ᆵ ύ ᄪ ҇ ᕴ ᙴ ଣ ᆅ ڋ Ў ҹ ु অ ቲ इ ᒵ ߄ - 台中榮總

(1)

ᆅ ڋ Ў ҹ ु অ ቲ इ ᒵ ߄

Record of Composition and Revisions of Controlled Documents

Ўҹጓဦ

Document Number

IRB-ҁ཮-πբதೕ-2007

IRB-Regulations of Operation-2007

ЎҹӜᆀ

Title

ཥਢቩࢗᆅ౛ำׇਜ

SOP for New Protocol Review

ुۓൂՏ

Composed by

ಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮

The First/Second IRB Committees

ᐒஏ฻ભ

Level of Confidentiality

Ŷද೯ Ƒஏҹ Ƒཱུᐒஏ

Ŷ8QFODVVLILHG Ƒ&RQILGHQWLDO Ƒ+LJKO\&RQILGHQWLDO

፾ҔൂՏ

Applied to

ƑӄଣƑAll units in the hospital

ŶځдǴፎຏܴǺಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮

ŶOther (Please specify): The First/Second IRB Committees

ހԛ

Version

।ኧ

No. Pages

Ўҹঅुᄔा

Summary of Revisions of the Document

ჴࡼВය

Date of Implementation

A 5 ཥुǶ

Newly composed.

20140519 B 7 җΓᡏ၂ᡍہ঩཮኱ྗբ཰ำׇ5.4 ހᙯඤԋԜހҁǶ

This version was converted from “Version 5.4 of the SOP of the Human Research Committee.”

20141125

C 8 1.ཥቚ5.5.11ځдቩࢗᔈݙཀ٣໨Ƕ

1. Added item 5.5.11 Other review key points

2.অׯߕҹ6.11೚ёਜӜຒǴӕ؁অׯ 5.1ǵ5.6Ƕ

2. Revised the terms in Appendix 6.11 Certificate of Approval, and revised item 5.1 and item 5.6

accordingly.

20150922

D 9 1.চȨΓᡏ၂ᡍہ঩཮ȩ׳ӜࣁȨಃ΋/ΒΓᡏࣴزউ౛

ቩࢗہ঩཮ȩǶ

1. The original “Human Research Committee” was renamed “The First/Second IRB Committees.”

2.চȨቩࢗཀـ߄ȩׯࣁȨཥਢਢҹቩࢗख़ᗺݙཀ٣໨

ᔠਡ߄ȩǺ5.1ǵ5.5.1.4ǵ5.5.12ǵ5.6ǵ6.7Ƕ 2. The original “Reviewers’ Comments Form” was

changed into “IRB Review Checklist” in items 5.1, 5.5.1.4, 5.5.12, 5.6, and 6.7.

3.Ўӷਠ҅Ƕ 3. Fixed typos.

4.অ҅4.2 c-IRB ቩࢗਔ໔Ƕ

4. Corrected the IRB review time period in item 4.2 c-IRB.

20160318

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D 9 5.অׯ5.4.2.2Ȩӄ଼҇நߥᓀၗ਑৤ࣴزीฝଌቩҙፎ

ਜȩᔠߕЎҹǶ

5. Revised the required attachments for “Protocol Submission of Research Using National Health Insurance Research Database” in item 5.4.2.2.

6.অׯଣѦ஑ৎࣁ஑ৎǺ5.1ǵ5.4ǵ5.5.4Ƕ

6. Changed the term “external expert” to “expert consultant” in items 5.1, 5.4, and 5.5.4.

7.অׯঅ҅ीฝЬ࡭Γံҹਔ໔ᇥܴǺ5.5.9ǵ5.5.10Ƕ 7. Revised the explanation of the time limit for the PI to

submit missing documents for a protocol submission in items 5.5.9 and 5.5.10.

8.մନচߕҹ6.4 PTMSس಍Ўҹǵ6.12ϦЎ٠уຏᇥ

ܴǶ

8. Deleted the original Appendix 6.4 “PTMS Documents” and Appendix 6.12 “Official

Correspondence” and added a note of explanation.

9.ཥቚ6.6-6.12Ӛᜪਢҹቩࢗख़ᗺݙཀ٣໨ᔠਡ߄Ƕ

9. Added the IRB Review Checklists for all categories of submissions in items 6.6 to 6.12.

20160318

E 9 1.׳ཥୖԵЎҹ3.1ހҁǴཥቚ 3.3- 3.6Ƕ

1. Updated the version of reference 3.1. Added items 3.3 to 3.6.

2.অׯ5.1ࢬำკȨӼ௨Ӛ໨ቩࢗȩϐ៾ೢǺཥቚ஑ৎǶ 2. Revised the responsible personnel for “Managing

Review of Protocols” in 5.1 Flow Chart: Added

“expert consultants.”

20170709

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Title

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E 9 3.অׯ5.4΋૓ቩࢗϷᙁܰቩࢗਢҹᔈഢЎҹǺմନቹ ҁǶ

3. Revised the required documents for protocol submissions for full board review and expedited review in item 5.4: Deleted “photocopies.”

4.অׯ5.5.3ǺቚӈȨ୺Չઝਜ٩ྣ኱ྗ߃؁ࡌ᝼ࢂց಄

ӝᙁܰቩࢗाҹǴҗȐୋȑЬҺہ঩ղۓȐऩ୺Չઝ ਜঋҺہ঩Ǵ߾ёޔௗ຾ՉղۓȑȩǴӕ؁অׯ 5.1ࢬำ კȨቩࢗБԄዴᇡȩϐ៾ೢǶ

4. Revised item 5.5.3: Added “The Executive Secretary shall make a primary recommendation as to whether the protocol qualifies for expedited review for the Chair or Vice Chair to approve (if the Executive Secretary is also an IRB member, she/he may make the decision directly)” and revised “Evaluation of Review Category” in 5.1 Flow Chart accordingly.

5.অׯ5.5.4ǵ5.5.5ǺȨPTMSس಍ȩԾ୏஌วႝηແҹǶ 5. Revised items 5.5.4 and 5.5.5: “PTMS will be used

to send automatic E-mail.”

6.մନচߕҹ6.5ଌቩڄǴӕ؁অׯ5.6इᒵߥӸЎҹϷ

5.1ࢬำკϐ࣬ᜢЎҹǹܜඤߕҹ6.1ǵ6.4ǵ6.13-15Ƕ 6. Deleted the original Appendix 6.5 “Letter of

Submission for Review” and revised the list of relevant documents in item 5.6 Records Retention and item 5.1 Flow Chart accordingly. Replaced Appendices 6.1, 6.4, 6.13, 6.14, and 6.15.

