Dear Colleagues,
I am writing to try and gain information on ethical practices in the
laboratory. The two main areas of concern to me are use of patient material
(usually old blood samples which will be discarded anyway) for internal QC
procedures and method validation, and collections from healthy volunteers
(usually lab staff) for setting reference inetrvals or stability studies etc.
I would like to develope guidelines for these issues and seek approval from
our institutional ethics committee for these practices. I would be very
interested in any guidelines or source material (Australian or otherwise)
that members of this discussion group may have. In reading things like the
Helsinki Declaration there does not seem to be any mention of this type of
activity and harm to the patient would seem to be very, very unlikely.
As I see it I would be asking that we use expired patient material,
collected under doctors instructions and analysed in the usual manner, for
internal QC procedures or method validation. No additional material would
be collected and all such samples would be de-identified.
Regarding volunteer donations we would need to develop a form indicating
consent, the tests that are consented to, the possibility (or not) of
further tests not envisaged at the time of collection, any exclusions (eg
DNA testing), do they want to receive the results, the offer of expert
support if an abnormality is found.
Thank you for your interest.
Regards,
Graham
Graham Jones
Staff Specialist in Chemical Pathology
St Vincent's Hospital, Sydney
Victoria St, Darlinghurst, 2010
NSW, Australia
Ph: (02) 8382-2170 Fax (02) 8382-2489
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