PMID: 9549558Apr 29, 1998Paper

Monitoring of health research by ethics committees

The New Zealand Medical Journal
A J DouglassS Bloore

Abstract

All health related research carried out within New Zealand requires appraisal from an accredited ethics committee. The purpose of this project was to pilot an active monitoring programme and to assess the effectiveness of such a programme for future monitoring by ethics committees. In this qualitative study interviews were undertaken by representatives from the Wellington and Manawatu-Whanganui ethics committees with principal investigators for sixteen research proposals which had been given ethical approval from the appropriate ethics committee. Issues discussed during the interviews included the protocol and any changes to the methods or research personnel, recruitment of participants, issues arising from informed consent, reporting of adverse events, funding and payment to researchers. Researchers were given the opportunity to provide feedback on the ethical review process and suggestions for improvement. The most significant deviation from the approved protocol concerned access to patient information. Some minor discrepancies between the approved protocols and subsequent research undertaken and the requirements for extending ethical approval of projects beyond the initial approval date were also discussed. The monitoring pr...Continue Reading

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