>
> Many thanks
>
> Paul Griffiths
>
============================================
Jonathan Middle, UK NEQAS Birmingham
tel 0121 414 7300 fax 0121 414 1179
This message is intended only for the above
recipient(s). The opinions expressed are
mine alone and do not necessarily represent
those of UK NEQAS Birmingham, the University
Hospital Birmingham NHS Trust or the UK NEQAS
Organisation.
==================================================
------ACB discussion List Information--------
This is an open discussion list for the academic and clinical
community working in clinical biochemistry.
Please note, archived messages are public and can be viewed
via the internet. Views expressed are those of the individual and
they are responsible for all message content.
ACB Web Site
http://www.acb.org.uk
List Archives
http://www.jiscmail.ac.uk/lists/ACB-CLIN-CHEM-GEN.html
List Instructions (How to leave etc.)
http://www.jiscmail.ac.uk/
|