評人體研究法的倫理審查機制——憲法疑義與修正建議

The Ethics Review Mechanism under the Human Subjects Research Act: Constitutional Problems and Suggestions to Reform

我國二○一一年通過的人體研究法，將倫理審查機制之適用，擴大及於藥品人體試驗以外的其他人體研究，是我國研究管制上的一項重大發展，對人體研究中受試者權益之保障意義匪淺。但是，倫理審查機制要求對研究計畫進行事先審查，產生限制研究自由的疑慮。倘若未妥善設計，可能因為審查者基於自身價值觀或學術意見而干預研究計畫之內容，造成對研究自由之戕害。不幸的是，研究自由的考量在人體研究法的立法中並未受到注意。
本文認為，我國人體研究法下的倫理審查機制具有高度之違憲嫌疑。相關規定構成針對言論內容之事前限制，但其規範設計恐無法通過事前限制所觸發的嚴苛審查。同時，本法適用範圍之規定亦有不夠明確的問題。本文建議，在適用範圍、審查權限與救濟機制這三個面向進行改革。而在修法之前，審查會、衛福部與法院，亦應體察憲法價值，將研究自由之精神融入對相關法條之解釋與適用。

The enactment the Human Subjects Research Act in 2011 is a significant development in Taiwan’s research regulation, The said act covers various kinds of research involving human subjects and extends the requirement of ethics review beyond drug clinical trials.
Ethics review mechanism, which requires a prior review of a research project, raises the issue concerning the freedom of research. If the mechanism is not carefully designed, reviewers might intervene in the content of research projects or even reject the projects because of different viewpoints and, consequently, create an undue burden on the freedom of research. Unfortunately, consideration regarding the freedom of research was absent in the enactment of the Human Subjects Research Act.
This study argues that the ethics review mechanism under the Human Subjects Research Act is likely to be unconstitutional. The regulation at issue constitutes a content-based prior restraint and its design cannot overcome the heavy presumption of unconstitutionality born by prior restraints. In addition, the provision regarding the scope of application is too vague. To solve these constitutional problems, this article proposes reforms in terms of application scope, review power, and remedy mechanism. Before the law is revised, IRBs, authorities, and courts should also interpret related provisions with the constitutional spirit of free research to limit review discretion and allow administrative appeals and litigations.