The Stored Tissue Issue : Biomedical Research, Ethics, and Law in the Era of Genomic Medicine.

Intro -- Contents -- Part I: From Unquestioned Traditional Practices to a Controversy About Research, Rights, and Rewards -- 1. Unprecedented Cases, Debatable Changes, and New Challenges -- The John Moore Case -- The NHANES III Study -- DeCODE Genetics -- The Challenges Presented in Writing This Book -- Cases and Vignettes -- 2. Concerns About Some Common Research Practices -- The Available Data About Tissues in Storage -- Segments of Public Opinion -- Genetic Privacy and Genetic Discrimination -- Relevant Concerns of Scientists -- Other Ethical and Legal Concerns -- On Terminology -- Cases and Vignettes -- 3. The Controversy over Stored Tissues, Research Practices, and Informed Consent -- Questions in the Ongoing Controversy -- Precursors to the NIH/CDC Workshop Statement -- The NIH/CDC Workshop Statement -- Critical Responses to the NIH/CDC Workshop Statement -- Alternative Solutions -- Cases and Vignettes -- 4. Molecular Genetics: Tissue Samples in the Laboratory -- Biological Sampling Methods -- Tissue Types -- Other "Types" of Tissues -- Sample Storage and Processing -- Types of Information -- Anonymized Samples -- New Technologies for DNA Testing -- DNA Sequence Storage -- The Impact of Molecular Genetics on Scientific Research -- From the HGP to Genomic Medicine and Public Health -- Scenario: Chapters in the Life of a Tissue Sample -- Cases and Vignettes -- Part II: Current Laws, Policies, and Recommendations -- 5. Recommendations and Policies in Other Countries -- The Health Council of the Netherlands (1994) -- The Nuffield Council on Bioethics (1995) -- The Human Genome Organization (1996, 1998) -- The Council of Europe (1997, 1999) -- The Canadian Tri-Council Policy Statement (1998, 2001) -- Summary -- Cases and Vignettes -- 6. The Federal Regulations for Human Tissue Research: Summary and Assessment -- A Summary of the Common Rule.

Informed Consent: The Basic Framework -- Exemption, Waiver, and Expedited Review -- Privacy and Confidentiality -- Research with Stored Tissue Samples Under the Federal Policy -- The HIPAA Privacy Standards -- State Regulation of Research -- Cases and Vignettes -- 7. The Larger Legal Framework for Human Tissue Research: Moore and Beyond -- John Moore's Spleen -- Ownership and Control of the Body and Its Parts -- Gene Patenting -- Privacy of Genetic and Other Health Information -- Genetic Discrimination: Health Insurance -- Genetic Discrimination: Genes in the Workplace -- Cases and Vignettes -- 8. The NBAC Report: Recommendations and Limitations -- NBAC's Mandate and Goals -- The NBAC Analysis and Recommendations -- Assessment -- The NBAC Report in an International Context -- Cases and Vignettes -- Part III: Ethical, Professional, and Legal Implications -- 9. Updating Informed Consent in the Era of Genomic Medicine -- The Need to Update the Informed Consent Process -- The Reasonable Person Standard of Disclosure -- Varieties of Consent -- Cases and Vignettes -- 10. Beyond Informed Consent: Other Ethical Issues and Concerns -- The Relevance of Ethical Principles to the Debate -- Some Special Issues Involving Research Without Adequate Consent -- The Risks of Other Kinds of Psychosocial Harm -- The Ownership of Body Parts -- Concerns About Commercialism -- Research Using Databases -- Some Special Issues in Forensic Settings -- Cases and Vignettes -- 11. An Agenda for the Near Future -- Recommendations -- Recommendations for Individuals and Families -- Recommendations for Physician-Investigators and Other Biomedical Investigators -- Recommendations for Administrators of Research Institutions -- Recommendations for Makers of Public Policy Related to Human Participants Research -- Appendix: Index of Acronyms -- Index -- A -- B -- C -- D -- E -- F -- G -- H.

I -- J -- K -- L -- M -- N -- O -- P -- Q -- R -- S -- T -- U -- V -- W -- Y.

This book provides a thorough, well-balanced analysis of common research practices with banked tissues, DNA, and genetic data. Describing many examples of beneficial tissue research, the authors focus on problematic research practices, controversial cases, and federal and institutional policies that limit the informed choices of patients and research participants. They offer a series of recommendations to help overcome these problems.

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Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2024. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries.