MONITORING OF HEALTH RESEARCH BY ETHICS COMMITTEES

Aims, All health related research carried out within New Zealand requi res 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 com mittees. 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 com mittee. Issues discussed during the interviews included the protocol a nd any changes to the methods or research personnel, recruitment of pa rticipants, issues arising from informed consent, reporting of adverse events, funding and payment to researchers. Researchers were given th e opportunity to provide feedback on the ethical review process and su ggestions for improvement. Results. The most significant deviation fro m the approved protocol concerned access to patient information. Some minor discrepancies between the approved protocols and subsequent rese arch undertaken and the requirements for extending ethical approval of projects beyond the initial approval date were also discussed. Conclu sions, The monitoring programme fulfilled all educational role, provid ing an opportunity for information sharing between ethics committees a nd researchers. All active monitoring programme by an ethics committee can detect deviations from the approved protocol beyond the current r equirements for researchers to provide annual progress reports. Future monitoring should include, where relevant, access to consent forms an d patients' notes.