ҁЎҹς࿶៾ೢЬᆅ҅Ԅਡ঑Ǵ ਡകइᒵϐ҅ҁᓯܫܭ ... - 臺中榮民總醫院

(1)

ᆅ ڋ Ў ҹ ु অ ቲ इ ᒵ ߄

Record of Composition and Revisions of Controlled Documents Ўҹጓဦ

Document Number

IRB-ҁ཮-πբதೕ-2018

IRB-Regulations of Operation-2018

ЎҹӜᆀ

Title

ᖏਔ཮᝼ᆅ౛ำׇਜ

SOP for Extraordinary IRB Meetings

ु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 6 ཥुǶNewly composed. 20140519

B 4

җΓᡏ၂ᡍہ঩཮኱ྗբ཰ำׇ 5.4ހᙯඤԋԜހҁǶ! This version was converted from “Version 5.4 of the SOP of the Human Research Committee.”!

20150119

C 4

চȨΓᡏ၂ᡍہ঩཮ȩ׳ӜࣁȨಃ΋0ΒΓᡏࣴزউ౛

ቩࢗہ঩཮ȩǶ!

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

20160318

D 4

অׯ 4.1.2অᜏǺཥቚ᝼ਢ຾ՉȨ૸ፕȩ2ӷǶ!

The wording of item 4.1.2 was revised: “Discussion” was added to the sentence regarding a new motion on the meeting agenda.!

20170709

E 6

1. অׯ 5.4.2ϐ׫౻БԄǶ

1. The voting method in item 5.4.2 was revised.

2. ܜඤߕҹ 6.1Ƕ!

2. Appendix 6.1 was replaced.

20190527

F 6

1. Ўӷਠ҅Ƕ

1. Typos were fixed.

2. ܜඤߕҹ 6.1Ƕ

2. Appendix 6.1 was replaced.

20210528

G 6 1. ܜඤߕҹ 6.1Ƕ

1. Appendix 6.1 was replaced. 20211209

ुঅቲ

Composed/Revised/Deleted

ቩਡ

Reviewed

ਡ঑

Approved

ɁᆅڋЎҹόளᏰԾ༡ׯϷ଺૶ဦ٠࿣ЗቹӑǶ

ɁҁЎҹаKMس಍ࣁനཥހҁǴરҁวՉሡ࿶SOPᆅ౛ύЈਡകǴᝄ࿣ԾՉӈӑǶ

Ɉ

ɈChanging, marking, or copying controlled documents without permission is prohibited.

Ɉ

ɈThe 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

2021.12.23

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Processing Unit Review Comments Head of Processing Unit

คၠ೽ࣽ཮ቩሡ؃Ƕ

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

澿ፎӚ཮ᒤൂՏЬᆅඁ፥ቩࢗཀـࡕਡകǴѸाਔளޔௗᆶुۓൂՏڐ୘Ƕ

䈜

䈜㻴㻴㼑㼍㼐㻌㼛㼒㻌㼑㼍㼏㼔㻌㼜㼞㼛㼏㼑㼟㼟㼕㼚㼓㻌㼡㼚㼕㼠㻌㼕㼟㻌㼍㼐㼢㼕㼟ed 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.

2021.12.23

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Ўҹጓဦ

Document Number

Ўҹ Ӝᆀ

Title

।ԛ!

Page 1/6 ހԛ!

Version!!G ހ!

1. Ҟޑ 1. Purpose

ҁᆅ౛ำׇਜुۓޑҞޑ㵝ዴҥᖏਔ཮᝼є໒ޑՉࡹࢬำǴхࡴቩ

ࢗБԄکਢҹ،᝼ޑำׇǶ

The purpose of this SOP is to provide guidelines for the

administrative procedures of extraordinary IRB meetings, which include the review procedure and the process of making a

resolution on a protocol.

