79C3C34C52B45572883A05D425EB0F82
Law on Research Using Human Subjects
https://leaux.net/URLS/General/Law_on_Research_Using_Human_Subjects_2011.pdf
http://leaux.net/URLS/ConvertAPI Text Files/4DBF8835F1E65405C06EC0757C6097FE.en.txt
Examining the file media/Synopses/4DBF8835F1E65405C06EC0757C6097FE.html:
This file was generated: 2020-12-01 07:47:57
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Indigenous
Searching for indicator indigenous:
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p.(None): subject to a fine of from NT$50,000 (about US$1,679) to NT$500,000 (art. 24). (Taiwan Legislature Greenlights New Human
p.(None): Subject Research Law, supra.)
p.(None):
p.(None): Before obtaining the consent of participants, those in charge of research projects must clearly inform them of such
p.(None): matters as the project's purpose, research methods, mechanisms for protection of the subjects' rights, measures of
p.(None): remedy against possible risks,
p.(None):
p.(None): https://www.loc.gov/law/foreign-news/article/taiwan-law-on-research-using-human-subjects/
p.(None): Page 1 of 2
p.(None):
p.(None): Taiwan: Law on Research Using Human Subjects | Global Legal Monitor
p.(None): 9/4/20, 6)47 PM
p.(None):
p.(None): and potential revenue from the research and methods for its allocation (art. 14, ¶ 1). (Shih Hsiu-chuan, Draft on Human
p.(None): Research Approved, TAIPEI TIMES (June 4, 2010).)
p.(None):
p.(None): Aborigines
p.(None):
p.(None): The Act prescribes that before aborigines may be used as research subjects, they must be consulted and their individual
p.(None): consent obtained (with certain exceptions, where the other articles on the protection of research subjects' rights
p.(None): apply); these conditions also apply to the release of the research results. Such matters as the arrangements for
p.(None): consultation and consent and for the commercial benefits resulting from the research and their use are to be handled by
p.(None): the central Council of Indigenous Peoples, along with the competent authorities. (Legislature Passes Act on Using Human
p.(None): Subjects in Research, supra; Act, art. 15.) The relevant article in the Act was not in the draft legislation submitted
p.(None): to the legislature by the Executive Yuan (Cabinet); the two legislators who sponsored its introduction deemed it
p.(None): necessary after several cases came to light involving the misuse of genetic material. For example, aborigines' blood
p.(None): samples collected for health research were subsequently used for genetic studies or sold to an overseas genetic
p.(None): database. (Legislature Passes Act on Using Human Subjects in Research, supra.)
p.(None):
p.(None): Some Related Legislation
p.(None):
p.(None): A number of provisions in the Act on Research Involving Human Subjects are mirrored in the Human Biobank Management Act
p.(None): of 2010. (Human Biobank Management Act [in English & toggle Chinese] (Feb. 3, 2010), Laws & Regulations Database of the
p.(None): Republic of China; Wendy Zeldin, Taiwan: Human Biological Database Management Statute Enacted, GLOBAL LEGAL MONITOR
p.(None): (Mar. 2, 2010).)
p.(None):
p.(None): Author: Wendy Zeldin
p.(None):
p.(None): Topic: Science and technology
p.(None):
p.(None): Jurisdiction: Taiwan
p.(None):
p.(None): Date: January 23, 2012
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...
Searching for indicator access to information:
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p.(None): Taiwan: Law on Research Using Human Subjects | Global Legal Monitor
p.(None): 9/4/20, 6)47 PM
p.(None):
p.(None): Library of Congress
p.(None): Law Library of Congress
p.(None):
p.(None): The Library of Congress > Law Library > News & Events > Global Legal Monitor
p.(None): Print Subscribe Share/Save Give Feedback
p.(None):
p.(None): Global Legal Monitor
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Home | Search | Browse All Jurisdictions | Browse All Topics | Browse All Authors | RSS | Top Recent Articles
p.(None): Taiwan: Law on Research Using Human Subjects
p.(None): (Jan. 23, 2012) On December 9, 2011, Taiwan's legislature adopted a new law on the use of human subjects in research
p.(None): projects. Previously, research involving humans was governed by the non-binding Ethical Guidelines for Human Research,
p.(None): formulated by the Department of Health in 2007. (Taiwan Legislature Greenlights New Human Subject Research Law, TAIWAN
p.(None): TODAY (Dec. 12, 2011).) One key feature of the new law is that it makes informed consent by aborigines a precondition
p.(None): for any research involving them and for release of the research results. (Shih Hsiu-chuan, Legislature Passes Act on
p.(None): Using Human Subjects in Research, TAIPEI TIMES (Dec. 10, 2011).)