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F 9 1.অׯୖԵЎҹ3.2ࣁȨΓᡏࣴزউ౛ቩࢗہ঩཮ಔᙃ

Ϸၮբᆅ౛ᒤݤȩǶՉࡹଣፁғᅽճ೽ፁ࿿ᙴӷಃ

1010265129ဦзǴ2012Ƕ(ፁғᅽճ೽ፁ೽ᙴӷಃ

1071661626ဦзঅ҅ಃ2ǵ3ǵ6ǵ7చచЎǴ2018) 1. Revised reference 3.2 to “Regulations for

Organization and Operation of IRB Committees

(Ministry of Health and Welfare, promulgated in 2012 pursuant to Wei-Shu-Yi-Zi No. 1010265129; articles 2, 3, 6, 7 amended in 2018 pursuant to Wei-Bu-Yi-Zi No. 1071661626).”

2. ीฝЬ࡭Γ໪٩Ᏽჴሞ௃׎ගҬȨճ੻ፂँᖂܴȩ (Conflict of Interest, COI)Ǵаߡہ঩ቩ᎙ࢂց಄ӝೕ

ጄǶ

2. Principal investigators shall submit Statements of Conflict of Interest for reviewers to see if all

regulations are followed.

3. অׯচ 5.5.12.7኱ဦࣁ 5.5.12.8Ƕ

3. Changed the original item number 5.5.12.7 to 5.5.12.8.

4. ܜඤߕҹ 6.1ǵ6.5 ~ 11ǵ6.14Ƕ

4. Replaced Appendices 6.1, 6.5 to 6.11, and 6.14.

20181026

G 17 1. ӢᔈIRBคરϯଌቩբ཰ǴঅׯᆶȨਜय़ၗ਑ȩ࣬ᜢ

ϐϣ৒Ƕ

1. Process related to hardcopies was revised to comply with the new IRB policy of paperless submission.

2.մନচ5.5.1ϣ৒Ƕ 2. Deleted item 5.5.1.

3.অׯ 5.5ϐη໨ҞጓဦǶ

3. Revised code number of sub-items of 5.5.

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G 17 4. ཥቚ5.5.12 ࡪȨᙴᕍݤȩಃ78చೕۓǺȨࣁගଯ୯ϣ ᙴᕍמೌНྗ܈Ⴃٛ੯ੰ΢ϐሡाǴ௲Ꮲᙴଣ࿶ᔕۓ

ीฝǴൔፎύѧЬᆅᐒᜢਡ঑Ǵ܈࿶ύѧЬᆅᐒᜢہ

ૼޣǴளࡼՉΓᡏ၂ᡍȩǶࡺΥղۓࣁΓᡏ၂ᡍϐी

ฝਢǴ֡໪ӕਔ࿶ፁғᅽճ೽ቩࢗ೯ၸࡕБё୺ՉǶ 4. Added 5.5.12 According to Article 78, Medical Care Act:

“For the purpose of improving the level of medical care or prevention of disease in the country, teaching hospitals may conduct human research after formulating a plan and obtaining approval from the central competent authority, or upon entrustment of the central competent authority.”

Therefore all protocols considered to be human research are required to obtain approval from the Ministry of Health and Welfare before implementation.

5. ܜඤߕҹ 6.1Ƕ

5. Replaced Appendix 6.1.

20190527

H 18 1. ཥቚ 5.5.11.9Ǻ๏ڙ၂ޣޑൔၿߎᚐǵБԄᆶਔำǴ

όёჹڙ၂ޣ೷ԋુॐ܈ό྽ճᇨޑቹៜǶ

1. Added 5.5.11.9: The amount, payment method and schedule of the reward provided to the subject must not be intimidating or improperly enticing for the subject.

2. ཥቚ5.5.11.10Ǻ๏ڙ၂ޣޑൔၿѸ໪ᒿ๱ࣴزޑ຾Չ

ϩࢤ๏бǴόёܭֹԋӄ೽ࣴزϐࡕω๏бǶ

2. Added 5.5.11.10: The reward provided to the subject must be paid by stage during the research rather than paid after the research completion.

3. ཥቚ5.5.11.11Ǻӵڙ၂ޣЬ୏܈೏୏ଏрࣴزਢǴϝ

ᔈࡪКٯ๏ϒൔၿǶ

3. Added 5.5.11.11: If the participant subject actively or passively withdraws from the research, he/she should still be rewarded on a pro rata basis.

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H 18 4. ཥቚ5.5.11.12Ǻֹԋ܌ԖࣴزำׇԶЍбϐൔၿ܈ံ

ᓭߎǴѸ໪ࣁӝ౛ߎᚐǴЪόளၸଯǴаठό྽ቹៜ চҁाଏрϐڙ၂ޣޑཀᜫǶ

4. Added 5.5.11.12: The reward or compensation paid after the research procedure completion must be reasonable rather than excessively high to avoid the inappropriate impact on the willingness of the subject.

5.ཥቚ 5.5.11.13ǺΓᡏࣴزউ౛ቩࢗہ঩཮όϢ೚၂ᡍ

ہૼޣගٮҺՖ׎Ԅϐᙯϟ຤Ȑߎᒲ܈ჴނȑǴ܈բࣁ

уೲڙ၂ޣޑܕ༅ޑၿമǶ

5. Added 5.5.11.13: IRB does not allow the sponsor to provide the referral fee in any forms (money or gifts) as the reward for accelerating the recruitment of the subject.

6.ܜඤߕҹ 6.1Ƕ

6. Appendix 6.1 was replaced.

20191018

I 18 1. অׯୖԵЎҹ 3.1 ࣁȨᛰࠔᓬؼᖏ׉၂ᡍբ཰ྗ߾ȩ

109 ԃ 08 Д 28 В ፁ ғ ᅽ ճ ೽ ೽ ௤ १ ӷ ಃ 1091407788ဦзঅ҅Ƕ

1. Updated reference 3.1 into ““Regulations for Good Clinical Practice” amended on August 28 2020, pursuant to Ministry of Health and Welfare Bu-Shou-Shi-Zi No. 1091407788.”

2. অׯୖԵЎҹ3.6ࣁύ๮҇୯109ԃ01Д15Вᕴ಍

๮ᕴ΋ကӷಃ10900003861 ဦзঅ҅ϦѲȨᙴᕍݤȩǶ 2. Updated reference 3.6 into “Medical Care Act, amended and promulgated as per the Presidential Order Hua-Zong-Yi-Yi-Zi No. 10900003861 dated 15 January 2020.”

3. চȨᆵύᄪ҇ᕴᙴଣಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮

ਢҹቩࢗख़ᗺݙཀ٣໨ᔠਡ߄ȩঅׯࣁ ȨPTMSਢҹ ቩࢗख़ᗺݙཀ٣໨ᔠਡ߄ȩǶ

3. The original “IRB Review Checklist” was replaced by

“PTMS Review Checklist.”

