79C3C34C52B45572883A05D425EB0F82

Human Subjects Research Act (2011):

https://law.moj.gov.tw/ENG/LawClass/LawAll.aspx?pcode=L0020176

http://leaux.net/URLS/ConvertAPI Text Files/838A1D9CD34768B8AB429C7DAFEF5A3C.en.txt

Examining the file media/Synopses/838A1D9CD34768B8AB429C7DAFEF5A3C.html:

This file was generated: 2020-12-01 07:48:29

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

Vulnerability Type	Vulnerability	Indicator	# Matches
Political	Indigenous	indigenous	3
Health	Drug Usage	influence	1
Social	Child	child	1
Social	Elderly	elderly	1
Social	Fetus/Neonate	fetus	3
Social	Property Ownership	home	1
Social	gender	gender	1
General/Other	Impaired Autonomy	autonomy	1
General/Other	Relationship to Authority	authority	10

Political / Indigenous

Searching for indicator indigenous:

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p.(None): 3. The decedent expressly intended prior to death to permit research use, and two or more physicians attest thereto in writing. Where
p.(None): the decedent’s identity is unknown or consent is refused by the relations under Paragraph 3 of the preceding Article, this provision
p.(None): shall not apply.
p.(None):
p.(None): Article 14
p.(None): Where the principal investigators have yet to obtain the consent under Article 12, they shall ensure that the human subjects or their
p.(None): relations, legal representatives, guardians, or assistants understand the following matters:
p.(None): 1. The research entity name and source of funds
p.(None): 2. The research purpose and methods
p.(None): 3. The principal investigator’s name, title and responsibilities
p.(None): 4. The person’s name and ways of contact related to the research
p.(None): 5. Protection of human research subject’s rights and mechanisms for their personal data protection
p.(None): 6. The fact that research subjects may revoke their consent at anytime and the ways of revocation
p.(None): 7. Foreseeable risks and ameliorative measures in the incidence of any damages
p.(None): 8. Research material preservation limits and plans for uses thereof
p.(None): 9. Agreed derivative commercial benefits and agreed uses of the research results relating thereto
p.(None): The principal investigator must obtain consent, without resort to any duress, solicitation or other improper means.
p.(None):
p.(None): Article 15
p.(None): Where the research purpose involves indigenous people, then besides the requirements of Article 12 through 14 supra, there shall
p.(None): additionally be required consultations to obtain the consent of their indigenous group; any publication of research results shall require
p.(None): the same consent.
p.(None): The Central Council of Indigenous Peoples shall stipulate the consultation mentioned in the preceding Paragraph, as well as consent,
p.(None): agreed commercial benefits, and other agreed uses in conformity with the competent authority.
p.(None):
p.(None): Chapter 4 Administration of Research Protocols
p.(None):
p.(None): Article 16
p.(None): Research entities shall ensure necessary supervision throughout conduct of the research protocol approved; where any significant
p.(None): non-conformity occurs, they shall order cessation or order termination of the research.
p.(None):
p.(None): Article 17
p.(None): The IRB shall, for every approved research protocol, throughout the conduct thereof, provide at least one annual audit.
p.(None): Where the IRB discovers any of the following conditions in the conduct of a research protocol, they shall order the research protocol
p.(None): into cessation for amelioration within a specified period of time, or to be terminated, and shall notify the research entity and the
p.(None): responsible ministry of central government:
p.(None): 1. Where a required IRB approval was not obtained, and amendments were undertaken in the research protocol without prior
p.(None): permission
p.(None): 2. Any matter materially affecting research subject rights or safety
p.(None): 3. Abnormal frequency of adverse events or irregular degrees of severity
p.(None): 4. Sufficient evidence evinces the research is not necessary
p.(None): 5. Any other matter arises affecting the research risks and benefits analysis
p.(None): After the research protocol is completed, should any of the following conditions arise, the IRB shall undertake an investigation, and
p.(None): notify the research entity and central competent authority of relevant entities:
...

Health / Drug Usage

Searching for indicator influence:

