79C3C34C52B45572883A05D425EB0F82
Regulations on Human Trial
https://law.moj.gov.tw/ENG/LawClass/LawAll.aspx?pcode=L0020162
http://leaux.net/URLS/ConvertAPI Text Files/4A3C06EA645C9D17886ECA6CC6AB0627.en.txt
Examining the file media/Synopses/4A3C06EA645C9D17886ECA6CC6AB0627.html:
This file was generated: 2020-12-01 07:49:32
| 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 / political affiliation
Searching for indicator party:
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p.(None): inspection, disposition or termination, retention, reporting, publication or promotion of the trial subject consent forms and proposals,
p.(None): as well as the destruction or reutilization of the data thereof, shall be subject to the applicable provisions of this Act and these
p.(None): Regulations.
p.(None):
p.(None): Article 4
p.(None): The trial conductor referred to in the preceding article shall possess the following qualifications:
p.(None): 1. being a licensed physician, dentist, or traditional Chinese medicine physician with five (5) or more years of experience in clinical
p.(None): treatment.
p.(None): 2. having received human trial related training of more than thirty (30) hours within the past six (6) years; being the trial conductor in
p.(None): Human Trials of somatic cells or gene therapy with additional five (5) or more hours of relevant training.
p.(None): 3. taking medical ethics related courses for more than nine (9) hours within the past six (6) years.
p.(None): Those who have been subject to physician disciplinary or whose licenses have been suspended for more than one (1) month or
p.(None): abolished due to any violation of laws and regulations related to Human Trials shall not serve as a trial conductor.
p.(None):
p.(None): Article 5
p.(None): With regard to the adult or minor but married Trial Subject recruited in accordance with the proviso of Article 79, Paragraph 1 of this
p.(None): Act, the trial conductor shall obtain the consent of his/her interested party in the following priority order:
p.(None): 1. Spouse
p.(None): 2. Parent
p.(None): 3. Cohabiting adult child
p.(None): 4. Cohabiting grandparent
p.(None): 5. Cohabiting brother or sister
p.(None): 6. Any relative who has cohabited with the Trial Subject within the past one(1) year
p.(None): The consent of the interested party set forth in the preceding paragraph shall not be against the Trial Subject’s will.
p.(None):
p.(None): Article 6
p.(None): With regard to the joint review of the Human Trial proposal referred to in Article 78, Paragraph 3 of this Act, the name list of the joint
p.(None): review board members and meeting minutes of the review board (hereinafter the “Review Board”) shall be disclosed to the public.
p.(None): Relevant rules regarding the review referred to in the preceding paragraph shall be stipulated and disclosed.
p.(None):
p.(None): Article 7
p.(None): The following matters shall be attended to when reviewing the Human Trial:
p.(None): 1. The design of the Human Trial shall be of the lowest risks and take into account the reasonable risks and benefits.
p.(None): 2. Execution and contents of the Human Trial in compliance with scientific principles.
p.(None): 3. Conditions of the Trial Subject and recruitment methods.
p.(None): 4. Medical care and compensation or other remedy provided to the Trial Subject.
p.(None): 5. Protection of the Trial Subject’s privacy.
p.(None): 6. Contents of Test Subject consent forms and notification procedure.
p.(None): 7. Protection of vulnerable groups.
p.(None): 8. Necessary management measures protecting the Trial Subject’s safety.
p.(None):
p.(None): Article 8
p.(None): A review board member shall immediately recuse himself/herself in any of the following circumstances:
p.(None): 1. serving as the trial conductor, assistant trial conductor, or entrustor of the Human Trial.
p.(None): 2. being, currently or in the past, the spouse, blood relative of four degrees or closer, or relative by marriage of three degrees or
p.(None): closer of the trial conductor.
...
Political / vulnerable
Searching for indicator vulnerable:
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p.(None): 1. Spouse
p.(None): 2. Parent
p.(None): 3. Cohabiting adult child
p.(None): 4. Cohabiting grandparent
p.(None): 5. Cohabiting brother or sister
p.(None): 6. Any relative who has cohabited with the Trial Subject within the past one(1) year
p.(None): The consent of the interested party set forth in the preceding paragraph shall not be against the Trial Subject’s will.
p.(None):
p.(None): Article 6
p.(None): With regard to the joint review of the Human Trial proposal referred to in Article 78, Paragraph 3 of this Act, the name list of the joint
p.(None): review board members and meeting minutes of the review board (hereinafter the “Review Board”) shall be disclosed to the public.
