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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


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


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


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