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p.(None): During IRB meetings, the IRB may invite the attendance of experts familiar with the research field, or representatives of any
p.(None): appropriate group affiliated with the human subjects, to attend and provide comments.
p.(None): The competent authority shall stipulate regulations to govern matters related to the IRB organization, meetings, review processes and
p.(None): scope, conflict of interest principles, supervision, administration, and other matters of compliance.
p.(None):
p.(None): Article 8
p.(None): Review of research protocol shall be conducted in accordance with the degree of risk presented, as docketed for standard review or
p.(None): expedited review.
p.(None): Expedited review procedures under the preceding Paragraph shall only be available if the scope of the research lies within the
p.(None): categories announced by the competent authority.
p.(None):
p.(None): Article 9
p.(None): Where research personnel are unaffiliated with a research entity or not engaged in cooperative research with a research entity, they
p.(None): shall nevertheless be required to obtain IRB approval from one research entity or approval from a non-research entity affiliated
p.(None): independent IRB, prior to engaging in a protocol.
p.(None):
p.(None): Article 10
p.(None): Where the research protocol involves two or more research entities, it may be approved by one of those IRBs agreed by the research
p.(None): entities involved, as well as to be responsible for the review, supervision and auditing.
p.(None):
p.(None): Article 11
p.(None): An IRB shall conduct review processes independently.
p.(None): Research entities shall ensure that the IRB review is not subject to any untoward influence of any research entity, principal
p.(None): investigator or protocol consignor.
p.(None):
p.(None): Chapter 3 Protection of Research Subjects Rights
p.(None):
p.(None): Article 12
p.(None): Where the research subjects are other than a fetus or corpse, such subjects shall consist only of adults capable of communication.
p.(None): However, where the research obviously benefit specific groups or the subjects are irreplaceable, is not subjected to this rule.
p.(None): Research protocol shall obtain the consent of participating research subjects as approved by the IRB. But the research protocol within
p.(None): the scope of exemption categories for consent requirements, as announced by the competent authority, shall not apply.
p.(None): Where the research subject is a fetus, the consent specified in the first Paragraph shall be obtained from the mother; where the
p.(None): subject has been judicially declared to be of limited legal capacity or under assistance, consent shall be obtained from both the
p.(None): individual and their legal representative or assistant; where the person is incompetent or under guardianship, consent shall be
p.(None): obtained from their legal representative or guardian; where the proviso in the first Paragraph is applicable, consent shall be obtained
...

Searching for indicator child:

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p.(None):
p.(None): Article 12
p.(None): Where the research subjects are other than a fetus or corpse, such subjects shall consist only of adults capable of communication.
p.(None): However, where the research obviously benefit specific groups or the subjects are irreplaceable, is not subjected to this rule.
p.(None): Research protocol shall obtain the consent of participating research subjects as approved by the IRB. But the research protocol within
p.(None): the scope of exemption categories for consent requirements, as announced by the competent authority, shall not apply.
p.(None): Where the research subject is a fetus, the consent specified in the first Paragraph shall be obtained from the mother; where the
p.(None): subject has been judicially declared to be of limited legal capacity or under assistance, consent shall be obtained from both the
p.(None): individual and their legal representative or assistant; where the person is incompetent or under guardianship, consent shall be
p.(None): obtained from their legal representative or guardian; where the proviso in the first Paragraph is applicable, consent shall be obtained
p.(None): in the following order of precedence from an appropriate relation:
p.(None): 1. A spouse
p.(None): 2. An adult child
p.(None): 3. Parents
p.(None): 4. Siblings
p.(None): 5. Grandparents
p.(None): Where the consent is provided in writing by a relation pursuant to the preceding Paragraph, such written consent may be sufficient
p.(None): where obtained from any such individual; where the express intent of such persons is not unanimous, the order of precedence above
p.(None): shall apply to determine the matter. In the preceding order of precedence, among the same order, closer relatives shall be accorded
p.(None): priority; where the relatives are of the same degree of closeness, cohabitation shall be accorded priority; and in case of non-
p.(None): cohabiting relatives, the elderly shall be accorded priority.
p.(None):
p.(None): Article 13
p.(None): Where the research subject is a corpse, one of the following conditions must apply:
p.(None): 1. The deceased had consented in writing prior to death or in a will.
p.(None): 2. In accordance with Paragraph 3 of the preceding Article, written consent is obtained from a relation. But such consent may not
p.(None): vitiate the express intent of the decedent prior to death.
p.(None): 3. The decedent expressly intended prior to death to permit research use, and two or more physicians attest thereto in writing. Where
p.(None): the decedent’s identity is unknown or consent is refused by the relations under Paragraph 3 of the preceding Article, this provision
p.(None): shall not apply.
p.(None):
p.(None): Article 14
...

Searching for indicator elderly:

(return to top)
p.(None): Where the research subject is a fetus, the consent specified in the first Paragraph shall be obtained from the mother; where the
p.(None): subject has been judicially declared to be of limited legal capacity or under assistance, consent shall be obtained from both the
p.(None): individual and their legal representative or assistant; where the person is incompetent or under guardianship, consent shall be
p.(None): obtained from their legal representative or guardian; where the proviso in the first Paragraph is applicable, consent shall be obtained
p.(None): in the following order of precedence from an appropriate relation:
p.(None): 1. A spouse
p.(None): 2. An adult child
p.(None): 3. Parents
p.(None): 4. Siblings
p.(None): 5. Grandparents
p.(None): Where the consent is provided in writing by a relation pursuant to the preceding Paragraph, such written consent may be sufficient
p.(None): where obtained from any such individual; where the express intent of such persons is not unanimous, the order of precedence above
p.(None): shall apply to determine the matter. In the preceding order of precedence, among the same order, closer relatives shall be accorded
p.(None): priority; where the relatives are of the same degree of closeness, cohabitation shall be accorded priority; and in case of non-
p.(None): cohabiting relatives, the elderly shall be accorded priority.
p.(None):
p.(None): Article 13
p.(None): Where the research subject is a corpse, one of the following conditions must apply:
p.(None): 1. The deceased had consented in writing prior to death or in a will.
p.(None): 2. In accordance with Paragraph 3 of the preceding Article, written consent is obtained from a relation. But such consent may not
p.(None): vitiate the express intent of the decedent prior to death.
p.(None): 3. The decedent expressly intended prior to death to permit research use, and two or more physicians attest thereto in writing. Where
p.(None): the decedent’s identity is unknown or consent is refused by the relations under Paragraph 3 of the preceding Article, this provision
p.(None): shall not apply.
p.(None):
p.(None): Article 14
p.(None): Where the principal investigators have yet to obtain the consent under Article 12, they shall ensure that the human subjects or their
p.(None): relations, legal representatives, guardians, or assistants understand the following matters:
p.(None): 1. The research entity name and source of funds
p.(None): 2. The research purpose and methods
p.(None): 3. The principal investigator’s name, title and responsibilities
p.(None): 4. The person’s name and ways of contact related to the research
p.(None): 5. Protection of human research subject’s rights and mechanisms for their personal data protection
p.(None): 6. The fact that research subjects may revoke their consent at anytime and the ways of revocation
...

