| Description |
xvii, 339 pages ; 25 cm |
| Contents |
Machine derived contents note: Part I From Unquestioned Traditional Practices to a -- Controversy About Research, Rights, and Rewards -- 1. Unprecedented Cases, Debatable Changes, and New Challenges, 3 -- The John Moore Case, 5 -- The NHANES III Study, 6 -- DeCODE Genetics, 10 -- The Challenges Presented in Writing This Book, 16 -- Cases and Vignettes, 18 -- 2. Concerns About Some Common Research Practices, 22 -- The Available Data About Tissues in Storage, 23 -- Segments of Public Opinion, 26 -- Genetic Privacy and Genetic Discrimination, 31 -- Relevant Concerns of Scientists, 36 -- Other Ethical and Legal Concerns, 37 -- On Terminology, 37 -- Cases and Vignettes, 41 -- 3. The Controversy over Stored Tissues, Research Practices, -- and Informed Consent, 45 -- Questions in the Ongoing Controversy, 47 -- -- -- -- -- Precursors to the NIH/CDC Workshop Statement, 50 -- The NIH/CDC Workshop Statement, 52 -- Critical Responses to the NIH/CDC Workshop Statement, 54 -- Alternative Solutions, 58 -- Cases and Vignettes, 64 -- 4. Molecular Genetics: Tissue Samples in the Laboratory, 68 -- Biological Sampling Methods, 69 -- Tissue Types, 71 -- Other "Types" of Tissues, 75 -- Sample Storage and Processing, 79 -- Types of Information, 80 -- Anonymized Samples, 82 -- New Technologies for DNA Testing, 83 -- DNA Sequence Storage, 84 -- The Impact of Molecular Genetics on Scientific Research, 86 -- From the HGP to Genomic Medicine and Public Health, 89 -- Scenario: Chapters in the Life of a Tissue Sample, 92 -- Cases and Vignettes, 94 -- -- -- Part II Current Laws, Policies, and Recommendations -- 5. Recommendations and Policies in Other Countries, 99 -- The Health Council of the Netherlands (1994), 100 -- The Nuffield Council on Bioethics (1995), 105 -- The Human Genome Organization (1996, 1998), 110 -- The Council of Europe (1997, 1999), 113 -- The Canadian Tri-Council Policy Statement (1998, 2001), 115 -- Summary, 120 -- Cases and Vignettes, 124 -- 6. The Federal Regulations for Human Tissue Research: Summary -. -- and Assessment, 128 -- A Summary of the Common Rule, 129 -- Informed Consent: The Basic Framework, 135 -- Exemption, Waiver, and Expedited Review, 138 -- Privacy and Confidentiality, 139 -- Research with Stored Tissue Samples Under the Federal Policy, 140 -- The HIPAA Privacy Standards, 146 -- State Regulation of Research, 148 -- Cases and Vignettes, 149 -- 7. The Larger Legal Framework for Human Tissue Research: -- Moore and Beyond, 155 -- John Moore's Spleen, 156 -- -- -- -- -- -- Ownership and Control of the Body and Its Parts, 165 -- Gene Patenting, 176 -- Privacy of Genetic and Other Health Information, 179 -- Genetic Discrimination: Health Insurance, 184 -- Genetic Discrimination: Genes in the Workplace, 186 -- Cases and Vignettes, 191 -- 8. The NBAC Report: Recommendations and Limitations, 201 -- NBAC's Mandate and Goals, 202 -- The NBAC Analysis and Recommendations, 205 -- Assessment, 212 -- The NBAC Report in an International Context, 217 -- Cases and Vignettes, 218 -- -- -- Part III Ethical, Professional, and Legal Implications -- 9. Updating Informed Consent in the Era of Genomic Medicine, 223 -- The Need to Update the Informed Consent Process, 224 -- The Reasonable Person Standard of Disclosure, 239 -- Varieties of Consent, 247 -- Cases and Vignettes, 264 -- 10. Beyond Informed Consent: Other Ethical Issues and Concerns, 270 -- The Relevance of Ethical Principles to the Debate, 271 -- Some Special Issues Involving Research Without Adequate Consent, 273 -- The Risks of Other Kinds of Psychosocial Harm, 284 -- The Ownership of Body Parts, 286 -- Concerns About Commercialism, 288 -- Research Using Databases, 293 -- Some Special Issues in Forensic Settings, 296 -- Cases and Vignettes, 299 -- 11. An Agenda for the Near Future, 306 -- Recommendations, 308 -- Recommendationsfor Individuals and Families, 308 -- Recommendations for Physician-Investigators and Other Biomedical -- Investigators, 314 -- Recommendations for Administrators of Research Institutions, 319 -- Recommendations for Makers of Public Policy Related to Human -- Participants Research, 323 -- Appendix: Index of Acronyms, 327 -- Index, 329 |
| Summary |
"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 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 risk 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 information plus 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 - a partnership for the benefit of all."--BOOK JACKET.or the ear |
| Notes |
Formerly CIP. Uk |
| Bibliography |
Includes bibliographical references and index |
| Notes |
Print version record |
| Subject |
Preservation of organs, tissues, etc. -- Moral and ethical aspects.
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Ethics, Medical.
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Organ Preservation.
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| Author |
Olick, Robert S.
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Murray, Jeffrey C.
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| LC no. |
2003190051 |
| ISBN |
0195123689 alkaline paper |
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