0A4F4F9BD490A749D5437F821CF06DF1
Human Biobank Management Act (2012)
https://law.moj.gov.tw/ENG/LawClass/LawAll.aspx?pcode=L0020164
http://leaux.net/URLS/ConvertAPI Text Files/FA1E271CF20143A21D57B62C3248195D.en.txt
Examining the file media/Synopses/FA1E271CF20143A21D57B62C3248195D.html:
This file was generated: 2020-08-23 05:59:42
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 / Illegal Activity
Searching for indicator unlawful:
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p.(None): of no less than two million New Taiwan Dollars (NT$ 2,000,000) and no more than ten million New Taiwan Dollars (NT$ 10,000,000).
p.(None): Any exported biological specimens and related data and information shall be immediately destroyed.
p.(None): Violations of Article 30 by failing to destroy any biological specimens and related data and information as required by law shall be
p.(None): subject to a fine of no less than two million New Taiwan Dollars (NT$ 2,000,000) and no more than ten million New Taiwan Dollars
p.(None): (NT$ 10,000,000).
p.(None): Where the circumstances set forth in the preceding four paragraphs constitute a serious offense, the Competent Authority may also
p.(None): revoke the establishment permit of the violator.
p.(None):
p.(None): Article 24
p.(None): When engaging in any of the following violations, an Operator shall be subject to a fine of no less than five hundred thousand New
p.(None): Taiwan Dollars (NT$ 500,000) and no more than two million and five hundred thousand New Taiwan Dollars (NT$ 2,500,000); and
p.(None): may be ordered to undertake timely corrective actions. An Operator who fails to timely undertake such corrective actions shall be
p.(None): subject to an additional fine imposed for each failure:
p.(None): 1.violating Article 5, Paragraph 1 or 3 by failing to establish an ethics committee, or failing to submit the management and application
p.(None): matters of the Biobank to the ethics committee for review and supervision, or failing to submit same to the Competent Authority for
p.(None): approval; violating Article 5, Paragraph 2 by allowing unlawful composition of the ethics committee; or violating Article 5, Paragraph 6
p.(None): by failing to recuse from a conflict of interests.
p.(None): 2.violating Article 6, Paragraphs 1-3 or Article 7 by collecting biological specimens; or violating Article 6, Paragraph 4 by failing to
p.(None): submit the agreement of consent to the ethics committee for review and approval.
p.(None): 3.violating Article 12 by disclosing any confidences or other personal data or information of a participant that is known or obtained as
p.(None): a result of the work.
p.(None): 4.violating Article 13, Paragraph 1 by failing to stipulate or disclose rules regarding information security, or for the reason that the
p.(None): management of biological specimens and related data and information violates any information security regulations; or failing to
p.(None): comply with Article 13, Paragraph 2 requiring that the information security rules pass the review of the concerned ethics committee or
p.(None): submitted to the Competent Authority for records.
p.(None): 5.violating Article 18, Paragraph 1 by failing to process the biological specimens and related data and information so that the
p.(None): participant ’ s identity is unable to be determined; or violating Article 18, Paragraph 4 by failing to adopt necessary measures to
p.(None): maintain the confidentiality of information contained in the documents that are unable to be separated from the information which can
p.(None): determine the identity of a participant; or violating Article 18, Paragraph 5.
...
Political / political affiliation
Searching for indicator party:
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p.(None): human body or produced by experimental operations and are sufficient to provide adequate information for identifying the
p.(None): participant’s biometrics.
p.(None): 2.Participant: This term refers to any natural person who provides his/her biological specimens, personal information, and other
p.(None): related data and information to the Biobank.
p.(None): 3.Biomedical research: This term refers to medical research on basic biometrics, such as genes.
p.(None): 4.Biobank: For the purpose of biomedical research, the Biobank contains participants’ biological specimens, natural
p.(None): persons’information and other related data and information based on human population or specific groups. These biological
p.(None): specimens, derivatives, or relevant data are stored in the Biobank without delinking websites for the need of follow-up applications.
p.(None): 5.Coding: Codes are used to substitute for the participant’s personal information, such as name, ID card number, and medical
p.(None): records number, to protect his/her privacy and identity.
p.(None): 6.Encryption: This term refers to the process of making the participant’s personal data and information unidentifiable.
p.(None): 7.Delinkage: This term refers to the operation of permanently disabling encoded biological specimens, data, and information from
p.(None): being linked to or matching them with the participant's personal data or information.
p.(None): 8.Operator: This term refers to a person that establishes and manages the Biobank.
p.(None): 9.Transfer: This term refers to the process where an operator transfers the Biobank and the rights and obligations between the
p.(None): operator and the participant to a third party.
p.(None):
p.(None): Chapter 2 Establishment of Biobank
p.(None):
p.(None): Article 4
p.(None): A Biobank Operator must be a governmental agency, medical or academic institution, research institution, or legal person (hereinafter
p.(None): collectively referred to as “Organization”) and shall apply to the Competent Authority for a permit.
p.(None): The Competent Authority shall stipulate rules and regulations to govern matters related to the permit applications mentioned in the
p.(None): preceding paragraph, such as applicant qualifications, application procedures, conditions for the establishment approval, review
p.(None): standards, regular inspections, relevant managerial matters, and other matters of compliance.
p.(None):
p.(None): Article 5
p.(None): A Biobank Operator shall establish an ethics committee to review and supervise matters relating to the management of the Biobank.
p.(None): There shall be between nine (9) to fifteen (15) commissioners in an ethics committee mentioned in the preceding paragraph, of which
p.(None): more than one half (1/2) shall be legal experts, social workers, and other disinterested community members; and at least two thirds
p.(None): (2/3) of the commissioners shall not be the personnel of the Organization.
p.(None): Any matters related to the applications of data and information contained in the Biobank shall be drafted as a plan to be submitted to
p.(None): the ethics committee for approval, after which the plan shall be submitted to the Competent Authority who will further invite legal
...
p.(None): 6.The purposes of collection and the range and duration of the use of the collected biological specimens; collection methods; types
p.(None): and quantities of specimens to be collected; and regions where specimens are collected.
p.(None): 7.Any complications and hazards that might possibly occur during and as a result of a collection(s).
p.(None): 8.Any possible impacts of the genetic information derived from the biological specimens on the participant, and his/her relatives or an
p.(None): ethnic group.
p.(None): 9.Any reasonable risks or inconvenience which the participant may anticipate.
p.(None): 10.The rights which are excluded by these Human Biobank Act.
p.(None): 11.The mechanism designed to safeguard personal privacy and other rights and benefits of the participant.
p.(None): 12.The Operator’s organizational structure and operating principles.
p.(None): 13.Specific type of health information of the participant that is expected to be linked in the future.
p.(None): 14.Relevant regulations governing the applications of the Biobank.
p.(None): 15.Anticipated commercial applications.