Searching for indicator fetus:

(return to top)
p.(None): Implementation of research involving human subjects shall be governed by this Act. Where another law provides special provisions in
p.(None): relation whereof, such regulations shall instead govern.
p.(None):
p.(None): Article 2
p.(None): Human subject research should respect the autonomy of the human subjects, and ensure balance of the risks and benefits from
p.(None): conduct of the research, minimizing invasiveness to the human subjects, and securing equitable distribution of research burdens and
p.(None): results, while protecting human subject’s rights.
p.(None):
p.(None): Article 3
p.(None): The “competent authority” as referred to herein means the Ministry of Health and Welfare.
p.(None): Supervision, audit, administration and penalization of human subject research, as well as human subject protection, shall lie with the
p.(None): central competent authority with responsibility over the organization (institution), school, legal entity or group (hereinafter “ the
p.(None): research entity”) that principal investigator of the human subject research (hereinafter “the principal investigator”) serves.
p.(None):
p.(None): Article 4
p.(None): Definitions:
p.(None): 1. Human subject research (hereinafter “research”): refers to research involving obtaining, investigating, analyzing, or using human
p.(None): specimens or an individual person’s biological behavior, physiological, psychological, genetic or medical information.
p.(None): 2. Human specimens: refer to human (including a fetus and corpse) organs, tissues, cells, body fluids, or any derivative biomaterial
p.(None): arising from experimentation therewith.
p.(None): 3. Delinkage: refers to the operation of permanently disabling encoded biological specimens, data, and information from being linked
p.(None): to or matching them with the subjects personal data or information.
p.(None):
p.(None): Chapter 2 Review of Research Portocols
p.(None):
p.(None): Article 5
p.(None): Prior to conduct a research, the principal investigator shall submit the research protocol for review and approval by the Institutional
p.(None): Review Board (hereinafter “IRB”). However, the research protocol within the scope of exemption categories for IRB review, as
p.(None): announced by the competent authority, shall not apply.
p.(None): The review in the preceding Paragraph shall be conducted by the research entity’s IRB. Where an entity does not have an
p.(None): established IRB, the review may be conducted by IRB of other entity.
p.(None): Amendments of an approved research protocol shall be submitted for IRB approval prior to its implementation.
p.(None): Article 6
p.(None): The research protocol in the preceding Article, shall include the following matters:
p.(None): 1. Protocol title, principal investigator, and research entity.
p.(None): 2. Abstract of the protocol, research subjects and experimental methods.
p.(None): 3. Estimated timetables.
p.(None): 4. Ways and content of human subject protection and consent obtaining.
p.(None): 5. Research personnel and equipment requirements.
p.(None): 6. Research funding requirements and sources.
p.(None): 7. Expected results and primary benefits from the research.
p.(None): 8. Attribution of research results and uses thereof.
...

p.(None): scope, conflict of interest principles, supervision, administration, and other matters of compliance.
p.(None):
p.(None): Article 8
p.(None): Review of research protocol shall be conducted in accordance with the degree of risk presented, as docketed for standard review or
p.(None): expedited review.
p.(None): Expedited review procedures under the preceding Paragraph shall only be available if the scope of the research lies within the
p.(None): categories announced by the competent authority.
p.(None):
p.(None): Article 9
p.(None): Where research personnel are unaffiliated with a research entity or not engaged in cooperative research with a research entity, they
p.(None): shall nevertheless be required to obtain IRB approval from one research entity or approval from a non-research entity affiliated
p.(None): independent IRB, prior to engaging in a protocol.
p.(None):
p.(None): Article 10
p.(None): Where the research protocol involves two or more research entities, it may be approved by one of those IRBs agreed by the research
p.(None): entities involved, as well as to be responsible for the review, supervision and auditing.
p.(None):
p.(None): Article 11
p.(None): An IRB shall conduct review processes independently.
p.(None): Research entities shall ensure that the IRB review is not subject to any untoward influence of any research entity, principal
p.(None): investigator or protocol consignor.
p.(None):
p.(None): Chapter 3 Protection of Research Subjects Rights
p.(None):
p.(None): Article 12
p.(None): Where the research subjects are other than a fetus or corpse, such subjects shall consist only of adults capable of communication.
p.(None): However, where the research obviously benefit specific groups or the subjects are irreplaceable, is not subjected to this rule.
p.(None): Research protocol shall obtain the consent of participating research subjects as approved by the IRB. But the research protocol within
p.(None): the scope of exemption categories for consent requirements, as announced by the competent authority, shall not apply.
p.(None): Where the research subject is a fetus, the consent specified in the first Paragraph shall be obtained from the mother; where the
p.(None): subject has been judicially declared to be of limited legal capacity or under assistance, consent shall be obtained from both the
p.(None): individual and their legal representative or assistant; where the person is incompetent or under guardianship, consent shall be
p.(None): obtained from their legal representative or guardian; where the proviso in the first Paragraph is applicable, consent shall be obtained
p.(None): in the following order of precedence from an appropriate relation:
p.(None): 1. A spouse
p.(None): 2. An adult child
p.(None): 3. Parents
p.(None): 4. Siblings
p.(None): 5. Grandparents
p.(None): Where the consent is provided in writing by a relation pursuant to the preceding Paragraph, such written consent may be sufficient
p.(None): where obtained from any such individual; where the express intent of such persons is not unanimous, the order of precedence above
p.(None): shall apply to determine the matter. In the preceding order of precedence, among the same order, closer relatives shall be accorded
p.(None): priority; where the relatives are of the same degree of closeness, cohabitation shall be accorded priority; and in case of non-
p.(None): cohabiting relatives, the elderly shall be accorded priority.
p.(None):
p.(None): Article 13
...

