PubMed · 8167760
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A Haddad. 1994-05-05. Do ethics committees work? Yes.. https://pubmed.ncbi.nlm.nih.gov/8167760/
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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.
50 years ago, in Nuremberg, 23 German doctors were accused of crimes against humanity. The anniversary is a solemn reminder of the dark origins of medical research ethics. Many researchers today believe that the medical experiments carried out under Hitler "vaccinated" postwar researchers against abuse. A review of the practices of postwar research shows that the "vaccination" had limited effect and that there is no reason to believe that the events which took place under Hitler were unique and will never happen again. After the war various measures were introduced to protect research subjects: informed consent, self regulation and independent research ethics committees. The measures have undoubtedly limited the abuse of subjects substantially. Nevertheless, in the Armed Forces, where abuse has been most rampant after the war, informed consent is not always practised and independent review is seldom carried out. With the support of grant institutions, journals and industry the protection of research subjects can be improved. It is recommended that medical faculties arrange an annual commemoration of the victims of medical research in order to raise consciousness and awareness among teachers and students.