p.(None): Relevant rules regarding the review referred to in the preceding paragraph shall be stipulated and disclosed.
p.(None):
p.(None): Article 7
p.(None): The following matters shall be attended to when reviewing the Human Trial:
p.(None): 1. The design of the Human Trial shall be of the lowest risks and take into account the reasonable risks and benefits.
p.(None): 2. Execution and contents of the Human Trial in compliance with scientific principles.
p.(None): 3. Conditions of the Trial Subject and recruitment methods.
p.(None): 4. Medical care and compensation or other remedy provided to the Trial Subject.
p.(None): 5. Protection of the Trial Subject’s privacy.
p.(None): 6. Contents of Test Subject consent forms and notification procedure.
p.(None): 7. Protection of vulnerable groups.
p.(None): 8. Necessary management measures protecting the Trial Subject’s safety.
p.(None):
p.(None): Article 8
p.(None): A review board member shall immediately recuse himself/herself in any of the following circumstances:
p.(None): 1. serving as the trial conductor, assistant trial conductor, or entrustor of the Human Trial.
p.(None): 2. being, currently or in the past, the spouse, blood relative of four degrees or closer, or relative by marriage of three degrees or
p.(None): closer of the trial conductor.
p.(None): 3. being in an employment relationship with the entrustor of the Human Trial.
p.(None): 4. being in other situations where the recusal of the review board member is deemed necessary by the Review Board.
p.(None): The Review Board shall audit those Human Trials reviewed and approved by this Review Board at least once a year.
p.(None):
p.(None): Article 9
p.(None): The Review Board, if discovering any of the following matters in the audit referred to in the preceding paragraph, may order the
p.(None): Human Trial to be improved within a prescribed period of time or terminated:
p.(None): 1. where the contents of the Human Trial are altered without the approval of the Review Board or central competent authority as
p.(None): required by law.
p.(None): 2. where the rights, interest, or safety of the Trial Subject is obviously affected.
p.(None): 3. where the frequency or seriousness of the occurrence of adverse events is abnormal.
p.(None): 4. where the existence of an occurrence is sufficient to affect the evaluation of Human Trial results.
p.(None): 5. where specific facts exist before the completion of the Human Trial proving that the Human Trial has no actual benefits, higher
...
Health / Drug Usage
Searching for indicator drug:
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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 Regulations on Human Trials CH
p.(None): Amended Date 2016-04-14
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): These regulations (hereinafter “Regulations”) are enacted pursuant to Article 79-1 of the Medical Care Act (hereinafter “this Act”).
p.(None):
p.(None): Article 2
p.(None): A human trial research (hereinafter “Human Trial” shall be conducted prior to the registration of a new drug or medical device or
p.(None): before a medical care institution lists a new medical technology as a regular medical disposition item.
p.(None):
p.(None): Article 3
p.(None): With regard to the Human Trial, a medical care institution shall draft a proposal and submit same to the central competent authority
p.(None): for approval.
p.(None): The proposal referred to in the preceding paragraph shall indicate the following items:
p.(None): 1. The subject.
p.(None): 2. The purpose.
p.(None): 3. The method.
p.(None): 1) The conditions of the person accepting the Human Trial (hereinafter the “Trial Subject”), recruitment method, and number of Trial
p.(None): Subjects required.
p.(None): 2) Implementation methods.
p.(None): 3) Duration of the Human Trial and scheduled progress.
p.(None): 4) Evaluation of treatment results and statistical methods.
p.(None): 5) Track of Trial Subjects and necessary rehabilitation plans.
p.(None): 4. The contents of Trial Subject consent forms.
p.(None): 5. The academic and professional background and received training of the trial conductor(s) and assistant trial conductor(s).
p.(None): 6. Relevant domestic and international publications and reports.
p.(None): 7. Relevant documents of proof in the event that the Human Trial has been approved overseas.
p.(None): 8. Required medicament or equipment including the name and quantity of the medicament or equipment to be imported.
p.(None): 9. Anticipated effects.
p.(None): 10. Possible damages and responding remedies.
p.(None):
p.(None): Article 3-1
p.(None): For the treatment of specific patients with life-threatening diseases or serious disabilities for which no effective drugs, medical
...