p.(None): 16.The participant may choose whether upon his/her death or incapacity, his/her biological specimens and related data and
p.(None): information will continue to be stored and used.
p.(None): 17.Other important matters related to the Biobank.
p.(None):
p.(None): Article 8
p.(None): A Participant may make a request to cease providing any biological specimen, withdraw, or change the scope of the use, which the
p.(None): Operator shall not refuse.
p.(None): Should any participant withdraw from the program, the Operator shall destroy the biological specimens and related data and
p.(None): information provided by the participant. In the event that such materials have been provided to a third party, the third party shall
p.(None): destroy same upon receiving the notification from the Operator. However, this rule shall be inapplicable if one of the following
p.(None): circumstances occurs:
p.(None): 1.The Participant agrees in writing to the continuous use of certain materials.
p.(None): 2.Materials have already been delinked.
p.(None): 3.The preservation of documents such as the agreement of consent is necessary for the purpose of inspections and approved by the
p.(None): ethics committee.
p.(None):
p.(None): Article 9
p.(None): In the event of a participant’s death or incapacity, except as otherwise agreed herein, the Biobank may, in accordance with the
p.(None): original agreement, continue the storage and use of the biological specimens and related data and information.
p.(None):
p.(None): Article 10
p.(None): A Participant shall not request to view, duplicate, add, or correct data or information related to collections or processing of their
p.(None): biological specimens, or data or information with regard to the collection and process of the biological specimens, data, or information
p.(None): pursuant to Human Biobank Act. However, the restriction shall not apply to the personal information that can identify the participant.
p.(None):
p.(None): Chapter 4 Biobank Management
p.(None):
p.(None): Article 11
p.(None): In the event that the biological specimens, data, or information is stolen, leaked, tampered with, or otherwise infringed, an Operator
p.(None): shall immediately investigate the matter, report same to the Competent Authority, and notify relevant participants in an appropriate
p.(None): manner.
...
p.(None): Such rules mentioned in the preceding Paragraph shall be submitted to the Competent Authority for records after being approved by
p.(None): the ethics committee.
p.(None):
p.(None): Article 14
p.(None): An Operator shall not transfer part or entire Biobank to another, unless the transfer is reviewed and approved by the Competent
p.(None): Authority.
p.(None): In conducting the review mentioned in the preceding Paragraph, the Competent Authority shall consider the following:
p.(None): 1.the rights and interests of the participants.
p.(None): 2.the nature of the concerned Operator and its transferee(s).
p.(None): 3.the transferee’s ability to protect the rights and interest of the participants.
p.(None): 4.the intention of the participants as expressed or may be inferred.
p.(None): In the event that an Operator plans to cease the operation of the Biobank, a follow-up plan therefor shall be submitted one (1) year in
p.(None): advance to the Competent Authority for approval before such a plan can be enforced.
p.(None):
p.(None): Article 15
p.(None): Biological specimens of the Biobank, other than the derivatives, shall not be exported.
p.(None): Any international transmission of Biobank data or the export of any derivatives mentioned in the preceding Paragraph shall be
p.(None): submitted to the Competent Authority for approval.
p.(None): In the event that the use of the Biobank is provided to a third party, the rules set forth in the preceding two paragraphs shall be
p.(None): specified in the contract of use with such third party.
p.(None):
p.(None): Chapter 5 Biobank Applications
p.(None):
p.(None): Article 16
p.(None): Any biomedical research being based on human population groups or specific population groups shall not use any materials obtained
p.(None): from a Biobank the establishment of which is not authorized.
p.(None): Where an Operator uses or provides to any third party the biological specimens, and related data and information, such use and the
p.(None): provision shall be conducted pursuant to the scope, duration, and method as agreed to by the Participant.
p.(None):
p.(None): Article 17
p.(None): In the event that a Biobank that is established for the purpose of public interests or subsidized by the government should provide its
p.(None): biological specimens and relevant data and information to a third party, the principle of fairness and equality shall apply.
p.(None):
p.(None): Article 18
p.(None): Any storage, use, or disclosure of the concerned operator’s entire biological specimens and related data and information shall be
p.(None): encoded, encrypted, delinked, or transformed so that the participant’s identity is unable to be determined.
p.(None): An Operator shall encrypt and independently administer information that can determine the identity of an individual participant, such
p.(None): as his/her name, identification number, and date of birth. An Operator shall establish a review and control procedure for cross
p.(None): referencing the aforesaid personal information with the biological specimens and relevant data and information. Such information
p.(None): shall be restored immediately after each necessary use.
p.(None): When an Operator cross references data or information of different sources, the Operator shall comply with Paragraph 1 hereof and
p.(None): restore the information immediately after the cross-reference is complete.
p.(None): Documents that are unable to be separated from the information which can determine the identity of a participant, such as the
p.(None): agreement of consent and declarations of participation termination, are not subject to the rules set forth in the preceding three
p.(None): paragraphs. Nevertheless, the Operator shall adopt other necessary measures to maintain the confidentiality.
p.(None): Article 5, Paragraph 3 hereof shall apply to the cross reference and application procedures referred to in Paragraphs 2 and 3.
p.(None):
p.(None): Article 19
p.(None): An Operator’s staff and interested parties shall recuse themselves in the event of conflict of interests.
p.(None):
p.(None): Article 20
...
p.(None): individual participant, failing to establish a review and control procedure for cross referencing the personal information with the
p.(None): biological specimens and relevant data and information, or failing to immediately restore such information after each necessary use;
p.(None): or violating Article 18, Paragraph 3 by failing to cross reference data with information by means that the participant ’ s identity is
p.(None): unable to be determined, or by failing to immediately restore such information after cross reference.
p.(None): 7.violating Article 20 by using biological specimens, derivatives, and related data and information for the purposes other than
p.(None): biomedical research.
p.(None): In the event of any of the violations set forth in the preceding paragraphs, the Competent Authority may order a temporary cessation
p.(None): of the operation of the Biobank pending timely corrective actions; where the circumstances constitute a serious offense, the
p.(None): Competent Authority may also revoke the establishment licensure of the violator.
p.(None):
p.(None): Article 25
p.(None): When engaging in any of the following violations, a Operator shall be subject to a fine of no less than two hundred thousand New
p.(None): Taiwan Dollars (NT$ 200,000) and no more than two million and one million New Taiwan Dollars (NT$ 1,000,000); and may be
p.(None): ordered to undertake timely corrective actions. An Operator who fails to timely undertake such corrective actions shall be subject to
p.(None): an additional fine imposed for each failure:
p.(None): 1.violating Article 8, Paragraph 1 for refusing a Participant ’ s requests; or violating Article 8, Paragraph 2 by failing to destroy or notify
p.(None): the concerned third party to destroy biological specimens and related data and information provided by a withdrawing Participant.
p.(None): 2.violating Article 16, Paragraph 2 by failing to use or provide to any third party the biological specimens and related data and
p.(None): information pursuant to the scope, duration, and method as agreed to by the Participant.
