79C3C34C52B45572883A05D425EB0F82

Regulations Governing the Organization and Operational Management of the Institutional Review Board for Human Subject Research

https://law.moj.gov.tw/Eng/LawClass/LawAll.aspx?PCode=L0020179

http://leaux.net/URLS/ConvertAPI Text Files/D515D4D99301588DB322989CEDBABDFD.en.txt

Examining the file media/Synopses/D515D4D99301588DB322989CEDBABDFD.html:

This file was generated: 2020-12-01 07:50:04

Indicators in focus are typically shown highlighted in yellow;

Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink;

"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green;

Trigger Words/Phrases are shown highlighted in gray.

Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)

Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability Type	Vulnerability	Indicator	# Matches
Health	Drug Usage	influence	1
Social	Occupation	job	1
Social	Occupation	occupation	1
Social	Property Ownership	home	1
Social	education	education	2
Social	gender	gender	1
General/Other	Relationship to Authority	authority	5

Health / Drug Usage

Searching for indicator influence:

(return to top)
p.(None): Article 14 of this Act
p.(None): 5.Protections for the research subjects, including the channel of enquiry and complaint, etc.
p.(None):
p.(None): Article 10
p.(None): The aforesaid way of making a decision in an IRB meeting is by majority rule in principle. When a decision is made by means of
p.(None): voting, both positive and negative votes shall be recorded. Board members not attending the meeting shall not vote.
p.(None):
p.(None): Article 11
p.(None): The expedited review as prescribed in Article 8 of this Act shall be conducted by at least one board member.
p.(None): For projects under the aforesaid expedited review, the board member may exercise the approval granting power on behalf of the IRB
p.(None): and the result shall be reported to the IRB.
p.(None): If the aforesaid project under review is not approved by the board member, it should undergo the standard review procedure.
p.(None):
p.(None): Article 12
p.(None): The minutes of the IRB meeting shall be published.
p.(None): The aforesaid published content shall at least include the date of the meeting, the name of the attending and absent board members,
p.(None): the name of the research project, a summary of the discussion and the resolutions.
p.(None):
p.(None): Article 13
p.(None): Pursuant to Paragraph 1, Article 17 of this Act, the IRB shall conduct at least one regular audit on the execution of the approved
p.(None): research project; an immediate audit shall be carried out in case of any one of the following situations:
p.(None): 1.Any matter that may affect the rights, safety or well-being of the research subjects.
p.(None): 2.Occurrence of any severely adverse event or response on the part of the research subjects.
p.(None): 3.Occurrence of important matters or information that may influence the risk and benefit assessment of the project.
p.(None): The aforesaid audit may be conducted in writing or by means of an on-site investigation.
p.(None):
p.(None): Article 14
p.(None): The principal investigator of the project shall be informed in writing of the result of the audit conducted by the IRB according to the
p.(None): previous Article, with any changes to the original review decision being stated.
p.(None): If the conditions prescribed in Paragraphs 2 and 3, Article 17 of this Act are found as a result of the IRB’s audit, the research
p.(None): institution and the central competent authority of the relevant industry shall be notified within 14 days after the decision is made.
p.(None):
p.(None): Article 15
p.(None): The IRB shall request the principal investigator of the project to submit a report of the execution and results of the research after the
p.(None): project is completed.
p.(None):
p.(None): Article 16
p.(None): The IRB shall keep the project review report, audit report, interim report, final report and other relevant information of a research
p.(None): project for three years after the completion of the project, so that they can be retrieved by the central competent authority of the
p.(None): relevant industry at any time.
p.(None):
p.(None): Article 17
p.(None): These Regulations shall take effect upon the date of promulgation hereof.
p.(None):
p.(None):
p.(None):
p.(None): News Law Convention
p.(None): Searching Justices of the Constitutional Court
p.(None):
p.(None):
p.(None): E-PAPER
p.(None): enter your email address
p.(None):
p.(None):
p.(None): Subscribe
...