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I 18 4. অׯ5.4.2.2ϣ৒Ƕ 4. Revised item 5.4.2.2.

5. অׯ5.5.8ϐीฝЬ࡭Γӣᙟයज़ࣁ28 ঁВ᏿ϺǶ

5. Revised the PI's reply period to 28 calendar days in item 5.5.8.

6. մନ5.5.8Ϸ5.5.9ϐҙፎ৖ۯᇥܴЎӷǶ

6. Deleted the description of the extension in item 5.5.8 and item 5.5.9.

7. ܜඤߕҹ6.1ǵ6.4~ 6.13ǵ6.15Ƕ

7. Appendices 6.1, 6.4 - 6.13, 6.15 were replaced.

20210528

ुঅቲ

Composed/Revised/Deleted

ቩਡ

Reviewed

ਡ঑

Approved

ɁᆅڋЎҹόளᏰԾ༡ׯϷ଺૶ဦ٠࿣ЗቹӑǶ

ɁҁЎҹаKMس಍ࣁനཥހҁǴરҁวՉሡ࿶SOPᆅ౛ύЈਡകǴᝄ࿣ԾՉӈӑǶ

䈜

䈜Changing, marking, or copying controlled documents without permission is prohibited.

䈜

䈜The latest version of this document in the Knowledge Management System (KMS) takes precedence. Distribution of hard copies of this document must be approved and stamped by the SOP Administrative Center. Copying without permission is strictly prohibited.

ҁЎҹς࿶៾ೢЬᆅ҅Ԅਡ঑Ǵ ਡകइᒵϐ҅ҁᓯܫܭ SOP ᆅ౛ύЈ

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ᆅ ڋ Ў ҹ ु অ ቲ ཮ ቩ ൂ

Review Form of Composition and Revisions of Controlled Documents

Ўҹጓဦ

Document Number

ЎҹӜᆀ

Title

཮ᒤൂՏ

Processing Unit

ቩࢗཀـ

Review Comments

཮ᒤൂՏЬᆅ

Head of Processing Unit

คၠ೽ࣽ཮ቩሡ؃Ƕ

There is no need for review by other departments or divisions.

䈜ፎӚ཮ᒤൂՏЬᆅඁ፥ቩࢗཀـࡕਡകǴѸाਔளޔௗᆶुۓൂՏڐ୘Ƕ

䈜

䈜The head of each processing unit is advised to provide comments before

signing/stamping to approve. If needed, it is recommended that the head of each processing unit discuss with the unit that made the SOP.

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Version Iހ 1.Ҟޑ

ࣁߦ٬ཥਢ߃ԛҙፎीฝਢቩࢗޑڙ౛ࢬำԖ΋ܴዴϐೕጄǴаዴߥ ਢҹϐҙፎᒥൻ࣬ᜢݤೕǴЪᆢ࡭ϷගܹΓᡏ၂ᡍہ঩཮஑཰ቩࢗࠔ

፦Ǵ੝ڋुҁำׇਜǶ 1. Purpose

The purpose of this SOP is to provide specific guidelines for the review of new protocols in order to ensure that 1) the review procedure follows relevant laws and regulations, and 2) the professional quality of IRB review is maintained.

2.፾Ҕጄൎ

Υҁᆅ౛ำׇਜᔈҔӧཥਢቩࢗำׇϐᆅ౛֡፾ҔҁำׇਜǶ 2. Scope

This SOP applies to the management of review of all new protocols.

3.ୖԵЎҹ 3. References

3.1Ȩᛰࠔᓬؼᖏ׉၂ᡍբ཰ྗ߾ȩ109ԃ 08Д 28Вፁғᅽճ೽೽

௤१ӷಃ1091407788ဦзঅ҅

3.1 “Regulations for Good Clinical Practice” amended on August 28 2020, pursuant to Ministry of Health and Welfare Bu-Shou-Shi-Zi No. 1091407788.

3.2ȨΓᡏࣴزউ౛ቩࢗہ঩཮ಔᙃϷၮբᆅ౛ᒤݤȩǶՉࡹଣፁғᅽ ճ೽ፁ࿿ᙴӷಃ 1010265129 ဦзǴ2012Ƕ(ፁғᅽճ೽ፁ೽ᙴ ӷಃ1071661626ဦзঅ҅ಃ2ǵ3ǵ6ǵ7చచЎǴ2018)

3.2 Regulations for Organization and Operation of IRB Committees (Ministry of Health and Welfare, promulgated in 2012, pursuant to Wei-Shu-Yi-Zi No. 1010265129; articles 2, 3, 6, 7 amended in 2018 pursuant to Wei-Bu-Yi-Zi No.

1071661626)

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3.3ȨΓᡏࣴزݤȩᕴ಍๮ᕴ΋ကӷಃ 10000291401 ဦзڋۓϦѲ

ӄЎ26చǴ҇୯ 100ԃ12 Д28ВࡼՉ

3.3 Human Subjects Research Act, promulgated as per the Presidential Order Hua-Zong-Yi-Yi-Zi No. 100002914011 dated 28 December 2011

3.4 101ԃ07Д 05Вፁ࿿ᙴӷಃ 1010265098ဦڄϦ֋Ȩউ౛ቩࢗ

ہ঩཮ளᙁܰำׇቩࢗϐΓᡏࣴزਢҹጄൎȩ

3.4 “The Scope of Expedited Categories for IRB Review”

announced by Ministry of Health and Welfare on 5 July 2012, pursuant to Wei-Shu-Yi-Zi No. 1010265098

3.5 101ԃ 07Д 05Вፁ࿿ᙴӷಃ1010265075ဦڄϦ֋Ȩளխউ౛

ቩࢗہ঩཮ቩࢗϐΓᡏࣴزਢҹጄൎȩ

3.5 “The Scope of Exemption Categories for IRB Review”

announced by Ministry of Health and Welfare on 5 July 2012, pursuant to Wei-Shu-Yi-Zi No. 1010265075

3.6ύ๮҇୯109ԃ01Д15Вᕴ಍๮ᕴ΋ကӷಃ10900003861ဦ зঅ҅ϦѲȨᙴᕍݤȩ

3.6 Medical Care Act, amended and promulgated as per the Presidential Order Hua-Zong-Yi-Yi-Zi No. 10900003861 dated 15 January 2020

4.Ӝຒۓက 4. Definitions

4.1 JIRBǺᖄӝΓᡏ၂ᡍہ঩཮(Joint Institutional Review Board)Ƕ 4.1 JIRB: Joint Institutional Review Board

4.2 c-IRBǺࣁፁғᅽճ೽ೕჄϐቩࢗᐒڋǶҗፁғᅽճ೽ံշϐȨڑ

ຫᖏ׉၂ᡍᆶࣴزीฝȩ໨ΠϐӭৎᙴᏢύЈ፺ࢬᏼҺ୯ϣѦӭ ύЈᛰࠔᖏ׉၂ᡍϐ IRB ЬቩύЈǴ؂ਢ IRB ቩࢗਔ໔ǴЬቩ ᙴଣа20ঁπբϺࣁচ߾Ȑό֖ीฝЬ࡭ΓံҹȑǴୋቩᙴଣа 10ঁπբϺࣁচ߾Ȑ֖ीฝЬ࡭ΓံҹȑǶ

4.2 c-IRB: C-IRB refers to the review mechanism established by

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Version Iހ the Ministry of Health and Welfare. The medical centers awarded “Excellent Clinical Trial Research Project” grants by the Ministry of Health and Welfare will take turns running the central IRB of domestic/international multicenter clinical trials.

