Rethinking the Regulation of Human Tissue Research
Date Issued
2015
Date
2015
Author(s)
Li, JYUN LIANG
Abstract
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.
Subjects
Human Tissue Research
Biobank
Informed consent
IRB
Conflicts of interest
Governmentality
Reflexivity
SDGs
Type
thesis
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