The Ethics of Research with Human Subjects (eBook)

Dr. Resnik has an M.A. and Ph.D. in philosophy from the University of North Carolina at Chapel Hill and J.D. from Concord University School of Law. He received his B.A. in philosophy from Davidson College.  Dr. Resnik was an Associate and Full Professor of Medical Humanities at the Brody School of Medicine at East Carolina University (ECU) from 1998-2004, and an Associate Director of the Bioethics Center at ECU and University Health Systems from 1998-2004.  Dr. Resnik was Assistant and Associate Professor of Philosophy at the University of Wyoming (UW) from 1990-1998, and Director of the Center for the Advancement of Ethics at UW from 1995-1998. Dr. Resnik has published over 200 articles on various topics in philosophy and bioethics and is the author of 8 books. He serves on several editorial boards and is an Associate Editor of the journal Accountability in Research. Dr. Resnik is also Chair of the NIEHS Institutional Review Board.  Dr. Resnik’s research interests focus on ethical, philosophical, and legal issues in scientific research.  

Dedication 6
Acknowledgements 7
Contents 8
Abbreviations 12
Chapter 1: Introduction 13
1.1 Perinatal HIV Prevention Trials 14
1.2 The SUPPORT Study 16
1.3 Hospital Quality Improvement Research 18
1.4 Henrietta Lacks 19
1.5 The Facebook Study 20
1.6 Overview of This Book 21
Chapter 2: Historical Background 25
2.1 Research with Human Subjects Before World War II 28
2.2 Research with Human Subjects During World War II 33
2.3 Research with Human Subjects After World War II 34
2.4 The Belmont Report 39
2.5 The U.S. Federal Regulations 41
2.6 Continuing Scandals and Controversies 46
2.7 Concerns About Integrity in Biomedical Research 51
2.8 Jesse Gelsinger’s Death 54
2.9 Concerns About Research on Human Biosamples 55
2.10 Conclusion: Human Research Regulations and Guidelines in Historical Context 59
Chapter 3: Moral Theory 64
3.1 What Is a Moral Theory? 64
3.2 Moral Subjectivism and Relativism 68
3.3 Classifying Moral Theories 71
3.4 Divine Command Theory 72
3.5 Virtue Ethics 73
3.6 Natural Law Theory 77
3.7 Utilitarianism 78
3.8 Kantianism 84
3.9 Natural Rights Theories 88
3.10 Pluralistic Theories 92
3.11 Conclusion: Toward a Decision-Making Framework 95
Chapter 4: Trust as a Foundation for Research with Human Subjects 97
4.1 What Is Trust? 97
4.2 Trust in Research Involving Research with Human Subjects 99
4.3 Trust as a Foundation for the Ethics of Research with Human Subjects: Some Alternative Views 102
4.4 Trust as a Foundation for the Ethics of Research with Human Subjects: My View 107
4.5 Promoting Trust in Research with Human Subjects 108
4.6 The Relationship Between Moral Principles and Research Regulations and Guidelines 111
4.7 The Role of Trust in Resolving Ethical Dilemmas in Research with Human Subjects 115
4.8 Objections to My View 117
4.9 Conclusion 120
Chapter 5: Informed Consent 122
5.1 Trust and Informed Consent 122
5.2 The Elements of Consent 123
5.3 Disclosure Standards 126
5.4 Documentation 129
5.5 Consent by Parties Other than the Subject 131
5.6 Research Without Consent 132
5.7 Opt-Out Consent 139
5.8 General Consent 140
5.9 Deception in Research 142
5.10 Assent 144
5.11 Payment for Research Participation 145
5.12 The Right to Withdraw 153
5.13 Conclusion 156
Chapter 6: Privacy and Confidentiality 157
6.1 Privacy, Confidentiality, and Trust 157
6.2 Sharing and Publishing Data and Samples 160
6.3 Justifiable Breaches of Privacy and Confidentiality 163
6.4 Harm to Self 163
6.5 Harm to Others 164
6.6 Suspected Abuse/Neglect 166
6.7 Communicable Disease Reporting 167
6.8 Informing Family Members About Genetic Diseases 168
6.9 Conclusion 170
Chapter 7: Risks 172
7.1 What Is Risk? 172
7.2 Types of Risk Related to Research Participation 173
7.3 Risk and Trust 173
7.4 Assessing Risk 174
7.5 Minimizing Risk 176
7.6 Minimal Risk 178
7.7 Research on Healthy Volunteers 183
7.8 Phase I Trials on Patients 187
7.9 Randomized Controlled Trials 188
7.10 Placebo-Controlled Trials 190
7.11 Risks to Researchers and Third Parties 193
7.12 Compensation for Research-Related Injuries 195
7.13 Conclusion 197
Chapter 8: Benefits 199
8.1 What Are Benefits? 199
8.2 What Are the Benefits of Research? 200
8.3 What Is the Relationship Between Research Design and Benefits? 200
8.4 Sources of Special Duties of Beneficence 201
8.5 Disclosing Individual Research Results to Human Subjects 201
8.6 Ancillary Care 207
8.7 Post-trial Access to Medications 210
8.8 Benefits in Placebo-Controlled Clinical Trials 215
8.9 Fair Benefits to Host Communities and Nations 217
8.10 Conclusion 219
Chapter 9: Vulnerable Subjects 220
9.1 Who or What Is a Vulnerable Subject? 221
9.2 Research Involving Children 225
9.3 Research Involving Adults with Mental Disabilities or Diseases that Impair Decision-Making 232
9.4 Research Involving Pregnant Women 235
9.5 Conclusion: Protection vs. Access 237
Chapter 10: Research Integrity 240
10.1 The Importance of Integrity in Research with Human Subjects 240
10.2 Misconduct in Research 243
10.3 Noncompliance 245
10.4 Whistleblowing in Research 246
10.5 Preventing Misconduct and Noncompliance 247
10.6 Conflict of Interest 248
10.7 Data Suppression 255
10.8 Dealing with Conflicts of Interest in Research 257
10.9 Conclusion 261
Chapter 11: Regulatory Reform 262
11.1 Institutional Review Boards: A Time for Reform 262
11.2 Risk-Based Review 264
11.3 IRB Mission Creep 264
11.4 IRB Conflict of Interest 265
11.5 Difficulties with Measuring IRB Performance 265
11.6 Centralized IRB Review 265
11.7 Lack of Harmonization of Regulations 268
11.8 Gaps in the Regulations 268
11.9 Problems with Informed Consent 269
11.10 Compensation for Injury 269
11.11 Revisions to the Common Rule 269
11.12 Expanding Exemptions 270
11.13 Defining Some Activities as Not Research 271
11.14 Limiting Continuing Review 271
11.15 Single IRB Mandate 272
11.16 Informed Consent Enhancements 272
11.17 Abridged Consent Process for Research Involving Biological Samples 273
11.18 Additional Changes to Informed Consent Requirements 274
11.19 Conclusion 274
Chapter 12: Conclusion 276
12.1 Trust and Consent 277
12.2 Trust and Confidentiality 278
12.3 Trust and Risks 279
12.4 Trust and Benefits 279
12.5 Trust and Vulnerable Subjects 280
12.6 Trust and Research Integrity 281
12.7 Regulatory Reform 281
References 283
Index 313