The processes and practices of the IMMP have been set up to comply with the NZ Health Information Privacy Code, and the Privacy Commissioner has been advised of the purpose and methodology of the programme.
PRIVACY AND ETHICAL
CONSIDERATIONS
The
processes and practices of the IMMP have been set up to comply with the NZ
Health Information Privacy Code, and the Privacy Commissioner has been advised
of the purpose and methodology of the programme (Coulter, 2001). In line with
the Privacy Code, there are processes in place within the IMMP to protect
patient privacy and maintain confidentiality. These include appointment of a
privacy officer and training of all staff in all aspects of confidentiality.
Regarding
patient consent for involvement in the programme, the IMMP operates on the
‘opt-out’ principle, like other national epidemiological studies. Patients
should be informed by their doctor that they have been prescribed a monitored
medicine, the reasons why their medicine is monitored and the type of
information collected. The IMMP also provides information leaflets that doctors
may give to patients. The patient then has the right to opt out of the
monitoring study by requesting that the IMMP does not store their personal
data. In practice, this happens very rarely and – although the reasons for this
have not been evaluated formally – it is possible that patients view the
monitoring of their medicine as a ‘safety net’ in place to protect them rather
than as an invasion of their privacy.
Ethics
Committee approval is not sought for routine monitoring of medicines in the
IMMP as the programme is longstanding and has regularly been scrutinized
without objection. However, for particular studies that are not part of the routine
monitoring, ethics approval is sought in the usual way and approval has
invariably been given.
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