Health / Mentally Disabled
Searching for indicator disability:
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p.(None): required by law.
p.(None): 2. where the rights, interest, or safety of the Trial Subject is obviously affected.
p.(None): 3. where the frequency or seriousness of the occurrence of adverse events is abnormal.
p.(None): 4. where the existence of an occurrence is sufficient to affect the evaluation of Human Trial results.
p.(None): 5. where specific facts exist before the completion of the Human Trial proving that the Human Trial has no actual benefits, higher
p.(None): risks than potential benefits, or actual benefits that are disadvantageous to the control group.
p.(None): The central competent authority when learning of the adverse event(s) referred to in the preceding paragraph may order the Human
p.(None): Trial to be terminated.
p.(None):
p.(None): Article 10
p.(None): The Review Board shall preserve the relevant documentation, such as Human Trial proposal, meeting minutes, or audit records for at
p.(None): least three(3) years after the completion of Human Trial.
p.(None):
p.(None): Article 11
p.(None): The medical care institution shall not charge the Trial Subject for any fees related to the Human Trial.
p.(None):
p.(None): Article 12
p.(None): The medical care institution shall report to the central competent authority when the Trial Subject experiences any of the following
p.(None): occurrences during the Human Trial period or anytime when any of the following occurrences are related to the Human Trial:
p.(None): 1. Death.
p.(None): 2. Life-threatening.
p.(None): 3. Permanent mental and physical disability.
p.(None): 4. where the fetus or newborn of the Trial Subject suffers congenital malformations.
p.(None): 5. Complications requiring hospitalization or prolonged hospitalization.
p.(None): 6. Other complications possibly causing permanent damages.
p.(None): The medical care institution shall make such report referred to in the preceding paragraph within seven (7) days after learning of the
p.(None): occurrence(s) and submit detailed investigation information to the central competent authority within fifteen (15) days.
p.(None):
p.(None): Article 13
p.(None): The central competent authority may order the medical care institution that conducts the Human Trial to provide relevant information,
p.(None): such as a summary of Human Trial proposal, case numbers, sex ratio, age statistics, review results of Trial Subject consent forms,
p.(None): and possible risks; or conduct necessary audit which the medical care institution shall not impede, avoid, or refuse.
p.(None): The audit referred to in the preceding paragraph may be done by relevant organizations as entrusted by the central competent
p.(None): authority.
p.(None):
p.(None): Article 14
p.(None): The Trial Subject’s biological samples, personal data, or derivatives shall be destroyed immediately upon completion of the Human
p.(None): Trial. The reutilization of aforesaid material(s) as subject to the Trial Subject’s consent shall be reviewed and approved by the Review
...
Social / Age
Searching for indicator age:
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p.(None):
p.(None): Article 10
p.(None): The Review Board shall preserve the relevant documentation, such as Human Trial proposal, meeting minutes, or audit records for at
p.(None): least three(3) years after the completion of Human Trial.
p.(None):
p.(None): Article 11
p.(None): The medical care institution shall not charge the Trial Subject for any fees related to the Human Trial.
p.(None):
p.(None): Article 12
p.(None): The medical care institution shall report to the central competent authority when the Trial Subject experiences any of the following
p.(None): occurrences during the Human Trial period or anytime when any of the following occurrences are related to the Human Trial:
p.(None): 1. Death.
p.(None): 2. Life-threatening.
p.(None): 3. Permanent mental and physical disability.
p.(None): 4. where the fetus or newborn of the Trial Subject suffers congenital malformations.
p.(None): 5. Complications requiring hospitalization or prolonged hospitalization.
p.(None): 6. Other complications possibly causing permanent damages.
p.(None): The medical care institution shall make such report referred to in the preceding paragraph within seven (7) days after learning of the
p.(None): occurrence(s) and submit detailed investigation information to the central competent authority within fifteen (15) days.
p.(None):
p.(None): Article 13
p.(None): The central competent authority may order the medical care institution that conducts the Human Trial to provide relevant information,
p.(None): such as a summary of Human Trial proposal, case numbers, sex ratio, age statistics, review results of Trial Subject consent forms,
p.(None): and possible risks; or conduct necessary audit which the medical care institution shall not impede, avoid, or refuse.
p.(None): The audit referred to in the preceding paragraph may be done by relevant organizations as entrusted by the central competent
p.(None): authority.
p.(None):
p.(None): Article 14
p.(None): The Trial Subject’s biological samples, personal data, or derivatives shall be destroyed immediately upon completion of the Human
p.(None): Trial. The reutilization of aforesaid material(s) as subject to the Trial Subject’s consent shall be reviewed and approved by the Review
p.(None): Board. A new written consent shall be obtained from the Trial Subject with regard to any non-delinked material(s).
p.(None):
p.(None): Article 15
p.(None): The medical care institution shall not publish or promote its results during the Human Trial period.
p.(None):
p.(None): Article 16
p.(None): These Regulations shall become effective as of the day of 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): This website does not provide legal counseling service, please contact with related public offices for more information.
