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Should We Worry about Money?

Alan Wertheimer

in Rethinking the Ethics of Clinical Research: Widening the Lens

Published in print:
2010
Published Online:
January 2011
ISBN:
9780199743513
eISBN:
9780199827145
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780199743513.003.0004
Subject:
Philosophy, Political Philosophy

Many bioethicists worry about the use of financial incentives to recruit research subjects. This chapter argues that most of those worries are not well founded. It considers arguments based on ... More


The Censor's Hand: The Misregulation of Human-Subject Research

Carl E. Schneider

Published in print:
2015
Published Online:
September 2015
ISBN:
9780262028912
eISBN:
9780262328784
Item type:
book
Publisher:
The MIT Press
DOI:
10.7551/mitpress/9780262028912.001.0001
Subject:
Biology, Bioethics

Medical and social progress depend on research with human subjects. When that research is done in institutions getting federal money, it is regulated by federally required and supervised ... More


The Institutional Review Board

Robert J. Levine

in Ethics and Epidemiology

Published in print:
2009
Published Online:
September 2009
ISBN:
9780195322934
eISBN:
9780199864416
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780195322934.003.0012
Subject:
Public Health and Epidemiology, Public Health, Epidemiology

This chapter describes the committees responsible for reviewing proposals to conduct research involving humans as subjects to determine whether they include adequate safeguards of the rights and ... More


Regulation of Trials

Curtis L. Meinert

in An Insider’s Guide to Clinical Trials

Published in print:
2011
Published Online:
September 2011
ISBN:
9780199742967
eISBN:
9780199897278
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780199742967.003.0009
Subject:
Public Health and Epidemiology, Epidemiology, Public Health

This chapter begins with a chronology of requirements/guidelines pursuant to research on human beings, with emphasis on clinical trials. It then describes institutional review boards (IRBs) and IRB ... More


Research Risk and Regulationist Stereotypes

Carl E. Schneider

in The Censor's Hand: The Misregulation of Human-Subject Research

Published in print:
2015
Published Online:
September 2015
ISBN:
9780262028912
eISBN:
9780262328784
Item type:
chapter
Publisher:
The MIT Press
DOI:
10.7551/mitpress/9780262028912.003.0001
Subject:
Biology, Bioethics

How much good IRB regulation can do depends on how much risk research subjects run. Biomedical research can harm subjects, but much of it needs no physical contact with patients, and most contact ... More


Cost Is No Object

Carl E. Schneider

in The Censor's Hand: The Misregulation of Human-Subject Research

Published in print:
2015
Published Online:
September 2015
ISBN:
9780262028912
eISBN:
9780262328784
Item type:
chapter
Publisher:
The MIT Press
DOI:
10.7551/mitpress/9780262028912.003.0002
Subject:
Biology, Bioethics

High costs are built into IRB regulation of research. Prior licensing of each study requires searching mountains of innocuous studies to find molehills of baneful ones. The bioethical ethos drives ... More


Arbitrary and Capricious Decisions

Carl E. Schneider

in The Censor's Hand: The Misregulation of Human-Subject Research

Published in print:
2015
Published Online:
September 2015
ISBN:
9780262028912
eISBN:
9780262328784
Item type:
chapter
Publisher:
The MIT Press
DOI:
10.7551/mitpress/9780262028912.003.0003
Subject:
Biology, Bioethics

Much evidence suggests that IRBs make decisions badly. For example, when multiple IRBs review the same research protocols, they treat them inconsistently. The IRB system makes error inevitable. ... More


The Misshapen Ideology of the IRB System

Carl E. Schneider

in The Censor's Hand: The Misregulation of Human-Subject Research

Published in print:
2015
Published Online:
September 2015
ISBN:
9780262028912
eISBN:
9780262328784
Item type:
chapter
Publisher:
The MIT Press
DOI:
10.7551/mitpress/9780262028912.003.0004
Subject:
Biology, Bioethics

Good regulation comes from good guidance. IRBs need a coherent and legible ethics but get three principles – respect for persons, justice, and beneficence. A workable ethics is unachievable because ... More


The Rule of Law: The Lessons of Due Process

Carl E. Schneider

in The Censor's Hand: The Misregulation of Human-Subject Research

Published in print:
2015
Published Online:
September 2015
ISBN:
9780262028912
eISBN:
9780262328784
Item type:
chapter
Publisher:
The MIT Press
DOI:
10.7551/mitpress/9780262028912.003.0005
Subject:
Biology, Bioethics

Good decisions come from good law. For government agencies, that means due process: good regulations and good procedures. The IRB regulations address so few issues that IRBs are relegated to ... More


Censorship in a System of Free Expression

Carl E. Schneider

in The Censor's Hand: The Misregulation of Human-Subject Research

Published in print:
2015
Published Online:
September 2015
ISBN:
9780262028912
eISBN:
9780262328784
Item type:
chapter
Publisher:
The MIT Press
DOI:
10.7551/mitpress/9780262028912.003.0006
Subject:
Biology, Bioethics

Censors notoriously err, and IRBs are censors. They tell researchers what they may study, how they may structure and conduct inquiries, what they may say to subjects, and how they may report results. ... More


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