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     Genetics research with stored human tissues provides many benefits and holds much promise. Yet how this critical research is conducted sometimes raises serious ethical, legal, and social concerns, and it is difficult to balance the promise of biomedical research with our time-honored commitments to individual choice in such fundamental matters as control over personal health information and the disposition of our bodily tissues....
    

 Weir and Olick provide a thorough analysis of this critical phase in the era of genomic medicine. While strongly supportive of the biomedical research enterprise, they develop a critique of many common research practices with banked tissues, DNA, and genetic data. Noting numerous examples of beneficial human tissue research, they focus on problematic research practices, controversial cases, and federal and institutional policies that limit the informed choices of patients and research participants. The authors offer a series of recommendations intended to limit the risks of inadequate informed consent to research for individuals, families, and groups, and to strengthen the bonds of trust between the research enterprise and the public upon which biomedical progress depends.
     This book offers a wealth of information plus well-reasoned recommendations that will be of keen interest to geneticists, other biomedical scientists, research institutions, policy makers, students, and others. It will serve as a clarion call to move beyond traditional policies and practices toward a richer understanding of partnership between patients and research participants and the biomedical research enterprise and partnership for the benefit of all.

CONTENTS

Part I From Unquestioned Traditional Practices to a Controversy About Research, Rights, and Rewards
3 1. Unprecedented Cases, Debatable Changes, and New Challenges,
5 The John Moore Case,
6 The NHANES III Study,
10 DeCODE Genetics,
16 The Challenges Presented in Writing This Book,
18 Cases and Vignettes,
22 2. Concerns About Some Common Research Practices,
23 The Available Data About Tissues in Storage,
26 Segments of Public Opinion,
31 Genetic Privacy and Genetic Discrimination,
36 Relevant Concerns of Scientists,
37 Other Ethical and Legal Concerns,
37 On Terminology,
41 Cases and Vignettes,
45 3. The Controversy over Stored Tissues, Research Practices,
and Informed Consent,
47 Questions in the Ongoing Controversy,
50 Precursors to the NIH/CDC Workshop Statement,
52 The NIH/CDC Workshop Statement,
54 Critical Responses to the NIH/CDC Workshop Statement,
58 Alternative Solutions,
64 Cases and Vignettes,
68 4. Molecular Genetics: Tissue Samples in the Laboratory,
69 Biological Sampling Methods,
71 Tissue Types,
75 Other "Types" of Tissues,
79 Sample Storage and Processing,
80 Types of Information,
82 Anonymized Samples,
83 New Technologies for DNA Testing,
84 DNA Sequence Storage,
86 The Impact of Molecular Genetics on Scientific Research,
89 From the HGP to Genomic Medicine and Public Health,
92 Scenario: Chapters in the Life of a Tissue Sample,
94 Cases and Vignettes,
Part II Current Laws, Policies, and Recommendations
99 5. Recommendations and Policies in Other Countries,
100 The Health Council of the Netherlands (1994),
105 The Nuffield Council on Bioethics (1995),
110 The Human Genome Organization (1996, 1998),
113 The Council of Europe (1997, 1999),
115 The Canadian Tri-Council Policy Statement (1998, 2001),
120 Summary,
124 Cases and Vignettes,
128 6. The Federal Regulations for Human Tissue Research: Summary
and Assessment,
129 A Summary of the Common Rule,
135 Informed Consent: The Basic Framework,
138 Exemption, Waiver, and Expedited Review,
139 Privacy and Confidentiality,
140 Research with Stored Tissue Samples Under the Federal Policy,
146 The HIPAA Privacy Standards,
148 State Regulation of Research,
149 Cases and Vignettes,
155 7. The Larger Legal Framework for Human Tissue Research:
Moore and Beyond,
156 John Moore's Spleen,
165 Ownership and Control of the Body and Its Parts,
176 Gene Patenting,
179 Privacy of Genetic and Other Health Information,
184 Genetic Discrimination: Health Insurance,
186 Genetic Discrimination: Genes in the Workplace,
191 Cases and Vignettes,
201 8. The NBAC Report: Recommendations and Limitations,
202 NBAC's Mandate and Goals,
205 The NBAC Analysis and Recommendations,
212 Assessment,
217 The NBAC Report in an International Context,
218 Cases and Vignettes,
Part III Ethical, Professional, and Legal Implications
223 9. Updating Informed Consent in the Era of Genomic Medicine,
224 The Need to Update the Informed Consent Process,
239 The Reasonable Person Standard of Disclosure,
264 Varieties of Consent,
247 Cases and Vignettes,
270 10. Beyond Informed Consent: Other Ethical Issues and Concerns,
271 The Relevance of Ethical Principles to the Debate,
273 Some Special Issues Involving Research Without Adequate Consent,
284 The Risks of Other Kinds of Psychosocial Harm,
286 The Ownership of Body Parts,
288 Concerns About Commercialism,
293 Research Using Databases,
296 Some Special Issues in Forensic Settings,
299 Cases and Vignettes,
306 11. An Agenda for the Near Future,
308 Recommendations,
308 Recommendations for Individuals and Families,
314 Recommendations for Physician-Investigators and Other Biomedical
Investigators,
319 Recommendations for Administrators of Research Institutions,
323 Recommendations for Makers of Public Policy Related to Human
Participants Research,
327 Appendix: Index of Acronyms,
329 Index,