p.(None): 3.violating the regulations stipulated pursuant to Article 21, Paragraph 2.
p.(None): 4.violating Article 22 by failing to regularly publish biomedical studies and results.
p.(None): Violations of Article 29 by collecting or using biological specimens in biomedical research being not based on the population groups
p.(None): or specific population groups shall be subject to fines a fine of no less than two hundred thousand New Taiwan Dollars (NT$ 200,000)
p.(None): and no more than two million and one million New Taiwan Dollars (NT$ 1,000,000). The violators may be ordered to undertake timely
p.(None): corrective actions. An Operator who fails to timely undertake such corrective actions shall be subject to an additional fine imposed for
p.(None): each failure.
p.(None):
p.(None): Article 26
p.(None): When engaging in any of the following violations, a person shall be subject to a fine of no less than sixty thousand New Taiwan
p.(None): Dollars (NT$ 60,000) and no more than two million and three hundred thousand New Taiwan Dollars (NT$ 300,000); and may be
p.(None): ordered to undertake timely corrective actions. The person who fails to timely undertake such corrective actions shall be subject to an
p.(None): additional fine imposed for each failure:
p.(None): 1.where any person other than an Operator violates Article 5, Paragraph 3.
p.(None): 2.where an Operator violates Article 6, Paragraph 4 by failing to submit the agreement of consent to the Competent Authority for
p.(None): records.
...
Social / Age
Searching for indicator age:
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p.(None): experts, social workers, and other disinterested community members to conduct a review on the plan. Only upon the final approval
p.(None): should the plan be enforced.
p.(None): The number of each type of professionals mentioned in the preceding paragraph shall be no less than one fourth (1/4) of the total
p.(None): seats; and the professionals of the same gender shall not amount to less than one third (1/3) of the total seats.
p.(None): The Competent Authority may commission private professional agencies (organizations) or groups to process the reviews set forth in
p.(None): Paragraph 3.
p.(None): The reviewers referred to in Paragraphs 2 and 3 shall be recused to avoid conflicts of interest if necessary.
p.(None):
p.(None): Chapter 3 Biological Specimens Collection and Participant Protection
p.(None):
p.(None): Article 6
p.(None): Collections of biological specimens shall be conducted in compliance with medical and research ethics. Participants shall be informed
p.(None): of related matters in a clearly comprehensible manner. Such matters shall be specified in an agreement of consent. Any collection
p.(None): may only be undertaken after the participant’s written consent is obtained.
p.(None): The Participant referred to in the preceding Paragraph must be at least twenty (20) years of age and have the legal capacity.
p.(None): However, a participant of the biobank on specific population groups is not subjected to this rule.
p.(None): In the event that a participant of the biobank on specific population groups set forth in the proviso in the preceding Paragraph is under
p.(None): seven (7) years of age or is subject to a declaration of guardianship, the Operator shall obtain the consent of the participant’s legal
p.(None): representative. In the event that a minor participant is seven (7) years of age or older or subject to a declaration of assistance,
p.(None): consent shall be obtained from the participant and his/her legal representative.
p.(None): The content of the agreement of consent mentioned in Paragraph 1 shall be submitted to the Competent Authority for records after
p.(None): being approved by the ethics committee of the concerned operator.
p.(None):
p.(None): Article 7
p.(None): As set forth in the preceding Article, a participant shall be informed of the following matters:
p.(None): 1.The legal authorities and their contents governing the establishment of the Biobank.
p.(None): 2.The identity of the Biobank Operator.
p.(None): 3.Information regarding the identity and the service unit of the biological specimen collectors.
p.(None): 4.The reasons why a particular participant was selected.
p.(None): 5.The rights and direct benefits to which the participant is entitled pursuant to the Human Biobank Act.
p.(None): 6.The purposes of collection and the range and duration of the use of the collected biological specimens; collection methods; types
p.(None): and quantities of specimens to be collected; and regions where specimens are collected.
p.(None): 7.Any complications and hazards that might possibly occur during and as a result of a collection(s).
p.(None): 8.Any possible impacts of the genetic information derived from the biological specimens on the participant, and his/her relatives or an
p.(None): ethnic group.
p.(None): 9.Any reasonable risks or inconvenience which the participant may anticipate.
p.(None): 10.The rights which are excluded by these Human Biobank Act.
...
Social / Property Ownership
Searching for indicator home:
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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 Biobank Management Act CH
p.(None): Amended Date 2019-06-12
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): The Human Biobank Management Act (hereinafter “Human Biobank Act”) is specifically stipulated to regulate the establishment,
p.(None): management, and applications of the human biobank (hereinafter “Biobank”), ensure the rights and benefits of biological database
p.(None): participants, and promote medical development and public welfare.
p.(None):
p.(None): Article 2
p.(None): The "competent authority” as referred to herein means the Ministry of Health and Welfare.
p.(None):
p.(None): Article 3
p.(None): Definitions:
p.(None): 1.Biological specimen: This term refers to derivatives, such as the cells, tissues, organs, or body fluids, which are collected from a
p.(None): human body or produced by experimental operations and are sufficient to provide adequate information for identifying the
p.(None): participant’s biometrics.
p.(None): 2.Participant: This term refers to any natural person who provides his/her biological specimens, personal information, and other
p.(None): related data and information to the Biobank.
p.(None): 3.Biomedical research: This term refers to medical research on basic biometrics, such as genes.
...
Social / Youth/Minors
Searching for indicator minor:
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p.(None): The Competent Authority may commission private professional agencies (organizations) or groups to process the reviews set forth in
p.(None): Paragraph 3.
p.(None): The reviewers referred to in Paragraphs 2 and 3 shall be recused to avoid conflicts of interest if necessary.
p.(None):
p.(None): Chapter 3 Biological Specimens Collection and Participant Protection
p.(None):
p.(None): Article 6
p.(None): Collections of biological specimens shall be conducted in compliance with medical and research ethics. Participants shall be informed
p.(None): of related matters in a clearly comprehensible manner. Such matters shall be specified in an agreement of consent. Any collection
p.(None): may only be undertaken after the participant’s written consent is obtained.
p.(None): The Participant referred to in the preceding Paragraph must be at least twenty (20) years of age and have the legal capacity.
p.(None): However, a participant of the biobank on specific population groups is not subjected to this rule.
p.(None): In the event that a participant of the biobank on specific population groups set forth in the proviso in the preceding Paragraph is under
p.(None): seven (7) years of age or is subject to a declaration of guardianship, the Operator shall obtain the consent of the participant’s legal
p.(None): representative. In the event that a minor participant is seven (7) years of age or older or subject to a declaration of assistance,
p.(None): consent shall be obtained from the participant and his/her legal representative.
p.(None): The content of the agreement of consent mentioned in Paragraph 1 shall be submitted to the Competent Authority for records after
p.(None): being approved by the ethics committee of the concerned operator.
p.(None):
p.(None): Article 7
p.(None): As set forth in the preceding Article, a participant shall be informed of the following matters:
p.(None): 1.The legal authorities and their contents governing the establishment of the Biobank.
p.(None): 2.The identity of the Biobank Operator.
p.(None): 3.Information regarding the identity and the service unit of the biological specimen collectors.
p.(None): 4.The reasons why a particular participant was selected.
p.(None): 5.The rights and direct benefits to which the participant is entitled pursuant to the Human Biobank Act.
p.(None): 6.The purposes of collection and the range and duration of the use of the collected biological specimens; collection methods; types
p.(None): and quantities of specimens to be collected; and regions where specimens are collected.
p.(None): 7.Any complications and hazards that might possibly occur during and as a result of a collection(s).
p.(None): 8.Any possible impacts of the genetic information derived from the biological specimens on the participant, and his/her relatives or an
p.(None): ethnic group.
p.(None): 9.Any reasonable risks or inconvenience which the participant may anticipate.
p.(None): 10.The rights which are excluded by these Human Biobank Act.
