Dear all,
I have replied to Sylvia directly about this issue but I thought other list
members might be interested:
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Dear Sylvia,
I read your email on the archives-nra about a proposed research project into
some pregnancy registers. I presume the registers are NHS records (any
records of an organisation which became part of the NHS are counted as NHS
records).
If I understand the situation correctly, a university wants to conduct
research into the registers, which are closed for 100 years because they
contain medical information, and it is not possible to anonymise the data or
gain consent from all the patients.
It seems as though this may be a case for research under Section 60 of the
Health and Social Care Act 2001. This legislation was brought into force by
the Department of Health, to allow organisations to conduct valuable medical
research into patient records where consent cannot be obtained and where the
information cannot be anonymised.
You can find more information about the Act here:
http://www.doh.gov.uk/ipu/confiden/index1.htm
and here:
http://www.doh.gov.uk/ipu/confiden/act/index.htm
As I understand it, the organisation which wishes to conduct the research
(in this case the university) must send a formal application to the PIAG
(the Patient Information Advisory Group) which will decide whether to allow
the research to go ahead. It would be the University's responsibiltiy to
apply to the PIAG, not the Record Office's.
It might be worth the university contacting the PIAG or the Information
Policy Unit of the DoH to find out if this proposal does fall within the
remit of Section 60 of the Health and Social Care Act. They can be contacted
at:
Confidentiality Issues Section
NHS
Information Policy Unit
Quarry House
Quarry Hill
Leeds LS2 7UE
Tel: 0113 254 6033
Fax: 0113 254 6045
With regards to the proposal to digitise the information and to put it on to
CD-Rom: they should not allow any information which is closed to come into
the public domain if the patient can be identified. If they wanted to put
the results of the study (e.g. general statistics etc) into the public
domain then I think this is okay, but they should definitely NOT allow
digitised images of information relating to identifiable patients to come
into public view.
I hope this helps.
Best wishes,
Catherine Redfern
Catherine Redfern
Archive Inspection Officer
Public Record Office
Kew, Richmond, Surrey TW9 4DU
Tel: 020 8876 3444 x.2354
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