The IRB review time period for each protocol shall be: (1) 20 days for the primary reviewing medical center (not including the time for the PI to submit missing documents); (2) 10 days for the secondary reviewing medical center (including the time for the PI to submit missing documents).

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5. Procedure

5.1ཥਢቩࢗᆅ౛ࢬำკ

5.1 Flow Chart of New Protocol Review

ࢬำ Flow Chart

៾ೢ

Responsible Personnel

࣬ᜢЎҹ Relevant Documents

ڙ౛ଌቩЎҹ Acceptance of Submissions

Ӽ௨Ӛ໨ቩࢗ

Managing Review of Protocols

इᒵߥӸ Records Retention

Yes

΋૓܈ᙁܰቩࢗ

Full Board or Expedited Review

ଌቩЎҹዴᇡ Confirmation of

Submissions

ቩࢗБԄዴᇡ Evaluation of Review Category

No

խቩ Exempt Review

܍ᒤΓ঩

Staff Members

ीฝਜଌቩᆅ౛ำׇਜ/Γᡏࣴزݤ/ᙴ ᕍݤ/Ӛᜪଌቩ࣬ᜢЎҹ

SOP of Managing Protocol Submissions/Human Subjects Research Act//Medical Care Act/Relevant Documents of

All Submissions

܍ᒤΓ঩

Staff Members

ଌቩЎҹ/ਢҹࢬำ߄/

ၗ਑௨ӈ໩ׇ߄

Submission Documents/Protocol Review Routing Form/List of

Organized Documents

୺ՉઝਜȐঋҺہ

঩ਔȑ/ȐୋȑЬҺ ہ঩

Executive Secretary (if also an IRB

member)/

(Vice) Chair

ीฝଌቩҙፎਜ/ቩࢗہ঩ᒦᒧ߄ /PTMSਢҹቩࢗख़ᗺݙཀ٣໨ᔠਡ߄ Protocol Application Form/Reviewers

Selection Form/PTMSReview Checklists

୺Չઝਜ/܍ᒤΓ

঩/ቩࢗہ঩/஑ৎ Executive Secretary/

Staff Members/

Reviewers/

Expert Consultants

ଌቩਢҹၗ਑/ቩࢗہ঩ᒦᒧ߄/PTMS س಍/ႝηແҹ/ಃ΋ǵΒΓᡏࣴزউ౛

ቩࢗہ঩཮ቩࢗཀـӣᙟ߄/অ҅Ўҹ/

ीฝਜୁङ/ᔞਢၗ਑૶ᒵ Documents of Protocol Submissions/Reviewers

Selection Form/PTMS/Email/

Form of Response to IRB Reviewers’

Comments/Revised Documents/Protocol Binder Spine Insert/Record of Documents

܍ᒤΓ঩

Staff Members

Γᡏࣴز/၂ᡍीฝ೚ёਜ/ϦЎ Certificate of Approval/

Official Correspondence

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5.2 Acceptance of Submissions

཰୍܍ᒤΓ঩ᔈ٩ྣȨीฝਜଌቩᆅ౛ำׇਜȩϐೕۓǴୖԵӵ ΠᇥܴǴڙ౛ཥਢଌቩЎҹǶ

When receiving submissions of new protocols, IRB staff members shall process them by following the SOP of Managing Protocol Submissions and the regulations below.

5.2.1ࡪȨΓᡏࣴزݤȩಃ4చಃ 1໨ǺȨΓᡏࣴزǺࡰவ٣ڗளǵ

ፓࢗǵϩ݋ǵၮҔΓᡏᔠᡏ܈ঁΓϐғނՉࣁǵғ౛ǵЈ౛ǵ ᒪ໺ǵᙴᏢ฻ԖᜢၗૻϐࣴزȩǶ

5.2.1 According to Article 4, Paragraph 1 of Human Subjects Research Act, “Human subject research (hereinafter

“research”): refers to research that involves obtaining, investigating, analyzing, or using human specimens or an individual person’s biological behavior, physiological, psychological, genetic or medical information.”

5.2.2 ࡪȨΓᡏࣴزݤȩಃ 5 చೕۓǺȨࣴزीฝЬ࡭Γჴࡼࣴز

߻ǴᔈᔕۓीฝǴ࿶উ౛ቩࢗہ঩཮ቩࢗ೯ၸǴۈளࣁϐǶȩǹ

ၴϸޣஒ٩၀ݤಃ22 చ࣬ᜢೕۓೀ౛Ƕ

5.2.2 According to Article 5 of Human Subjects Research Act,

“Prior to conducting research, the principal investigator shall submit the research protocol for review and approval by the Institutional Review Board (hereinafter “IRB”).”

Violators of Article 5 will be penalized according to Article 22.

5.2.3 ࡪȨᙴᕍݤȩಃ 8 చೕۓǺȨҁݤ܌ᆀΓᡏ၂ᡍǴ߯ࡰᙴᕍ

ᐒᄬ٩ᙴᏢ౛ፕܭΓᡏࡼՉཥᙴᕍמೌǵཥᛰࠔǵཥᙴᕍᏔ

׷ϷᏢӜᛰғᡏёҔ౗ǵғᡏ࣬฻܄ϐ၂ᡍࣴزǶΓᡏ၂ᡍ ϐࡼՉᔈ൧ख़ௗڙ၂ᡍޣϐԾЬཀᜫǴ٠ߥምځ଼ந៾੻ᆶ ᗦد៾Ƕȩ

5.2.3 According to Article 8 of the Medical Care Act, “The term

‘human trial’ as used in the Act shall refer to experimental

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Version Iހ research of new medical technology, new medicament, new medical implement, or the bioavailability and bioequivalence of generic drugs conducted by medical care institutions on humans based on medical theory. In conducting a human trial, the medical care institution shall respect the voluntary intent of the trial subjects and protect their right to health and privacy.”