...
Social / gender
Searching for indicator gender:
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p.(None): The Competent Authority shall stipulate rules and regulations to govern matters related to the permit applications mentioned in the
p.(None): preceding paragraph, such as applicant qualifications, application procedures, conditions for the establishment approval, review
p.(None): standards, regular inspections, relevant managerial matters, and other matters of compliance.
p.(None):
p.(None): Article 5
p.(None): A Biobank Operator shall establish an ethics committee to review and supervise matters relating to the management of the Biobank.
p.(None): There shall be between nine (9) to fifteen (15) commissioners in an ethics committee mentioned in the preceding paragraph, of which
p.(None): more than one half (1/2) shall be legal experts, social workers, and other disinterested community members; and at least two thirds
p.(None): (2/3) of the commissioners shall not be the personnel of the Organization.
p.(None): Any matters related to the applications of data and information contained in the Biobank shall be drafted as a plan to be submitted to
p.(None): the ethics committee for approval, after which the plan shall be submitted to the Competent Authority who will further invite legal
p.(None): experts, social workers, and other disinterested community members to conduct a review on the plan. Only upon the final approval
p.(None): should the plan be enforced.
p.(None): The number of each type of professionals mentioned in the preceding paragraph shall be no less than one fourth (1/4) of the total
p.(None): seats; and the professionals of the same gender shall not amount to less than one third (1/3) of the total seats.
p.(None): The Competent Authority may commission private professional agencies (organizations) or groups to process the reviews set forth in
p.(None): Paragraph 3.
p.(None): The reviewers referred to in Paragraphs 2 and 3 shall be recused to avoid conflicts of interest if necessary.
p.(None):
p.(None): Chapter 3 Biological Specimens Collection and Participant Protection
p.(None):
p.(None): Article 6
p.(None): Collections of biological specimens shall be conducted in compliance with medical and research ethics. Participants shall be informed
p.(None): of related matters in a clearly comprehensible manner. Such matters shall be specified in an agreement of consent. Any collection
p.(None): may only be undertaken after the participant’s written consent is obtained.
p.(None): The Participant referred to in the preceding Paragraph must be at least twenty (20) years of age and have the legal capacity.
p.(None): However, a participant of the biobank on specific population groups is not subjected to this rule.
p.(None): In the event that a participant of the biobank on specific population groups set forth in the proviso in the preceding Paragraph is under
p.(None): seven (7) years of age or is subject to a declaration of guardianship, the Operator shall obtain the consent of the participant’s legal
...
General/Other / Incapacitated
Searching for indicator incapacity:
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p.(None):
p.(None): Article 7
p.(None): As set forth in the preceding Article, a participant shall be informed of the following matters:
p.(None): 1.The legal authorities and their contents governing the establishment of the Biobank.
p.(None): 2.The identity of the Biobank Operator.
p.(None): 3.Information regarding the identity and the service unit of the biological specimen collectors.
p.(None): 4.The reasons why a particular participant was selected.
p.(None): 5.The rights and direct benefits to which the participant is entitled pursuant to the Human Biobank Act.
p.(None): 6.The purposes of collection and the range and duration of the use of the collected biological specimens; collection methods; types
p.(None): and quantities of specimens to be collected; and regions where specimens are collected.
p.(None): 7.Any complications and hazards that might possibly occur during and as a result of a collection(s).
p.(None): 8.Any possible impacts of the genetic information derived from the biological specimens on the participant, and his/her relatives or an
p.(None): ethnic group.
p.(None): 9.Any reasonable risks or inconvenience which the participant may anticipate.
p.(None): 10.The rights which are excluded by these Human Biobank Act.
p.(None): 11.The mechanism designed to safeguard personal privacy and other rights and benefits of the participant.
p.(None): 12.The Operator’s organizational structure and operating principles.
p.(None): 13.Specific type of health information of the participant that is expected to be linked in the future.
p.(None): 14.Relevant regulations governing the applications of the Biobank.
p.(None): 15.Anticipated commercial applications.
p.(None): 16.The participant may choose whether upon his/her death or incapacity, his/her biological specimens and related data and
p.(None): information will continue to be stored and used.
p.(None): 17.Other important matters related to the Biobank.
p.(None):
p.(None): Article 8
p.(None): A Participant may make a request to cease providing any biological specimen, withdraw, or change the scope of the use, which the
p.(None): Operator shall not refuse.
p.(None): Should any participant withdraw from the program, the Operator shall destroy the biological specimens and related data and
p.(None): information provided by the participant. In the event that such materials have been provided to a third party, the third party shall
p.(None): destroy same upon receiving the notification from the Operator. However, this rule shall be inapplicable if one of the following
p.(None): circumstances occurs:
p.(None): 1.The Participant agrees in writing to the continuous use of certain materials.
p.(None): 2.Materials have already been delinked.
p.(None): 3.The preservation of documents such as the agreement of consent is necessary for the purpose of inspections and approved by the
p.(None): ethics committee.
p.(None):
p.(None): Article 9
p.(None): In the event of a participant’s death or incapacity, except as otherwise agreed herein, the Biobank may, in accordance with the
p.(None): original agreement, continue the storage and use of the biological specimens and related data and information.
p.(None):
p.(None): Article 10
p.(None): A Participant shall not request to view, duplicate, add, or correct data or information related to collections or processing of their
p.(None): biological specimens, or data or information with regard to the collection and process of the biological specimens, data, or information
p.(None): pursuant to Human Biobank Act. However, the restriction shall not apply to the personal information that can identify the participant.
p.(None):
p.(None): Chapter 4 Biobank Management
p.(None):
p.(None): Article 11
p.(None): In the event that the biological specimens, data, or information is stolen, leaked, tampered with, or otherwise infringed, an Operator
p.(None): shall immediately investigate the matter, report same to the Competent Authority, and notify relevant participants in an appropriate
p.(None): manner.
