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

(1)

Ta i c h u n g V e t e r a n s G e n e r a l H o s p i t a l

ᆅ ڋ Ў ҹ ु অ ቲ इ ᒵ ߄

Record of Composition and Revisions of Controlled Documents

Ўҹጓဦ

Document Number

IRB-ҁ཮-πբதೕ-2019

IRB-Regulations of Operation-2019

ЎҹӜᆀ

Title

ڙ၂ޣҙນᆅ౛ำׇਜ

SOP for Handling Subject Complaints

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

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

20150119

C 4 1. চȨΓᡏ၂ᡍہ঩཮ȩ׳ӜࣁȨಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮ȩǶ 1. The original “Human Research Committee” was

renamed “The First/Second IRB Committees.”

2. অׯ4.1ӜຒۓကҔຒǺচᖏ׉၂ᡍׯࣁΓᡏࣴز/၂ᡍǶ 2. Item 4.1 was revised: The original “clinical trial” was

replaced by “human research/clinical trial.”

3.অׯ5.1ࢬำკϐ࣬ᜢЎҹǶ

3. The list of relevant documents was revised in item 5.1 Flow Chart.

20160318

D 3 অׯ5.3.1Ȩҙນ૶ᒵ߄ȩଌȐୋȑЬҺہ঩অᜏǺཥቚץ

Ң2ӷǶ

Item 5.3.1 was revised: “Review and approval” was added to the sentence “The subject complaint form should be submitted to the (Vice) Chair for review and approval.”

20170709

E 6 1.অׯ5.4.1ȐୋȑЬҺہ঩ளࡰࢴہ঩܈܍ᒤΓ঩຾Չڐ

ፓೀ౛܈ፓࢗǶ

1. Item 5.4.1 was revised: “The (Vice) Chair may assign an IRB member or staff member to conduct an investigation or intervention.”

2. অׯ5.4.4܍ᒣΓளӧԏډҙນፎ؃Вଆϐ14ঁВ᏿Ϻ

ϣӣᙟҙນޣ߃؁ೀ౛຾ࡋǶ

2. Item 5.4.4 was revised: “The staff member may inform the

complainant of the initial handling progress within 14 calendar days after receiving the complaint or request.”

20190527

2021.06.10

臺中榮民總醫院

參考文件

(2)

ᆅ ڋ Ў ҹ ु অ ቲ इ ᒵ ߄

Record of Composition and Revisions of Controlled Documents

Ўҹጓဦ

Document Number

ЎҹӜᆀ

Title

ु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

E 6 3.ཥቚ5.6.2ीฝЬ࡭Γӧԏډ IRBϐ೯ޕࡕǴᔈӧ7ঁВ

᏿Ϻϣ๏ϒਜय़ӣᙟǴനᒨόૈຬၸ14ঁВ᏿ϺǶ 3. Item 5.6.2 was added: “The PI should provide a response within 7 calendar

days after receiving the IRB's notice, no later than 14 calendar days.”

4.ཥቚ5.6.3܍ᒣΓளܭε཮่״ࡕ 14ϺϣǴ೯ޕҙນޣ

܈ीฝЬ࡭Γϐനಖೀ౛،᝼Ƕ

4. Item 5.6.3 was added: “The staff member should inform the complainant or PI of the final handling decision within 14 calendar days after a decision is done at the IRB board meeting.”

5.ཥቚ5.6.4ҙນޣ܈ीฝЬ࡭Γჹܭനಖ،᝼Ӹӧόӕཀ

ـਔǴёܭ7ঁВ᏿ϺϣගрҙນҙፎǴҙນа΋ԛࣁज़Ƕ 5. Item 5.6.4 was added: “Where there is a disagreeing on the final

decision made at the review meeting, the appeal should be filed within 7 calendar days by the complainant or PI, and the appeal would be limited to one time.”

6.অׯߕҹ6.1Ƕ

6. Appendix 6.1 was replaced.

20190527

E 6 ٩ҁଣೕۓǴܭ2021ԃ03 Д25Вख़ཥቩຎҁЎҹǴϣ

৒ค໪অुǶ

Complied with the regulations of TCVGH, this document was to be re-examined on 25 March, 2021, and the content did not need to be revised.

20190527

ु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

2021.06.10

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(3)

Taichung Veterans General Hospital

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.

ɈፎӚ཮ᒤൂՏЬᆅඁ፥ቩࢗཀـࡕਡകǴѸाਔளޔௗᆶुۓൂՏڐ୘Ƕ

Ɉ

ɈThe 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.

