National Ethical Guidelines for Health Research 2011

8/12/2019 National Ethical Guidelines for Health Research 2011

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NATIONAL ETHICAL GUIDELINESFOR HEALTH RESEARCH

2011

Prepared by the Philippine HealthResearch Ethics Board

Ad Hoc Committee for the Revision of theEthical Guidelines


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TABLE OF CONTENTS

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1. 2. 3. ( / )

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LIST OF ACRONYMS

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FOREWORD

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MESSAGE

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HOW TO USE THE GUIDELINES

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INTRODUCTION

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RESEARCH ETHICS AGENCIES

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Philippine Health Research Ethics Board (PHREB)

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Regional Research Ethics Boards (RREBs)

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Ethics Review Committees (ERCs)

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National Ethics Committee (NEC)

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Regional Ethics Review Committees (RERCs)

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Institutional Ethics Review Committees (IERCs)

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GUIDELINES FOR ETHICS REVIEW COMMITTEES

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GENERAL ETHICAL GUIDELINES FOR HEALTH RESEARCH

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Elements of Research Ethics

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Other Considerations

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ETHICAL GUIDELINES FOR CLINICAL TRIALS ON DRUGS,DEVICES, AND DIAGNOSTICS

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Protocol

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Informed Consent

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Research on Medical Devices, Diagnostic Procedures and Preventive Measures

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ETHICAL GUIDELINES FOR HERBAL RESEARCH

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ETHICAL GUIDELINES FOR COMPLEMENTARY ANDALTERNATIVE MEDICINE RESEARCH

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ETHICAL GUIDELINES FOR RESEARCH ON ASSISTEDREPRODUCTIVE TECHNOLOGY

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ETHICAL GUIDELINES FOR EMERGING TECHNOLOGIES

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ETHICAL GUIDELINES FOR GENETIC RESEARCH WITH ASECTION ON STEM CELL RESEARCH


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ETHICAL GUIDELINES FOR EPIDEMIOLOGIC RESEARCH

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ETHICAL GUIDELINES FOR THE CONDUCT OF RESEARCHON SPECIFIC POPULATION

I. IN EMERGENCIES AND DISASTERS

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ETHICAL GUIDELINES FOR HIV AND AIDS RESEARCH

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ETHICAL GUIDELINES FOR INTERNATIONALCOLLABORATIVE RESEARCHES

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THE RESEARCH ETHICS REVIEW PROCESS

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GUIDELINES ON AUTHORSHIP AND PUBLICATION

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GLOSSARY

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REFERENCES

, . A. (2000). : A .

80(3), 114 120.

B , . & , . (2003). . 57(4), 254 258.

( ). (2002

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(A 47 A 2001). : .

, . ., ., , . (2000). A A 283(20): 2701 11.

A

( A ). (2005).

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. (1996). 6 : .

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. (1995).

, ( 3). :// . . / /

/ / / / 3/ 4/ 3.

. (1996).

, ( 6) ( 1). :// . . / /

/ / / / 6 1/ 4/ 6 1 .

. (1997). ,

( 8). :// . . / // / / / 8/ 4/ 8 .

. (2000).

, ( 10). :// . .

/ / / / / 104/ 10 .

. (1998). : 11 . ,

. (2010). : 11 . , ( )

, . . & , . . (2000). . 321, 777 778.

, ., , ., , ., & , . (1999). ?

, 2, 35 36.

, ,

(2006). :// . . /

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A , , .

(2011). :// . . / / / 347.

B B . (1978).

. . :// .

. . / / / .

, . ( ), 2004. , ,

, A. ., ., ., . . (2008). 10:715 728. 10.1007/

11051 007 9266 .

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. : .

, . (1991). . , 44, 25 28 .

A . (2005). . A : A .

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. B : A .

, . . (1999). . ,

319, 438 441.

, . & , . . (2000). . , 289, 1142 1144.

. (2000). .

:// . . / /A / / /

.

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SUBJECT INDEX


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Appendix A1: Template for Patient Information and

Informed Consent Form

( )


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Appendix A2:Sample Checklist for the Assessment of the

Informed Consent Form

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Appendix B: Ethics Review Committees Standard Application Form for

Ethical Evaluation of Proposed Study

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Appendix C: List of Documents Required for Submission to the Ethics

Review Committee

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Appendix D: Composition of the National Ethics Committee (2011)

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Appendix E: Composition of the Philippine Health Research Ethics

Board (20102013)


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Appendix F: Policies and Procedures for Registration and Accreditation

of Research Ethics Committees

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Appendix H:Standard Operating Procedure (SOP) Template

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National Ethical Guidelines for Health Research 2011

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