Searching for indicator home:

Searching for indicator gender:

(return to top)
p.(None):
p.(None): Article 5
p.(None): Prior to conduct a research, the principal investigator shall submit the research protocol for review and approval by the Institutional
p.(None): Review Board (hereinafter “IRB”). However, the research protocol within the scope of exemption categories for IRB review, as
p.(None): announced by the competent authority, shall not apply.
p.(None): The review in the preceding Paragraph shall be conducted by the research entity’s IRB. Where an entity does not have an
p.(None): established IRB, the review may be conducted by IRB of other entity.
p.(None): Amendments of an approved research protocol shall be submitted for IRB approval prior to its implementation.
p.(None): Article 6
p.(None): The research protocol in the preceding Article, shall include the following matters:
p.(None): 1. Protocol title, principal investigator, and research entity.
p.(None): 2. Abstract of the protocol, research subjects and experimental methods.
p.(None): 3. Estimated timetables.
p.(None): 4. Ways and content of human subject protection and consent obtaining.
p.(None): 5. Research personnel and equipment requirements.
p.(None): 6. Research funding requirements and sources.
p.(None): 7. Expected results and primary benefits from the research.
p.(None): 8. Attribution of research results and uses thereof.
p.(None): 9. Disclosure of any conflicts of interest affecting research personnel.
p.(None):
p.(None): Article 7
p.(None): The IRB shall consist of five or more members, including legal expert and other persons of disinterested community members; more
p.(None): than two-fifths shall not be affiliated with the research entity; and no gender shall constitute less than one-third.
p.(None): During IRB meetings, the IRB may invite the attendance of experts familiar with the research field, or representatives of any
p.(None): appropriate group affiliated with the human subjects, to attend and provide comments.
p.(None): The competent authority shall stipulate regulations to govern matters related to the IRB organization, meetings, review processes and
p.(None): scope, conflict of interest principles, supervision, administration, and other matters of compliance.
p.(None):
p.(None): Article 8
p.(None): Review of research protocol shall be conducted in accordance with the degree of risk presented, as docketed for standard review or
p.(None): expedited review.
p.(None): Expedited review procedures under the preceding Paragraph shall only be available if the scope of the research lies within the
p.(None): categories announced by the competent authority.
p.(None):
p.(None): Article 9
p.(None): Where research personnel are unaffiliated with a research entity or not engaged in cooperative research with a research entity, they
p.(None): shall nevertheless be required to obtain IRB approval from one research entity or approval from a non-research entity affiliated
p.(None): independent IRB, prior to engaging in a protocol.
p.(None):
p.(None): Article 10
p.(None): Where the research protocol involves two or more research entities, it may be approved by one of those IRBs agreed by the research
p.(None): entities involved, as well as to be responsible for the review, supervision and auditing.
p.(None):
p.(None): Article 11
p.(None): An IRB shall conduct review processes independently.
...

General/Other / Impaired Autonomy

Searching for indicator autonomy:

General/Other / Relationship to Authority

Searching for indicator authority:

