論人體檢體生物醫學研究之管制體系─以委員會控核機制及研究倫理法律義務為核心

Abstract

本文研究範圍乃在探討「人體檢體生醫研究」之管制體系，限定於「在國內，研究者利用自一活的成人研究參與者，無常態心神耗弱或心神喪失之個人身上所取得之檢體，以為研究對象而進行之生物醫學研究」。我國法對「人體檢體生醫研究」之管制法規，應兼有「人體研究法」與「人體生物資料庫管理條例」與其下的諸行政命令。 人體檢體生醫研究之管制機制，係以「研究倫理及法律義務」與「機構內委員會控核」二者為主軸。其中，「研究倫理及法律義務」中最為重要且實現可能性最高者，乃是基於「尊重個人原則」下的「告知後同意」機制。 本文核心問題圍繞在人體檢體生醫研究之管制機制的礎石中，即「「『告知後同意』機制如何可能？」以及「『機構內委員會控核』機制如何可能？」本文從我國法、國際倫理規範、美國法及日本法相互比較作為素材，而以Barthes神話學、Foucault之權力視角作為觀點，探討上揭問題。 但若將「『告知後同意』（能指）─『尊重個人原則』（所指）」視為一個符號，而將之問題化之後，反思其在第二系統內的意義之後，反而會發現正是「告知後同意」蘊含了「增強對生物醫學知識的『不反身』與盲目接受」、「永遠缺憾的同意」，並強化新自由主義下過度資訊的挹注而要求研究參與者基於自我負責原則，在其同意之後即須承擔一切之後果，此一主體性的形塑。 為解消告知後同意這種溝通形式帶來的各種權力機制以及暴力，必須要製造的是，身處於互動中具有較高資訊優勢的研究者�生物資料庫運營者足以反身的契機。本文認為透過事後「風險社會損害共擔」機制之建構，或許得以展開出客觀形上基礎中的削弱機制。因此，建議行政機關透過法規命令，形塑相關之契約義務、責任等定型化契約條款，要求訂入契約。但契約責任以非財產上損害賠償為主。除了風險共擔機制的建構，也仍應當強調對研究參與者之利益回饋約款，始得促發研究參與者與研究者共同形塑知識生產過程的誘因。另一方面，透過「損失墊償保證基金」的設置，作為對應於風險共擔機制的「保險機制」。 一般認為，「機構內委員會控核」機制則係以研究參與者自主權保障為核心理念，要求研究計畫書必須先由機構內倫理審查委員會考量、評論、指導及核准後，方可進行研究，重點在於跳脫研究者的判斷，自倫理之觀點判斷研究計畫之過程是否足以保障研究參與者之人身安全、尊嚴及隱私等權益 本文認為「機構內倫理審查委員會控核」─IRB倫理審查制度所呈現的治理性有：1. 生命倫理成為一項新的專業場域，而研究的正當性與否取決於此。2. 從科學的客觀性誡命產出「集體審查制度模型」決定研究執行的正當性。3. 決定研究是否具有正當性僅屬純粹的「生命倫理專業場域內的象徵鬥爭」。4 機構內倫理審查委員會的集體審查判斷，形塑了「最適當的研究規矩」以規訓研究者。 本文在機構內委員會控核機制上建議：1. 委員會行政組織得設置類似於組織之監督者與協力者的職位。2. 確保審核過程中，能有審查組織多元意見性之確保。3. 預算經費獨立化。4. 明確化「倫理審查委員之財務上利益衝突」之規範文義範圍。5. 應公開所有倫理審查委員會之利益關係。6. 得有主管機關介入之可能性。7. 針對研究計畫各階段可能具有不同的風險種類，設計不同的適用程序。8.引入公眾參與，進入查核制度與查核項目的形構 至於生物資料庫式人體檢體生醫研究，我國法的缺點在於：1. 採用「概括同意」的立法模式，過度削弱研究參與者自主權行使，並使其高度暴露於自主權侵害風險。2. 生物資料庫式人體檢體生醫研究之規制上採取行政機關監理制，有違反言論自由事前檢查禁止原則。3. 人體生物資料庫商業運用利益回饋辦法立法上可能導致嚴重妨害財務上弱勢研究者的研究自由，且僅得用於個人，殊有不足。 本文則建議在生物資料庫式人體檢體生醫研究上：1. 設置許可申請審查程序中應當有公眾參與之程序。2. 應當透過wiki治理模式，針對營運事項上，建置一政策平台由生物資料庫倫理委員會提出運營政策草案，再由研究參與者增修刪改。3. 倫理委員會得容由研究參與者選任一定比例之成員。4. 應設置監察組織，且由研究參與者具有一定之選任權。5.生物資料庫式人體檢體生醫研究管制上應廢除「行政機關監理」制。 關於研究者之利益衝突，我國法規範無論是文義明確性或管制實效性均有疑慮。本文認為：1. 將利益衝突事項列入告知事項。2. 主管機關應當頒布一解釋函令，對於「利益衝突」訂立一定之標準，並採取「例示類型」連攜「概括條款」之規範模式。3.參照美國法之規範，倫理審查委員會認定為利益衝突時，應當公開。公開方式係得以在倫理審查委員會於公開網站公開。4. 增列倫理審查委員會對主管機關針對「利益衝突」之通報機制。5. 立法上應當認為對於有嚴重利益衝突之研究，在倫理審查委員會怠為介入，主管機關具有暫時中止研究之權力。