...
Social / Fetus/Neonate
Searching for indicator fetus:
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p.(None): required by law.
p.(None): 2. where the rights, interest, or safety of the Trial Subject is obviously affected.
p.(None): 3. where the frequency or seriousness of the occurrence of adverse events is abnormal.
p.(None): 4. where the existence of an occurrence is sufficient to affect the evaluation of Human Trial results.
p.(None): 5. where specific facts exist before the completion of the Human Trial proving that the Human Trial has no actual benefits, higher
p.(None): risks than potential benefits, or actual benefits that are disadvantageous to the control group.
p.(None): The central competent authority when learning of the adverse event(s) referred to in the preceding paragraph may order the Human
p.(None): Trial to be terminated.
p.(None):
p.(None): Article 10
p.(None): The Review Board shall preserve the relevant documentation, such as Human Trial proposal, meeting minutes, or audit records for at
p.(None): least three(3) years after the completion of Human Trial.
p.(None):
p.(None): Article 11
p.(None): The medical care institution shall not charge the Trial Subject for any fees related to the Human Trial.
p.(None):
p.(None): Article 12
p.(None): The medical care institution shall report to the central competent authority when the Trial Subject experiences any of the following
p.(None): occurrences during the Human Trial period or anytime when any of the following occurrences are related to the Human Trial:
p.(None): 1. Death.
p.(None): 2. Life-threatening.
p.(None): 3. Permanent mental and physical disability.
p.(None): 4. where the fetus or newborn of the Trial Subject suffers congenital malformations.
p.(None): 5. Complications requiring hospitalization or prolonged hospitalization.
p.(None): 6. Other complications possibly causing permanent damages.
p.(None): The medical care institution shall make such report referred to in the preceding paragraph within seven (7) days after learning of the
p.(None): occurrence(s) and submit detailed investigation information to the central competent authority within fifteen (15) days.
p.(None):
p.(None): Article 13
p.(None): The central competent authority may order the medical care institution that conducts the Human Trial to provide relevant information,
p.(None): such as a summary of Human Trial proposal, case numbers, sex ratio, age statistics, review results of Trial Subject consent forms,
p.(None): and possible risks; or conduct necessary audit which the medical care institution shall not impede, avoid, or refuse.
p.(None): The audit referred to in the preceding paragraph may be done by relevant organizations as entrusted by the central competent
p.(None): authority.
p.(None):
p.(None): Article 14
p.(None): The Trial Subject’s biological samples, personal data, or derivatives shall be destroyed immediately upon completion of the Human
p.(None): Trial. The reutilization of aforesaid material(s) as subject to the Trial Subject’s consent shall be reviewed and approved by the Review
p.(None): Board. A new written consent shall be obtained from the Trial Subject with regard to any non-delinked material(s).
p.(None):
...
Social / Marital Status
Searching for indicator married:
(return to top)
p.(None): of subsidies if subsidies are provided.
p.(None): The number of specific patients enrolled, as set forth in Subparagraph 2 of the preceding paragraph, shall not exceed the number of
p.(None): original human trial subjects.
p.(None): The subsidiary proposal conductor shall be the conductor of the original human trial proposal. The disclosure, review, avoidance,
p.(None): inspection, disposition or termination, retention, reporting, publication or promotion of the trial subject consent forms and proposals,
p.(None): as well as the destruction or reutilization of the data thereof, shall be subject to the applicable provisions of this Act and these
p.(None): Regulations.
p.(None):
p.(None): Article 4
p.(None): The trial conductor referred to in the preceding article shall possess the following qualifications:
p.(None): 1. being a licensed physician, dentist, or traditional Chinese medicine physician with five (5) or more years of experience in clinical
p.(None): treatment.
p.(None): 2. having received human trial related training of more than thirty (30) hours within the past six (6) years; being the trial conductor in
p.(None): Human Trials of somatic cells or gene therapy with additional five (5) or more hours of relevant training.
p.(None): 3. taking medical ethics related courses for more than nine (9) hours within the past six (6) years.