5.3ଌቩЎҹዴᇡ

5.3 Confirmation of Submissions

཰୍܍ᒤΓ঩ᔈ٩ྣӵΠϐೕጄǴ຾ՉଌቩЎҹዴᇡǶ

Staff members shall follow the guidelines and confirm the correctness of submitted documents.

5.3.1٩ྣଌቩమൂ܌ӈϐ໨Ҟ೴໨ቩࢗǴਡჹࡕऩว౜ЎҹԖ౧

ᅅ܈ᒱᇤǴа PTMSس಍೯ޕीฝЬ࡭Γ٠ଏӣ܌ԖଌቩЎ ҹǴଏӣଌቩЎҹа΋ԛࣁज़ǴऩीฝЬ࡭ΓԖόӕཀـǴ

߾೵ଌہ঩ቩࢗǶ

5.3.1 Staff members shall check if all needed documents are submitted according to the submission checklist. Upon finding any missing or mistaken item, staff members shall send a PTMS notice to the principal investigator (PI) and return all submitted documents to the PI. Any incomplete submission may only be returned once. If the PI disagrees, the case shall be sent to an IRB member for judgment.

5.3.2ՉࡹቩࢗዴᇡࡕǴᔈ٩ྣӵΠೕጄǴ๏ϒीฝਢҁ཮ጓဦǴ

٠ࡌҥ஑ឦीฝᔞਢϷၗ਑֨Ƕ

5.3.2 Upon completion of the administrative review of protocol submissions, staff members shall assign each submission with an IRB number following the guidelines below and set up a designated folder for all files of the protocol.

ዸձ Digit

ಃ΋ዸ 1st

ಃΒዸ 2nd

ಃΟǵѤዸ 3rd & 4th

ಃϖԿΎዸ 5th to 7th

ಃΖዸ 8th ж߄ཀက

Meaning of the digit

ਢҹ܄፦

Type of protocol

ቩࢗำׇ

Review category

ཥਢ ڙ౛ԃҽ Year of

ࢬНဦ Serial number

Γᡏࣴزউ౛

ቩࢗہ঩཮

ጓဦ

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submission IRB

Committee жዸཀက

Meanings of letter codes

JǺJIRBਢҹ J: JIRB

SǺԖӝբቷ୘

S: Collaboration with a company CǺଣϣԾՉࣴز C: Research within TCVGH NǺ୯ፁଣਢҹ N: Research from the National Health Research Institutes (NHRI)

FǺ΋૓ቩ

F: Full board review EǺᙁܰቩ

E: Expedited review WǺխቩ

W: Exempt review GǺᙁܰቩׯࣁ΋૓ቩ G: Category changed from expedited to full board review CǺ܍ௗځдӝݤቩࢗ཮೯ၸ ϐࣴزीฝ

C: Contracted protocol approved by another legal IRB

Ջϡԃ Last two digits of the year

001Կ999 001 to 999

AǺಃ΋Γᡏࣴ

زউ౛ቩࢗہ

঩཮

A: The First IRB

Committee BǺಃΒΓᡏࣴ

زউ౛ቩࢗہ

঩཮

B: The Second IRB

Committee

5.4ቩࢗБԄዴᇡ

5.4 Evaluation of Review Category

ہ঩ᔈୖྣӵΠೕጄǴ຾ՉቩࢗБԄϐዴᇡǶ

IRB members shall evaluate and decide the review category of each protocol according to the guidelines below.

5.4.1΋૓ቩࢗਢҹҙፎਢ

5.4.1 Full Board Review Protocols

፾Ҕܭόё࿶ᙁܰቩࢗϷխቩำׇǴीฝЬ࡭Γሡ٩Ȩཥਢ ଌቩЎҹమൂȩȐፎୖԵߕҹ6.1ȑྗഢЎҹǶ

Protocols not qualified for expedited or exempt review are categorized as full board review protocols. Principal investigators shall prepare the documents according to the

“New Protocol Submission Checklist” (refer to Appendix 6.1).

5.4.2ᙁܰቩࢗਢҹҙፎਢ

5.4.2 Expedited Review Protocols

5.4.2.1ҙፎጄൎ٩101ԃ07Д05Вፁ࿿ᙴӷಃ1010265098 ဦڄϦ֋Ȩউ౛ቩࢗہ঩཮ளᙁܰำׇቩࢗϐΓᡏࣴز

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5.4.2.1 The research categories for expedited review are defined in “The Scope of Expedited Categories for IRB Review” announced by Ministry of Health and Welfare on 5 July 2012, pursuant to Wei-Shu-Yi-Zi No.

1010265098.

5.4.2.2Ȩӄ଼҇நߥᓀၗ਑৤ࣴزीฝଌቩҙፎਜȩϣ৒ǺȐ1ȑ

ύЎᄔाǹȐ2ȑҁ཮ύЎΓᡏࣴز/၂ᡍीฝਜϷႣᆉ ߄ǹȐ3ȑीฝЬ࡭ΓǵӅӕीฝЬ࡭ΓǵڐӕीฝЬ࡭

Γϐճ੻଑ᗉᖂܴਜϷࣴزԋ঩ߥஏᖂܴਜǹȐ4ȑᡉ๱

଄୍ճ੻ᄤߚ଄୍ᜢ߯ҙൔᇥܴϷҙൔ߄ǹȐ5ȑीฝЬ

࡭ΓǵӅӕीฝЬ࡭ΓǵڐӕीฝЬ࡭ΓϷࣴزΓ঩ϐ നཥቬᐕၗ਑ǹीฝЬ࡭ΓǵӅӕीฝЬ࡭ΓᔠߕΟԃ ϣ 6λਔа΢ǵڐӕीฝЬ࡭ΓϷࣴزԋ঩ᔠߕ߈Οԃ ϣԖ࣬ᜢ૽ግ᛾ܴջё(ቷ୘ගٮϐΓᡏ၂ᡍ࣬ᜢ௲ػ

૽ግ᛾ܴคݤௗڙ)ǹȐ6ȑ؂Տࣴزი໗ԋ঩໪ௗڙ 1 λਔа΢ϐճ੻ፂँᆅ౛ϐ௲ػ૽ግǶ

5.4.2.2 The “Protocol Application Form for Research Using National Health Insurance Research Database”

includes the following content: (1) Abstract in Chinese, (2) Human Research/Clinical Trial Proposal and Budget Form, (3) Statements of Conflict of Interest by the Principal Investigator (PI), Co-Investigator (Co-I), and Sub-Investigator (Sub-I), and Confidentiality Statement by Research Members, (4) Statement of Significant Financial Interest and Other Relationships, (5) Updated CVs of the PI, Co-I, and Sub-I; proof of 6 or more hours of human research training received by the PI within the past three years, and proof of human research training received by the Co-I and Sub-I within the past three years. (Proof of training provided by companies will not be accepted.) (6) Each research personnel must receive at least 1 hour of educational training on conflicts of interest.

