Regulations on Institutional Review Boards--Focusing on the Protection of Human Subjects
Recently the biotechnology and medicine industry has become one focal point of the research and development policies; hence our government then has taken a series of reformative measures. To assure the safety and efficiency, human subject researches should be done as a cornerstone before biomedical products appearing on the market, and the number of human subject researches has kept growing thereafter. Due to the essential risk and commonly presented conflict of interests, if a peaceful coexistence lies between the evolution and the participant protection in the experiment will depend on the completeness and the capability of the institutional review board（IRB）system. In 2009 the Legislative Yuan passed an amendment of the Medical Care Act, exempting the generic drug human experiment from review by Center for Drug Evaluation（CDE）. Although the new clause was appended because of the relative low risk in the sort of experiments, generic drug has held the most market share of the pharmaceutical industry this decade, so has its human experiments. Once the IRB system was broken, the participants would be the only subjects bear all the consequences. Besides, one of the responsibilities of IRB members is to monitor the whole process during the experiment, and in the meantime our IRB is essentially an “ethic research board”, what if the research involves the vulnerable groups, or the particularly high risk, or the complicated surgery process, the regular and ethic approaches may not be sufficient to guarantee the safety and rights of the participants evidently. In an exposition to informed consent, the resources from empirical studies are too few to clarify the mystery that how exactly the participants can get the correct information from the researchers, and a good system wouldn’t be built unless the situation become lucid. Finally, the conflict of interest problem in IRB system should be solved from the independence, including the personnel management and financial aspect. Therefore we are going to devise a two-year proposal. The first year we suppose to apply ourselves to studying the IRB systems internationally; then analyze the structures, the problems, and the would-be solutions. Furthermore the empirical studies will proceed in internal circumstance. Afterwards in the second year, the material integrated above will be the foundation the domestically designed system we deduced from, and the standard review process in IRB systems. During the process of this project, we will gather opinions from scholars and professionals from diverse fields, and present the result of this project in an international symposium. All the information, results and conclusions will be summing up to be published.