p.(None):
p.(None): The purpose of the Act on Human Research Subjects is to better protect the subjects' rights, because those rights “tend
p.(None): to be neglected and thus impinged upon, due to such factors as differential access to information and conflicts of
p.(None): interest between subjects and researchers.” (Id.) The Act stipulates that research conducted on humans must respect the
p.(None): subjects' decision-making power, ensure a balance between risks and benefits, minimize infringements, and also attend
p.(None): to the fair assignment of the research burdens and the achievements alike, in order to safeguard the subjects' rights.
p.(None): (Jen-t'i yen-chiu fa [Act on Research Involving Human Subjects] (Dec. 9, 2011) arts. 1 & 2, Parliamentary Library
p.(None): Legislative Yuan website.)
p.(None):
p.(None): Definitions
p.(None):
p.(None): The Act defines research on human subjects as engaging in research on behavioral ecology, physiology, psychology,
p.(None): genetics, medicine, and the like by obtaining, investigating, analyzing, and applying data related to human specimens
p.(None): or individuals.
p.(None):
p.(None): “Human specimens” refers to human organs (including those from fetuses and corpses), tissue, cells, body fluids, or
p.(None): materials derived from test results. (Id. art. 4, items 1 & 2).) The Act also contains a definition for delinking,
p.(None): whereby once the research material or data has been coded or handled by other means, it will become impossible to link
p.(None): or compare it with any identifiable human research subjects. (Id. item 3.)
p.(None):
p.(None): Ethics Review
p.(None):
p.(None): The Act prescribes that a research plan must be approved by an ethics review committee before a research project that
p.(None): involves human subjects can proceed. The committee, to be set up by the research institute concerned, is to comprise a
...
Social / Fetus/Neonate
Searching for indicator fetuses:
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p.(None): formulated by the Department of Health in 2007. (Taiwan Legislature Greenlights New Human Subject Research Law, TAIWAN
p.(None): TODAY (Dec. 12, 2011).) One key feature of the new law is that it makes informed consent by aborigines a precondition
p.(None): for any research involving them and for release of the research results. (Shih Hsiu-chuan, Legislature Passes Act on
p.(None): Using Human Subjects in Research, TAIPEI TIMES (Dec. 10, 2011).)
p.(None):
p.(None): The purpose of the Act on Human Research Subjects is to better protect the subjects' rights, because those rights “tend
p.(None): to be neglected and thus impinged upon, due to such factors as differential access to information and conflicts of
p.(None): interest between subjects and researchers.” (Id.) The Act stipulates that research conducted on humans must respect the
p.(None): subjects' decision-making power, ensure a balance between risks and benefits, minimize infringements, and also attend
p.(None): to the fair assignment of the research burdens and the achievements alike, in order to safeguard the subjects' rights.
p.(None): (Jen-t'i yen-chiu fa [Act on Research Involving Human Subjects] (Dec. 9, 2011) arts. 1 & 2, Parliamentary Library
p.(None): Legislative Yuan website.)
p.(None):
p.(None): Definitions
p.(None):
p.(None): The Act defines research on human subjects as engaging in research on behavioral ecology, physiology, psychology,
p.(None): genetics, medicine, and the like by obtaining, investigating, analyzing, and applying data related to human specimens
p.(None): or individuals.
p.(None):
p.(None): “Human specimens” refers to human organs (including those from fetuses and corpses), tissue, cells, body fluids, or
p.(None): materials derived from test results. (Id. art. 4, items 1 & 2).) The Act also contains a definition for delinking,
p.(None): whereby once the research material or data has been coded or handled by other means, it will become impossible to link
p.(None): or compare it with any identifiable human research subjects. (Id. item 3.)