Searching for indicator job:

(return to top)
p.(None): for the exemption from the IRB review as provided in Paragraph 1, Article 5 of this Act or for expedited review or standard review as
p.(None): provided in Article 8 of this Act.
p.(None):
p.(None): Article 5
p.(None): The IRB shall set down and publish the standard operational procedures for reviewing a research project, including the extent of
p.(None): authority and the procedures of accessing or extracting and using various types of documents, files and databases and the regular
p.(None): examination and review.
p.(None):
p.(None): Article 6
p.(None): When the IRB or a sub-IRB convenes a standard review meeting, the attending members shall include at least one member without a
p.(None): biomedical science background outside the institution.
p.(None): For an IRB or sub-IRB that consists of at least five but less than seven members, a meeting shall not be held unless it is attended by
p.(None): at least two-thirds of the members; for an IRB or sub-IRB that consists of seven or more members, a meeting shall not be held unless
p.(None): it is attended by at least half of the members.
p.(None): A meeting shall not be held if all attending members are of the same gender.
p.(None):
p.(None): Article 7
p.(None): An IRB shall comply with the following criteria:
p.(None): 1. The IRB members, the administrative staff and expert advisors shall sign an agreement of confidentiality.
p.(None): 2. The IRB members and the administrative staff shall receive regular education and training.
p.(None): 3. It shall be manned with appropriate administrative staff whose job duties are clearly defined.
p.(None): 4. It shall be equipped with an office for handling administrative matters and an appropriate space for filing.
p.(None): Proofs of education and training as mentioned in Subparagraph 2 above shall be reviewed by the IRB and retained properly.
p.(None):
p.(None): Article 8
p.(None): In case of any one of the following situations, IRB members shall recuse themselves from the review:
p.(None): 1.Being the principal investigator, co-investigator or client of the research project or sub-project under review.
p.(None): 2.Being the spouse of the principal investigator of the research project under review or being or having been related to the principal
p.(None): investigator by fourth degree blood relation or third degree affined relationship.
p.(None): 3.Having an employment relationship with the commissioning enterprise of the research project under review.
p.(None): 4.There are specific facts pointing to potential bias.
p.(None): 5.Other situations in which recusal is deemed necessary upon the IRB’s resolution.
p.(None):
p.(None): Article 9
p.(None): The review of a research project shall at least include the following:
p.(None): 1.Qualifications of the principal investigator
p.(None): 2.Eligibility criteria for the research subjects and the way of recruitment
p.(None): 3.Content of the project and way and place of execution
p.(None): 4.Items of agreement to be informed, the subjects to be informed, the way and procedure of indicating agreement as provided in
p.(None): Article 14 of this Act
p.(None): 5.Protections for the research subjects, including the channel of enquiry and complaint, etc.
p.(None):
p.(None): Article 10
p.(None): The aforesaid way of making a decision in an IRB meeting is by majority rule in principle. When a decision is made by means of
...

Searching for indicator occupation:

