AIMS: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: The monitoring programme fulfilled an educational role, providing an opportunity for information sharing between ethics committees and researchers. An active monitoring programme by an ethics committee can detect deviations from the approved protocol beyond the current requirements for researchers to provide annual progress reports. Future monitoring should include, where relevant, access to consent forms and patients' notes.
AIMS: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: The monitoring programme fulfilled an educational role, providing an opportunity for information sharing between ethics committees and researchers. An active monitoring programme by an ethics committee can detect deviations from the approved protocol beyond the current requirements for researchers to provide annual progress reports. Future monitoring should include, where relevant, access to consent forms and patients' notes.
Entities:
Keywords:
Biomedical and Behavioral Research; Empirical Approach