EXPERIENCES IN REVIEW OF CLINICAL TRIALS

The purpose of an IHEC (Institutional Human Ethics Committee) review is to ensure that appropriate steps are taken to protect the rights and welfare of participants as subjects of research. If the risks to participants are found to be too great, the IHEC will not approve the research, or it will specify changes that must be made before the research can be done. The EC (Ethics committee) review process of a trial protocol includes three different considerations: science, ethics and data quality. Any clinical trial with poor science, poor ethics or poor data quality puts participants at unnecessary risk of harm. This study aims to list out the scientific and ethical issues identified during review of clinical trials at IHEC. On IHEC approval, all the clinical trials approved over the past five years in IHEC, were analyzed using a proforma by the investigators (1-3) who are IHEC members & the anonymized raw data was given to the investigator number 4 who is not an IHEC member. 33 clinical trials were included for the study. Scientific and ethical considerations that were raised by IHEC was noted. The results of the study revealed that the issues were mainly related to the methodology and selection of participants as well as on the risks involved, insurance aspects and post-trial access. Most of the clinical trials were approved after the required modifications and some required major revision. Few unacceptable projects were rejected. The data indicate that the ethical committee reviews both scientific as well as ethical aspects.