(return to top)
p.(None): Search SEARCH
p.(None):
p.(None): : Location Home > Law > Article Content
p.(None): P
p.(None):
p.(None): Article Content
p.(None):
p.(None):
p.(None):
p.(None): Title Human Subjects Research Act CH
p.(None): Amended Date 2019-01-02
p.(None): Category Ministry of Health and Welfare
p.(None):
p.(None):
p.(None): Article Content Chapter Article No Search Content Search Legislative History
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Chapter 1 General Provisions
p.(None):
p.(None): Article 1
p.(None): This Act is specially stipulated to regulate the right protection of human research subjects.
p.(None): Implementation of research involving human subjects shall be governed by this Act. Where another law provides special provisions in
p.(None): relation whereof, such regulations shall instead govern.
p.(None):
p.(None): Article 2
p.(None): Human subject research should respect the autonomy of the human subjects, and ensure balance of the risks and benefits from
p.(None): conduct of the research, minimizing invasiveness to the human subjects, and securing equitable distribution of research burdens and
p.(None): results, while protecting human subject’s rights.
p.(None):
p.(None): Article 3
p.(None): The “competent authority” as referred to herein means the Ministry of Health and Welfare.
p.(None): Supervision, audit, administration and penalization of human subject research, as well as human subject protection, shall lie with the
p.(None): central competent authority with responsibility over the organization (institution), school, legal entity or group (hereinafter “ the
p.(None): research entity”) that principal investigator of the human subject research (hereinafter “the principal investigator”) serves.
p.(None):
p.(None): Article 4
p.(None): Definitions:
p.(None): 1. Human subject research (hereinafter “research”): refers to research involving obtaining, investigating, analyzing, or using human
p.(None): specimens or an individual person’s biological behavior, physiological, psychological, genetic or medical information.
p.(None): 2. Human specimens: refer to human (including a fetus and corpse) organs, tissues, cells, body fluids, or any derivative biomaterial
p.(None): arising from experimentation therewith.
p.(None): 3. Delinkage: refers to the operation of permanently disabling encoded biological specimens, data, and information from being linked
p.(None): to or matching them with the subjects personal data or information.
p.(None):
p.(None): Chapter 2 Review of Research Portocols
p.(None):
p.(None): Article 5
p.(None): Prior to conduct a research, the principal investigator shall submit the research protocol for review and approval by the Institutional
p.(None): Review Board (hereinafter “IRB”). However, the research protocol within the scope of exemption categories for IRB review, as
p.(None): announced by the competent authority, shall not apply.
p.(None): The review in the preceding Paragraph shall be conducted by the research entity’s IRB. Where an entity does not have an
p.(None): established IRB, the review may be conducted by IRB of other entity.
p.(None): Amendments of an approved research protocol shall be submitted for IRB approval prior to its implementation.
p.(None): Article 6
p.(None): The research protocol in the preceding Article, shall include the following matters:
p.(None): 1. Protocol title, principal investigator, and research entity.
p.(None): 2. Abstract of the protocol, research subjects and experimental methods.
p.(None): 3. Estimated timetables.
p.(None): 4. Ways and content of human subject protection and consent obtaining.
p.(None): 5. Research personnel and equipment requirements.
p.(None): 6. Research funding requirements and sources.
p.(None): 7. Expected results and primary benefits from the research.
p.(None): 8. Attribution of research results and uses thereof.
p.(None): 9. Disclosure of any conflicts of interest affecting research personnel.
p.(None):
p.(None): Article 7
p.(None): The IRB shall consist of five or more members, including legal expert and other persons of disinterested community members; more
p.(None): than two-fifths shall not be affiliated with the research entity; and no gender shall constitute less than one-third.
p.(None): During IRB meetings, the IRB may invite the attendance of experts familiar with the research field, or representatives of any
p.(None): appropriate group affiliated with the human subjects, to attend and provide comments.
p.(None): The competent authority shall stipulate regulations to govern matters related to the IRB organization, meetings, review processes and
p.(None): scope, conflict of interest principles, supervision, administration, and other matters of compliance.
p.(None):
p.(None): Article 8
p.(None): Review of research protocol shall be conducted in accordance with the degree of risk presented, as docketed for standard review or
p.(None): expedited review.
p.(None): Expedited review procedures under the preceding Paragraph shall only be available if the scope of the research lies within the
p.(None): categories announced by the competent authority.
p.(None):
p.(None): Article 9
p.(None): Where research personnel are unaffiliated with a research entity or not engaged in cooperative research with a research entity, they
p.(None): shall nevertheless be required to obtain IRB approval from one research entity or approval from a non-research entity affiliated
p.(None): independent IRB, prior to engaging in a protocol.
p.(None):
p.(None): Article 10
p.(None): Where the research protocol involves two or more research entities, it may be approved by one of those IRBs agreed by the research
p.(None): entities involved, as well as to be responsible for the review, supervision and auditing.
p.(None):
p.(None): Article 11
p.(None): An IRB shall conduct review processes independently.
p.(None): Research entities shall ensure that the IRB review is not subject to any untoward influence of any research entity, principal
p.(None): investigator or protocol consignor.
p.(None):
p.(None): Chapter 3 Protection of Research Subjects Rights
p.(None):
p.(None): Article 12
p.(None): Where the research subjects are other than a fetus or corpse, such subjects shall consist only of adults capable of communication.
p.(None): However, where the research obviously benefit specific groups or the subjects are irreplaceable, is not subjected to this rule.
p.(None): Research protocol shall obtain the consent of participating research subjects as approved by the IRB. But the research protocol within
p.(None): the scope of exemption categories for consent requirements, as announced by the competent authority, shall not apply.
p.(None): Where the research subject is a fetus, the consent specified in the first Paragraph shall be obtained from the mother; where the
p.(None): subject has been judicially declared to be of limited legal capacity or under assistance, consent shall be obtained from both the
p.(None): individual and their legal representative or assistant; where the person is incompetent or under guardianship, consent shall be
p.(None): obtained from their legal representative or guardian; where the proviso in the first Paragraph is applicable, consent shall be obtained
p.(None): in the following order of precedence from an appropriate relation:
p.(None): 1. A spouse
p.(None): 2. An adult child
p.(None): 3. Parents
p.(None): 4. Siblings
p.(None): 5. Grandparents
p.(None): Where the consent is provided in writing by a relation pursuant to the preceding Paragraph, such written consent may be sufficient
p.(None): where obtained from any such individual; where the express intent of such persons is not unanimous, the order of precedence above
p.(None): shall apply to determine the matter. In the preceding order of precedence, among the same order, closer relatives shall be accorded
p.(None): priority; where the relatives are of the same degree of closeness, cohabitation shall be accorded priority; and in case of non-
...

