Challenges Encountered when Applying for the Ethics and Permission to Conduct the Non-Clinical Trial Study in the Hospitals and Clinic
A case study on the process of applying for ethical
and provincial clearance to conduct a medical informatics research for a PhD
programme in South African Hospitals. The programme was looking for current status of
medical informatics and implementing electronic healthcare record, challenges,
and future direction in South Africa. Nine provinces were contacted and all
approved the study, however, the approval was obtained after averaged of 9
months which was longer than expected. The public hospital CEOs and medical
managers were also contacted to acknowledge participation and give clearance
for the study to be conducted at hospitals. After an average of 3 months to give
clearance and out of 40 hospitals contacted only 70% acknowledged. Overall the
process took longer than expected to approve a non-clinical trial study for
academic purpose. This has delayed the start of the PhD research program and
the challenges encountered in the
provinces applications are due to autonomy and lack of standardisation of
procedure between the provinces, lack of understanding the procedure of the
study by the province personnel and hospitals, lack of expertise in handling
electronic submissions and non-clinical trial submissions. IT is still a
challenge to most of government employees and the infrastructure that can
accommodate amount of information.
Ethics committee, South African Provincial
clearance, Hospital clearance.
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