p.(None): Those who have been subject to physician disciplinary or whose licenses have been suspended for more than one (1) month or
p.(None): abolished due to any violation of laws and regulations related to Human Trials shall not serve as a trial conductor.
p.(None):
p.(None): Article 5
p.(None): With regard to the adult or minor but married Trial Subject recruited in accordance with the proviso of Article 79, Paragraph 1 of this
p.(None): Act, the trial conductor shall obtain the consent of his/her interested party in the following priority order:
p.(None): 1. Spouse
p.(None): 2. Parent
p.(None): 3. Cohabiting adult child
p.(None): 4. Cohabiting grandparent
p.(None): 5. Cohabiting brother or sister
p.(None): 6. Any relative who has cohabited with the Trial Subject within the past one(1) year
p.(None): The consent of the interested party set forth in the preceding paragraph shall not be against the Trial Subject’s will.
p.(None):
p.(None): Article 6
p.(None): With regard to the joint review of the Human Trial proposal referred to in Article 78, Paragraph 3 of this Act, the name list of the joint
p.(None): review board members and meeting minutes of the review board (hereinafter the “Review Board”) shall be disclosed to the public.
p.(None): Relevant rules regarding the review referred to in the preceding paragraph shall be stipulated and disclosed.
p.(None):
p.(None): Article 7
p.(None): The following matters shall be attended to when reviewing the Human Trial:
p.(None): 1. The design of the Human Trial shall be of the lowest risks and take into account the reasonable risks and benefits.
p.(None): 2. Execution and contents of the Human Trial in compliance with scientific principles.
p.(None): 3. Conditions of the Trial Subject and recruitment methods.
p.(None): 4. Medical care and compensation or other remedy provided to the Trial Subject.
p.(None): 5. Protection of the Trial Subject’s privacy.
...
Social / Property Ownership
Searching for indicator home:
(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 Regulations on Human Trials CH
p.(None): Amended Date 2016-04-14
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): These regulations (hereinafter “Regulations”) are enacted pursuant to Article 79-1 of the Medical Care Act (hereinafter “this Act”).
p.(None):
p.(None): Article 2
p.(None): A human trial research (hereinafter “Human Trial” shall be conducted prior to the registration of a new drug or medical device or
p.(None): before a medical care institution lists a new medical technology as a regular medical disposition item.
p.(None):
p.(None): Article 3
p.(None): With regard to the Human Trial, a medical care institution shall draft a proposal and submit same to the central competent authority
p.(None): for approval.
p.(None): The proposal referred to in the preceding paragraph shall indicate the following items:
p.(None): 1. The subject.
p.(None): 2. The purpose.
p.(None): 3. The method.
p.(None): 1) The conditions of the person accepting the Human Trial (hereinafter the “Trial Subject”), recruitment method, and number of Trial
p.(None): Subjects required.
p.(None): 2) Implementation methods.
p.(None): 3) Duration of the Human Trial and scheduled progress.
p.(None): 4) Evaluation of treatment results and statistical methods.
p.(None): 5) Track of Trial Subjects and necessary rehabilitation plans.
p.(None): 4. The contents of Trial Subject consent forms.
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.(None): of subsidies if subsidies are provided.
p.(None): The number of specific patients enrolled, as set forth in Subparagraph 2 of the preceding paragraph, shall not exceed the number of
p.(None): original human trial subjects.
p.(None): The subsidiary proposal conductor shall be the conductor of the original human trial proposal. The disclosure, review, avoidance,
p.(None): inspection, disposition or termination, retention, reporting, publication or promotion of the trial subject consent forms and proposals,
p.(None): as well as the destruction or reutilization of the data thereof, shall be subject to the applicable provisions of this Act and these
p.(None): Regulations.
p.(None):
p.(None): Article 4
p.(None): The trial conductor referred to in the preceding article shall possess the following qualifications:
p.(None): 1. being a licensed physician, dentist, or traditional Chinese medicine physician with five (5) or more years of experience in clinical
p.(None): treatment.
p.(None): 2. having received human trial related training of more than thirty (30) hours within the past six (6) years; being the trial conductor in
p.(None): Human Trials of somatic cells or gene therapy with additional five (5) or more hours of relevant training.
p.(None): 3. taking medical ethics related courses for more than nine (9) hours within the past six (6) years.
p.(None): Those who have been subject to physician disciplinary or whose licenses have been suspended for more than one (1) month or
p.(None): abolished due to any violation of laws and regulations related to Human Trials shall not serve as a trial conductor.
