RESUMO
Adverse drug reactions (ADRs) have ethical implications. These include assessment of the risk-benefit ratio and re-administering informed consent based on the new ADRs identified. The Indian Council of Medical Research ethical guidelines mandate the scrutiny of ADR; and the standard operating procedures of the ethics committee of the authors' medical school endorse this line. However, institutional review board members are often hardpressed for time and are unable to analyse all the reported ADRs as thoroughly as required. This calls for a dedicated system for the scrutiny of ADRs. This paper seeks to share the experience of development and implementation of a review mechanism for ADR monitoring. The authors report an innovation in ADR monitoring by appointing a technical advisor on ADR (TA-ADR). During routine assessment, an unusual occurrence of ADRs was noticed from internal and external sites which were related to the study drug, which in turn resulted in the trial being put on hold. This system is being reported here for possible adoption by others.