(return to top)
p.(None): P
p.(None):
p.(None): Article Content
p.(None):
p.(None):
p.(None):
p.(None): Title Regulations for Organization and Operation of Human Research Ethics Review Board CH
p.(None): Amended Date 2018-05-07
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 are set forth pursuant to Paragraph 3, Article 7 of the Human Subjects Research Act (referred to as “this Act”
p.(None): hereafter).
p.(None):
p.(None): Article 2
p.(None): The research institutions set out in Paragraph 2, Article 3 of this Act may set up at least one Institutional Review Board (hereafter
p.(None): referred to as “IRB”).
p.(None): The aforesaid IRB may set up sub-groups (hereafter referred to as “sub-IRBs”) for operational purposes, and the IRB and sub-IRBs
p.(None): shall all be subject to inspections by the central authority in charge of the sector. The resolutions adopted at meetings of a sub-IRB
p.(None): shall be deemed as resolutions adopted at meetings of the IRB.
p.(None): The research institutions set forth in Paragraph 1 include schools, hospitals, government agencies (or offices), statutory entities and
p.(None): associations.
p.(None):
p.(None): Article 3
p.(None): The research institutions shall establish rules on the selection criteria, procedures, term of appointment, duties, meeting procedures,
p.(None): the way of reaching a resolution, operation and other related matters for the IRB members.
p.(None): The name and occupation of the IRB members and their relationship with the research institution shall be disclosed to the public and
p.(None): reported to the central authority in charge of the sector for recording purposes.
p.(None):
p.(None): Article 4
p.(None): When reviewing a research project, the IRB shall first of all make a general assessment of the objective of study, nature of study,
p.(None): relevance and degree of invasion of the data, information or specimens to be collected, etc. and then judge whether it fits the criteria
p.(None): for the exemption from the IRB review as provided in Paragraph 1, Article 5 of this Act or for expedited review or standard review as
p.(None): provided in Article 8 of this Act.
p.(None):
p.(None): Article 5
p.(None): The IRB shall set down and publish the standard operational procedures for reviewing a research project, including the extent of
p.(None): authority and the procedures of accessing or extracting and using various types of documents, files and databases and the regular
p.(None): examination and review.
p.(None):
p.(None): Article 6
p.(None): When the IRB or a sub-IRB convenes a standard review meeting, the attending members shall include at least one member without a
p.(None): biomedical science background outside the institution.
p.(None): For an IRB or sub-IRB that consists of at least five but less than seven members, a meeting shall not be held unless it is attended by
p.(None): at least two-thirds of the members; for an IRB or sub-IRB that consists of seven or more members, a meeting shall not be held unless
p.(None): it is attended by at least half of the members.
p.(None): A meeting shall not be held if all attending members are of the same gender.
p.(None):
p.(None): Article 7
...

Searching for indicator home:

Searching for indicator education:

(return to top)
p.(None): relevance and degree of invasion of the data, information or specimens to be collected, etc. and then judge whether it fits the criteria
p.(None): for the exemption from the IRB review as provided in Paragraph 1, Article 5 of this Act or for expedited review or standard review as
p.(None): provided in Article 8 of this Act.
p.(None):
p.(None): Article 5
p.(None): The IRB shall set down and publish the standard operational procedures for reviewing a research project, including the extent of
p.(None): authority and the procedures of accessing or extracting and using various types of documents, files and databases and the regular
p.(None): examination and review.
p.(None):
p.(None): Article 6
p.(None): When the IRB or a sub-IRB convenes a standard review meeting, the attending members shall include at least one member without a
p.(None): biomedical science background outside the institution.
p.(None): For an IRB or sub-IRB that consists of at least five but less than seven members, a meeting shall not be held unless it is attended by
p.(None): at least two-thirds of the members; for an IRB or sub-IRB that consists of seven or more members, a meeting shall not be held unless
p.(None): it is attended by at least half of the members.
p.(None): A meeting shall not be held if all attending members are of the same gender.
p.(None):
p.(None): Article 7
p.(None): An IRB shall comply with the following criteria:
p.(None): 1. The IRB members, the administrative staff and expert advisors shall sign an agreement of confidentiality.
p.(None): 2. The IRB members and the administrative staff shall receive regular education and training.
p.(None): 3. It shall be manned with appropriate administrative staff whose job duties are clearly defined.
p.(None): 4. It shall be equipped with an office for handling administrative matters and an appropriate space for filing.
p.(None): Proofs of education and training as mentioned in Subparagraph 2 above shall be reviewed by the IRB and retained properly.
p.(None):
p.(None): Article 8
p.(None): In case of any one of the following situations, IRB members shall recuse themselves from the review:
p.(None): 1.Being the principal investigator, co-investigator or client of the research project or sub-project under review.
p.(None): 2.Being the spouse of the principal investigator of the research project under review or being or having been related to the principal
p.(None): investigator by fourth degree blood relation or third degree affined relationship.
p.(None): 3.Having an employment relationship with the commissioning enterprise of the research project under review.
p.(None): 4.There are specific facts pointing to potential bias.
p.(None): 5.Other situations in which recusal is deemed necessary upon the IRB’s resolution.
p.(None):
p.(None): Article 9
p.(None): The review of a research project shall at least include the following:
p.(None): 1.Qualifications of the principal investigator
p.(None): 2.Eligibility criteria for the research subjects and the way of recruitment
p.(None): 3.Content of the project and way and place of execution
p.(None): 4.Items of agreement to be informed, the subjects to be informed, the way and procedure of indicating agreement as provided in
p.(None): Article 14 of this Act
p.(None): 5.Protections for the research subjects, including the channel of enquiry and complaint, etc.
p.(None):
p.(None): Article 10
p.(None): The aforesaid way of making a decision in an IRB meeting is by majority rule in principle. When a decision is made by means of
p.(None): voting, both positive and negative votes shall be recorded. Board members not attending the meeting shall not vote.
p.(None):
p.(None): Article 11
p.(None): The expedited review as prescribed in Article 8 of this Act shall be conducted by at least one board member.
...

