人體試驗委員會之行政管制---以受試者保護為中心

Abstract

生醫產業為我國近年來政府之重點發展項目，而人體試驗既為產品上市前之必要階 段，有鑑於試驗自始存在之風險以及利益衝突，「人體試驗委員會」機制之完整性與功 能性，將成為生醫產業發展與受試者權益兼容並進之重要關鍵。我國於2009年醫療法修 正將學名藥試驗免經中央主管機關審查，一旦人體試驗委員會制度出現缺漏，試驗風險 將由受試者全數承擔。另外，我國現行人體試驗委員會性質上為「倫理委員會」，惟要 求其同時監督試驗數據與進行，如針對特定風險或專業程度較高之試驗時，顯然有保護 密度不足之問題。而於醫療行為中受廣泛討論之「告知後同意」與「利益衝突」，尚欠 缺相關之臨床實證研究以反映我國實際之情形與困境。 本研究進程分為二年，第一年將投注於國外立法例、各類型人體試驗委員會之制度、 相關文獻收集與分析，同時對國內修正後醫療法制下現況進行實證研究；第二年則以各 種改革方案的理論基礎、具體操作、改革實例，研擬可適用於我國的基礎，以及人體試 驗委員會的審查程序及標準進行探索，並將舉辦座談以進行研討與意見交流，最後將彙 整研究成果，於學術研討會上報告，並進行論文發表及參與國際研討會。

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.