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From 1966 to 2005: Balancing Protection and Access in Pediatric Research

Lainie Friedman Ross

in Children in Medical Research: Access versus Protection

Published in print:
2006
Published Online:
May 2006
ISBN:
9780199273287
eISBN:
9780191603655
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/0199273286.003.0002
Subject:
Philosophy, Moral Philosophy

This chapter examines the changes in policies regarding children in research between 1966 and 2003. It reviews Henry Beecher’s famous article, Ethics and Clinical Research, which described 22 ... More


Payment in Pediatric Research

Lainie Friedman Ross

in Children in Medical Research: Access versus Protection

Published in print:
2006
Published Online:
May 2006
ISBN:
9780199273287
eISBN:
9780191603655
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/0199273286.003.0009
Subject:
Philosophy, Moral Philosophy

This chapter examines the ethics of payment in pediatric research that does not offer the prospect of direct benefit (nontherapeutic research). It addresses the ethical objection that payment ... More


The Ethics of Pediatric Research

David Wendler

Published in print:
2010
Published Online:
May 2010
ISBN:
9780199730087
eISBN:
9780199776689
Item type:
book
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780199730087.001.0001
Subject:
Philosophy, Moral Philosophy

Millions of children suffer from diseases and illnesses who do not have adequate treatment. And many other children are harmed by medicines intended to help them. To protect and help these children ... More


Access versus Protection: Minority Representation in Pediatric Research

Lainie Friedman Ross

in Children in Medical Research: Access versus Protection

Published in print:
2006
Published Online:
May 2006
ISBN:
9780199273287
eISBN:
9780191603655
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/0199273286.003.0003
Subject:
Philosophy, Moral Philosophy

This chapter examines the extent to which pediatric researchers reported race and ethnicity (R/E) data; the representation of Black, Hispanic, and Asian children and their parents in pediatric ... More


Phase I Research and the Meaning of ‘Prospect of Direct Benefit’

Lainie Friedman Ross

in Children in Medical Research: Access versus Protection

Published in print:
2006
Published Online:
May 2006
ISBN:
9780199273287
eISBN:
9780191603655
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/0199273286.003.0007
Subject:
Philosophy, Moral Philosophy

This chapter examines the issue of whether phase I pediatric oncology trials offer the prospect of direct benefit. Phase I research is carried out to determine toxicity; the possibility of direct ... More


Human Subject Protections in Pediatric Research

Lainie Friedman Ross

in Children in Medical Research: Access versus Protection

Published in print:
2006
Published Online:
May 2006
ISBN:
9780199273287
eISBN:
9780191603655
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/0199273286.003.0008
Subject:
Philosophy, Moral Philosophy

Institutional review board (IRB) review is required for all federally funded research involving human subjects regulated by the Food and Drug Administration, or performed at an institution that ... More


Evolution of the 407 Process

Lainie Friedman Ross

in Children in Medical Research: Access versus Protection

Published in print:
2006
Published Online:
May 2006
ISBN:
9780199273287
eISBN:
9780191603655
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/0199273286.003.0016
Subject:
Philosophy, Moral Philosophy

Fourteen 407 panels have been convened in the more than two decades since passage of Subpart D. The first two were in the early 1990s, and the remainder since 2001. This chapter provides a brief ... More


Children in Medical Research: Access versus Protection

Lainie Friedman Ross

Published in print:
2006
Published Online:
May 2006
ISBN:
9780199273287
eISBN:
9780191603655
Item type:
book
Publisher:
Oxford University Press
DOI:
10.1093/0199273286.001.0001
Subject:
Philosophy, Moral Philosophy

This book examines the ethical issues in pediatric medical research. It argues that policies and practices on the participation of children must focus primarily on minimizing risks. It offers ... More


Clinical Asthma Trials

Lainie Friedman Ross

in Children in Medical Research: Access versus Protection

Published in print:
2006
Published Online:
May 2006
ISBN:
9780199273287
eISBN:
9780191603655
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/0199273286.003.0014
Subject:
Philosophy, Moral Philosophy

