0A4F4F9BD490A749D5437F821CF06DF1
Administrative Regulations on the Establishment of Human Biobanks
https://law.moj.gov.tw/Eng/LawClass/LawAll.aspx?PCode=L0020173
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This file was generated: 2020-08-23 06:00:42
| 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
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 Administrative Regulations on the Establishment of Human Biobank CH
p.(None): Announced Date 2011-01-31
p.(None): Category Ministry of Health and Welfare
p.(None):
p.(None):
p.(None): Article Content Article No Search Content Search Legislative History
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Article 1
p.(None): This set of Regulations is formulated in accordance with regulations of Paragraph 2, Article 4 of the Human Biobank Management Act
p.(None): (hereafter referred to as the Act).
p.(None):
p.(None): Article 2
p.(None): Institutions meet one of the following qualifications and have set up a bio-medical director and an information director shall apply for a
p.(None): biobank establishment to the central competent authority after approved by the Ethics Committee specified in Paragraph 1 of Article 5
p.(None): (hereafter referred to as the Ethics Committee):
p.(None): 1. Government agencies of justice, health, bio-technology industries or scientific development-related;
p.(None): 2. Hospitals who have passed the accreditation of teaching hospitals;
p.(None): 3. Public/Private technological academies or above; or
p.(None): 4. Central government-associated institutions or national incorporated foundations and judicial associations that have been set up for
p.(None): life science research.
p.(None):
p.(None): Article 3
...
General/Other / Incapacitated
Searching for indicator incapacity:
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p.(None): 1. Setting proposal that contains following matters:
p.(None): (1) Representatives of the institution and the Biobank;
p.(None): (2) Addresses of the institution and the Biobank;
p.(None): (3)Types, quantities and related data and information of biological specimens planned to be collected and preserved;
p.(None): (4) Planned setting schedule;
p.(None): (5) Staff, organization and operating processes of the Biobank;
p.(None): (6) A simplified representation of facilities, equipments and the planned preservation place of the Biobank as well as related
p.(None): environmental control and monitoring;
p.(None): (7)Contents of informed consent and the measures of participant’s rights and interests protection;
p.(None): (8) Operating procedures of dealing with biological specimens and related data and information.
p.(None): 2. Organization and membership list of the Ethics Committee;
p.(None): 3. Names of the bio-medical director and the information director as well as photocopies of their qualification certificates;
p.(None): 4. Management provisions on information security set by the operator;
p.(None): 5. Rules of notification mechanisms and remedies applicable when participants’ biological specimens or related data and information
p.(None): are stolen, leaked, altered or suffer from other violations;
p.(None): 6. Rules related to benefits or feedbacks from commercial use and received by the operator;
p.(None): 7. Relevant measures to be taken so that collected biological specimens and related data and information will not be destroyed in the
p.(None): event that the corrective action may not be completed due to the death or incapacity of the participant as specified in the
p.(None): supplementary provisions in Article 30 of the Act.
p.(None):
p.(None): Article 4
p.(None): Qualifications and responsibilities of the bio-medical director and the information director of the Biobank are as follows:
p.(None): 1. The bio-medical director: holds a Physician Certificate, Medical Technologist License or Master’s degree in biology-related subject
p.(None): and has practical experience of more than three years in bio-medical related fields; responsible for supervision and maintenance of
p.(None): the quality management of collections, preservation, application and destruction of biological specimens of the Biobank and for other
p.(None): matters related to biomedicine of the Biobank;
p.(None): 2. The information director: holds a Master’s degree in an information-related subject and has practical experience of more than three
p.(None): years in information-related fields; responsible for supervision and maintenance of the safety management of data and information in
p.(None): the Biobank and for other matters related to information safety of the Biobank.
p.(None): When a Biobank has more than 2 places for biospecimens preservation, one bio-medical director shall be set for each address.
p.(None):
p.(None): Article 5
p.(None): Competent authority should examine and approve applications for setting up of a Biobank based on following standards:
p.(None): 1. Completeness and feasibility of the proposal;
p.(None): 2. Considerateness of guarantee of participants’ rights and interests;
p.(None): 3. Appropriateness of the review process carried out by the Ethics Committee.
p.(None):
p.(None): Article 6
p.(None): A Permission Certificate with a valid period of three years will be issued after the application for the setting up of a Biobank which has
...
General/Other / Relationship to Authority
Searching for indicator authority:
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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 Administrative Regulations on the Establishment of Human Biobank CH
p.(None): Announced Date 2011-01-31
p.(None): Category Ministry of Health and Welfare
p.(None):
p.(None):
p.(None): Article Content Article No Search Content Search Legislative History
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Article 1
p.(None): This set of Regulations is formulated in accordance with regulations of Paragraph 2, Article 4 of the Human Biobank Management Act
p.(None): (hereafter referred to as the Act).
p.(None):
p.(None): Article 2
p.(None): Institutions meet one of the following qualifications and have set up a bio-medical director and an information director shall apply for a
p.(None): biobank establishment to the central competent authority after approved by the Ethics Committee specified in Paragraph 1 of Article 5
p.(None): (hereafter referred to as the Ethics Committee):
p.(None): 1. Government agencies of justice, health, bio-technology industries or scientific development-related;
p.(None): 2. Hospitals who have passed the accreditation of teaching hospitals;
p.(None): 3. Public/Private technological academies or above; or
p.(None): 4. Central government-associated institutions or national incorporated foundations and judicial associations that have been set up for
p.(None): life science research.
