建置生物資料庫之概括同意問題研究

Abstract

自人類基因圖譜完成定序以來，基因體醫學之研究即邁入新的境界。不同的研究可能、研究方法紛紛如雨後春筍般出現，而生物資料庫挾著近代突飛猛進之資訊技術，不僅成為一供長期研究之資源，也連帶產生不同之社會、倫理、法律(ELSI)層面之衝擊，其中關於因應未來不確定研究之授權所提出之概括同意，更是產生醫學實務、倫理、法律上之重大爭議。台灣目前承接政府打造「生醫科技島」之願景，本著深厚之醫療健保紀錄，搭配完善之戶籍資料以及精進之醫學技術，亦開始著手建立國家型之生物資料庫Taiwan biobank，然而在建置之際，前述問題之解決與釐清即屬重要。 本文以此為問題背景，先追本溯源探究醫學研究倫理當中之指導原則，初步建立告知後同意之規範源起與基本內涵；其次，比較向來告知後同意之模式與概括同意之模式究竟有何不同，並考察國際倫理規範及各國實務運作之規則；再次，於評價各方論點以及比較其優缺後，本文更進一步回歸倫理方面重新檢討作為告知後同意原則基礎之自主(autonomy)概念，嘗試藉由分析自主概念之不同面向後，重新廓清對於告知後同意規範意旨之理解與解釋運用。 本文認為，對於自主之理解，向來之學說太過強調「獨立」、「自我」之特徵，導致評價、描述之重點限於決定者之決定過程是否全然出自其「本身」之價值判斷，然而此種機械式、過分理念式的理解並不適於亟需重建信賴之醫學研究關係，此種詮釋下之告知後同意模式亦無法促進參與者與研究者間之真正互動，並增進雙方之互信和合作。因此，本文嘗試解析自主之不同意涵，認為自主應係一處於「與社會脈絡互動」、「以信賴為基礎」之決定，申言之，在決策之過程當中，對於他人之信賴就系爭決定之自主性應有所助益，甚至係屬必要，在此理解下之自主，也才能提供為參與者與研究者間對話與溝通之基礎，並進而建立雙方之互信合作。 在上述之理解下，本文進一步認為容許概括同意無疑能更進一步地類型化告知後同意原則，且能兼顧不同研究類型之個別需求，在確認有相應之配套機制下，概括同意應屬可行。而所謂之配套機制，係指第一，類型化同意書條款，使參與者與研究者有機會討論並選擇其所欲之參與模式(包括概括同意)。並且須強調參與者對於是否同意(consent)進行人體組織和相關基因資料之蒐集，以及日後是否退出(withdraw)享有決定權；第二，須有一獨立、可代表多元價值之倫理審查委員會可以積極、有效地審查生物資料庫之營運，包含監理資料庫有關檢體收集、保存、管理、使用等流程；並制定自治之倫理規範供生物資料庫營運者遵循，且該倫理規範應事先予以公開供社會大眾或同業審查(peer review)和評價；第三，系爭人體組織以及資料之保存原則上皆應以匿名化之方式處理，且該匿名化措施應受到倫理委員會嚴密之監督。須注意者，所謂匿名化亦有程度上之差異，故即便該人體組織或資料不可識別，但其使用仍應經倫理委員會審查通過為當；第四，就概括同意之後續研究，應有妥當之揭露方式(disclosure)，使參與者得以持續掌握其檢體及資料之使用狀況，以確保其得有意義之行使其退出之權利。我國就Taiwan Biobank之建置雖在眾人努力之下提出了管理條例之草案，惟本文認為因其相應之配套措施仍有不足，尤其是缺乏對於參與者揭露後續資訊和檢體使用之相關資訊之平台與管道，不能確保參與者之信賴，若其推行概括同意仍稍嫌不妥。 於生命科技領域，首要課題當在信賴之重建，法律規範之當為要求尤應著眼此等事實上之存在特徵，以形塑其規範價值，如此方不會產生規範扭曲社會生活正常發展之情形。告知後同意原則作為生醫研究之圭臬，如何廣納各種觀點以形成符合我國社會民情之在地法則，值得吾人繼續努力，本文謹藉探討英、美文獻對於生物資料庫建置中概括同意之爭議，嘗試以另一觀點理解告知後同意原則，期能作為相關論點之討論基礎，亦希冀能為我國生物資料庫之建置提供新的思維。至於更具體之議題，諸如：同意模式之選擇設計、同意書之條款設計、資訊揭露之平台、倫理委員會之具體執掌、自治規範之規劃、生物資料庫資料之儲存與管理流程、資訊安全、第三人之使用條件與監理，乃至於生物資料庫建置所賴之公眾信賴等，僅能留待另文探討。

Following the completion of Human Genome Project, the research of genetic medic has turned to a new page. Benefiting from the improvement of information technology, the establishment of population-based genetic database has become feasible, which also brings new ELSI issues. In Taiwan, based upon the well developed household registrations and medic records, Taiwan Government has initiated the Taiwan Biobank project, which intended to build a long-term researching resource for medic study. However, disputes and doubts over the adoption one-time consent for the unforeseen future research, so called general consent, are still unresolved. This article attempts to provide another approach to examine the consent issue in biobank. By reviewing the ethical principles, this article first introduces the background of the consent issues arising in the field of medic research, and further highlights the differences between general consent and the traditional model of informed consent. After gaining better understanding to the background, this article furthermore examines the relevant international guidelines and compares different consent models in biobank among different countries. For solving issues surrounding general consent, this article opines a revisit to the concept of autonomy is needed. In modern bioethics, the concept of autonomy has been so narrowly interpreted as a form of independence, or at least as a capacity for independent decision and action. However, putting so much emphasis on these perspectives shall bring no good to the development of trust between researcher and participants. As such, this article holds the position that autonomy should be construed on the basis of trust, especially in the context of bioethics. Under this approach, respect of autonomy shall not be merely the pursuit or reserve of independent or individual choices made by participants, but to rebuild trust between researchers and participants. Following this context, the purpose of informed consent doctrine, as far as this article is concerned, is to promote the communication and understanding between researchers and participants, and in turn reestablish trust. As per aforementioned discussion, this article argues that under certain circumstances, one-time consent in biobank shall be acceptable and reasonable in practice, because adopting rigid type of informed consent may sometimes improperly deepen the gap and limit the potential choices between researcher and participants, which contradicts the vary purpose of informed consent. At the mean time, this article also provides certain measures to act as counter-balance to justify the ethical base of general consent, and review the existing regulations in Taiwan, with an attempt to form better basis for further debates on this matter.