Searching for indicator gender:

(return to top)
p.(None): reported to the central authority in charge of the sector for recording purposes.
p.(None):
p.(None): Article 4
p.(None): When reviewing a research project, the IRB shall first of all make a general assessment of the objective of study, nature of study,
p.(None): relevance and degree of invasion of the data, information or specimens to be collected, etc. and then judge whether it fits the criteria
p.(None): for the exemption from the IRB review as provided in Paragraph 1, Article 5 of this Act or for expedited review or standard review as
p.(None): provided in Article 8 of this Act.
p.(None):
p.(None): Article 5
p.(None): The IRB shall set down and publish the standard operational procedures for reviewing a research project, including the extent of
p.(None): authority and the procedures of accessing or extracting and using various types of documents, files and databases and the regular
p.(None): examination and review.
p.(None):
p.(None): Article 6
p.(None): When the IRB or a sub-IRB convenes a standard review meeting, the attending members shall include at least one member without a
p.(None): biomedical science background outside the institution.
p.(None): For an IRB or sub-IRB that consists of at least five but less than seven members, a meeting shall not be held unless it is attended by
p.(None): at least two-thirds of the members; for an IRB or sub-IRB that consists of seven or more members, a meeting shall not be held unless
p.(None): it is attended by at least half of the members.
p.(None): A meeting shall not be held if all attending members are of the same gender.
p.(None):
p.(None): Article 7
p.(None): An IRB shall comply with the following criteria:
p.(None): 1. The IRB members, the administrative staff and expert advisors shall sign an agreement of confidentiality.
p.(None): 2. The IRB members and the administrative staff shall receive regular education and training.
p.(None): 3. It shall be manned with appropriate administrative staff whose job duties are clearly defined.
p.(None): 4. It shall be equipped with an office for handling administrative matters and an appropriate space for filing.
p.(None): Proofs of education and training as mentioned in Subparagraph 2 above shall be reviewed by the IRB and retained properly.
p.(None):
p.(None): Article 8
p.(None): In case of any one of the following situations, IRB members shall recuse themselves from the review:
p.(None): 1.Being the principal investigator, co-investigator or client of the research project or sub-project under review.
p.(None): 2.Being the spouse of the principal investigator of the research project under review or being or having been related to the principal
p.(None): investigator by fourth degree blood relation or third degree affined relationship.
p.(None): 3.Having an employment relationship with the commissioning enterprise of the research project under review.
p.(None): 4.There are specific facts pointing to potential bias.
p.(None): 5.Other situations in which recusal is deemed necessary upon the IRB’s resolution.
p.(None):
p.(None): Article 9
p.(None): The review of a research project shall at least include the following:
p.(None): 1.Qualifications of the principal investigator
p.(None): 2.Eligibility criteria for the research subjects and the way of recruitment
...