p.(None):
p.(None): Article 5
p.(None): With regard to the adult or minor but married Trial Subject recruited in accordance with the proviso of Article 79, Paragraph 1 of this
p.(None): Act, the trial conductor shall obtain the consent of his/her interested party in the following priority order:
p.(None): 1. Spouse
p.(None): 2. Parent
p.(None): 3. Cohabiting adult child
p.(None): 4. Cohabiting grandparent
p.(None): 5. Cohabiting brother or sister
p.(None): 6. Any relative who has cohabited with the Trial Subject within the past one(1) year
p.(None): The consent of the interested party set forth in the preceding paragraph shall not be against the Trial Subject’s will.
p.(None):
p.(None): Article 6
p.(None): With regard to the joint review of the Human Trial proposal referred to in Article 78, Paragraph 3 of this Act, the name list of the joint
p.(None): review board members and meeting minutes of the review board (hereinafter the “Review Board”) shall be disclosed to the public.
p.(None): Relevant rules regarding the review referred to in the preceding paragraph shall be stipulated and disclosed.
p.(None):
p.(None): Article 7
p.(None): The following matters shall be attended to when reviewing the Human Trial:
p.(None): 1. The design of the Human Trial shall be of the lowest risks and take into account the reasonable risks and benefits.
p.(None): 2. Execution and contents of the Human Trial in compliance with scientific principles.
p.(None): 3. Conditions of the Trial Subject and recruitment methods.
p.(None): 4. Medical care and compensation or other remedy provided to the Trial Subject.
p.(None): 5. Protection of the Trial Subject’s privacy.
...
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 Regulations on Human Trials CH
p.(None): Amended Date 2016-04-14
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): These regulations (hereinafter “Regulations”) are enacted pursuant to Article 79-1 of the Medical Care Act (hereinafter “this Act”).
p.(None):
p.(None): Article 2
p.(None): A human trial research (hereinafter “Human Trial” shall be conducted prior to the registration of a new drug or medical device or
p.(None): before a medical care institution lists a new medical technology as a regular medical disposition item.
p.(None):
p.(None): Article 3
p.(None): With regard to the Human Trial, a medical care institution shall draft a proposal and submit same to the central competent authority
p.(None): for approval.
p.(None): The proposal referred to in the preceding paragraph shall indicate the following items:
p.(None): 1. The subject.
p.(None): 2. The purpose.
p.(None): 3. The method.
p.(None): 1) The conditions of the person accepting the Human Trial (hereinafter the “Trial Subject”), recruitment method, and number of Trial
p.(None): Subjects required.
p.(None): 2) Implementation methods.
p.(None): 3) Duration of the Human Trial and scheduled progress.
p.(None): 4) Evaluation of treatment results and statistical methods.
p.(None): 5) Track of Trial Subjects and necessary rehabilitation plans.
p.(None): 4. The contents of Trial Subject consent forms.
p.(None): 5. The academic and professional background and received training of the trial conductor(s) and assistant trial conductor(s).
p.(None): 6. Relevant domestic and international publications and reports.
p.(None): 7. Relevant documents of proof in the event that the Human Trial has been approved overseas.
p.(None): 8. Required medicament or equipment including the name and quantity of the medicament or equipment to be imported.
p.(None): 9. Anticipated effects.
p.(None): 10. Possible damages and responding remedies.
p.(None):
p.(None): Article 3-1
p.(None): For the treatment of specific patients with life-threatening diseases or serious disabilities for which no effective drugs, medical
p.(None): devices, or medical technologies are available in Taiwan, a medical care institution may draft a subsidiary proposal for a human cell
p.(None): therapy trial that has been approved by the central competent authority and has accumulated a considerable amount of safety data,
p.(None): and may submit the same, together with a photocopy of the original human trial proposal approved, for review in accordance with
p.(None): Paragraph 3 of Article 78 of this Act. After approval by the Review Board, the institution may apply to the central competent authority
p.(None): for approval of using the drugs, medical devices, or medical technologies involved on patients who meet the indications but fail to
p.(None): meet the eligibility criteria for original human trial subjects.
p.(None): A medical care institution may charge the specific patients set forth in the preceding paragraph fees, without being subject to the
p.(None): provisions of Article 11. However, the amount of fees charged shall be limited to an amount that is sufficient to cover the fees
p.(None): incurred by handling, manufacturing, obtaining, transporting, or storing the drugs, medical devices, or medical technologies required
p.(None): for performing human cell therapies on such specific patients.
