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European CF
Registry (ECFR)
Ethics and Patient Confidentiality
Obtaining the necessary patient
consents is an essential part of joining the European registry, as required by
the EU Directive 95/46/EC. As each participating country will have its own legal
interpretation of this Directive, it is important to check the suggested sample
consent forms with your local Data Protection Officers.
Furthermore, patients should be
notified accurately of all plans for collecting and processing their data, and
this is determined by the design of the European registry. The explanatory
information sheet provides fuller information. Please follow the relevant
course below depending on whether your country already has patient consents or
not.
If you have existing consents which satisfy your
local laws:
-
Compulsory Step:
If you already have existing
consents, please check with your local Data Protection Officer to make
sure these forms meet the requirements of the new European Registry or whether
you will need new patient consents using the ‘Sample Patient Information
Sheet’ and ‘Sample Patient Consent Form’ attached.
-
Compulsory Step:
If
your local Data Protection Officer approves your existing consents, please
inform Gita Mehta on
g.mehta@dundee.ac.uk along with a copy of the
consent form. This is a necessary requirement of the EU funding as legal and
ethics experts of EuroCareCF have also to approve this.
If you do not have existing
consents, or you need new patient consents:
-
Compulsory Step:
Please check this Explanatory Information
sheet, the accompanying ‘Sample Patient Information Sheet’ and ‘Sample
Patient Consent Form’ with your local Data Protection Officer to
make sure these forms meet the requirements of your local legal and ethics
laws.
-
For
more information for your local laws, please consult
http://www.privireal.org/
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Compulsory Step:
Please make any changes as required for your
country to comply with these sample forms.
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Please inform Gita Mehta on
g.mehta@dundee.ac.uk along with a copy of the
revised consent form. This is a necessary requirement of the EU funding as
legal and ethics experts of EuroCareCF have also to approve this.
-
Compulsory Step:
Please get the ‘Sample Patient Information
Sheet’ and ‘Sample Patient Consent Form’ translated if necessary,
before getting your patients to sign
-
Compulsory
Step:
Patients can only be entered into the registry
once you have received their signed, informed consent to do so.
-
Compulsory Step:
Please store all the consent forms that your
patients have signed safely in your local hospital.
It is the responsibility of the reporting centres/countries/registries to have the
acquired permissions to export/report data to the European registry. It is
the responsibility of ECFS
and the European registry steering committee that data are stored and handled
according to Danish Data Protection laws. The European Registry is registered
under the Danish Data Protection Agency, file no
2005-41-5321.
For
questions concerning the above please feel free to contact Hanne Vebert Olesen
(hvo@dadlnet.dk) or Gita Mehta (
g.mehta@dundee.ac.uk)
Documents associated with this
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