p.(None): An Operator shall stipulate emergency response measures in relation to matters mentioned in the preceding Paragraph, and submit
p.(None): same to the Competent Authority for approval.
p.(None):
p.(None): Article 12
p.(None): Personnel engaged in the collections, processing, storage, or use of biological specimens shall not disclose any confidences or other
p.(None): personal data or information of the participant, that is known or obtained as a result of their work.
p.(None):
p.(None): Article 13
p.(None): An Operator shall stipulate and disclose its own rules on information security management pursuant to the Biobank information
...
p.(None): With regard to the sanctions set forth in the preceding four articles, the Operation who actually committed the act of violation shall be
p.(None): subject to a fine of no less than thirty thousand New Taiwan Dollars (NT$ 30,000) and no more than three hundred thousand New
p.(None): Taiwan Dollars (NT$ 300,000).
p.(None): In the event that an individual violator referred to in the preceding Paragraph is a licensed healthcare worker, he/she shall also be
p.(None): punished in accordance with laws and regulations governing healthcare professionals.
p.(None):
p.(None): Article 28
p.(None): In the event that the establishment of a Biobank is in violation of the regulations stipulated by the Competent Authority pursuant to
p.(None): Article 4, Paragraph 2, in additional to the penalties set forth herein, the Competent Authority may order a timely corrective action. If
p.(None): necessary, the Operator may be ordered to cease operations pending the correction actions. Where the nature of the offense is
p.(None): serious, the establishment permit of the violator may be revoked.
p.(None):
p.(None): Chapter 7 Supplementary Provisions
p.(None):
p.(None): Article 29
p.(None): (deleted)
p.(None):
p.(None): Article 30
p.(None): For any Biobank established prior to the enforcement of Human Biobank Act, its Operator shall, within no later than February 5, 2012,
p.(None): complete all necessary corrective actions to conform to Human Biobank Act. Those who fail to undertake complete corrective actions
p.(None): within the time specified shall destroy and may not re-use any and all biological specimens and related data and information.
p.(None): However, in the event that the corrective action may not be completed due to the death or incapacity of the Participant, the biological
p.(None): specimens and related data and information may be preserved with the approval of the ethics committee and the Competent
p.(None): Authority.
p.(None):
p.(None): Article 31
p.(None): The Human Biobank Act shall become effective as of the day of promulgation.
p.(None): News Law Convention
p.(None): Searching Justices of the Constitutional Court
p.(None):
p.(None):
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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
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General/Other / Public Emergency
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p.(None): destroy same upon receiving the notification from the Operator. However, this rule shall be inapplicable if one of the following
p.(None): circumstances occurs:
p.(None): 1.The Participant agrees in writing to the continuous use of certain materials.
p.(None): 2.Materials have already been delinked.
p.(None): 3.The preservation of documents such as the agreement of consent is necessary for the purpose of inspections and approved by the
p.(None): ethics committee.
p.(None):
p.(None): Article 9
p.(None): In the event of a participant’s death or incapacity, except as otherwise agreed herein, the Biobank may, in accordance with the
p.(None): original agreement, continue the storage and use of the biological specimens and related data and information.
p.(None):
p.(None): Article 10
p.(None): A Participant shall not request to view, duplicate, add, or correct data or information related to collections or processing of their
p.(None): biological specimens, or data or information with regard to the collection and process of the biological specimens, data, or information
p.(None): pursuant to Human Biobank Act. However, the restriction shall not apply to the personal information that can identify the participant.
p.(None):
p.(None): Chapter 4 Biobank Management
p.(None):
p.(None): Article 11
p.(None): In the event that the biological specimens, data, or information is stolen, leaked, tampered with, or otherwise infringed, an Operator
p.(None): shall immediately investigate the matter, report same to the Competent Authority, and notify relevant participants in an appropriate
p.(None): manner.
p.(None): An Operator shall stipulate emergency response measures in relation to matters mentioned in the preceding Paragraph, and submit
p.(None): same to the Competent Authority for approval.
p.(None):
p.(None): Article 12
p.(None): Personnel engaged in the collections, processing, storage, or use of biological specimens shall not disclose any confidences or other
p.(None): personal data or information of the participant, that is known or obtained as a result of their work.
p.(None):
p.(None): Article 13
p.(None): An Operator shall stipulate and disclose its own rules on information security management pursuant to the Biobank information
p.(None): security regulations promulgated by the Competent Authority.
p.(None): Such rules mentioned in the preceding Paragraph shall be submitted to the Competent Authority for records after being approved by
p.(None): the ethics committee.
p.(None):
p.(None): Article 14
p.(None): An Operator shall not transfer part or entire Biobank to another, unless the transfer is reviewed and approved by the Competent
p.(None): Authority.
p.(None): In conducting the review mentioned in the preceding Paragraph, the Competent Authority shall consider the following:
p.(None): 1.the rights and interests of the participants.
p.(None): 2.the nature of the concerned Operator and its transferee(s).
p.(None): 3.the transferee’s ability to protect the rights and interest of the participants.
p.(None): 4.the intention of the participants as expressed or may be inferred.
...
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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 Biobank Management Act CH
p.(None): Amended Date 2019-06-12
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): The Human Biobank Management Act (hereinafter “Human Biobank Act”) is specifically stipulated to regulate the establishment,
p.(None): management, and applications of the human biobank (hereinafter “Biobank”), ensure the rights and benefits of biological database
p.(None): participants, and promote medical development and public welfare.
p.(None):
p.(None): Article 2
p.(None): The "competent authority” as referred to herein means the Ministry of Health and Welfare.
p.(None):
p.(None): Article 3
p.(None): Definitions:
p.(None): 1.Biological specimen: This term refers to derivatives, such as the cells, tissues, organs, or body fluids, which are collected from a
p.(None): human body or produced by experimental operations and are sufficient to provide adequate information for identifying the
p.(None): participant’s biometrics.
p.(None): 2.Participant: This term refers to any natural person who provides his/her biological specimens, personal information, and other
p.(None): related data and information to the Biobank.
p.(None): 3.Biomedical research: This term refers to medical research on basic biometrics, such as genes.
p.(None): 4.Biobank: For the purpose of biomedical research, the Biobank contains participants’ biological specimens, natural
p.(None): persons’information and other related data and information based on human population or specific groups. These biological
p.(None): specimens, derivatives, or relevant data are stored in the Biobank without delinking websites for the need of follow-up applications.
p.(None): 5.Coding: Codes are used to substitute for the participant’s personal information, such as name, ID card number, and medical
p.(None): records number, to protect his/her privacy and identity.
p.(None): 6.Encryption: This term refers to the process of making the participant’s personal data and information unidentifiable.
p.(None): 7.Delinkage: This term refers to the operation of permanently disabling encoded biological specimens, data, and information from
p.(None): being linked to or matching them with the participant's personal data or information.
p.(None): 8.Operator: This term refers to a person that establishes and manages the Biobank.
