Abstract
The study is part of continuous review of the Ethics Committee. The objective of the study is to
follow up the adherence of the research proposals approved by the Ethics Committee of the Institute for
the Developments of Human Research Protections (IHRP). Methods: All the studies approved during the
year 2008-2010 were randomized by stratified random sampling. The sample size is 20 from the total of
197 studies. The relevant documents were revised and the researchers were interviewed. The data were
analysed by percentage. Findings: Majority or almost all of the studies adhered to the approved protocol,
i.e., volunteer recruitment, information provision and consent process, submission for protocol amendments,
documentation in case of protocol deviation, keeping and control of studied drugs, provision of
compensation for the volunteers, keeping of confidentiality, data record and the operating procedure in
case of termination of the study. Conclusion: The studies that strictly adhere to the research protocol are
those drug studies, including both new drugs and bioequivalent studies. The main reason for good adherence
is to maintain the credibility of the data, otherwise it will not be accepted for drug registration. Some
studies that were not fully adhere to the practice guidelines for drug studies were social science studies.
Since there was no appropriate guidelines available. The operational guidelines for social science studies
should be developed.