p.(None): 4. The person’s name and ways of contact related to the research
p.(None): 5. Protection of human research subject’s rights and mechanisms for their personal data protection
p.(None): 6. The fact that research subjects may revoke their consent at anytime and the ways of revocation
p.(None): 7. Foreseeable risks and ameliorative measures in the incidence of any damages
p.(None): 8. Research material preservation limits and plans for uses thereof
p.(None): 9. Agreed derivative commercial benefits and agreed uses of the research results relating thereto
p.(None): The principal investigator must obtain consent, without resort to any duress, solicitation or other improper means.
p.(None):
p.(None): Article 15
p.(None): Where the research purpose involves indigenous people, then besides the requirements of Article 12 through 14 supra, there shall
p.(None): additionally be required consultations to obtain the consent of their indigenous group; any publication of research results shall require
p.(None): the same consent.
p.(None): The Central Council of Indigenous Peoples shall stipulate the consultation mentioned in the preceding Paragraph, as well as consent,
p.(None): agreed commercial benefits, and other agreed uses in conformity with the competent authority.
p.(None):
p.(None): Chapter 4 Administration of Research Protocols
p.(None):
p.(None): Article 16
p.(None): Research entities shall ensure necessary supervision throughout conduct of the research protocol approved; where any significant
p.(None): non-conformity occurs, they shall order cessation or order termination of the research.
p.(None):
p.(None): Article 17
p.(None): The IRB shall, for every approved research protocol, throughout the conduct thereof, provide at least one annual audit.
p.(None): Where the IRB discovers any of the following conditions in the conduct of a research protocol, they shall order the research protocol
p.(None): into cessation for amelioration within a specified period of time, or to be terminated, and shall notify the research entity and the
p.(None): responsible ministry of central government:
p.(None): 1. Where a required IRB approval was not obtained, and amendments were undertaken in the research protocol without prior
p.(None): permission
p.(None): 2. Any matter materially affecting research subject rights or safety
p.(None): 3. Abnormal frequency of adverse events or irregular degrees of severity
p.(None): 4. Sufficient evidence evinces the research is not necessary
p.(None): 5. Any other matter arises affecting the research risks and benefits analysis
p.(None): After the research protocol is completed, should any of the following conditions arise, the IRB shall undertake an investigation, and
p.(None): notify the research entity and central competent authority of relevant entities:
p.(None): 1. Serious late onset adverse events
p.(None): 2. Any violation of law or act contrary to the research project’s contents
p.(None): 3. Any serious adverse effect on human subject’s rights
p.(None):
p.(None): Article 18
p.(None): The responsible ministry of central government shall routinely inspect IRBs, and publish the inspection results.
p.(None): The preceding inspection may be conducted as delegated by the responsible ministry of central government to a private professional
p.(None): entity or group.
p.(None): Where an IRB fails to pass inspection, they may not approve any research protocols.
p.(None):
p.(None): Article 19
p.(None): After completion of a research protocol, or expiration of the date of preservation in accordance with Subparagraph 8, Paragraph 1 of
p.(None): Article 14, all research materials shall be immediately destroyed. But where the affected individual consents otherwise, or delinkage of
p.(None): the materials has been completed, this provision shall not apply.
p.(None): Where any use of non-delinked research materials beyond the permitted scope of written consent, then in accordance with the
p.(None): provisions of Article 5 and Article 12 through Article 15, IRB review shall be conducted and the procedures to give notification and
p.(None): obtain appropriate consent shall be completed.
p.(None): Where non-delinked research materials will be provided for specified research purposes overseas, besides notifying the human
p.(None): subjects and obtaining their written consent, the overseas research entity shall sign a Certification of Guarantee to follow our
p.(None): domestic regulations and research material scope of permitted uses, for review by the IRB, and after approval thereby, for
p.(None): consideration by the competent authority, prior to conduct of any such use.
p.(None):
p.(None): Article 20
p.(None): Where the responsible ministry of central government deems conduct of the research protocol as posing a risk of infringement of
p.(None): human subjects’ rights, they may audit or review research information at anytime; research entities and related personnel shall not
p.(None): impede, refuse, or avoid such audit or review.
p.(None):
p.(None): Article 21
p.(None): The principal investigator and research personnel shall not disclose any confidential matter obtained in the course of the research or
p.(None): any information relating to the human subjects.
p.(None):
p.(None): Chapter 5 Penal Provisions
p.(None):
p.(None): Article 22
p.(None): Where any research entity affiliated principal investigator or research personnel are subject to any of the following conditions, the
p.(None): responsible ministry of central government may fine the research entity a penalty in the amount of no less than NT$100,000 nor more
p.(None): than NT$1,000,000;
p.(None): 1. Violation of Paragraph 1 of Article 5, Article 8, Article 9, or Article 10, for conduct of any activity without IRB approval
p.(None): 2. Violation of Paragraph 1 of Article 19, for failure to destroy non-delinked research materials after the end of the research or
p.(None): expiration of the preservation period
p.(None): 3. Violation of Paragraph 2 of Article 19, for use of non-delinked research materials, use beyond the scope of consent, failure to
p.(None): engage in processes to obtain additional IRB review, or failure to notify and obtain additional consent.
p.(None): 4. Violation of Paragraph 3 of Article 19, through provision of research materials for overseas uses without obtaining the human
...