This chapter examines four ethical issues raised by clinical asthma research involving children subjects: (1) to what extent are clinical asthma trials designed as placebo-controlled trials as ... More


Informed Consent in Pediatric Research

Lainie Friedman Ross

in Children in Medical Research: Access versus Protection

Published in print:
2006
Published Online:
May 2006
ISBN:
9780199273287
eISBN:
9780191603655
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/0199273286.003.0006
Subject:
Philosophy, Moral Philosophy

This chapter presents an overview of the informed consent requirements and waivers in pediatric research under current federal regulations. These consent policies were adopted by the Food and Drug ... More


9 9 Research in Schools

Lainie Friedman Ross

in Children in Medical Research: Access versus Protection

Published in print:
2006
Published Online:
May 2006
ISBN:
9780199273287
eISBN:
9780191603655
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/0199273286.003.0010
Subject:
Philosophy, Moral Philosophy

This chapter examines the arguments for and against conducting biomedical and behavioral research in schools; whether additional human subject protections are necessary; and whose consent is ... More


Overview of the Common Rule and Subpart D

Lainie Friedman Ross

in Children in Medical Research: Access versus Protection

Published in print:
2006
Published Online:
May 2006
ISBN:
9780199273287
eISBN:
9780191603655
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/0199273286.003.0004
Subject:
Philosophy, Moral Philosophy

The Code of Federal Regulations (CFR) 45 part 46, Federal Policy for the Protection of Human Subjects, were developed based on reports published by the National Commission (for the Protection of ... More


Diabetes Prediction and Prevention Research in Childhood

Lainie Friedman Ross

in Children in Medical Research: Access versus Protection

Published in print:
2006
Published Online:
May 2006
ISBN:
9780199273287
eISBN:
9780191603655
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/0199273286.003.0012
Subject:
Philosophy, Moral Philosophy

This chapter provides an overview of recent diabetes prediction and prediction/prevention studies beyond the newborn period. It examines whether these studies are permissible under current federal ... More


Minimizing Risks: Diabetes Research in Newborns

Lainie Friedman Ross

in Children in Medical Research: Access versus Protection

Published in print:
2006
Published Online:
May 2006
ISBN:
9780199273287
eISBN:
9780191603655
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/0199273286.003.0011
Subject:
Philosophy, Moral Philosophy

This chapter examines the meta-ethical question regarding subject selection in newborn screening for diabetes. Data show that over 90% of parents give permission for diabetes screening of their ... More


Lead Abatement Research

Lainie Friedman Ross

in Children in Medical Research: Access versus Protection

Published in print:
2006
Published Online:
May 2006
ISBN:
9780199273287
eISBN:
9780191603655
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/0199273286.003.0013
Subject:
Philosophy, Moral Philosophy

In August 2001, the Maryland Court of Appeals harshly criticized the Kennedy Krieger Institute of Johns Hopkins University for knowingly exposing poor children to lead-based paint. This chapter ... More


Babes and Baboons: Jesica Santillan and Experimental Pediatric Transplant Research in America

Lesley A. Sharp

in A Death Retold: Jesica Santillan, the Bungled Transplant, and Paradoxes of Medical Citizenship

Published in print:
2006
Published Online:
September 2014
ISBN:
9780807830598
eISBN:
9781469605432
Item type:
chapter
Publisher:
University of North Carolina Press
DOI:
10.5149/9780807877524_wailoo.17
Subject:
History, Social History

This chapter investigates the growing trend in high-risk, high-technology experimental pediatric research in America and the problematic relationship between experimentation, transplantation, and ... More


Parental Decision-Making

Joseph Millum

in Moral Parenthood

Published in print:
2018
Published Online:
December 2017
ISBN:
9780190695439
eISBN:
9780190695460
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/oso/9780190695439.003.0006
Subject:
Philosophy, Moral Philosophy

This chapter considers how parents should make decisions on their child’s behalf when the child’s interests are in conflict with the interests of other people. This includes such issues as the extent ... More


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