Planning Ethically Responsible Research : A

This book provides readers with the practical knowledge needed to plan ethically responsible social and behavioural research. It includes: detailed instructions on development of an effective protocol; methods for handling issues of consent, privacy, confidentiality and deception; ways to assess risk and benefit to optimize research outcomes; and how to respect the needs of vulnerable research populations such as children and the urban poor, including those at risk from HIV infection.

Preface

xi

Part I: Research Ethics, Regulations, and the IRB

1

(24)

Research Ethics and IRBs

3

(11)

Ethics in Social and Behavioral Research

3

(2)

What Is an IRB?

5

(1)

How Federal Regulations and IRBs Came About

5

(5)

How IRBs Work

10

(1)

Is Pilot Testing Reviewed by the IRB?

11

(1)

Why IRBs Have Been Controversial

12

(1)

What if You Think Your IRB May Disapprove Your Protocol?

12

(2)

The Research Protocol

14

(4)

What Is a Protocol?

14

(2)

Control Documentation

16

(2)

General Ethical Principles of Research on Humans

18

(7)

Three Ethical Principles: Beneficence, Respect, and Justice

18

(1)

Six Norms of Scientific Research

18

(1)

Understanding the Relationship of Norms to Principles

19

(2)

Applying These Principles and Norms to the Design of Research

21

(1)

Some Answers to the Exercises in 3.3

22

(1)

Other Ethical Principles

22

(3)

Part II: Basic Ethical Issues in Social and Behavioral Research

25

(50)

Voluntary Informed Consent and Debriefing

26

(18)

The Communication Process of Voluntary Informed Consent

26

(7)

Legal Elements of Voluntary Informed Consent

33

(1)

Effective Consent Statements

34

(3)

Consent: Signed, Oral, or Behavioral?

37

(1)

Consent as an Ongoing Process

38

(1)

Debriefing and Discussion of Findings

39

(2)

Consent and Debriefing in Community-Based Research

41

(3)

Privacy

44

(8)

How Do Privacy, Confidentiality, and Anonymity Differ?

44

(1)

Why Is Privacy an Issue in Research?

45

(2)

Is There a Right to Privacy?

47

(1)

A Behavioral Definition of Privacy

48

(1)

Privacy and Informed Consent

49

(1)

Gaining Sensitivity to Privacy Interests of Subjects

49

(1)

``Brokered'' Data

50

(2)

Strategies for Assuring Confidentiality

52

(12)

What Is Confidentiality?

52

(1)

Why Is Confidentiality an Issue in Research?

53

(2)

Confidentiality or Anonymity?

55

(1)

Procedural Approaches to Assuring Confidentiality

56

(2)

Cross-Sectional Research

57

(1)

Longitudinal Data

57

(1)

Interfile Linkage

58

(1)

Statistical Strategies for Assuring Confidentiality

58

(1)

Certificates of Confidentiality

59

(1)

Confidentiality and Consent

60

(2)

Data Sharing

62

(2)

Deception Research

64

(11)

Why Is Deception Used in Research?

64

(2)

Alternatives to Deception

66

(1)

Consent to Conceal Versus Deception

67

(3)

Minimizing Wrong and Harm

70

(1)

Dehoaxing

71

(1)

Desensitizing

72

(1)

When not to Dehoax

73

(2)

Part III: Risk/Benefit Assessment and Planning

75

(34)

Why Assess Risk and Benefit?

75

(1)

Misconceptions about Risk/Benefit Assessment

75

(1)

What Is Risk/Benefit Assessment?

76

(2)

How Does an Investigator Identify Risks and Plan Benefits?

78

(1)

Recognizing Elements of Risk

79

(17)

What Is Research Risk?

80

(1)

Why Research Risk Is Difficult to Assess

80

(2)

Stages or Aspects of Scientific Activity That May Involve Risk

82

(7)

The Theory or Research Idea

82

(1)

The Research Process

83

(2)

The Institutional Setting of the Research

85

(2)

Uses of the Research Findings

87

(2)

Risk-Related Factors in Social Research

89

(4)

Privacy and Confidentiality

90

(1)

Personal Safety and Well-Being

90

(1)

Lack of Validity

90

(1)

Deception and Debriefing

91

(1)

Informed Consent, Respectful Communication, and Consultation

91

(1)

Justice and Equitable Treatment

91

(1)

Ownership of Data and Knowledge

92

(1)

Gatekeepers and Opinion Leaders

92

(1)

Persons or Institutions That May Be Vulnerable

93

(1)

Researchers' Perception of Risk

94

(2)

Maximizing Benefit

96

(13)

The Risk/Benefit Requirement

98

(2)

Feasible Benefits and False Promises

100

(3)

False Promises

100

(1)

Feasible Benefits

101

(2)

A Matrix of Research Benefits and Beneficiaries

103

(3)

The Hierarchy of Benefits

104

(1)

The Hierarchy of Beneficiaries

104

(2)

Using the Matrix to Plan Protocols and Proposals

106

(3)

The Discussion of Benefits in the IRB Protocol

107

(1)

The Discussion of Benefits in the Research Proposal

108

(1)

Part IV: Vulnerable Populations

109

(32)

Research on Children and Adolescents

111

(13)

Legal Constraints on Research on Minors

111

(4)

Risk From a Developmental Perspective

115

(1)

Privacy and Autonomy From a Developmental Perspective

116

(2)

Assent, Consent, and Parental Permission

118

(1)

High-Risk Behavior

119

(2)

School Settings

121

(3)

Community-Based Research on Vulnerable Urban Populations and AIDS

124

(17)

Community-Based Intervention Research

126

(3)

Settings for Community-Based AIDS Research

126

(2)

Community Gatekeepers

128

(1)

Community Cultures

128

(1)

What Is Cultural Sensitivity?

129

(2)

Why Is AIDS-Related Research Problematic?

131

(3)

Techniques for Creating Consent and Shared Trust

134

(2)

Community Consultation and Consent

134

(1)

Focus Groups

135

(1)

``Hot Dog Ethnography''

135

(1)

Working With Gatekeepers

136

(2)

Street-Based Research

136

(1)

Clinic-Based Research

137

(1)

Other Agencies and Institutions

138

(1)

Research Design

138

(1)

What to Discuss in the Protocol

139

(2)

Part V: Developing an Effective Human Subjects Protocol

141

(8)

Developing a Research Protocol

142

(7)

Suggested Elements of a Protocol

142

(3)

Supplemental Protocol Checklist

145

(4)

Appendix: Sample Consent and Assent Forms for Use With Older Children

149

(3)

References

152

(6)

Author Index

158

(2)

Subject Index

160

(3)

About the Author

163

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Planning Ethically Responsible Research : A Guide for Students and Internal Review Boards

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