p.(None): A medical care institution must not perform regular medical treatments under the pretense of carrying out the subsidiary proposal,
p.(None): and must not charge fees from specific patients in violation of the fee rules stipulated in the approved subsidiary proposal.
p.(None): The subsidiary proposal, as set forth in Paragraph 1, shall indicate the following:
p.(None): 1. Reasons and purposes;
p.(None): 2. Methods: including the conditions of the specific patient(s), recruitment method, number of persons enrolled, implementation
p.(None): method, duration and schedule, track and necessary rehabilitation plans;
p.(None): 3. Possible damages and responding remedies;
p.(None): 4. An analysis, list, and amount of the cost for the fees if fees will be charged, and the methods of providing subsidies or the amount
p.(None): of subsidies if subsidies are provided.
p.(None): The number of specific patients enrolled, as set forth in Subparagraph 2 of the preceding paragraph, shall not exceed the number of
p.(None): original human trial subjects.
p.(None): The subsidiary proposal conductor shall be the conductor of the original human trial proposal. The disclosure, review, avoidance,
...
p.(None): 3. Conditions of the Trial Subject and recruitment methods.
p.(None): 4. Medical care and compensation or other remedy provided to the Trial Subject.
p.(None): 5. Protection of the Trial Subject’s privacy.
p.(None): 6. Contents of Test Subject consent forms and notification procedure.
p.(None): 7. Protection of vulnerable groups.
p.(None): 8. Necessary management measures protecting the Trial Subject’s safety.
p.(None):
p.(None): Article 8
p.(None): A review board member shall immediately recuse himself/herself in any of the following circumstances:
p.(None): 1. serving as the trial conductor, assistant trial conductor, or entrustor of the Human Trial.
p.(None): 2. being, currently or in the past, the spouse, blood relative of four degrees or closer, or relative by marriage of three degrees or
p.(None): closer of the trial conductor.
p.(None): 3. being in an employment relationship with the entrustor of the Human Trial.
p.(None): 4. being in other situations where the recusal of the review board member is deemed necessary by the Review Board.
p.(None): The Review Board shall audit those Human Trials reviewed and approved by this Review Board at least once a year.
p.(None):
p.(None): Article 9
p.(None): The Review Board, if discovering any of the following matters in the audit referred to in the preceding paragraph, may order the
p.(None): Human Trial to be improved within a prescribed period of time or terminated:
p.(None): 1. where the contents of the Human Trial are altered without the approval of the Review Board or central competent authority as
p.(None): required by law.
p.(None): 2. where the rights, interest, or safety of the Trial Subject is obviously affected.
p.(None): 3. where the frequency or seriousness of the occurrence of adverse events is abnormal.
p.(None): 4. where the existence of an occurrence is sufficient to affect the evaluation of Human Trial results.
p.(None): 5. where specific facts exist before the completion of the Human Trial proving that the Human Trial has no actual benefits, higher
p.(None): risks than potential benefits, or actual benefits that are disadvantageous to the control group.
p.(None): The central competent authority when learning of the adverse event(s) referred to in the preceding paragraph may order the Human
p.(None): Trial to be terminated.
p.(None):
p.(None): Article 10
p.(None): The Review Board shall preserve the relevant documentation, such as Human Trial proposal, meeting minutes, or audit records for at
p.(None): least three(3) years after the completion of Human Trial.
p.(None):
p.(None): Article 11
p.(None): The medical care institution shall not charge the Trial Subject for any fees related to the Human Trial.
p.(None):
p.(None): Article 12
p.(None): The medical care institution shall report to the central competent authority when the Trial Subject experiences any of the following
p.(None): occurrences during the Human Trial period or anytime when any of the following occurrences are related to the Human Trial:
p.(None): 1. Death.
p.(None): 2. Life-threatening.
p.(None): 3. Permanent mental and physical disability.
p.(None): 4. where the fetus or newborn of the Trial Subject suffers congenital malformations.
p.(None): 5. Complications requiring hospitalization or prolonged hospitalization.
p.(None): 6. Other complications possibly causing permanent damages.
p.(None): The medical care institution shall make such report referred to in the preceding paragraph within seven (7) days after learning of the
p.(None): occurrence(s) and submit detailed investigation information to the central competent authority within fifteen (15) days.
