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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


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


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


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


Children's Consent and ‘Assent’ to Healthcare Research

Priscilla Alderson

in Law and Childhood Studies: Current Legal Issues Volume 14

Published in print:
2012
Published Online:
May 2012
ISBN:
9780199652501
eISBN:
9780191739217
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780199652501.003.0012
Subject:
Law, Family Law, Human Rights and Immigration

The idea of children's ‘assent’ to medical research became part of English law in 2004. However, this overrides English legal traditions of children's consent. Although this chapter concentrates on ... More


Should We Provide Healthy Children with Greater Protection in Medical 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:
10.1093/0199273286.003.0005
Subject:
Philosophy, Moral Philosophy

This chapter examines whether Subpart D of the federal regulations on human subject protections provides appropriate protection for all children, when research offers no prospect of direct benefit ... 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


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


World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects

Rebecca J. Cook, Bernard M. Dickens, and Mahmoud F. Fathalla

in Reproductive Health and Human Rights: Integrating Medicine, Ethics, and Law

Published in print:
2003
Published Online:
October 2011
ISBN:
9780199241323
eISBN:
9780191696909
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780199241323.003.0025
Subject:
Philosophy, Moral Philosophy

This chapter outlines the provisions of the World Medical Association's Declaration of Helsinki, which was developed as a statement of ethical principles to provide guidance to physicians and other ... 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


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


Getting Down to Cases

Ruth W. Grant

in Strings Attached: Untangling the Ethics of Incentives

Published in print:
2011
Published Online:
October 2017
ISBN:
9780691151601
eISBN:
9781400839742
Item type:
chapter
Publisher:
Princeton University Press
DOI:
10.23943/princeton/9780691151601.003.0006
Subject:
Business and Management, Knowledge Management

This chapter explores in more detail four very different domains where incentives have been controversial: plea bargaining, recruiting medical research subjects, the loan policies of the ... More


The American Medical School Between the World Wars

Kenneth M. Ludmerer

in Time to Heal: American medical education from the turn of the century to the era of managed care

Published in print:
2005
Published Online:
October 2011
ISBN:
9780195181364
eISBN:
9780199850167
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780195181364.003.0002
Subject:
History, American History: 20th Century

Typically regarded as a quiet time in American medical education, the interwar period was in fact highly dynamic. Medical research advanced and medical schools grew in size, wealth, and complexity. ... 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


Consent to Clinical Research

Franklin G. Miller

in The Ethics of Consent: Theory and Practice

Published in print:
2009
Published Online:
February 2010
ISBN:
9780195335149
eISBN:
9780199866335
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780195335149.003.0015
Subject:
Philosophy, Moral Philosophy

This chapter considers the scope and limits of consent to participate in research. Following discussion of a famous historical case of clinical research without informed consent, it examines the ... More


The Ascendancy of Research

Kenneth M. Ludmerer

in Time to Heal: American medical education from the turn of the century to the era of managed care

Published in print:
2005
Published Online:
October 2011
ISBN:
9780195181364
eISBN:
9780199850167
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780195181364.003.0008
Subject:
History, American History: 20th Century

The ties formed between the federal government and academic medical centers during World War II irrevocably altered the scale of medical research in the United States. Over the next two decades, ... More


Doctoring: The Nature of Primary Care Medicine

Eric J. Cassell

Published in print:
1997
Published Online:
November 2011
ISBN:
9780195113235
eISBN:
9780199999828
Item type:
book
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780195113235.001.0001
Subject:
Palliative Care, Patient Care and End-of-Life Decision Making, Pain Management and Palliative Pharmacology

This book shows how much better fitted advanced concepts of primary care medicine are to America's health-care needs. It offers insights into how primary care physicians can be better trained to meet ... More


World War II and Medical Education

Kenneth M. Ludmerer

in Time to Heal: American medical education from the turn of the century to the era of managed care

Published in print:
2005
Published Online:
October 2011
ISBN:
9780195181364
eISBN:
9780199850167
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780195181364.003.0007
Subject:
History, American History: 20th Century

Medical schools had long been responsible for the quality of care rendered civilians, but during World War II they took direct responsibility for the military's medical care as well. The proportion ... More


Can We Trust Our Researchers?

Jerome P. Kassirer

in On the Take: How Medicine's Complicity with Big Business Can Endanger Your Health

Published in print:
2005
Published Online:
October 2011
ISBN:
9780195300048
eISBN:
9780199850518
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780195300048.003.0008
Subject:
Economics and Finance, Economic Systems

Medical research has become an enormous enterprise in the United States. The federal government spent approximately 20 billion dollars in 2001 on it, and private industry spent even more: in the ... More


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