p.(None): government may fine the research entity or independent IRB a penalty in the amount of not less than NT$60,000 nor more than
p.(None): NT$600,000, and order amelioration within a specified period of time; where such amelioration is not timely completed, the IRB may
p.(None): be ordered dissolved; where the violation is grievous, the IRB may be ordered to cease operations for not less than one month nor
p.(None): greater than one year.
p.(None): 1. Violation of Paragraph 1 of Article 7
p.(None): 2. Violation of Paragraph 3 of Article 7 as to IRB review processes and scope, conflicts of interest principle, supervision,
p.(None): administration or other matters
p.(None): 3. Violation of Article 17, for failure to supervise and audit IRB approved research protocol.
p.(None): 4. Violation of Paragraph 3 of Article 18
p.(None):
p.(None): Article 24
p.(None): Research entities or their affiliated principal investigator, or other personnel who are subject to any of the following conditions, may
p.(None): be fined by the responsible ministry of central government a penalty of no less than NT$50,000 nor greater than NT$500,000, and
p.(None): ordered to adjourn or terminate the research project:
p.(None): 1. Violation of Article 12 or Article 13
p.(None): 2. Violation of Article 14, for having failed to ensure understanding of the required disclosure items, or having obtained consent
p.(None): through duress, solicitation or other improper means
p.(None): 3. Violation of Paragraph 1 of Article 15
p.(None): 4. Violation of Article 16, for failure to ensure adequate supervision of an IRB approved research protocol
p.(None): 5. Violation of Paragraph 3 of Article 19, for failure to obtain approval from the competent authority, prior to provision of study
p.(None): materials for overseas use
p.(None): 6. Violation of Article 20, for obstructing, refusing or avoiding auditing or provision of information therefor
p.(None): 7. Violation of Article 21, for disclosure of confidential matters relating to research subjects obtained in the course of the research or
p.(None): disclosing information related to research subjects.
p.(None):
p.(None): Article 25
p.(None): Where a research entity shall have been penalized in accordance with the provisions of Article 22 or the preceding Article, a penalty
p.(None): may be jointly assessed against the principal investigator or affiliated personnel on the same basis. Where the violation is grievous,
p.(None): after the penalty has become finally effective as to the violator, for a period of one year thenceforth, the violator may not apply to any
p.(None): government agency nor to any government funded foundation for research grant assistance.
p.(None):
p.(None): Chapter 6 Supplementary Provisions
p.(None):
p.(None): Article 26
p.(None): This Act shall take effect immediately upon the date of promulgation hereof.
p.(None):
p.(None):
p.(None):
p.(None): News Law Convention
p.(None): Searching Justices of the Constitutional Court
p.(None):
p.(None):
p.(None): E-PAPER
p.(None): enter your email address
p.(None):
p.(None):
p.(None): Subscribe
p.(None):
p.(None):
p.(None): Unsubscribe
p.(None):
p.(None):
p.(None): This website does not provide legal counseling service, please contact with related public offices for more information.
p.(None): In case of any discrepancy between the English version and the Chinese version, the latter shall prevail.
p.(None):
p.(None):
...