The scope of this thesis is concerning the regulation of “Human Tissue Research”, and is restricted to discussing that “researchers use the tissues from living persons who aren’t vulnerable, psychotic, mental-disturbed or in a state of unconsciousness, in order to conduct biomedical tissue researches.” In Taiwan, the regulation is “Human Subjects Research Act”, “Human Biobank Management Act”, and related administrative rules. The axes of the regulation of human tissue research are “researchers’ responsibilities from law and bioethics” and “IRB control”. Among the researchers’ responsibilities, the most significant one is “informed consent.” “IRB control” means all the human tissue research proposals should be asked to be carefully examined by an independent ethical review committee. The core issues in this thesis are “how is ‘informed consent’ possible?” and “how is ‘IRB control’ possible?.” The horizons of this thesis are “Mythology(addressed by Roland Barthes)” and “Perspective of Foucauldian Theory of Power” with reference to the “international regulations”, “U.S. laws and regulations” and “Japanese regulations” on purpose to analyze these questions and rethink the regulation in Taiwan. Through “Mythology”, we can become aware that “informed consent” strengthens a tendency which research participants would accept the legitimacy thoughtlessly and authority of biomedical knowledge production and have no reflexive thought on it. And meantime, “informed consent” respond to the crafting of subjectivity in Neo-liberalism, which means research participants will bear all the consequences and responsibilities based on the neoliberal logics of self-responsibility(personal responsibility) after consenting the providing and research use on their tissues. To resist to and liberate from the mechanism of power in the communicating form which the process of “informed consent” contains, it is necessary to create a moment that researchers/ biobank operators can reflexively rethink the reason of human tissue researches. Hence, this thesis proposes that by constructing the mechanism of “damage partaking” in risk society, there would produce a threshold that can weaken the groundwork for the objective metaphysics. For this reason, the competent authority should promulgate administrative rules to make rights and obligations related to “communication on the process of knowledge production” and responsibilities for damage partaking(mainly compensation for non-pecuniary damage) included in the contractual relationship between researchers and research participants. Moreover, the competent authority should promulgate administrative rules to bring “the benefit sharing mechanism” into the contractual relationship between researchers and research participants in order to give research participants some motives for participate in the process of knowledge production substantially. On the other hand, the competent authority should found the “compensation insurance fund” to be a “insurance” correlated to the mechanism of “damage partaking.” Generally considering, the purpose of the mechanism of “IRB control”, is to protect the rights and benefits of research participants, because these review works should be conducted by a group of independent experts, not researchers themselves. The governmentality on which the mechanism of “IRB control” is based is: 1. “Bioethics” has become an important professional field and the legitimacy of human tissue research is dependent on bioethics, 2. It is the model of “group review” based on Science’s and Professionalism’s objectivity, rationality, and generalizability to decide if the examined research is legitimate, 3. The mechanism of “IRB control” is substantially symbolic struggles conducted by researchers and IRB commissioners in “Bioethics” and academic fields, and 4. Group consideration of IRB defines the most appropriate manner to discipline the researchers. To reform the mechanism of “IRB control”, this thesis proposes that: 1. In IRB, there should set up IRB analysts to be responsible for overseeing and assisting the operation of IRB, 2. In IRB review process, the composition of conferees should be asked to appear on multivariate stands, 3. The funding resources of IRB should be independent, 4. The regulation on “ financial conflicts of interest of IRB commissioners” should be specified, 5. All financial relationship of IRB should be public, 6. On specific conditions, the competent authority would intervene in the operation of IRB, 7. There should be diversified review processes devised corresponding to various types of risk, and 8. In surveying and evaluating ethical review practices, there should be public participation to form the concrete surveying and evaluating details. Regarding human tissue research with biobank, the defects of “Human Biobank Management Act” are: 1. Accepting “board consent” in research participants’ consent results in decreasing the autonomy of research participants, 2. The conduct of human tissue research with biobank should be permitted previously by the competent authority, so it violates the prior restraint doctrine based on freedom of speech, and 3. The administrative rule concerning distribution of profits derived from the commercial use of research findings with biobank causes discrimination against impoverished researchers, and it is inappropriate to permit the biobank share benefit only with population, not with person. With regard to the regulation of human tissue research with biobank, this thesis proposes that: 1. There should be public participation in the administrative of biobank institution permit, 2. For operation of biobank, there should be forum and platform which the researcher participants, researchers, biobank operators, ethics committee commissioners and other interested person can discuss, exchange views with each other and form binding governance policies on by means of “wiki-governance”, 3. A specific proportion of ethics committee commissioners should be elected by research participants, 4. There should be supervisors of which a specific proportion elected by research participants in biobank, and 5. The prior permit process of the conduct of human tissue research with biobank by the competent authority should be abolished. Regarding the regulation of researchers’ conflicts of interest, the related law or administrative rules in Taiwan is inadequate about legal certainty and validity. Therefore, this thesis proposes that: 1. The matters of researchers’ conflicts of interest should be informed research participants by researchers in the process of informed consent, 2. The competent authority should promulgate interpretative letters, guidances or directives to define the regulated conflicts of interest, 3. All the regulated conflicts of interest identified by IRB should be public in Website of the IRB or by other means, 4. There should be a notification mechanism to the competent authority for the regulated conflicts of interest , and 5. When the researchers’ conflicts of interest are so serious that it have sufficient negative effects on the credibility of researches and the IRB is inactive, the competent authority should be authorized to suspend the research.