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

by Weir, Robert F.; Olick, Robert S.; Murray, Jeffrey C.

• ISBN13: 9780195123685
• ISBN10: 0195123689
• Format: Hardcover
• Copyright: 2004-05-20
• Publisher: Oxford University Press

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 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 Biography

Robert F. Weir is Richard M. Caplan Chair in Biomedical Ethics and Medical Humanities; Director of the Program in Biomedical Ethics and Medical Humanities; and Professor in the Departments of Pediatrics and Religious Studies at the University of Iowa.

Table of Contents

Part I From Unquestioned Traditional Practices to a Controversy About Research, Rights, and Rewards
Unprecedented Cases, Debatable Changes, and New Challenges	3	(19)
The John Moore Case	5	(1)
The Nhanes III Study	6	(4)
DeCode Genetics	10	(6)
The Challenges Presented in Writing This Book	16	(2)
Cases and Vignettes	18	(4)
Concerns About Some Common Research Practices	22	(23)
The Available Data About Tissues in Storage	23	(3)
Segments of Public Opinion	26	(5)
Genetic Privacy and Genetic Discrimination	31	(5)
Relevant Concerns of Scientists	36	(1)
Other Ethical and Legal Concerns	37	(1)
On Terminology	37	(4)
Cases and Vignettes	41	(4)
The Controversy over Stored Tissues, Research Practices, and Informed Consent	45	(23)
Questions in the Ongoing Controversy	47	(3)
Precursors to the NIH/CDC Workshop Statement	50	(2)
The NIH/CDC Workshop Statement	52	(2)
Critical Responses to the NIH/CDC Workshop Statement	54	(4)
Alternative Solutions	58	(6)
Cases and Vignettes	64	(4)
Molecular Genetics: Tissue Samples in the Laboratory	68	(31)
Biological Sampling Methods	69	(2)
Tissue Types	71	(4)
Other ``Types'' of Tissues	75	(4)
Sample Storage and Processing	79	(1)
Types of Information	80	(2)
Anonymized Samples	82	(1)
New Technologies for DNA Testing	83	(1)
DNA Sequence Storage	84	(2)
The Impact of Molecular Genetics on Scientific Research	86	(3)
From the HGP to Genomic Medicine and Public Health	89	(3)
Scenario: Chapters in the Life of a Tissue Sample	92	(2)
Cases and Vignettes	94	(5)
Part II Current Laws, Policies, and Recommendations
Recommendations and Policies in Other Countries	99	(29)
The Health Council of the Netherlands (1994)	100	(5)
The Nuffield Council on Bioethics (1995)	105	(5)
The Human Genome Organization (1996, 1998)	110	(3)
The Council of Europe (1997, 1999)	113	(2)
The Canadian Tri-Council Policy Statement (1998, 2001)	115	(5)
Summary	120	(4)
Cases and Vignettes	124	(4)
The Federal Regulations for Human Tissue Research: Summary and Assessment	128	(27)
A Summary of the Common Rule	129	(6)
Informed Consent: The Basic Framework	135	(3)
Exemption, Waiver, and Expedited Review	138	(1)
Privacy and Confidentiality	139	(1)
Research with Stored Tissue Samples Under the Federal Policy	140	(6)
The HIPAA Privacy Standards	146	(2)
State Regulation of Research	148	(1)
Cases and Vignettes	149	(6)
The Larger Legal Framework for Human Tissue Research: Moore and Beyond	155	(46)
John Moore's Spleen	156	(9)
Ownership and Control of the Body and Its Parts	165	(11)
Gene Patenting	176	(3)
Privacy of Genetic and Other Health Information	179	(5)
Genetic Discrimination: Health Insurance	184	(2)
Genetic Discrimination: Genes in the Workplace	186	(5)
Cases and Vignettes	191	(10)
The NBAC Report: Recommendations and Limitations	201	(22)
NBAC's Mandate and Goals	202	(3)
The NBAC Analysis and Recommendations	205	(7)
Assessment	212	(5)
The NBAC Report in an International Context	217	(1)
Cases and Vignettes	218	(5)
Part III Ethical, Professional, and Legal Implications
Updating Informed Consent in the Era of Genomic Medicine	223	(47)
The Need to Update the Informed Consent Process	224	(15)
The Reasonable Person Standard of Disclosure	239	(8)
Varieties of Consent	247	(17)
Cases and Vignettes	264	(6)
Beyond Informed Consent: Other Ethical Issues and Concerns	270	(36)
The Relevance of Ethical Principles to the Debate	271	(2)
Some Special Issues Involving Research Without Adequate Consent	273	(11)
The Risks of Other Kinds of Psychosocial Harm	284	(2)
The Ownership of Body Parts	286	(2)
Concerns About Commercialism	288	(5)
Research Using Databases	293	(3)
Some Special Issues in Forensic Settings	296	(3)
Cases and Vignettes	299	(7)
An Agenda for the Near Future	306	(21)
Recommendations	308	(1)
Recommendations for Individuals and Families	308	(6)
Recommendations for Physician-Investigators and Other Biomedical Investigators	314	(5)
Recommendations for Administrators of Research Institutions	319	(4)
Recommendations for Makers of Public Policy Related to Human Participants Research	323	(4)
Appendix: Index of Acronyms	327	(2)
Index	329