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, policymakers, 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 - a partnership for the benefit of all.
Author(s): Robert F. Weir, Robert S. Olick
Edition: 1
Year: 2004
Language: English
Pages: 366
0195123689......Page 1
Contents......Page 16
Part I: From Unquestioned Traditional Practices to a Controversy About Research, Rights, and Rewards......Page 20
1. Unprecedented Cases, Debatable Changes, and New Challenges......Page 22
The John Moore Case......Page 24
The NHANES III Study......Page 25
DeCODE Genetics......Page 29
The Challenges Presented in Writing This Book......Page 35
Cases and Vignettes......Page 37
2. Concerns About Some Common Research Practices......Page 41
The Available Data About Tissues in Storage......Page 42
Segments of Public Opinion......Page 45
Genetic Privacy and Genetic Discrimination......Page 50
Relevant Concerns of Scientists......Page 55
On Terminology......Page 56
Cases and Vignettes......Page 60
3. The Controversy over Stored Tissues, Research Practices, and Informed Consent......Page 64
Questions in the Ongoing Controversy......Page 66
Precursors to the NIH/CDC Workshop Statement......Page 69
The NIH/CDC Workshop Statement......Page 71
Critical Responses to the NIH/CDC Workshop Statement......Page 73
Alternative Solutions......Page 77
Cases and Vignettes......Page 83
4. Molecular Genetics: Tissue Samples in the Laboratory......Page 87
Biological Sampling Methods......Page 88
Tissue Types......Page 90
Other "Types" of Tissues......Page 94
Sample Storage and Processing......Page 98
Types of Information......Page 99
Anonymized Samples......Page 101
New Technologies for DNA Testing......Page 102
DNA Sequence Storage......Page 103
The Impact of Molecular Genetics on Scientific Research......Page 105
From the HGP to Genomic Medicine and Public Health......Page 108
Scenario: Chapters in the Life of a Tissue Sample......Page 111
Cases and Vignettes......Page 113
Part II: Current Laws, Policies, and Recommendations......Page 116
5. Recommendations and Policies in Other Countries......Page 118
The Health Council of the Netherlands (1994)......Page 119
The Nuffield Council on Bioethics (1995)......Page 124
The Human Genome Organization (1996, 1998)......Page 129
The Council of Europe (1997, 1999)......Page 132
The Canadian Tri-Council Policy Statement (1998, 2001)......Page 134
Summary......Page 139
Cases and Vignettes......Page 143
6. The Federal Regulations for Human Tissue Research: Summary and Assessment......Page 147
A Summary of the Common Rule......Page 148
Informed Consent: The Basic Framework......Page 154
Exemption, Waiver, and Expedited Review......Page 157
Privacy and Confidentiality......Page 158
Research with Stored Tissue Samples Under the Federal Policy......Page 159
The HIPAA Privacy Standards......Page 165
State Regulation of Research......Page 167
Cases and Vignettes......Page 168
7. The Larger Legal Framework for Human Tissue Research: Moore and Beyond......Page 174
John Moore's Spleen......Page 175
Ownership and Control of the Body and Its Parts......Page 184
Gene Patenting......Page 195
Privacy of Genetic and Other Health Information......Page 198
Genetic Discrimination: Health Insurance......Page 203
Genetic Discrimination: Genes in the Workplace......Page 205
Cases and Vignettes......Page 210
8. The NBAC Report: Recommendations and Limitations......Page 220
NBAC's Mandate and Goals......Page 221
The NBAC Analysis and Recommendations......Page 224
Assessment......Page 231
The NBAC Report in an International Context......Page 236
Cases and Vignettes......Page 283
Part III: Ethical, Professional, and Legal Implications......Page 240
9. Updating Informed Consent in the Era of Genomic Medicine......Page 242
The Need to Update the Informed Consent Process......Page 243
The Reasonable Person Standard of Disclosure......Page 258
Varieties of Consent......Page 266
10. Beyond Informed Consent: Other Ethical Issues and Concerns......Page 289
The Relevance of Ethical Principles to the Debate......Page 290
Some Special Issues Involving Research Without Adequate Consent......Page 292
The Risks of Other Kinds of Psychosocial Harm......Page 303
The Ownership of Body Parts......Page 305
Concerns About Commercialism......Page 307
Research Using Databases......Page 312
Some Special Issues in Forensic Settings......Page 315
Cases and Vignettes......Page 318
11. An Agenda for the Near Future......Page 325
Recommendations for Individuals and Families......Page 327
Recommendations for Physician-Investigators and Other Biomedical Investigators......Page 333
Recommendations for Administrators of Research Institutions......Page 338
Recommendations for Makers of Public Policy Related to Human Participants Research......Page 342
Appendix: Index of Acronyms......Page 346
A......Page 348
C......Page 349
D......Page 350
G......Page 351
I......Page 352
M......Page 353
N......Page 354
P......Page 355
S......Page 356
W......Page 357
Y......Page 358
