| 摘要: | 醫藥與生物科技不斷地快速發展，人類因醫藥科技發達之緣故，使生命得較以往更為延長。醫藥既應用於人類身體，則新醫療技術或新藥品等，在全面性應用於人體之前，必然先經過試驗之過程，以確保該項新醫療技術或新藥品確實具有效用。是以，人體試驗即為無可避免之過程。然人體試驗係以「人」作為試驗之客體，研究者進行人體試驗，將會侵害受試者之基本權。準此，為保障受試者之基本權，法規範必須對人體試驗予以適當之限制，惟此一限制在維護受試者基本權之餘，仍應兼顧醫藥科技之發展。準此，法規範限制人體試驗之分際，乃為重要之課題。
我國之人體試驗相關規定，主要見於醫療法。本文將先行介紹人體試驗之定義與起源，復說明人體試驗之國內外相關規範，闡述人體試驗之相關國際倫理規範，並參酌美國法，與我國之醫療法、藥事法、人體研究法等相關法規作一對照，探究我國之人體試驗法令有無不足之處，以期作為未來修法時之參考。
當人成為人體試驗之受試者後，基本權將無可避免地受到侵害。是以，研究者應重視受試者之基本權，減少不必要之侵害。準此，為落實保障受試者，人體試驗應以「告知後同意」為核心，由受試者自行決定其是否參與人體試驗。本文將說明人體試驗所牽涉之受試者基本權，並以告知後同意作為中心，探討保護受試者基本權與生命倫理之相關問題。
人體試驗在實務操作上，仍然存有些許爭議問題。例如：限制行為（無）行為能力人、受刑人或俘虜、孕婦等族群，因其本身意思能力、所處環境、身體狀況等因素較為特殊，是以，在這些族群成為人體試驗之受試者時，應給予其不同於一般受試者之合理差別待遇。再者，關於人體試驗產生利益衝突之問題，其解決之道亦未見於我國人體試驗法令之中。此外，人體試驗是否應除罪化，向為一具有高度爭議之問題，雖現今醫療法第79條第5項業已明文規定人體試驗除罪化，然此一規定是否妥適，仍非無疑。因此，本文就上揭爭議問題進行研究並提出淺見。
最後，本文將綜合上述研究結果，於結論章節提出本文見解，以期受試者權利得以受到更妥適之保護，人體試驗亦能更加順利地發展。
With the development of medical technology, people’s life is longer than the past. In order to ensure the new technology of cure or the new medicine is useful to heal the sick, researchers have to make experiments before it is applied to human beings. So, the human subject research is a necessary process of the medical technology. The human subject research will cause damage to human subjects’ rights. In order to protect human subjects, the law has to restrain the research involving human subjects.
First, this thesis will bring up the definition and the history of human research. Then, the thesis is going to discuss about the international ethical principles for medical research involving human subjects. And this thesis will introduce the principles for human subject research in the United States, too. In our nation, the rules for human subject research are located in “Medical Care Act”. The thesis will have an explanation about the principles of our nation, comparing the rules of our nation with the American and the international ethical principles to find out what we lack.
In the human subject research, “informed consent” is the most important concept. In my opinion, it is the kernel of human subject research. Researchers must ensure that all the human subjects are willingly to join the research to avoid ruining their human rights. In this paragraph, the thesis will have an introduction about the rights of human subjects first, and then explain the meaning of “informed consent”. Finally, it will concentrate on protection of human subjects and the issues of life ethics.
Some controversies still exist in the practical operation of the human subject research. First, we should offer additional protections for children, prisoners, and pregnant women involved in research because they are vulnerable and much more different from general human subjects. Second, conflict of interest may happen when the research is proceeding, but there seem no proper rules about conflict of interest in our human research regulations. Furthermore, decriminalization of human subject research is a highly controversial issue. Though we have the rules of decriminalization of human subject research in Medical Care Act, it doesn't seem to offer a good answer about this issue.
Finally, the thesis will propose the conclusions about these issues and make humble opinions at the end. |