p.(None): 9.Transfer: This term refers to the process where an operator transfers the Biobank and the rights and obligations between the
p.(None): operator and the participant to a third party.
p.(None):
p.(None): Chapter 2 Establishment of Biobank
p.(None):
p.(None): Article 4
p.(None): A Biobank Operator must be a governmental agency, medical or academic institution, research institution, or legal person (hereinafter
p.(None): collectively referred to as “Organization”) and shall apply to the Competent Authority for a permit.
p.(None): The Competent Authority shall stipulate rules and regulations to govern matters related to the permit applications mentioned in the
p.(None): preceding paragraph, such as applicant qualifications, application procedures, conditions for the establishment approval, review
p.(None): standards, regular inspections, relevant managerial matters, and other matters of compliance.
p.(None):
p.(None): Article 5
p.(None): A Biobank Operator shall establish an ethics committee to review and supervise matters relating to the management of the Biobank.
p.(None): There shall be between nine (9) to fifteen (15) commissioners in an ethics committee mentioned in the preceding paragraph, of which
p.(None): more than one half (1/2) shall be legal experts, social workers, and other disinterested community members; and at least two thirds
p.(None): (2/3) of the commissioners shall not be the personnel of the Organization.
p.(None): Any matters related to the applications of data and information contained in the Biobank shall be drafted as a plan to be submitted to
p.(None): the ethics committee for approval, after which the plan shall be submitted to the Competent Authority who will further invite legal
p.(None): experts, social workers, and other disinterested community members to conduct a review on the plan. Only upon the final approval
p.(None): should the plan be enforced.
p.(None): The number of each type of professionals mentioned in the preceding paragraph shall be no less than one fourth (1/4) of the total
p.(None): seats; and the professionals of the same gender shall not amount to less than one third (1/3) of the total seats.
p.(None): The Competent Authority may commission private professional agencies (organizations) or groups to process the reviews set forth in
p.(None): Paragraph 3.
p.(None): The reviewers referred to in Paragraphs 2 and 3 shall be recused to avoid conflicts of interest if necessary.
p.(None):
p.(None): Chapter 3 Biological Specimens Collection and Participant Protection
p.(None):
p.(None): Article 6
p.(None): Collections of biological specimens shall be conducted in compliance with medical and research ethics. Participants shall be informed
p.(None): of related matters in a clearly comprehensible manner. Such matters shall be specified in an agreement of consent. Any collection
p.(None): may only be undertaken after the participant’s written consent is obtained.
p.(None): The Participant referred to in the preceding Paragraph must be at least twenty (20) years of age and have the legal capacity.
p.(None): However, a participant of the biobank on specific population groups is not subjected to this rule.
p.(None): In the event that a participant of the biobank on specific population groups set forth in the proviso in the preceding Paragraph is under
p.(None): seven (7) years of age or is subject to a declaration of guardianship, the Operator shall obtain the consent of the participant’s legal
p.(None): representative. In the event that a minor participant is seven (7) years of age or older or subject to a declaration of assistance,
p.(None): consent shall be obtained from the participant and his/her legal representative.
p.(None): The content of the agreement of consent mentioned in Paragraph 1 shall be submitted to the Competent Authority for records after
p.(None): being approved by the ethics committee of the concerned operator.
p.(None):
p.(None): Article 7
p.(None): As set forth in the preceding Article, a participant shall be informed of the following matters:
p.(None): 1.The legal authorities and their contents governing the establishment of the Biobank.
p.(None): 2.The identity of the Biobank Operator.
p.(None): 3.Information regarding the identity and the service unit of the biological specimen collectors.
p.(None): 4.The reasons why a particular participant was selected.
p.(None): 5.The rights and direct benefits to which the participant is entitled pursuant to the Human Biobank Act.
p.(None): 6.The purposes of collection and the range and duration of the use of the collected biological specimens; collection methods; types
p.(None): and quantities of specimens to be collected; and regions where specimens are collected.
p.(None): 7.Any complications and hazards that might possibly occur during and as a result of a collection(s).
p.(None): 8.Any possible impacts of the genetic information derived from the biological specimens on the participant, and his/her relatives or an
p.(None): ethnic group.
p.(None): 9.Any reasonable risks or inconvenience which the participant may anticipate.
p.(None): 10.The rights which are excluded by these Human Biobank Act.
p.(None): 11.The mechanism designed to safeguard personal privacy and other rights and benefits of the participant.
p.(None): 12.The Operator’s organizational structure and operating principles.
p.(None): 13.Specific type of health information of the participant that is expected to be linked in the future.
p.(None): 14.Relevant regulations governing the applications of the Biobank.
p.(None): 15.Anticipated commercial applications.
...
p.(None): destroy same upon receiving the notification from the Operator. However, this rule shall be inapplicable if one of the following
p.(None): circumstances occurs:
p.(None): 1.The Participant agrees in writing to the continuous use of certain materials.
p.(None): 2.Materials have already been delinked.
p.(None): 3.The preservation of documents such as the agreement of consent is necessary for the purpose of inspections and approved by the
p.(None): ethics committee.
p.(None):
p.(None): Article 9
p.(None): In the event of a participant’s death or incapacity, except as otherwise agreed herein, the Biobank may, in accordance with the
p.(None): original agreement, continue the storage and use of the biological specimens and related data and information.
p.(None):
p.(None): Article 10
p.(None): A Participant shall not request to view, duplicate, add, or correct data or information related to collections or processing of their
p.(None): biological specimens, or data or information with regard to the collection and process of the biological specimens, data, or information
p.(None): pursuant to Human Biobank Act. However, the restriction shall not apply to the personal information that can identify the participant.
p.(None):
p.(None): Chapter 4 Biobank Management
p.(None):
p.(None): Article 11
p.(None): In the event that the biological specimens, data, or information is stolen, leaked, tampered with, or otherwise infringed, an Operator
p.(None): shall immediately investigate the matter, report same to the Competent Authority, and notify relevant participants in an appropriate
p.(None): manner.
p.(None): An Operator shall stipulate emergency response measures in relation to matters mentioned in the preceding Paragraph, and submit
p.(None): same to the Competent Authority for approval.
p.(None):
p.(None): Article 12
p.(None): Personnel engaged in the collections, processing, storage, or use of biological specimens shall not disclose any confidences or other
p.(None): personal data or information of the participant, that is known or obtained as a result of their work.
p.(None):
p.(None): Article 13
p.(None): An Operator shall stipulate and disclose its own rules on information security management pursuant to the Biobank information
p.(None): security regulations promulgated by the Competent Authority.
p.(None): Such rules mentioned in the preceding Paragraph shall be submitted to the Competent Authority for records after being approved by
p.(None): the ethics committee.
p.(None):
p.(None): Article 14
p.(None): An Operator shall not transfer part or entire Biobank to another, unless the transfer is reviewed and approved by the Competent
p.(None): Authority.