2. ፾Ҕጄൎ

2. Scope

2.1 ҁᆅ౛ำׇਜ፾Ҕܭಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮ᖏਔє໒ ϐ཮᝼Ƕ

2.1 This SOP applies to extraordinary IRB meetings held by the First/Second IRB Committees.

2.2 Ьाࢂቩࢗ྽วғӒϷᖏ׉၂ᡍڙ၂ޣғڮӼӄϐ᝼ᚒ܈ँว ٣ҹਔǴᖏਔє໒ϐ཮᝼Ƕ

2.2 An extraordinary IRB meeting is convened in order to review an urgent issue or incident that threatens the safety of the subjects.

3. ୖԵЎҹ

3. References คǶ

None.

4. Ӝຒۓက

4. Definitions 4.1ᖏਔ཮᝼

4.1 Extraordinary IRB Meeting

4.1.1ନΑۓයᖐՉޑಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮ε཮ѦǴຎ

ჴሞ௃ݩሡाԶᖏਔє໒ϐ཮᝼Ƕ

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convened outside the schedule of regular IRB board meetings.

4.1.2ሡၲݤۓΓኧБளє໒཮᝼Ϸ൩᝼ਢ຾Չ૸ፕϷ׫౻߄،Ƕ

4.1.2 A quorum has to be present for the meeting to be called to order and for the motions to be discussed and voted on.

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Ўҹጓဦ

Document Number

Ўҹ Ӝᆀ

Title

।ԛ!

Page 3/6 ހԛ!

Version!!G ހ!

5.բ཰ϣ৒

5. Procedure

5.1ᖏਔ཮᝼ᆅ౛ࢬำკ

5.1 Flow Chart of the Extraordinary IRB Meeting

ࢬำ Flow Chart

៾ೢ

Responsible Personnel

࣬ᜢЎҹ Relevant Document

इᒵߥӸ Records retention

୺Չ،᝼٣໨

Follow-up on resolutions

ௗᕇᖏਔ཮᝼೯ޕ Calling an extraordinary

IRB meeting

཮᝼૸ፕ Meeting ᖏਔ཮᝼཮߻ྗഢ

Pre-meeting preparation

ਡഢ Approval

ȐୋȑЬҺہ঩/୺Չઝਜ/ہ

঩/܍ᒤΓ঩

(Vice) Chair/Executive Secretary/IRB Members/Staff ȐୋȑЬҺہ঩/୺Չઝਜ/ہ

঩/܍ᒤΓ঩

(Vice) Chair/Executive Secretary/IRB Members/Staff

཮᝼ၗ਑/

཮᝼ᛝډൂ

Meeting documents/

Meeting sign-in sheet ȐୋȑЬҺہ঩/୺Չઝਜ/ہ

঩/܍ᒤΓ঩

(Vice) Chair/Executive Secretary/IRB Members/Staff

܍ᒤΓ঩/ࣴز࣬ᜢΓ঩

Staff/Research personnel

཮᝼،᝼

Meeting resolutions

܍ᒤΓ঩

Staff Members

཮᝼इᒵ Meeting minutes

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5.2ௗᕇᖏਔ཮᝼೯ޕ

5.2 Calling an Extraordinary IRB Meeting

5.2.1ЬҺہ঩є໒ᖏਔ཮᝼ϐ௃ݩǺ

5.2.1 In one of the following situations, the IRB Chair may call an extraordinary IRB meeting:

5.2.1.1Ӓ্ϦӅᅽࣸǵ୯ৎ࿶ᔮϐँว٣ҹǶ

5.2.1.1 An urgent incident occurred that had a negative impact on public welfare or national economy.

5.2.1.2วғߚႣයᝄख़όؼϸᔈ٣ҹǶ

5.2.1.2 An unexpected serious adverse event occurred.

5.2.1.3วғױᜢڙ၂ޣԝΫޑ٣ҹǶ

5.2.1.3 A subject died due to participating in the study.

5.2.1.4ځѬǶ 5.2.1.4 Others.

