Challenges Encountered when Applying for the Ethics and Permission to Conduct the Non-Clinical Trial Study in the Hospitals and Clinic

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Authors : Michael Sello Seahloli

Abstract:

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.

KEY WORDS

Ethics committee, South African Provincial clearance, Hospital clearance.

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