p.(None):
p.(None): Ethics Review
p.(None):
p.(None): The Act prescribes that a research plan must be approved by an ethics review committee before a research project that
p.(None): involves human subjects can proceed. The committee, to be set up by the research institute concerned, is to comprise a
p.(None): minimum of five disinterested persons of whom at least two-fifths are from outside the institution; neither gender,
p.(None): moreover, may exceed two-thirds of the membership. The Act requires that approved research projects undergo annual
p.(None): reviews. Should irregularities be discovered that affect the rights or safety of the participants, the ethics review
p.(None): committee may suspend the given project until the situation is corrected or cancel it. Any committee member who
p.(None): violates legal procedures during a review or who is found to be involved in the research project will be subject to a
p.(None): fine of from NT$60,000 (about US$1,982) to NT$600,000. (Taiwan Legislature Greenlights New Human Subject Research Law,
p.(None): supra; Act, Ch. 2, Review of Research Plan, arts. 5-11.)
p.(None):
p.(None): Consent
p.(None):
p.(None): Generally speaking, research subjects are to be limited to adults with the capacity of intent. This restriction will
p.(None): not apply, however, in cases where the research is “clearly beneficial” to a specific population or when “it is not
p.(None): possible to find another research subject as a replacement” for such persons (art. 12, ¶ 1). The Act requires that the
p.(None): informed consent of the adult subjects targeted for research be obtained (art. 12, ¶ 2). For participants who are
p.(None): minors, parental consent is necessary; in the case of research involving corpses, the person's pre-death permission or
p.(None): their relatives' consent is required; where fetuses are used, the mothers' consent must be obtained (arts. 12, 13). A
p.(None): research organization that fails to obtain informed consent or that obtains data through force or inducement will be
p.(None): subject to a fine of from NT$50,000 (about US$1,679) to NT$500,000 (art. 24). (Taiwan Legislature Greenlights New Human
p.(None): Subject Research Law, supra.)
p.(None):
p.(None): Before obtaining the consent of participants, those in charge of research projects must clearly inform them of such
p.(None): matters as the project's purpose, research methods, mechanisms for protection of the subjects' rights, measures of
p.(None): remedy against possible risks,
p.(None):
p.(None): https://www.loc.gov/law/foreign-news/article/taiwan-law-on-research-using-human-subjects/
p.(None): Page 1 of 2
p.(None):
p.(None): Taiwan: Law on Research Using Human Subjects | Global Legal Monitor
p.(None): 9/4/20, 6)47 PM
p.(None):
p.(None): and potential revenue from the research and methods for its allocation (art. 14, ¶ 1). (Shih Hsiu-chuan, Draft on Human
p.(None): Research Approved, TAIPEI TIMES (June 4, 2010).)
p.(None):
p.(None): Aborigines
p.(None):
p.(None): The Act prescribes that before aborigines may be used as research subjects, they must be consulted and their individual
p.(None): consent obtained (with certain exceptions, where the other articles on the protection of research subjects' rights
p.(None): apply); these conditions also apply to the release of the research results. Such matters as the arrangements for
...
Social / Mothers
Searching for indicator mothers:
(return to top)
p.(None): moreover, may exceed two-thirds of the membership. The Act requires that approved research projects undergo annual
p.(None): reviews. Should irregularities be discovered that affect the rights or safety of the participants, the ethics review
p.(None): committee may suspend the given project until the situation is corrected or cancel it. Any committee member who
p.(None): violates legal procedures during a review or who is found to be involved in the research project will be subject to a
p.(None): fine of from NT$60,000 (about US$1,982) to NT$600,000. (Taiwan Legislature Greenlights New Human Subject Research Law,
p.(None): supra; Act, Ch. 2, Review of Research Plan, arts. 5-11.)
p.(None):
p.(None): Consent
p.(None):
p.(None): Generally speaking, research subjects are to be limited to adults with the capacity of intent. This restriction will
p.(None): not apply, however, in cases where the research is “clearly beneficial” to a specific population or when “it is not
p.(None): possible to find another research subject as a replacement” for such persons (art. 12, ¶ 1). The Act requires that the
p.(None): informed consent of the adult subjects targeted for research be obtained (art. 12, ¶ 2). For participants who are
p.(None): minors, parental consent is necessary; in the case of research involving corpses, the person's pre-death permission or
p.(None): their relatives' consent is required; where fetuses are used, the mothers' consent must be obtained (arts. 12, 13). A
p.(None): research organization that fails to obtain informed consent or that obtains data through force or inducement will be
p.(None): subject to a fine of from NT$50,000 (about US$1,679) to NT$500,000 (art. 24). (Taiwan Legislature Greenlights New Human
p.(None): Subject Research Law, supra.)
