The stored tissue issue : biomedical research, ethics, and law in the era of genomic medicine / Robert F. Weir, Robert S. Olick.

Format:

Book

Author/Creator:

Weir, Robert F., 1943- author.

Olick, Robert S., author.

Series:

Oxford scholarship online.

Oxford scholarship online

Language:

English

Subjects (All):

Preservation of organs, tissues, etc--Moral and ethical aspects.

Preservation of organs, tissues, etc.

Physical Description:

1 online resource (xvii, 339 pages)

Edition:

1st ed.

Place of Publication:

New York ; Oxford University Press, 2023.

Language Note:

English

Summary:

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

Contents:

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

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

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

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

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

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

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

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

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

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.

Notes:

CIP entry (Aug.)

Previously issued in print: 2004.

Includes bibliographical references and index.

Derived record based on print version record and publisher information.

ISBN:

0-19-770869-2

1-280-76116-4

0-19-974884-5

1-4294-3104-0

OCLC:

77847167