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5.4.3 Exempt Review Protocols

ҙፎጄൎ٩ 101ԃ07 Д05Вፁ࿿ᙴӷಃ 1010265075ဦ ڄϦ֋Ȩளխউ౛ቩࢗہ঩཮ቩࢗϐΓᡏࣴزਢҹጄൎȩु

ۓǴȨीฝଌቩҙፎਜȩ҅ҁ΋ҽǶ

The research categories for exempt review are defined in

“The Scope of Exemption Categories for IRB Review”

announced by Ministry of Health and Welfare on 5 July 2012, pursuant to Wei-Shu-Yi-Zi No. 1010265075. An original copy of the “Protocol Application Form” shall be submitted.

5.5Ӽ௨Ӛ໨ቩࢗ

5.5 Managing Review of Protocols

5.5.1஑ਢᔞਢᆅ౛Ǵ຾ՉཥਢጓဦǵႝတࡌᔞϷ૶ᒵӚ໘ࢤޑਔ

໔ࢬำǶ

5.5.1 Project management, assignment of IRB numbers, creating electronic files and recording the timeline of each step.

5.5.2܍ᒤΓ঩ܭڙ౛ीฝࡕଌҬ୺ՉઝਜϩਢǶ୺Չઝਜ٩ྣ኱

ྗ߃؁ࡌ᝼ࢂց಄ӝᙁܰቩࢗाҹǴҗȐୋȑЬҺہ঩ղۓ Ȑऩ୺ՉઝਜঋҺہ঩Ǵ߾ёޔௗ຾ՉղۓȑǴ٠ຎሡाᒦ ᒧቩࢗہ঩Ƕ

5.5.2 After the staff members acknowledge receipt of a new review application, the Executive Secretary shall make a primary recommendation as to whether the protocol qualifies for expedited review for the (Vice) Chair to approve (if the Executive Secretary is also an IRB member, she/he may make the decision directly). The Executive Secretary shall then select reviewers.

5.5.3 ςץҢϐཥਢीฝǴȨPTMS س಍ȩԾ୏஌วႝηແҹ೯ޕ

ቩࢗہ঩܈஑ৎ຾ՉቩࢗǶ

5.5.3 PTMS will be used to send automatic E-mail messages to

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Version Iހ notify reviewers or expert consultants to review new protocol submissions.

5.5.4૶ᒵቩࢗہ঩ӣٰਔ໔Ϸ༼໣ᇙբȨቩࢗہ঩ཀـӣᙟ߄ȩǴ

аȨPTMS س಍ȩԾ୏஌วႝηແҹ೯ޕीฝЬ࡭ΓǶ 5.5.4 Staff members shall record the time of receiving comments

from each reviewer, compile comments and create the

“Form of Response to IRB Reviewers’ Comments.”

PTMS will be used to send automatic E-mail to notify the PI.

5.5.5ᔠࢗଌቩہ঩ҙፎਢࢂցၻයǶ

5.5.5 Staff members shall check if a protocol submitted for review has passed the deadline.

5.5.6ዴᇡቩࢗہ঩ϐቩࢗයज़Ǵ٠E-mail ගᒬቩࢗہ঩Ƕ

5.5.6 Staff members shall check the review deadline and remind reviewers via E-mail.

5.5.7ᔠࢗଌҬीฝЬ࡭ΓϐቩࢗཀـࢂցၻයǶ

5.5.7 Staff members shall check if the reviewers’ comments sent to the PI has past the deadline.

5.5.8ीฝЬ࡭ΓံҹȐӣᙟቩࢗཀـȑϺኧࣁ7ঁВ᏿ϺǴऩຬ

ၸ28ঁВ᏿Ϻϝ҂ӣᙟ߾೵ՉᄖਢǶ

5.5.8 The time period for re-submission of documents (or response to reviewers’ comments) by the PI shall be within 7 calendar days. If the re-submission or response has passed 28 calendar days, the protocol shall be withdrawn.

5.5.9 c-IRBਢҹа3ঁπբϺࣁচ߾Ƕ

5.5.9 In the case of c-IRB protocol submission, the time period for re-submission of documents or response to reviewers’

comments shall be 3 work days.

5.5.10 ीฝЬ࡭Γ҂ܭज़යϣӣᙟϐीฝਢǴளຎࣁᄖਢȐϝ໪

ᛦҬቩࢗ຤ȑǴीฝЬ࡭Γள༤ቪȨᄖਢҙፎਜȩ܈җ܍ᒤ

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Version Iހ Γ঩ගൔε཮೵ՉᄖਢǴځࡕऩట຾Չᔈаཥਢख़ཥଌቩǶ 5.5.10 If the PI does not respond within the deadline, the

protocol will be withdrawn (the PI still needs to pay the review fee). The PI shall then fill out and submit the

“Protocol Withdrawal Application Form”, or the protocol withdrawal may be submitted by the staff members to the IRB board meeting. If the PI intends to submit the protocol again, it shall be submitted as a new protocol.

5.5.11ځдቩࢗᔈݙཀ٣໨

5.5.11 Other Review Key Points

ہ঩ቩࢗीฝਢਔǴନ٩ȨPTMSਢҹቩࢗख़ᗺݙཀ٣໨ᔠ ਡ߄ȩ೴໨ቩࢗϐѦǴԖ΋٤੝ۓ௃ݩ໪੝ձݙཀǺ When IRB members review a protocol, in addition to following the PTMS Review Checklists, they shall pay special attention to the following aspects:

5.5.11.1 ीฝ೛ीԖჹྣಔ܈ຬၸȐ֖ȑΒಔڙ၂ޣਔǴᔈԵ

ໆځϦѳ܄Ǵ٠ݙཀࢂցჹڙ၂ޣԖֹ᏾ޑߥៈǶ 5.5.11.1 If the research design involves a control group or two

or more groups of trial subjects, special attention shall be given to whether the trial subjects would be well protected and whether the research would be conducted with fairness.

5.5.11.2 ीฝਜᔈၩܴวғՖᅿ௃ݩ཮ኩଶ܈ಖЗ၂ᡍϐ຾

ՉǴЪᔈԖኩଶ܈ಖЗ၂ᡍਔᆢៈڙ၂ޣӼӄᆶ៾੻

ޑೀ࿼БԄǶ

5.5.11.2 The protocol shall specify in which conditions the trial would be suspended or terminated, and how the trial subjects’ rights and safety would be protected in the case of trial suspension or termination.

