THE STORED TISSUE ISSUE: BIOMEDICAL RESEARCH, ETHICS, AND LAW IN THE ERA OF GENOMIC MEDICINE

Abstract

Pt. I. From unquestioned traditional practices to a controversy about research, rights, and rewards -- Ch. 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 - - Ch. 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 -- Ch. 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 -- Ch. 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 -- Pt. II. Current laws, policies, and recommendations -- Ch. 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 -- Ch. 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 -- Ch. 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 -- Ch. 8. The NBAC Report: recommendations and limitations -- NBAC's mandates and goals -- The NBAC analysis and recommendations -- Assessment -- The NBAC report in an internatinal context -- Cases and vignettes -- Pt. III. Ethical, professional, and legal implications -- Ch. 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 vigettes -- Ch. 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 risk 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 -- Ch. 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