Protecting Study Volunteers in Research: A

In addition to addressing current and emerging issues that are critical to our system of human subject protection oversight, Protecting Study Volunteers in Research has been expanded to include a chapter on how to implement the HIPPAA Privacy Rule in research. Protecting Study Volunteers in Research is a suggested educational resource by NIH and FDA (source: NIH Notice OD-00-039, 2000, page 37841, Federal Registry 2003, page 47342) and was designed to help organizations provide the highest standards of safe and ethical treatment of study volunteers. This manual will be routinely referenced for ethical considerations and insights, and for a comprehensive review of regulations and guidelines not conveniently found elsewhere. Protecting Study Volunteers in Research has become required reading in many academic institutions, IRBs and investigative sites and is a suggested training resource by regulatory agencies and research sponsors. Biopharmaceutical and CRO companies ha

Cynthia McGuire Dunn, M.D., is President of CMD Advisor in Rochester, N.Y., which specializes in clinical monitoring and drug development Gary L. Chadwick, Pharm.D., M.P.H., CIP, is Associate Provost and Director, Office for Human Subject Protection for the University of Rochester, and Associate Professor, Division of Medical Humanities at the University of Rochester School of Medicine and Dentistry

Instructions for Obtaining Continuing Education Credit

10

(3)

Historical Perspectives on Human Subject Research

13

(15)

Introduction

13

(1)

The Nuremberg Doctors Trial of 1946

14

(3)

The Milgram Study

17

(2)

Thalidomide Tragedy

19

(1)

The Study of Untreated Syphilis in the Negro Male

20

(3)

Human Radiation Experiments

23

(2)

The University of Pennsylvania Gene Transfer Experiment

25

(1)

Conclusion

26

(2)

Ethics and Federal Regulations

28

(16)

Introduction

28

(1)

Belmont Report

29

(1)

Basic Principles of the Belmont Report

29

(7)

Federal Regulations

36

(8)

Roles and Responsibilities of Institutions in Human Subject Research

44

(7)

Introduction

44

(4)

Federal Agencies

48

(1)

Good Clinical Practice

49

(2)

Roles and Responsibilities of the Investigator and the Study Process

51

(11)

Introduction

51

(5)

Study Process

56

(6)

FDA-Regulated Research

62

(14)

Introduction

62

(1)

Drugs and Biologics/INDs

63

(2)

Sponsor Responsibilities in FDA-Regulated Research

65

(2)

The Study Process for Industry-Sponsored Studies

67

(4)

Sponsor--Investigator--Institution Interaction Issues

71

(1)

Responsibilities of the Investigator-Sponsor

72

(4)

Behavioral Research Issues

76

(7)

Introduction

76

(1)

Federal Regulations

77

(1)

Psychological/Social Risks

77

(1)

Deception

78

(1)

Vulnerable Subjects

78

(1)

Privacy and Confidentiality

79

(2)

Study Methods

81

(1)

Quality of Life Issues

81

(1)

Points to Consider

81

(2)

Publication of Study Results

83

(10)

Introduction

83

(6)

Withholding Data

89

(1)

Lessons to Be Learned from These Cases

89

(2)

The Data

91

(2)

Conflicts of Interest in Research

93

(6)

Introduction

93

(1)

Financial Conflict of Interest

94

(5)

Informed Consent---Beyond the Basics

99

(8)

Introduction

99

(2)

Context

101

(2)

Vulnerable Subjects

103

(2)

Additional Consent Considerations

105

(1)

Conclusion

106

(1)

Community-Based Qualitative Research

107

(7)

Introduction

107

(1)

Defining Community-Based Qualitative Research (CBQR)

108

(1)

Maintaining Confidentiality

109

(1)

Study Methods

109

(3)

Disenfranchised Populations

112

(1)

Further Resources

113

(1)

Ethical Issues in Genetic Research

114

(15)

Introduction

114

(1)

Federal and State Regulations

115

(1)

Some Points to Consider

115

(2)

Genetic Research and Genetic Testing

117

(4)

Behavioral Genetic Studies

121

(1)

Special Considerations in Protocols and Consent Forms

121

(4)

Gene Transfer Research

125

(4)

Special Ethical Concerns in Clinical Research

129

(12)

The Use of Placebo

129

(5)

Data Monitoring Committees

134

(7)

Participant Recruitment and Retention in Clinical Trials

141

(9)

Introduction

141

(1)

Education of Potential Participants

142

(1)

Why Patients Join Clinical Trials

142

(1)

Recruitment of Special Populations

143

(2)

Recruiting Study Participants

145

(2)

Participant Recruitment/Retention Incentives

147

(1)

Recruitment Strategies by Sponsors

148

(1)

Setting the Proper Tone in Recruiting Subjects

148

(1)

Conclusion

149

(1)

Research with Secondary Subjects, Tissue Studies and Records Reviews

150

(9)

Introduction

150

(1)

Secondary Subjects

151

(2)

Research Involving Human Tissues

153

(4)

Research Involving Record Reviews

157

(2)

Implementing the HIPAA Privacy Rule in Research

159

(22)

Introduction

159

(3)

Covered Entities in Research

162

(2)

Classes of Data Under the Privacy Rule

164

(4)

General Requirements for Uses and Disclosures of PHI

168

(2)

Uses and Disclosures of PHI for Research

170

(2)

Authorizations to Use or Disclose PHI for Research

172

(2)

Waivers of Authorization

174

(1)

Reviews Preparatory to Research

175

(1)

PHI From Deceased Persons

175

(1)

Use or Disclosure of Limited Data Sets

176

(1)

Disclosures to Business Associates

176

(1)

Subject Screening

177

(1)

Subject Recruitment

177

(2)

Research Databases and Repositories

179

(1)

Conclusion

180

(1)

Appendix A: References, Resources and Suggested Readings

181

(7)

Appendix B: The Belmont Report

188

(11)

Appendix C: Code of Federal Regulations

199

(155)

Title 21---Food and Drugs

Part 50---Protection of Human Subjects

200

(16)

Part 56---Institutional Review Boards

216

(13)

Part 312---Investigational New Drug Application

229

(50)

Part 600---Biological Products: General

279

(20)

Part 812---Investigational Device Exemptions

299

(27)

Title 45---Public Welfare

Part 46---Protection of Human Subjects

326

(28)

Appendix D: Glossary

354

(6)

Appendix E: Abbreviations

360

(2)

Index

362

(4)

Examination

366

(11)

About CenterWatch

377

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Protecting Study Volunteers in Research: A Manual for Investigative Sites

Summary

Author Biography

Table of Contents

Supplemental Materials