5.5.11.3 ჹीฝϐڙ၂ޣȐ֖ܰڙ໾্௼ဂȑᔈຑ՗ځୖᆶ၂

ᡍёૈ೷ԋޑӒᓀࢂցӧёௗڙޑำࡋϐϣǶᔈݙཀ

ࢂց፾྽ޑߥៈځ៾੻ᆶᅽࣸǶҭᔈݙཀޕ௃ӕཀϐ ำׇǵᛝ࿿ӕཀਜБԄǵڙ၂ޣӕཀਜڗளำׇࢂց

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Version Iހ ӝ౛Ƕ፾྽ߥៈ،ۓૈΚԖЖલϐڙ၂ޣǴຑ՗ڙ၂ ޣୖᆶࣴزीฝ܌ᕇளϐံշࢂց࡞྽ǶϷዴᇡࣴز ი໗ܭࣴزीฝ୺Չ่״ࡕǴࢂցૈ୼ዴჴ୺Չڙ၂ ޣᗦدϷёᒣ᛽ၗ਑ᐒஏϐߥៈ௛ࡼǶ

5.5.11.3 The protocol shall detail the risk assessment of the clinical trial for the trial subjects (including vulnerable subjects), and specify whether the risk would be acceptable. Special attention shall be given to whether the trial subjects’ rights and benefits would be well protected. The procedure for obtaining signed Informed Consent Forms shall be reasonable and appropriate. When the research is concluded, the research members shall continue to protect the privacy of trial subjects and keep all classified information confidential.

5.5.11.4٩Ȩᙴᕍݤȩಃ79చೕۓǴௗڙ၂ᡍޣаԖཀ᛽ૈΚ

ϐԋԃΓࣁज़ǶՠᡉԖ੻ܭ੝ۓΓαဂ܈੝ਸ੯ੰᑡ

஻ޣ଼ந៾੻ϐ၂ᡍǴόӧԜज़Ƕ

5.5.11.4 According to Article 79 of the Medical Care Act, “the subjects of human research must be adults with disposing capacity. The preceding provision however does not apply to human research that is apparently beneficial to the health of specific population or patients with a special disease.”

5.5.11.5 ڙ၂ޣӕཀਜϣ৒ǴᔈᅰໆαᇟϯǴόᔈຬၸ΋૓୯

ύғ܌ૈᕕှޑำࡋǶ

5.5.11.5 The wording of the Informed Consent Form shall be colloquial and shall be understandable to a person with the reading level of an average middle school student.

a.ڙ၂ޣӕཀਜᔈ֋ޕԜࣁ၂ᡍǴߚதೕݯᕍѸ໪ޑำ

ׇǶЪᔈ֋ޕڙ၂ޣёаӧֹӄԾЬޑ௃ݩΠ،ۓ

ࢂցᜫཀୖуǶ

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Version Iހ a. The Informed Consent Form shall specify that the

clinical trial is not a necessary procedure in a standard medical treatment. It shall also state that the participation in the trial is completely voluntary and up to the trial subjects to decide whether to participate or not.

b.ჹܭ 7 ྃԿ 12 ྃϐڙ၂ޣǴளा؃ीฝЬ࡭ΓќѦ ኗቪȨٽูހڙ၂ޣᇥܴਜȩଌቩǴڙ၂ޣᇥܴਜϣ

৒ەࣁ୯λғ܌ૈᕕှޑำࡋǶ

b. For research involving subjects between ages 7 and 12, the PI may be required to compose the

“Informed Consent Form and Instructions for Children” and submit the form for IRB review. The content of the form shall be understandable to a person with the reading ability of an average primary school student.

5.5.11.6 ऩीฝࣁӧ࡚ບ࠻܈Ѹ໪ӧᆙ࡚௃ݩΠ຾ՉǴᔈ၁ಒ

ຑ՗ڗளڙ၂ޣᛝ࿿ӕཀਜϐࢬำࢂց࡞྽Ƕ

5.5.11.6 If the research is conducted in the emergency room or in an emergency situation, the protocol shall provide details to ensure that the procedure of obtaining signed Informed Consent Forms is appropriate.

5.5.11.7 ीฝЬ࡭Γ໪٩Ᏽჴሞ௃׎ගҬȨճ੻ፂँᖂܴȩ

(Conflict of Interest, COI)Ǵаߡہ঩ቩ᎙ࢂց಄ӝೕ

ጄǶ

5.5.11.7 The PI shall submit Statements of Conflict of Interest (COI) for the reviewers to see if all regulations are followed.

5.5.11.8 ࣴز่݀ϐൔ֋܈ว߄Ǵᗨߚہ঩཮ϐᙍೢǴՠЬ࡭

Γᔈܭीฝਜύഋॊ཮൧ख़٠ߥៈڙ၂ޣϐᗦدǶ 5.5.11.8 The PI shall state in the protocol that the trial

subjects’ privacy will be protected and respected

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Version Iހ when the research results are announced or published, even though it is not the responsibility of the IRB to regulate the publication of the results.

5.5.11.9 ๏ڙ၂ޣޑൔၿߎᚐǵБԄᆶਔำǴόёჹڙ၂ޣ೷

ԋુॐ܈ό྽ճᇨޑቹៜǶ

5.5.11.9 The amount, payment method and schedule of the reward provided to the subject must not be intimidating or improperly enticing for the subject.

5.5.11.10 ๏ڙ၂ޣޑൔၿѸ໪ᒿ๱ࣴزޑ຾Չϩࢤ๏бǴόё

ܭֹԋӄ೽ࣴزϐࡕω๏бǶ

5.5.11.10 The reward provided to the subject must be paid by stage during the research rather than paid after the research completion.

5.5.11.11ӵڙ၂ޣЬ୏܈೏୏ଏрࣴزਢǴϝᔈࡪКٯ๏ϒൔ

ၿǶ

5.5.11.11 If the participant subject actively or passively withdraws from the research, he/she should still be rewarded on a pro rata basis.

5.5.11.12 ֹԋ܌ԖࣴزำׇԶЍбϐൔၿ܈ံᓭߎǴѸ໪ࣁӝ

౛ߎᚐǴЪόளၸଯǴаठό྽ቹៜচҁाଏрϐڙ ၂ޣޑཀᜫǶ

5.5.11.12 The reward or compensation paid after the research procedure completion must be reasonable rather than excessively high to avoid the inappropriate impact on the willingness of the subject.

5.5.11.13 Γᡏࣴزউ౛ቩࢗہ঩཮όϢ೚၂ᡍہૼޣගٮҺ

Ֆ׎Ԅϐᙯϟ຤Ȑߎᒲ܈ჴނȑǴ܈բࣁуೲڙ၂ޣ ޑܕ༅ޑၿമǶ

5.5.11.13 IRB does not allow the sponsor to provide the referral fee in any forms (money or gifts) as the reward for accelerating the recruitment of the

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Version Iހ subject.