p.(None):
p.(None): Article 13
p.(None): The central competent authority may order the medical care institution that conducts the Human Trial to provide relevant information,
p.(None): such as a summary of Human Trial proposal, case numbers, sex ratio, age statistics, review results of Trial Subject consent forms,
p.(None): and possible risks; or conduct necessary audit which the medical care institution shall not impede, avoid, or refuse.
p.(None): The audit referred to in the preceding paragraph may be done by relevant organizations as entrusted by the central competent
p.(None): authority.
p.(None):
p.(None): Article 14
p.(None): The Trial Subject’s biological samples, personal data, or derivatives shall be destroyed immediately upon completion of the Human
p.(None): Trial. The reutilization of aforesaid material(s) as subject to the Trial Subject’s consent shall be reviewed and approved by the Review
p.(None): Board. A new written consent shall be obtained from the Trial Subject with regard to any non-delinked material(s).
p.(None):
p.(None): Article 15
p.(None): The medical care institution shall not publish or promote its results during the Human Trial period.
p.(None):
p.(None): Article 16
p.(None): These Regulations shall become effective as of the day of 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): 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.
...
General/Other / participants in a control group
Searching for indicator control group:
(return to top)
p.(None): 8. Necessary management measures protecting the Trial Subject’s safety.
p.(None):
p.(None): Article 8
p.(None): A review board member shall immediately recuse himself/herself in any of the following circumstances:
p.(None): 1. serving as the trial conductor, assistant trial conductor, or entrustor of the Human Trial.
p.(None): 2. being, currently or in the past, the spouse, blood relative of four degrees or closer, or relative by marriage of three degrees or
p.(None): closer of the trial conductor.
p.(None): 3. being in an employment relationship with the entrustor of the Human Trial.
p.(None): 4. being in other situations where the recusal of the review board member is deemed necessary by the Review Board.
p.(None): The Review Board shall audit those Human Trials reviewed and approved by this Review Board at least once a year.
p.(None):
p.(None): Article 9
p.(None): The Review Board, if discovering any of the following matters in the audit referred to in the preceding paragraph, may order the
p.(None): Human Trial to be improved within a prescribed period of time or terminated:
p.(None): 1. where the contents of the Human Trial are altered without the approval of the Review Board or central competent authority as
p.(None): required by law.
p.(None): 2. where the rights, interest, or safety of the Trial Subject is obviously affected.
p.(None): 3. where the frequency or seriousness of the occurrence of adverse events is abnormal.
p.(None): 4. where the existence of an occurrence is sufficient to affect the evaluation of Human Trial results.
p.(None): 5. where specific facts exist before the completion of the Human Trial proving that the Human Trial has no actual benefits, higher
p.(None): risks than potential benefits, or actual benefits that are disadvantageous to the control group.
p.(None): The central competent authority when learning of the adverse event(s) referred to in the preceding paragraph may order the Human
p.(None): Trial to be terminated.
p.(None):
p.(None): Article 10
p.(None): The Review Board shall preserve the relevant documentation, such as Human Trial proposal, meeting minutes, or audit records for at
p.(None): least three(3) years after the completion of Human Trial.
p.(None):
p.(None): Article 11
p.(None): The medical care institution shall not charge the Trial Subject for any fees related to the Human Trial.
p.(None):
p.(None): Article 12
p.(None): The medical care institution shall report to the central competent authority when the Trial Subject experiences any of the following
p.(None): occurrences during the Human Trial period or anytime when any of the following occurrences are related to the Human Trial:
p.(None): 1. Death.
p.(None): 2. Life-threatening.
p.(None): 3. Permanent mental and physical disability.
p.(None): 4. where the fetus or newborn of the Trial Subject suffers congenital malformations.
p.(None): 5. Complications requiring hospitalization or prolonged hospitalization.
p.(None): 6. Other complications possibly causing permanent damages.
p.(None): The medical care institution shall make such report referred to in the preceding paragraph within seven (7) days after learning of the
p.(None): occurrence(s) and submit detailed investigation information to the central competent authority within fifteen (15) days.
p.(None):
p.(None): Article 13
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| age | Age |
| authority | Relationship to Authority |
| control group | participants in a control group |
| disability | Mentally Disabled |
| drug | Drug Usage |
| fetus | Fetus/Neonate |
| home | Property Ownership |
| married | Marital Status |
| minor | Youth/Minors |
| party | political affiliation |
| vulnerable | vulnerable |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
consent
ethics
justice
protection
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input