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 for Organization and Operation of Human Research Ethics Review Board CH
p.(None): Amended Date 2018-05-07
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 are set forth pursuant to Paragraph 3, Article 7 of the Human Subjects Research Act (referred to as “this Act”
p.(None): hereafter).
p.(None):
p.(None): Article 2
p.(None): The research institutions set out in Paragraph 2, Article 3 of this Act may set up at least one Institutional Review Board (hereafter
p.(None): referred to as “IRB”).
p.(None): The aforesaid IRB may set up sub-groups (hereafter referred to as “sub-IRBs”) for operational purposes, and the IRB and sub-IRBs
p.(None): shall all be subject to inspections by the central authority in charge of the sector. The resolutions adopted at meetings of a sub-IRB
p.(None): shall be deemed as resolutions adopted at meetings of the IRB.
p.(None): The research institutions set forth in Paragraph 1 include schools, hospitals, government agencies (or offices), statutory entities and
p.(None): associations.
p.(None):
p.(None): Article 3
p.(None): The research institutions shall establish rules on the selection criteria, procedures, term of appointment, duties, meeting procedures,
p.(None): the way of reaching a resolution, operation and other related matters for the IRB members.
p.(None): The name and occupation of the IRB members and their relationship with the research institution shall be disclosed to the public and
p.(None): reported to the central authority in charge of the sector for recording purposes.
p.(None):
p.(None): Article 4
p.(None): When reviewing a research project, the IRB shall first of all make a general assessment of the objective of study, nature of study,
p.(None): relevance and degree of invasion of the data, information or specimens to be collected, etc. and then judge whether it fits the criteria
p.(None): for the exemption from the IRB review as provided in Paragraph 1, Article 5 of this Act or for expedited review or standard review as
p.(None): provided in Article 8 of this Act.
p.(None):
p.(None): Article 5
p.(None): The IRB shall set down and publish the standard operational procedures for reviewing a research project, including the extent of
p.(None): authority and the procedures of accessing or extracting and using various types of documents, files and databases and the regular
p.(None): examination and review.
p.(None):
p.(None): Article 6
p.(None): When the IRB or a sub-IRB convenes a standard review meeting, the attending members shall include at least one member without a
p.(None): biomedical science background outside the institution.
p.(None): For an IRB or sub-IRB that consists of at least five but less than seven members, a meeting shall not be held unless it is attended by
p.(None): at least two-thirds of the members; for an IRB or sub-IRB that consists of seven or more members, a meeting shall not be held unless
p.(None): it is attended by at least half of the members.
p.(None): A meeting shall not be held if all attending members are of the same gender.
p.(None):
p.(None): Article 7
p.(None): An IRB shall comply with the following criteria:
p.(None): 1. The IRB members, the administrative staff and expert advisors shall sign an agreement of confidentiality.
p.(None): 2. The IRB members and the administrative staff shall receive regular education and training.
p.(None): 3. It shall be manned with appropriate administrative staff whose job duties are clearly defined.
p.(None): 4. It shall be equipped with an office for handling administrative matters and an appropriate space for filing.
p.(None): Proofs of education and training as mentioned in Subparagraph 2 above shall be reviewed by the IRB and retained properly.
p.(None):
p.(None): Article 8
p.(None): In case of any one of the following situations, IRB members shall recuse themselves from the review:
...