p.(None): In conducting the review mentioned in the preceding Paragraph, the Competent Authority shall consider the following:
p.(None): 1.the rights and interests of the participants.
p.(None): 2.the nature of the concerned Operator and its transferee(s).
p.(None): 3.the transferee’s ability to protect the rights and interest of the participants.
p.(None): 4.the intention of the participants as expressed or may be inferred.
p.(None): In the event that an Operator plans to cease the operation of the Biobank, a follow-up plan therefor shall be submitted one (1) year in
p.(None): advance to the Competent Authority for approval before such a plan can be enforced.
p.(None):
p.(None): Article 15
p.(None): Biological specimens of the Biobank, other than the derivatives, shall not be exported.
p.(None): Any international transmission of Biobank data or the export of any derivatives mentioned in the preceding Paragraph shall be
p.(None): submitted to the Competent Authority for approval.
p.(None): In the event that the use of the Biobank is provided to a third party, the rules set forth in the preceding two paragraphs shall be
p.(None): specified in the contract of use with such third party.
p.(None):
p.(None): Chapter 5 Biobank Applications
p.(None):
p.(None): Article 16
p.(None): Any biomedical research being based on human population groups or specific population groups shall not use any materials obtained
p.(None): from a Biobank the establishment of which is not authorized.
p.(None): Where an Operator uses or provides to any third party the biological specimens, and related data and information, such use and the
p.(None): provision shall be conducted pursuant to the scope, duration, and method as agreed to by the Participant.
p.(None):
p.(None): Article 17
p.(None): In the event that a Biobank that is established for the purpose of public interests or subsidized by the government should provide its
p.(None): biological specimens and relevant data and information to a third party, the principle of fairness and equality shall apply.
p.(None):
p.(None): Article 18
p.(None): Any storage, use, or disclosure of the concerned operator’s entire biological specimens and related data and information shall be
p.(None): encoded, encrypted, delinked, or transformed so that the participant’s identity is unable to be determined.
p.(None): An Operator shall encrypt and independently administer information that can determine the identity of an individual participant, such
p.(None): as his/her name, identification number, and date of birth. An Operator shall establish a review and control procedure for cross
p.(None): referencing the aforesaid personal information with the biological specimens and relevant data and information. Such information
p.(None): shall be restored immediately after each necessary use.
p.(None): When an Operator cross references data or information of different sources, the Operator shall comply with Paragraph 1 hereof and
p.(None): restore the information immediately after the cross-reference is complete.
p.(None): Documents that are unable to be separated from the information which can determine the identity of a participant, such as the
p.(None): agreement of consent and declarations of participation termination, are not subject to the rules set forth in the preceding three
p.(None): paragraphs. Nevertheless, the Operator shall adopt other necessary measures to maintain the confidentiality.
p.(None): Article 5, Paragraph 3 hereof shall apply to the cross reference and application procedures referred to in Paragraphs 2 and 3.
p.(None):
p.(None): Article 19
p.(None): An Operator’s staff and interested parties shall recuse themselves in the event of conflict of interests.
p.(None):
p.(None): Article 20
p.(None): Any use of biological specimens, derivatives and relevant data and information in the Biobank shall not be used for purposes other
p.(None): than biomedical research. Medical research approved in accordance with Particle 5, Paragraph 3 hereof shall not be subject to this
p.(None): rule.
p.(None):
p.(None): Article 21
p.(None): Any profits derived from the commercial use and received by an Operator and Biobank shall be given back to the human population
p.(None): groups or specific population groups to which the respective participants belong.
p.(None): The Competent Authority shall stipulate regulations governing the distribution of profits mentioned in the preceding Paragraph.
p.(None):
p.(None): Article 22
p.(None): An Operator shall regularly publish studies and research results of using the Biobank.
p.(None):
p.(None): Chapter 6 Penalties
p.(None):
p.(None): Article 23
p.(None): Violations of Article 4, Paragraph 1 hereof by establishing any Biobank without an approval from the Competent Authority shall be
p.(None): subject to a fine of no less than two million New Taiwan Dollars (NT$ 2,000,000) and no more than ten million New Taiwan Dollars
p.(None): (NT$ 10,000,000). Any and all biological specimens and other data and information stored in such a Biobank shall be destroyed.
p.(None): However, in the event that the qualification and condition requirements for the establishment set for in Article 4, paragraph 2 hereof
p.(None): are met and that other relevant procedures may be supplemented or corrected, the violator may be first ordered to make such
p.(None): supplement or correction within a prescribed deadline.
p.(None): Violations of Article 14, Paragraph 1 hereof or Article 14, Paragraph 3 by failing to submit a follow-up plan to the competent authority
p.(None): for a prior approval with regard to of any future cessation of Biobank operation within the time specified; or by failing to comply with
p.(None): the approved follow-up plan shall be subject to a fine of no less than two million New Taiwan Dollars (NT$ 2,000,000) and no more
p.(None): than ten million New Taiwan Dollars (NT$ 10,000,000).
p.(None): Violations of Article 15, Paragraph 1 or Paragraph 2 by failing to apply to the Competent Authority for approval shall be subject a fine
p.(None): of no less than two million New Taiwan Dollars (NT$ 2,000,000) and no more than ten million New Taiwan Dollars (NT$ 10,000,000).
p.(None): Any exported biological specimens and related data and information shall be immediately destroyed.
p.(None): Violations of Article 30 by failing to destroy any biological specimens and related data and information as required by law shall be
p.(None): subject to a fine of no less than two million New Taiwan Dollars (NT$ 2,000,000) and no more than ten million New Taiwan Dollars
p.(None): (NT$ 10,000,000).
p.(None): Where the circumstances set forth in the preceding four paragraphs constitute a serious offense, the Competent Authority may also
p.(None): revoke the establishment permit of the violator.
p.(None):
p.(None): Article 24
p.(None): When engaging in any of the following violations, an Operator shall be subject to a fine of no less than five hundred thousand New
p.(None): Taiwan Dollars (NT$ 500,000) and no more than two million and five hundred thousand New Taiwan Dollars (NT$ 2,500,000); and
p.(None): may be ordered to undertake timely corrective actions. An Operator who fails to timely undertake such corrective actions shall be
p.(None): subject to an additional fine imposed for each failure:
p.(None): 1.violating Article 5, Paragraph 1 or 3 by failing to establish an ethics committee, or failing to submit the management and application
p.(None): matters of the Biobank to the ethics committee for review and supervision, or failing to submit same to the Competent Authority for
p.(None): approval; violating Article 5, Paragraph 2 by allowing unlawful composition of the ethics committee; or violating Article 5, Paragraph 6
p.(None): by failing to recuse from a conflict of interests.
p.(None): 2.violating Article 6, Paragraphs 1-3 or Article 7 by collecting biological specimens; or violating Article 6, Paragraph 4 by failing to
p.(None): submit the agreement of consent to the ethics committee for review and approval.