5.5.12 ࡪȨᙴᕍݤȩಃ 78 చೕۓǺȨࣁගଯ୯ϣᙴᕍמೌНྗ܈

Ⴃٛ੯ੰ΢ϐሡाǴ௲Ꮲᙴଣ࿶ᔕۓीฝǴൔፎύѧЬᆅ ᐒᜢਡ঑Ǵ܈࿶ύѧЬᆅᐒᜢہૼޣǴளࡼՉΓᡏ၂ᡍȩǶ

ࡺΥղۓࣁΓᡏ၂ᡍϐीฝਢǴ֡໪ӕਔ࿶ፁғᅽճ೽ቩ

ࢗ೯ၸࡕБё୺ՉǶ

5.5.12 Article 78, Medical Care Act: “For the purpose of improving the level of medical care or prevention of disease in the country, teaching hospitals may conduct human research after formulating a plan and obtaining approval from the central competent authority, or upon entrustment of the central competent authority.”

Therefore all protocols considered to be human research are required to obtain approval from the Ministry of Health and Welfare before implementation.

5.6इᒵߥӸ

5.6 Records Retention

࣬ᜢΓ঩ᔈ٩ᏵӵΠೕۓǴִ๓ߥӸӚ໨इᒵǶ

Relevant personnel should keep all records carefully following the guidelines below.

ጓဦ Number

इᒵӜᆀ Name of Document

ߥӸӦᗺ Retention Location

ߥӸයज़ Retention Period 1

ཥਢቩࢗଌቩЎҹమൂ

New Protocol Submission Checklist

IRBᒤϦ࠻

IRB Office

၂ᡍ่״ࡕ3ԃ At least 3 years after

the trial is closed 2 ᖏ׉ࣴزᙁܰቩࢗጄൎਡჹ߄(A)

Expedited Review Checklist (A)

IRBᒤϦ࠻

IRB Office

the trial is closed 3 ᖏ׉ࣴزᙁܰቩࢗጄൎਡჹ߄(B)

Expedited Review Checklist (B)

IRBᒤϦ࠻

IRB Office

the trial is closed 4

PTMSཥਢҙፎਜ

PTMS New Protocol Application Form

IRBᒤϦ࠻

IRB Office

the trial is closed 5 ቩࢗہ঩ᒦᒧ߄

Reviewers Selection Form

IRBᒤϦ࠻

IRB Office

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Version Iހ

ጓဦ Number

इᒵӜᆀ Name of Document

ߥӸӦᗺ Retention Location

ߥӸයज़ Retention Period the trial is closed

6

ਢҹ॥ᓀᆶճ੻ຑ՗ᔠਡ߄

IRB Risk and Benefit Assessment Checklist

IRBᒤϦ࠻

IRB Office

the trial is closed

7

ಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮Γ ᡏࣴز/၂ᡍਢҹયΕܰڙ໾্௼ဂ ҙፎ߄

IRB Vulnerable Subjects Application Form for Research

IRBᒤϦ࠻

IRB Office

the trial is closed

8

ቩࢗཀـӣᙟ߄

Form of Response to IRB Reviewers’ Comments

IRBᒤϦ࠻

IRB Office

the trial is closed

9

ᄖਢҙፎਜ

Protocol Withdrawal Application Form

IRBᒤϦ࠻

IRB Office

the trial is closed 10 ਢҹࢬำ߄

Protocol Review Routing Form

IRBᒤϦ࠻

IRB Office

the trial is closed 11 Γᡏࣴز/၂ᡍीฝ೚ёਜ

Certificate of Approval

IRBᒤϦ࠻

IRB Office

the trial is closed

12 ϦЎ

Official Correspondence

IRBᒤϦ࠻

IRB Office

the trial is closed

6.ߕҹ

6. Appendices

ȨPTMSس಍ЎҹȩǵȨPTMSਢҹቩࢗख़ᗺݙཀ٣໨ᔠਡ߄ȩǵȨϦ Ўȩࣁጕ΢س಍ᒡрǴคހҁᇤҔϐဤǹࡺόӈΕߕҹᆅ౛Ƕ

“PTMS Documents” “PTMS Review Checklist” and “Official Correspondence” are generated from the online system, preventing the usage of the wrong version; therefore, the above two items are not listed in the management of appendices.

6.1ཥਢቩࢗଌቩЎҹమൂ

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Version Iހ 6.1 New Protocol Submission Checklist

6.2ᖏ׉ࣴزᙁܰቩࢗጄൎਡჹ߄(A) 6.2 Expedited Review Checklist (A) 6.3ᖏ׉ࣴزᙁܰቩࢗጄൎਡჹ߄(B) 6.3 Expedited Review Checklist (B) 6.4ቩࢗہ঩ᒦᒧ߄

6.4 Reviewers Selection Form

6.5 ಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮΋૓ቩࢗਢҹ॥ᓀᆶճ੻ຑ՗

ᔠਡ߄

6.5 IRB Risk and Benefit Assessment Checklist for Full Board Review

6.6 ಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮ᙁܰቩࢗਢҹ॥ᓀᆶճ੻ຑ՗

ᔠਡ߄

6.6 IRB Risk and Benefit Assessment Checklist for Expedited Review

6.7 ಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮Γᡏࣴز/၂ᡍਢҹયΕܰڙ໾

্௼ဂҙፎ߄-፾Ҕឦѫ஁܈जٽϐࣴز

6.7 IRB Vulnerable Subjects Application Form for Research Involving Pregnant Women or Fetuses

্௼ဂҙፎ߄-፾Ҕឦ҂ԋԃΓϐࣴز

6.8 IRB Vulnerable Subjects Application Form for Research Involving Children

্௼ဂҙፎ߄-፾ҔឦғӸΚόܴޑཥғٽϐࣴز

6.9 IRB Vulnerable Subjects Application Form for Research Involving Neonates of Uncertain Viability

6.10 ಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮Γᡏࣴز/၂ᡍਢҹયΕܰڙ

໾্௼ဂҙፎ߄-፾Ҕឦڙܥ࿣Γϐࣴز

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Version Iހ 6.10 IRB Vulnerable Subjects Application Form for Research

Involving Prisoners

6.11 ಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮Γᡏࣴز/၂ᡍਢҹયΕܰڙ

໾্௼ဂҙፎ߄-፾ҔឦคݤӸࢲޑཥғٽϐࣴز

6.11 IRB Vulnerable Subjects Application Form for Research Involving Nonviable Neonates

6.12ಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮ቩࢗཀـӣᙟ߄ 6.12 Form of Response to IRB Reviewers’ Comments 6.13ᄖਢҙፎਜ

6.13 Protocol Withdrawal Application Form 6.14ਢҹࢬำ߄

6.14 Protocol Review Routing Form 6.15Γᡏࣴز/၂ᡍीฝ೚ёਜ 6.15 Certificate of Approval

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