p.(None):
p.(None): Before obtaining the consent of participants, those in charge of research projects must clearly inform them of such
p.(None): matters as the project's purpose, research methods, mechanisms for protection of the subjects' rights, measures of
p.(None): remedy against possible risks,
p.(None):
p.(None): https://www.loc.gov/law/foreign-news/article/taiwan-law-on-research-using-human-subjects/
p.(None): Page 1 of 2
p.(None):
p.(None): Taiwan: Law on Research Using Human Subjects | Global Legal Monitor
p.(None): 9/4/20, 6)47 PM
p.(None):
p.(None): and potential revenue from the research and methods for its allocation (art. 14, ¶ 1). (Shih Hsiu-chuan, Draft on Human
p.(None): Research Approved, TAIPEI TIMES (June 4, 2010).)
p.(None):
p.(None): Aborigines
p.(None):
p.(None): The Act prescribes that before aborigines may be used as research subjects, they must be consulted and their individual
p.(None): consent obtained (with certain exceptions, where the other articles on the protection of research subjects' rights
p.(None): apply); these conditions also apply to the release of the research results. Such matters as the arrangements for
...
Social / gender
Searching for indicator gender:
(return to top)
p.(None): subjects' decision-making power, ensure a balance between risks and benefits, minimize infringements, and also attend
p.(None): to the fair assignment of the research burdens and the achievements alike, in order to safeguard the subjects' rights.
p.(None): (Jen-t'i yen-chiu fa [Act on Research Involving Human Subjects] (Dec. 9, 2011) arts. 1 & 2, Parliamentary Library
p.(None): Legislative Yuan website.)
p.(None):
p.(None): Definitions
p.(None):
p.(None): The Act defines research on human subjects as engaging in research on behavioral ecology, physiology, psychology,
p.(None): genetics, medicine, and the like by obtaining, investigating, analyzing, and applying data related to human specimens
p.(None): or individuals.
p.(None):
p.(None): “Human specimens” refers to human organs (including those from fetuses and corpses), tissue, cells, body fluids, or
p.(None): materials derived from test results. (Id. art. 4, items 1 & 2).) The Act also contains a definition for delinking,
p.(None): whereby once the research material or data has been coded or handled by other means, it will become impossible to link
p.(None): or compare it with any identifiable human research subjects. (Id. item 3.)
p.(None):
p.(None): Ethics Review
p.(None):
p.(None): The Act prescribes that a research plan must be approved by an ethics review committee before a research project that
p.(None): involves human subjects can proceed. The committee, to be set up by the research institute concerned, is to comprise a
p.(None): minimum of five disinterested persons of whom at least two-fifths are from outside the institution; neither gender,
p.(None): moreover, may exceed two-thirds of the membership. The Act requires that approved research projects undergo annual
p.(None): reviews. Should irregularities be discovered that affect the rights or safety of the participants, the ethics review
p.(None): committee may suspend the given project until the situation is corrected or cancel it. Any committee member who
p.(None): violates legal procedures during a review or who is found to be involved in the research project will be subject to a
p.(None): fine of from NT$60,000 (about US$1,982) to NT$600,000. (Taiwan Legislature Greenlights New Human Subject Research Law,
p.(None): supra; Act, Ch. 2, Review of Research Plan, arts. 5-11.)
p.(None):
p.(None): Consent
p.(None):
p.(None): Generally speaking, research subjects are to be limited to adults with the capacity of intent. This restriction will
p.(None): not apply, however, in cases where the research is “clearly beneficial” to a specific population or when “it is not
p.(None): possible to find another research subject as a replacement” for such persons (art. 12, ¶ 1). The Act requires that the
p.(None): informed consent of the adult subjects targeted for research be obtained (art. 12, ¶ 2). For participants who are
p.(None): minors, parental consent is necessary; in the case of research involving corpses, the person's pre-death permission or
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access to information | Access to information |
| fetuses | Fetus/Neonate |
| gender | gender |
| indigenous | Indigenous |
| mothers | Mothers |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
capacity
consent
ethics
protect
protection
Applicable Type / Vulnerability / Indicator Overlay for this Input