2021.06.10

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Ўҹጓဦ

Document Number

Ўҹ Ӝᆀ

Title

।ԛ

Page 1/6 ހԛ

Version E ހ

1.Ҟޑ

ಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮ޑҺ୍ӧߥៈڙ၂ޣޑ៾ճᆶᅽ

ࣸǴቩࢗ೯ၸޑڙ၂ޣӕཀਜύ೿཮ԖȬऩாჹܭୖᆶҁᖏ׉၂ᡍޑ

࣬ᜢ៾੻Ԗ܌ᅪୢǴாёᆶҁଣಃ΋/ΒΓᡏࣴزউ౛ቩࢗہ঩཮ϐ

܍ᒤΓᖄ๎ȭޑӷѡǴЪԖᖄ๎ႝ၉ǵ໺੿ᆶႝηߞጃޑၗૻǶҁᆅ

౛ำׇਜЬाࢂගٮ྽ڙ၂ޣჹځ៾੻ԖᅪቾԶҙນਔޑೀ౛চ

߾ǴѸाਔҁ཮ஒᑈཱུϟΕǵڐፓǴаڐշڙ၂ޣݾڗᔈԖϐ៾੻Ƕ 1. Purpose

It is the responsibility of the First/Second IRB Committees to protect the rights and welfare of research subjects. On each approved ICF, the following passage should be included: “If you have concerns or questions about your rights regarding participating in this clinical trial, you may contact TCVGH-IRB staff.”

Contact information including telephone number, fax, and e-mail should also be included. The purpose of this SOP is to provide guidance for handling complaints by research subjects who have concerns about their rights. The IRB, if necessary, will intervene and assist the subjects to protect their rights.

2.፾Ҕጄൎ

ҁᆅ౛ำׇਜ፾Ҕܭ܌Ԗڙ၂ޣჹځԾي៾੻܈ᅽࣸԖᅪቾԶගр ҙນϐਢҹǶ

2. Scope

This SOP applies to all cases of complaints by research subjects who have concerns about their rights or welfare.

3.ୖԵЎҹ คǶ

3. References None.

4.Ӝຒۓက 4. Definitions

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Ўҹጓဦ

Document Number

Ўҹ Ӝᆀ

Title

।ԛ

Page 2/6 ހԛ

Version E ހ 4.1ڙ၂ޣ៾੻

ୖᆶΓᡏࣴز/၂ᡍϐڙ၂ޣǴځঁΓ൧ᝄϷ܌Ԗৎ৥ԋ঩ޑ៾

੻ǴѸ໪аԾҗǵ҅ကϷکѳࣁ୷ᘵϒаߥៈǴځΓ៾ᔈ೏ݤࡓ

ೕጄ܌ߥៈǶ 4.1 Subjects’ Rights

The human rights and dignity of human research/clinical trial subjects and their family members should be protected by laws and regulations on the foundation of freedom, justice, and peace.

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Ўҹጓဦ

Document Number

Ўҹ Ӝᆀ

Title

।ԛ

Page 3/6 ހԛ

Version E ހ

5.բ཰ϣ৒

5. Procedure

5.1ڙ၂ޣҙນᆅ౛ࢬำკ

5.1 Flow Chart for Handling Subject Complaints

ࢬำ Flow Chart

៾ೢ

Responsible Personnel

࣬ᜢЎҹ Relevant Documents

इᒵߥӸ Records Retention

ௗᕇᒌ၌܈ҙນ Receiving subject complaints or questions

ፓࢗ܈ೀ౛

Investigation or intervention ߃؁ΑှϷೀ౛

Initial review and handling

ीฝЬ࡭Γӣᙟ Response by PI

ε཮૸ፕ Board Meeting

܍ᒤΓ঩/ہ঩/୺Չઝਜ/ȐୋȑЬҺہ঩

Staff Members/Executive Secretary/(Vice) Chair

ҙນइᒵ߄ Subject Complaint

Form

܍ᒤΓ঩/୺Չઝਜ/ȐୋȑЬҺہ঩

ҙນ૶ᒵ߄ Subject Complaint

Form

܍ᒤΓ঩/ہ঩/୺Չઝਜ/ȐୋȑЬҺہ঩

ҙນ૶ᒵ߄ Subject Complaint

Form ہ঩

Members

ीฝЬ࡭Γ Principal Investigator

܍ᒤΓ঩

Staff Members

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Ўҹጓဦ

Document Number

Ўҹ Ӝᆀ

Title

।ԛ

Page 4/6 ހԛ

Version E ހ 5.2ௗᕇᒌ၌܈ҙນ

5.2 Receiving subject complaints or questions

5.2.1ȐୋȑЬҺہ঩ǵ୺Չઝਜǵہ঩܈܍ᒤΓ঩֡ёڙ౛ᖏ׉

၂ᡍڙ၂ޣϐᒌ၌܈ҙນǶ

5.2.1 Questions or complaints raised by clinical trial subjects may be handled by the (Vice) Chair, Executive Secretary, IRB members, or staff members.

5.2.2܍ᒤΓ঩ஒԜҙນ٣ҹ૶ᒵܭȨҙນ૶ᒵ߄ȩύǴ٠բ߃؁

ೀ౛Ƕ

5.2.2 The IRB staff member is responsible for initial review and handling of the subject complaint and record it in the Subject Complaint Form.

