Editorial Board

Editor's Note

i

Acknowledgements

v-viii

Preface

i-xviii

Evidence Retrieval and Synthesis

xiv-xv

Preamble

xvi

Scientific and Social Value and Respect for Rights

1-3

Research Conducted in Low-resource Settings

4-7

Equitable Distribution of Benefits and Burdens in the Selection of Individuals and Groups of Participants in Research

8-10

Potential Individual Benefits and Risks of Research

11-18

Choice of Control in Clinical Trials

19-26

Caring for Participants' Health Needs

27-31

Community Engagement

32-35

Collaborative Partnership and Capacity-building for Research and Research Review

36-39

Individuals Capable of Giving Informed Consent

40-45

Modifications and Waivers of Informed Consent

46-49

Collection, Storage and Use of Biological Materials and Related Data

50-57

Collection, Storage and Use of Data in Health Related Research

58-66

Reimursement and Compensation for Research Participants

67-69

Treatment and Compensation for Research-related Harms

70-71

Research Involving Vulnerable Persons and Groups

72-75

Research Involving Adults Incapable of Giving Informed Consent

76-80

Research Involving Children and Adolescents

81-86

Women as Research Participants

87-89

Pregnant and Breastfeeding Women as Research Participants

90-93

Research in Disasters and Disease Outbreaks

94-99

Cluster Randomized Trials

100-103

Use of Data Obtained from the Online Environment and Digital Tools in Health Related Research

104-108

Requirements for Establishing Research Ethics Committees and for Their Review of Protocols

109-114

Public Accountability for Health-related Research

115-118

Conflicts of Interest

119-123

Items to be Included in a Protocol (or Associated Documents) for Health-related Research Involving Humans

124-128

Obtaing Informed Consent: Essential Information for Prospective Research Participants

129-133