Bioethics in Law (eBook)

Preface 6
Contents 9
Introduction 10
1. Law’s Receptivity to Bioethics 10
2. Bioethics’ Eclecticism 12
3. The Approach of This Book 15
Endnotes 17
How Does Bioethics Help Judicial Reasoning? 21
1. How Can Bioethics Testimony Help? 22
2. When Is Bioethics Testimony Unhelpful? 27
3. How Can Bioethics Briefs Help? 36
4. When Are Briefs Unhelpful? 40
5. Summary 42
Endnotes 43
Health Care Ethics Committee Determinations 49
1. HEC Determinations and Adjudicative Fact 50
2. HEC Determinations as Legislative Facts 51
3. HEC Determinations as Normative Fact 55
4. Summary 61
Endnotes 62
Institutional Review Board Determinations 65
1. IRB Determinations as Normative Fact 67
2. Normative Weight Conditioned on Legal Compliance 71
3. IRB Determinations as Legislative Fact 74
4. IRB Determinations as Adjudicative Facts 75
5. Summary 77
Endnotes 78
Bioethics Commission Reports 81
1. Reports Provide Adjudicative Facts 82
2. Reports Provide Legislative Facts 85
3. Representational Versus Rhetorical Uses 88
4. Reports Provide Normative Facts 90
5. Approaches to Moral Pluralism 94
6. Summary 97
Endnotes 98
Bioethics Scholarship 106
1. Introduction 106
2. Compelling the Scholar 109
3. Protective Orders 116
4. Compensation 117
5. Summary 119
Endnotes 120
Reliability of Bioethics Testimony 128
1. Bioethics’ Eclecticism 128
2. Reliability of Ethics Strands 129
3. Steps in Generally Accepted Approaches to Ethical Reasoning 131
4. Summary 140
Endnotes 140
Reliability of Bioethics Testimony 144
1. Peer Review as a Default Standard 144
2. Limits of Peer Review 154
3. Summary 157
Endnotes 157
Reliability of Bioethics Testimony 161
1. Bioethics Experience and Skills 161
2. Skills and the Task at Hand 163
3. Steps in Reaching a Conclusion 166
4. Reliable Application of the Skill 170
5. Another Criterion and Other Skills 171
6. Summary 176
Endnotes 177
Conclusion 181

3 ,Institutional Review Board Determinations (p. 56-57)

Institutional review boards (IRBs) were created pursuant to the 1974 National Research Act1 to ensure that the rights and welfare of human subjects would be protected. The Act and implementing regulations were a response to research scandals, such as the Tuskegee Syphilis study, in which black men with syphilis were left untreated for more than three decades by the US Public Health Service, and the Jewish Chronic Disease Hospital study, in which live cancer cells were injected into hospital patients without consent. The regulations delegated to IRBs the responsibility to review and oversee research on human subjects. Although they would be highly regulated, law would rely on them in an ongoing manner. Susan Wolf describes IRBs as a "perfect example of a body conceived to do both law and ethics. They are required to apply the federal regulations, which are law, but those regulations are so open-textured and the overriding mission of IRBs is so clearly to protect human subjects, that IRBs must do ethics too."

IRB recommendations are developed for a particular study and a particular set of researchers—not for litigation purposes. Those recommendations may include whether a study involving human subjects could ethically proceed, whether potential research subjects are "at risk," and if so, whether the risks outweigh the potential benefits to the research subjects and the importance of the knowledge that might be gained from the research, what information should be disclosed in the informed consent process, whether the selection of subjects is equitable, what methods should be used for protecting confidentiality, whether disclosures to subjects regarding confidentiality are adequate, how the data will be monitored to ensure the safety of subjects, and whether incentives to participate can be offered, and, if so, the conditions under which the offer may be made.3 Today, any of these bioethics recommendations, as well as communications regarding the processes by which they were reached, may interact with law.