p.(None): and the result shall be reported to the IRB.
p.(None): If the aforesaid project under review is not approved by the board member, it should undergo the standard review procedure.
p.(None):
p.(None): Article 12
p.(None): The minutes of the IRB meeting shall be published.
p.(None): The aforesaid published content shall at least include the date of the meeting, the name of the attending and absent board members,
p.(None): the name of the research project, a summary of the discussion and the resolutions.
p.(None):
p.(None): Article 13
p.(None): Pursuant to Paragraph 1, Article 17 of this Act, the IRB shall conduct at least one regular audit on the execution of the approved
p.(None): research project; an immediate audit shall be carried out in case of any one of the following situations:
p.(None): 1.Any matter that may affect the rights, safety or well-being of the research subjects.
p.(None): 2.Occurrence of any severely adverse event or response on the part of the research subjects.
p.(None): 3.Occurrence of important matters or information that may influence the risk and benefit assessment of the project.
p.(None): The aforesaid audit may be conducted in writing or by means of an on-site investigation.
p.(None):
p.(None): Article 14
p.(None): The principal investigator of the project shall be informed in writing of the result of the audit conducted by the IRB according to the
p.(None): previous Article, with any changes to the original review decision being stated.
p.(None): If the conditions prescribed in Paragraphs 2 and 3, Article 17 of this Act are found as a result of the IRB’s audit, the research
p.(None): institution and the central competent authority of the relevant industry shall be notified within 14 days after the decision is made.
p.(None):
p.(None): Article 15
p.(None): The IRB shall request the principal investigator of the project to submit a report of the execution and results of the research after the
p.(None): project is completed.
p.(None):
p.(None): Article 16
p.(None): The IRB shall keep the project review report, audit report, interim report, final report and other relevant information of a research
p.(None): project for three years after the completion of the project, so that they can be retrieved by the central competent authority of the
p.(None): relevant industry at any time.
p.(None):
p.(None): Article 17
p.(None): These Regulations shall take effect upon the date of promulgation hereof.
p.(None):
p.(None):
p.(None):
p.(None): News Law Convention
p.(None): Searching Justices of the Constitutional Court
p.(None):
p.(None):
p.(None): E-PAPER
p.(None): enter your email address
p.(None):
p.(None):
p.(None): Subscribe
p.(None):
p.(None):
p.(None): Unsubscribe
p.(None):
p.(None):
p.(None): This website does not provide legal counseling service, please contact with related public offices for more information.
p.(None): In case of any discrepancy between the English version and the Chinese version, the latter shall prevail.
p.(None):
p.(None):
p.(None): │ Government Website Open Information Announcement │ Declaration on Privacy Right Protection │ Information Security Policy │ EMail │
p.(None): OPERATING BY THE WORKING GROUP OF THE R.O.C LAWS & REGULATIONS DATABASE, MINISTRY OF JUSTICE.
p.(None): NO. 130, Sec. 1, Chongqing S. Rd., Taipei, 10048, Taiwan(R.O.C.)
p.(None): Service Phone-Call: +886-2-2191-0189
...

Orphaned Trigger Words

Appendix

Indicator List

Indicator	Vulnerability
authority	Relationship to Authority
education	education
gender	gender
home	Property Ownership
influence	Drug Usage
job	Occupation
occupation	Occupation

Indicator Peers (Indicators in Same Vulnerability)

Indicator	Peers
job	['occupation']
occupation	['job']

Trigger Words

ethics

justice

protection

risk

welfare

Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability Type	Vulnerability	Indicator	# Matches
Health	Drug Usage	influence	1
Social	Occupation	job	1
Social	Occupation	occupation	1
Social	Property Ownership	home	1
Social	education	education	2
Social	gender	gender	1
General/Other	Relationship to Authority	authority	5

Regulations Governing the Organization and Operational Management of the Institutional Review Board for Human Subject Research

Applicable Type / Vulnerability / Indicator Overlay for this Input

Health / Drug Usage

Social / Occupation

Social / Property Ownership

Social / education

Social / gender

General/Other / Relationship to Authority

Orphaned Trigger Words

Appendix

Indicator List

Indicator Peers (Indicators in Same Vulnerability)

Trigger Words

Applicable Type / Vulnerability / Indicator Overlay for this Input