5.3߃؁ΑှϷೀ౛

5.3 Initial review and handling

5.3.1܍ᒤΓ঩ஒȨҙນ૶ᒵ߄ȩҬ୺Չઝਜೀ౛ࡕǴଌȐୋȑЬ

Һہ঩ץҢǶ

5.3.1 The staff member should submit the Subject Complaint Form to the Executive Secretary for initial handling. The Executive Secretary should then submit the case to the (Vice) Chair for review and determination.

5.3.2ȐୋȑЬҺہ঩໪Ǻ 5.3.2 The (Vice) Chair should:

5.3.2.1ዴᇡᆶڙ၂ޣྎ೯ޑ௃ݩǶ

5.3.2.1 review the status of communication between the subject and the IRB office or research personnel.

5.3.2.2ፎڙ၂ޣගٮࡕុၗ਑Ƕ

5.3.2.2 ask the subject to provide follow-up information.

5.3.2.3ຎሡाගрࡌ᝼Ƕ

5.3.2.3 give recommendations based on needs.

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Ўҹጓဦ

Document Number

Ўҹ Ӝᆀ

Title

।ԛ

Page 5/6 ހԛ

Version E ހ 5.4ፓࢗ܈ೀ౛

5.4 Investigation or intervention

5.4.1ȐୋȑЬҺہ঩ளࡰࢴہ঩܈܍ᒤΓ঩຾Չڐፓೀ౛܈ፓࢗǶ

5.4.1 The (Vice) Chair may assign an IRB member or staff member to conduct an investigation or intervention.

5.4.2ӧҙນइᒵ߄ύ૶ᒵ܌ԖޑၗૻϷՉ୏ǴхࡴࡕុଓᙫǶ

5.4.2 All relevant information and actions taken should be recorded on the subject complaint form, including follow-up monitoring.

5.4.3ӧȨइᒵ߄ȩ΢ᛝӜ٠ຏܴВයکਔ໔Ƕ

5.4.3 The subject complaint form should be signed and dated by the IRB member or staff member.

5.4.4܍ᒣΓளӧԏډҙນፎ؃Вଆϐ 14 ঁВ᏿Ϻϣӣᙟҙນޣ

߃؁ೀ౛຾ࡋǶ

5.4.4 The staff member may inform the complainant of the initial handling progress within 14 calendar days after receiving the complaint or request.

5.5ε཮૸ፕ

5.5 IRB Board Meeting Discussion

ऩࣁᝄख़ቹៜڙ၂ޣ៾੻ϐҙນǴஒගε཮૸ፕ٠٩ε཮،᝼ᒤ

౛Ƕ

A subject complaint determined by the IRB to have major impact on the subject’s rights should be placed on the agenda for the IRB board meeting for discussion and resolution.

5.6ीฝЬ࡭Γӣᙟ 5.6 The PI’s Response

5.6.1ஒ཮᝼،᝼аਜय़೯ޕीฝЬ࡭ΓǴ٠ፎीฝЬ࡭Γගрᇥ

ܴǶ

5.6.1 The PI should be notified by writing of the IRB board meeting resolution regarding a subject complaint. The PI

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Ўҹጓဦ

Document Number

Ўҹ Ӝᆀ

Title

।ԛ

Page 6/6 ހԛ

Version E ހ should be required to provide an explanation.

5.6.2 ीฝЬ࡭ΓӧԏډIRBϐ೯ޕࡕǴᔈӧ 7 ঁВ᏿Ϻϣ๏ϒਜ

य़ӣᙟǴനᒨόૈຬၸ14 ঁВ᏿ϺǶ

5.6.2 The PI should provide a response within 7 calendar days after receiving the IRB's notice, no later than 14 calendar days.

5.6.3 ܍ᒣΓளܭε཮่״ࡕ 14 ϺϣǴ೯ޕҙນޣ܈ीฝЬ࡭Γ

ϐനಖೀ౛،᝼Ƕ

5.6.3 The staff member should inform the complainant or PI of the final handling decision within 14 calendar days after a decision is done at the IRB board meeting.

5.6.4 ҙນޣ܈ीฝЬ࡭Γჹܭനಖ،᝼ӸӧόӕཀـਔǴёܭ 7

ঁВ᏿ϺϣගрҙນҙፎǴҙນа΋ԛࣁज़Ƕ

5.6.4 Where there is a disagreeing on the final decision made at the review meeting, the appeal should be filed within 7 calendar days by the complainant or PI, and the appeal would be limited to one time.

5.7इᒵߥӸ

5.7 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 ҙນइᒵ߄

Subject Complaint Form

IRBᒤϦ࠻

IRB Office

၂ᡍ่״ࡕ3ԃ At least 3 years after

the trial is closed

6.ߕҹ 6. Appendix

6.1ҙນइᒵ߄

6.1 Subject Complaint Form

2021.06.10

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