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May 13, 2014Article Details
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Auditing the process of ethics approval for Master's degrees at a South African university
Abstract
Objective. This study audited the process of ethics approval for Master's research at the Nelson R Mandela School of Medicine, Durban, KwaZulu-Natal, South Africa.
Methods. After obtaining the appropriate ethical approval, all the correspondence surrounding each Master's proposal for the year 2010 was reviewed.
Results. A total of 53 proposals for Master's degrees were available for review. All the proposals were for low-risk studies, and all were subjected to expedited review. It took an average of 15 weeks (range 3 - 32) for the institutional ethics review board (the Biomedical Research Ethics Committee (BREC)) to respond to each of the 53 proposals. Twenty-three studies (43.4%) received provisional approval on the first response, 2 proposals (3.8%) were rejected, and 28 proposals (52.8%) were sent back with major queries. For the 28 proposals that required major revisions, 11 responses had been submitted by the time the data were collected. The average length of time to receive a response from the applicants to BREC queries was 4 weeks.
Conclusion. This study suggests that there is a potential cumulative delay of over 4 months before data collection for low-risk clinical audits can be commenced. Any system designed to improve this situation must ensure that high standards of vigilance are maintained, but must be flexible enough to allow for a faster review and approval process.
Methods. After obtaining the appropriate ethical approval, all the correspondence surrounding each Master's proposal for the year 2010 was reviewed.
Results. A total of 53 proposals for Master's degrees were available for review. All the proposals were for low-risk studies, and all were subjected to expedited review. It took an average of 15 weeks (range 3 - 32) for the institutional ethics review board (the Biomedical Research Ethics Committee (BREC)) to respond to each of the 53 proposals. Twenty-three studies (43.4%) received provisional approval on the first response, 2 proposals (3.8%) were rejected, and 28 proposals (52.8%) were sent back with major queries. For the 28 proposals that required major revisions, 11 responses had been submitted by the time the data were collected. The average length of time to receive a response from the applicants to BREC queries was 4 weeks.
Conclusion. This study suggests that there is a potential cumulative delay of over 4 months before data collection for low-risk clinical audits can be commenced. Any system designed to improve this situation must ensure that high standards of vigilance are maintained, but must be flexible enough to allow for a faster review and approval process.