5.2.2ᖄ๎࣬ᜢрৢہ঩Ǵ٠೯ޕ཮᝼ϐє໒ਔ໔ϷӦᗺǶ

5.2.2 The staff member should contact IRB members who should attend the meeting, and inform them of the time and the location of the meeting.

5.2.2.1 ཮᝼ԿϿѸ໪Ԗъኧа΢ϐہ঩рৢǴځύԿϿ໪Ԗ΋

ӜғނᙴᏢࣽᏢङඳہ঩ǵ΋ՏߚғނᙴᏢࣽᏢङඳہ

঩ǵଣѦΓ঩Ϸόӕ܄ձϐہ঩ж߄рৢǶ

5.2.2.1 The members present should be more than half of the total number of members. At least one member present should be with a biomedical science background. At least one member present should be without a biomedical science background. At least one member present should be non-TCVGH-affiliated.

Attending members should include both men and women.

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Ўҹጓဦ

Document Number

Ўҹ Ӝᆀ

Title

।ԛ!

Page 5/6 ހԛ!

Version!!G ހ!

5.2.2.2 ຎჴሞ௃ݩёᗎፎ࣬ᜢ᝼ᚒϐ஑ৎȐࣁہ঩܈ߚہ঩ȑ

рৢǶ

5.2.2.2 Expert consultants (IRB members or non-IRB members) may be invited to attend the meeting based on actual needs.

5.2.2.3ѸाਔǴёፎीฝЬ࡭Γ܈࣬ᜢΓ঩ӈৢᇥܴǶ

5.2.2.3 If needed, the PI or relevant personnel may be invited to attend the meeting as guests and give presentations.

5.3ᖏਔ཮᝼཮߻ྗഢ

5.3 Pre-meeting Preparation

܍ᒤΓ঩ྗഢЎҹӵΠǺ!

The staff member should prepare the following documents:

5.3.1ྗഢ཮᝼ၗ਑ϩଌ๏Ӛрৢہ঩Ƕ

5.3.1 Prepare meeting documents and distribute them to the attending members.

5.3.2ྗഢ཮᝼ᛝډൂǶ

5.3.2 Prepare a sign-in sheet for the meeting.

5.4཮᝼૸ፕ 5.4 Meeting

5.4.1܍ᒤΓ঩ዴۓрৢہ঩ςၲݤۓΓኧǶ

5.4.1 The staff member should confirm that a quorum is present before the meeting is called to order.

5.4.2 рৢہ঩ک஑ৎᔈ൩є໒ᖏਔ཮᝼ϐ᝼ᚒ૸ፕǴ٠଺р،

᝼Ƕ่݀ϐ߄،ǴаȨӭኧ،БԄȩࣁচ߾Ƕ

5.4.2 Attending members and expert consultants should discuss the issues on the agenda of the extraordinary meeting and make resolutions. Voting outcome is based on the principle of "Majority rule".

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5.5୺Չ،᝼٣໨

5.5 Follow-Up on Resolutions

܍ᒤΓ঩٩ྣ཮᝼،᝼Ϸஏ฻ǴᇙբԋȨ཮᝼इᒵȩǴ٠೯ޕЬ

࡭ΓϷ࣬ᜢΓ঩/ൂՏǶ

The staff member should write meeting minutes based on the resolutions and levels of classification, and notify the PI and relevant personnel/units.

5.6इᒵߥӸ

5.6 Records Retention

࣬ᜢΓ঩ᔈ٩ᏵӵΠೕۓǴִ๓ߥӸӚ໨इᒵǶ

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

ጓဦ Number

इᒵӜᆀ Name of Document

ߥӸӦᗺ Retention Location

ߥӸයज़ Retention Period

1 ཮᝼इᒵ

Meeting Minutes

IRB ᒤϦ࠻

IRB Office

཮᝼่״ࡕԿϿ3 ԃ

At least 3 years after the meeting

is over 6.ߕҹ

6. Appendix 6.1཮᝼इᒵ

6.1 Meeting Minutes

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