p.(None):
p.(None): Article 3
p.(None): Applicants involved in the previous article shall submit flowing documents to the competent authority for approval:
p.(None): 1. Setting proposal that contains following matters:
p.(None): (1) Representatives of the institution and the Biobank;
p.(None): (2) Addresses of the institution and the Biobank;
p.(None): (3)Types, quantities and related data and information of biological specimens planned to be collected and preserved;
p.(None): (4) Planned setting schedule;
p.(None): (5) Staff, organization and operating processes of the Biobank;
p.(None): (6) A simplified representation of facilities, equipments and the planned preservation place of the Biobank as well as related
p.(None): environmental control and monitoring;
p.(None): (7)Contents of informed consent and the measures of participant’s rights and interests protection;
p.(None): (8) Operating procedures of dealing with biological specimens and related data and information.
p.(None): 2. Organization and membership list of the Ethics Committee;
p.(None): 3. Names of the bio-medical director and the information director as well as photocopies of their qualification certificates;
p.(None): 4. Management provisions on information security set by the operator;
p.(None): 5. Rules of notification mechanisms and remedies applicable when participants’ biological specimens or related data and information
p.(None): are stolen, leaked, altered or suffer from other violations;
p.(None): 6. Rules related to benefits or feedbacks from commercial use and received by the operator;
p.(None): 7. Relevant measures to be taken so that collected biological specimens and related data and information will not be destroyed in the
p.(None): event that the corrective action may not be completed due to the death or incapacity of the participant as specified in the
p.(None): supplementary provisions in Article 30 of the Act.
p.(None):
p.(None): Article 4
p.(None): Qualifications and responsibilities of the bio-medical director and the information director of the Biobank are as follows:
p.(None): 1. The bio-medical director: holds a Physician Certificate, Medical Technologist License or Master’s degree in biology-related subject
p.(None): and has practical experience of more than three years in bio-medical related fields; responsible for supervision and maintenance of
p.(None): the quality management of collections, preservation, application and destruction of biological specimens of the Biobank and for other
p.(None): matters related to biomedicine of the Biobank;
p.(None): 2. The information director: holds a Master’s degree in an information-related subject and has practical experience of more than three
p.(None): years in information-related fields; responsible for supervision and maintenance of the safety management of data and information in
p.(None): the Biobank and for other matters related to information safety of the Biobank.
p.(None): When a Biobank has more than 2 places for biospecimens preservation, one bio-medical director shall be set for each address.
p.(None):
p.(None): Article 5
p.(None): Competent authority should examine and approve applications for setting up of a Biobank based on following standards:
p.(None): 1. Completeness and feasibility of the proposal;
p.(None): 2. Considerateness of guarantee of participants’ rights and interests;
p.(None): 3. Appropriateness of the review process carried out by the Ethics Committee.
p.(None):
p.(None): Article 6
p.(None): A Permission Certificate with a valid period of three years will be issued after the application for the setting up of a Biobank which has
p.(None): been reviewed and approved by competent authority.
p.(None): In the Permission Certificate, following information shall be clearly stated:
p.(None): 1. Name and address of the Biobank;
p.(None): 2. Name and representative of the operator;
p.(None): 3. Address of the operator;
p.(None): 4. Preservation address of the biological specimens.
p.(None):
p.(None): Article 7
p.(None): The operator should submit following documents to the competent authority for applying an extension to the permission certificate for
p.(None): setting up of a Biobank three months before its expiration:
p.(None): 1. A copy of the original permission certificate;
p.(None): 2. An explanation regarding collection, preservation status and application of the biological specimens within the current period of
p.(None): validity, which shall be signed by the bio-medical director;
p.(None): 3. Explanation of implementation related to information security within the current period of validity, which shall be signed by the
p.(None): information director;
p.(None): 4. Explanation of matters to be added or altered within the next period of validity.
p.(None): Each extension to the permission certificate is limited to three years after the previous application has passed the examination.
p.(None):
p.(None): Article 8
p.(None): Within the period of validity of the permission certificate, should there be any alternation of matters handled or staff that causes
p.(None): inconsistency with the original plan or with document descriptions submitted during application for extension to period of validity,
p.(None): operator should report it to competent authority for approval within one month from the date of making the alternation.
p.(None):
p.(None): Article 9
p.(None): Operator should submit relevant plans as well as documents reviewed and approved by the Ethics Committee to the competent
p.(None): authority for approval in order to apply for overseas transport or export of derivatives of biological specimens.
p.(None):
p.(None): Article 10
p.(None): Operators who have seriously violated provisions in Article 23, 24 or 28 of the Act and have been revoked permission certificates by
p.(None): the competent authority shall stop operation immediately and submit follow-up disposal plans to the competent authority for approval
p.(None): within three months from the date of revocation.
p.(None):
p.(None): Article 11
p.(None): Institutions shall apply provisions in Articles 2 to 5 when partial or complete transfer of Biobank according to provisions in Paragraph 1
p.(None): of Article 14 in the Act, or correcting relevant procedures according to provisions in Article 30 in the Act.
p.(None):
p.(None): Article 12
p.(None): Operator and relevant personnel should not evade, obstruct or refuse regular checks of the Biobank or reading of related documents
p.(None): carried out by the competent authority.
p.(None):
p.(None): Article 13
p.(None): This Administrative Regulations shall come into effect on the date of the promulgation.
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):
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
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| authority | Relationship to Authority |
| home | Property Ownership |
| incapacity | Incapacitated |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
consent
ethics
justice
protection
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input