p.(None): 3.violating Article 12 by disclosing any confidences or other personal data or information of a participant that is known or obtained as
p.(None): a result of the work.
p.(None): 4.violating Article 13, Paragraph 1 by failing to stipulate or disclose rules regarding information security, or for the reason that the
p.(None): management of biological specimens and related data and information violates any information security regulations; or failing to
p.(None): comply with Article 13, Paragraph 2 requiring that the information security rules pass the review of the concerned ethics committee or
p.(None): submitted to the Competent Authority for records.
p.(None): 5.violating Article 18, Paragraph 1 by failing to process the biological specimens and related data and information so that the
p.(None): participant ’ s identity is unable to be determined; or violating Article 18, Paragraph 4 by failing to adopt necessary measures to
p.(None): maintain the confidentiality of information contained in the documents that are unable to be separated from the information which can
p.(None): determine the identity of a participant; or violating Article 18, Paragraph 5.
p.(None): 6.violating Article 18, Paragraph 2 by failing to encrypt and independently administer information that can determine the identity of an
p.(None): individual participant, failing to establish a review and control procedure for cross referencing the personal information with the
p.(None): biological specimens and relevant data and information, or failing to immediately restore such information after each necessary use;
p.(None): or violating Article 18, Paragraph 3 by failing to cross reference data with information by means that the participant ’ s identity is
p.(None): unable to be determined, or by failing to immediately restore such information after cross reference.
p.(None): 7.violating Article 20 by using biological specimens, derivatives, and related data and information for the purposes other than
p.(None): biomedical research.
p.(None): In the event of any of the violations set forth in the preceding paragraphs, the Competent Authority may order a temporary cessation
p.(None): of the operation of the Biobank pending timely corrective actions; where the circumstances constitute a serious offense, the
p.(None): Competent Authority may also revoke the establishment licensure of the violator.
p.(None):
p.(None): Article 25
p.(None): When engaging in any of the following violations, a Operator shall be subject to a fine of no less than two hundred thousand New
p.(None): Taiwan Dollars (NT$ 200,000) and no more than two million and one million New Taiwan Dollars (NT$ 1,000,000); and may be
p.(None): ordered to undertake timely corrective actions. An Operator who fails to timely undertake such corrective actions shall be subject to
p.(None): an additional fine imposed for each failure:
p.(None): 1.violating Article 8, Paragraph 1 for refusing a Participant ’ s requests; or violating Article 8, Paragraph 2 by failing to destroy or notify
p.(None): the concerned third party to destroy biological specimens and related data and information provided by a withdrawing Participant.
p.(None): 2.violating Article 16, Paragraph 2 by failing to use or provide to any third party the biological specimens and related data and
p.(None): information pursuant to the scope, duration, and method as agreed to by the Participant.
p.(None): 3.violating the regulations stipulated pursuant to Article 21, Paragraph 2.
p.(None): 4.violating Article 22 by failing to regularly publish biomedical studies and results.
p.(None): Violations of Article 29 by collecting or using biological specimens in biomedical research being not based on the population groups
p.(None): or specific population groups shall be subject to fines a fine of no less than two hundred thousand New Taiwan Dollars (NT$ 200,000)
p.(None): and no more than two million and one million New Taiwan Dollars (NT$ 1,000,000). The violators may be ordered to undertake timely
p.(None): corrective actions. An Operator who fails to timely undertake such corrective actions shall be subject to an additional fine imposed for
p.(None): each failure.
p.(None):
p.(None): Article 26
p.(None): When engaging in any of the following violations, a person shall be subject to a fine of no less than sixty thousand New Taiwan
p.(None): Dollars (NT$ 60,000) and no more than two million and three hundred thousand New Taiwan Dollars (NT$ 300,000); and may be
p.(None): ordered to undertake timely corrective actions. The person who fails to timely undertake such corrective actions shall be subject to an
p.(None): additional fine imposed for each failure:
p.(None): 1.where any person other than an Operator violates Article 5, Paragraph 3.
p.(None): 2.where an Operator violates Article 6, Paragraph 4 by failing to submit the agreement of consent to the Competent Authority for
p.(None): records.
p.(None): 3.violating Article 11, Paragraph 1 by failing to report to the Competent Authority the infringement on the biological specimens, or
p.(None): related data or information, or where an Operator fails to immediately investigate the situations and notify the relevant participants in
p.(None): an appropriate manner; or violating Paragraph 2 of the same Article.
p.(None): 4.where any person other than an Operator violates Article 12 by divulging any confidence or other personal data or information of a
p.(None): Participant that is known or held by him/her as a result of his/her work.
p.(None): 5.violating Article 16, Paragraph 1 by obtaining materials that are used for biomedical research being based on population groups or
p.(None): specific population groups from a Biobank whose establishment has not been approved.
p.(None):
p.(None): Article 27
p.(None): With regard to the sanctions set forth in the preceding four articles, the Operation who actually committed the act of violation shall be
p.(None): subject to a fine of no less than thirty thousand New Taiwan Dollars (NT$ 30,000) and no more than three hundred thousand New
p.(None): Taiwan Dollars (NT$ 300,000).
p.(None): In the event that an individual violator referred to in the preceding Paragraph is a licensed healthcare worker, he/she shall also be
p.(None): punished in accordance with laws and regulations governing healthcare professionals.
p.(None):
p.(None): Article 28
p.(None): In the event that the establishment of a Biobank is in violation of the regulations stipulated by the Competent Authority pursuant to
p.(None): Article 4, Paragraph 2, in additional to the penalties set forth herein, the Competent Authority may order a timely corrective action. If
p.(None): necessary, the Operator may be ordered to cease operations pending the correction actions. Where the nature of the offense is
p.(None): serious, the establishment permit of the violator may be revoked.
p.(None):
p.(None): Chapter 7 Supplementary Provisions
p.(None):
p.(None): Article 29
p.(None): (deleted)
p.(None):
p.(None): Article 30
p.(None): For any Biobank established prior to the enforcement of Human Biobank Act, its Operator shall, within no later than February 5, 2012,
p.(None): complete all necessary corrective actions to conform to Human Biobank Act. Those who fail to undertake complete corrective actions
p.(None): within the time specified shall destroy and may not re-use any and all biological specimens and related data and information.
p.(None): However, in the event that the corrective action may not be completed due to the death or incapacity of the Participant, the biological
p.(None): specimens and related data and information may be preserved with the approval of the ethics committee and the Competent
p.(None): Authority.
p.(None):
p.(None): Article 31
p.(None): The Human Biobank Act shall become effective as of the day of promulgation.
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...
Orphaned Trigger Words
Appendix
Indicator List
Indicator | Vulnerability |
age | Age |
authority | Relationship to Authority |
emergency | Public Emergency |
gender | gender |
home | Property Ownership |
incapacity | Incapacitated |
minor | Youth/Minors |
party | political affiliation |
unlawful | Illegal Activity |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
capacity
consent
ethics
justice
protect
protection
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input