Orphaned Trigger Words

p.(None):
p.(None): Article 20
p.(None): Where the responsible ministry of central government deems conduct of the research protocol as posing a risk of infringement of
p.(None): human subjects’ rights, they may audit or review research information at anytime; research entities and related personnel shall not
p.(None): impede, refuse, or avoid such audit or review.
p.(None):
p.(None): Article 21
p.(None): The principal investigator and research personnel shall not disclose any confidential matter obtained in the course of the research or
p.(None): any information relating to the human subjects.
p.(None):
p.(None): Chapter 5 Penal Provisions
p.(None):
p.(None): Article 22
p.(None): Where any research entity affiliated principal investigator or research personnel are subject to any of the following conditions, the
p.(None): responsible ministry of central government may fine the research entity a penalty in the amount of no less than NT$100,000 nor more
p.(None): than NT$1,000,000;
p.(None): 1. Violation of Paragraph 1 of Article 5, Article 8, Article 9, or Article 10, for conduct of any activity without IRB approval
p.(None): 2. Violation of Paragraph 1 of Article 19, for failure to destroy non-delinked research materials after the end of the research or
p.(None): expiration of the preservation period
p.(None): 3. Violation of Paragraph 2 of Article 19, for use of non-delinked research materials, use beyond the scope of consent, failure to
p.(None): engage in processes to obtain additional IRB review, or failure to notify and obtain additional consent.
p.(None): 4. Violation of Paragraph 3 of Article 19, through provision of research materials for overseas uses without obtaining the human
p.(None): subject’s written consent therefor.
p.(None): Where any of the preceding Subparagraphs apply, should the violation be particularly serious, the responsible ministry of central
p.(None): government may terminate the research, and may publish the name of the research entity so penalized.
p.(None):
p.(None): Article 23
p.(None): Where a research entity’s IRB or independent IRB violates any of the following provisions, the responsible ministry of central
p.(None): government may fine the research entity or independent IRB a penalty in the amount of not less than NT$60,000 nor more than
p.(None): NT$600,000, and order amelioration within a specified period of time; where such amelioration is not timely completed, the IRB may
p.(None): be ordered dissolved; where the violation is grievous, the IRB may be ordered to cease operations for not less than one month nor
p.(None): greater than one year.
p.(None): 1. Violation of Paragraph 1 of Article 7
p.(None): 2. Violation of Paragraph 3 of Article 7 as to IRB review processes and scope, conflicts of interest principle, supervision,
p.(None): administration or other matters
p.(None): 3. Violation of Article 17, for failure to supervise and audit IRB approved research protocol.
p.(None): 4. Violation of Paragraph 3 of Article 18
p.(None):
p.(None): Article 24
p.(None): Research entities or their affiliated principal investigator, or other personnel who are subject to any of the following conditions, may
p.(None): be fined by the responsible ministry of central government a penalty of no less than NT$50,000 nor greater than NT$500,000, and
p.(None): ordered to adjourn or terminate the research project:
p.(None): 1. Violation of Article 12 or Article 13
p.(None): 2. Violation of Article 14, for having failed to ensure understanding of the required disclosure items, or having obtained consent ...

p.(None): materials for overseas use
p.(None): 6. Violation of Article 20, for obstructing, refusing or avoiding auditing or provision of information therefor
p.(None): 7. Violation of Article 21, for disclosure of confidential matters relating to research subjects obtained in the course of the research or
p.(None): disclosing information related to research subjects.
p.(None):
p.(None): Article 25
p.(None): Where a research entity shall have been penalized in accordance with the provisions of Article 22 or the preceding Article, a penalty
p.(None): may be jointly assessed against the principal investigator or affiliated personnel on the same basis. Where the violation is grievous,
p.(None): after the penalty has become finally effective as to the violator, for a period of one year thenceforth, the violator may not apply to any
p.(None): government agency nor to any government funded foundation for research grant assistance.
p.(None):
p.(None): Chapter 6 Supplementary Provisions
p.(None):
p.(None): Article 26
p.(None): This Act shall take effect immediately upon the date of promulgation hereof.
p.(None):
p.(None):
p.(None):
p.(None): News Law Convention
p.(None): Searching Justices of the Constitutional Court
p.(None):
p.(None):
p.(None): E-PAPER
p.(None): enter your email address
p.(None):
p.(None):
p.(None): Subscribe
p.(None):
p.(None):
p.(None): Unsubscribe
p.(None):
p.(None):
p.(None): This website does not provide legal counseling service, please contact with related public offices for more information.
p.(None): In case of any discrepancy between the English version and the Chinese version, the latter shall prevail.
p.(None):
p.(None):
p.(None): │ Government Website Open Information Announcement │ Declaration on Privacy Right Protection │ Information Security Policy │ EMail │
p.(None): OPERATING BY THE WORKING GROUP OF THE R.O.C LAWS & REGULATIONS DATABASE, MINISTRY OF JUSTICE.
p.(None): NO. 130, Sec. 1, Chongqing S. Rd., Taipei, 10048, Taiwan(R.O.C.)
p.(None): Service Phone-Call: +886-2-2191-0189 ...

Appendix

Indicator List

Indicator	Vulnerability
authority	Relationship to Authority
autonomy	Impaired Autonomy
child	Child
elderly	Elderly
fetus	Fetus/Neonate
gender	gender
home	Property Ownership
indigenous	Indigenous
influence	Drug Usage

Indicator Peers (Indicators in Same Vulnerability)

Indicator	Peers

Trigger Words

capacity

consent

justice

protection

risk

welfare

Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability Type	Vulnerability	Indicator	# Matches
Political	Indigenous	indigenous	3
Health	Drug Usage	influence	1
Social	Child	child	1
Social	Elderly	elderly	1
Social	Fetus/Neonate	fetus	3
Social	Property Ownership	home	1
Social	gender	gender	1
General/Other	Impaired Autonomy	autonomy	1
General/Other	Relationship to Authority	authority	10

Human Subjects Research Act (2011):

Applicable Type / Vulnerability / Indicator Overlay for this Input

Political / Indigenous

Health / Drug Usage

Social / Child

Social / Elderly

Social / Fetus/Neonate

Social / Property Ownership

Social / gender

General/Other / Impaired Autonomy

General/Other / Relationship to Authority

Orphaned Trigger Words

Appendix

Indicator List

Indicator Peers (Indicators in Same Vulnerability)

Trigger Words

Applicable Type / Vulnerability / Indicator Overlay for this Input