美沙酮戒癮治療之緩起訴處分及其成效分析與人體研究法之關係

The Applicable Doubt between the Law of Research Involving Human Subjects with Deferred Prosecution and Its Effectiveness Analysis of Methadone Maintenance Treatment

"法務部自2006年底起實施「毒品減害計畫」，對於施用第一級毒品海洛因（Heroin）之成癮行為人，倘其願意接受美沙酮（美沙冬）替代治療法（Methadone Maintenance Treatment, MMT），則檢察官即可給予緩起訴處分，命其完成戒癮治療，嗣再交由醫療院所執行，其後乃藉由實施此替代療法之成效分析，評判能否有效降低毒品或財產性犯罪再犯率及減少HIV病毒（AIDS）感染之個案數。經實施MMT計畫數年來，官方或非官方研究者，均絡繹不絕地發表其成效分析結果，雖MMT計畫前階段之執行處遇，不適用《人體研究法》之管制，但後階段之成效分析，是否屬於豁免審查範圍？依現行法是否可由研究者自行決定而無庸送相關倫理審查委員會綜合評估後判斷？非無疑義。這也許是《人體研究法》立法時未能慮及不同科學領域相互間之運作實況及特殊性所導致，尤其在學術研究方面，更涉及思想研究自由、言論出版自由之憲法保障問題，故就立法論而言，本文認為將來應修法，讓本質上與人體研究原始目的所欲規範之生物醫學領域迥然不同之人文社會科學之研究，及負有具體特定刑事政策職責之官方機關（構），均無庸適用《人體研究法》之相關規管措施，以自律取代他律，應較妥適。Ministry of Justice since the end of 2006, implemented a ''drug harm reduction'' program for administering Heroin, and if he or she willing to accept Methadone Maintenance Treatment (MMT), the public prosecutor can making a ruling on deferred prosecution, and required the defendant(him or her) to complete drug Rehabilitation treatment, then executed by medical institutions, by analyzing the effectiveness of implemented this alternative therapy, to evaluate whether it can effectively reduce the recidivism rate of drug or property crime, and to reduce infection of the HIV virus (AIDS). After implemented MMT program for several years, official or unofficial researchers published the results of effectiveness analysis constant stream, although the previous stage disposal of MMT program need not applies the regulation of Law of Research involving human subjects, but it's later stage effectiveness analysis, whether or not it should belong to Exempt, should be still submitted to the relevant RECs or IRBs comprehensive assessment, thereafter can be make a decision, it’s can’t determined by the researchers themselves. This is perhaps caused by the Law of Research involving human subjects fail to take into account the actual operation and the special nature between different scientific fields, especially in academic research also involves the research freedom, freedom of speech of constitutional protection issue. Therefore, this article suggests that The Legislative Yuan should be amend the law of Research involving human subjects, to allow the different nature-Humanities and Social Sciences Research field and official authorities that have specific duties for criminal policies--adopt self-discipline replace heteronomy and need not applies this law that its original purpose wanted to regulate the biomedical field."