On Thursday 29 April 2004 13:50, Leon Geffen wrote:
> > I am looking at referrals and the complexity of the
> > process/volume of data generated.
It is about data...
> > I need to know what the average length of referral letters is
> > and how many non referral letters are sent by GPs.

> This type of research needs to be passed by an ethics committee.
I think that still depends on what information is involved, and how it is
extracted.
> The
> nature of research and unfortunately the abuse of medical subjects that
> has occurred in the past has necessitated all research has to have a
> protocol as well as be passed by an ethics committee.

Lets work up... Does a question to all practices on the volume of data they
hold (essentially, "how large a hard drive are you using and how full is it")
require ethical ctee approval?
I beleive that ethical ctee members, apart from a definite "why are you asking
me that" expression on their glazed countenances might feel that people
designing clinical infroamtion systems and carrying out activities around
them clealry need such information, and that it carries nothing of patient
detail.

As we get into sizes of particualr data elements, I don't see any ethical ctee
involvement unless one goes beyond "what is the size of the smallest record"
to "what is the content of the smallest record".

> "The World Medical Association has developed the Declaration of Helsinki
> as a statement of ethical principles to provide guidance to physicians
> and other participants in medical research involving human subjects.
> Medical research involving human subjects includes research on
> identifiable human material or identifiable data."

So we need to ensure that the research is not on identifiable data.

> Considering that the referral letters will have identifiable data, this
> type of research is clearly covered by the
> Declaration of Helsinki. It can be argued that the potential harm to any
> individual by seeing the referral letters is negligible

I would argue that it is not necessary for any new individual to see the
letters, and that therefore they should not.

>I do believe that as we become more fearful of electronic
> records and privacy of information becomes more important, we will have
> to get consent before including patient information in anonymised
> surveys.

I regret to say that the UK is going the other way, as is the USA.
With biometric ID cards to carry on the horizon (which would actually serve
most of their admitted purposes far better if they did not have any link to
an _absolute_ identity) the idea that anyoen can expect to keep their privacy
is looking very shaky.


--
Adrian Midgley                   (Linux desktop)
GP, Exeter
http://www.defoam.net/