Lainie Ross presents a rigorous critical investigation of the development of policy governing the involvement of children in medical research. She examines the shift in focus from protection of medical research subjects, enshrined in post-World War II legislation, to the current era in which access is assuming greater precedence. Infamous studies such as Willowbrook (where mentally retarded children were infected with hepatitis) are evidence that before the policy shift protection was not always adequate, even for the most vulnerable groups. Additional safeguards for children were first implemented in many countries in the 1970s and 1980s; more recent policies and guidelines are trying to promote greater participation. Ross examines whether the safeguards work, whether they are fair, and how they apply in actual research practice, and she offers specific recommendations to modify current policies and guidelines.
Children in Medical Research
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Editorial Reviews
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"The book challenges everyone involved in research with children to consider whether current policies and practices provide them with adequate protection, whether additional safeguards are needed, and whether some barriers to enrolling children in medical research should be removed."--The New England Journal of Medicine
"The book presents the arguments on both sides of numerous regulatory and ethical issues, asks important questions, and draws logical conclusions."--Journal of Clinical Research Best Practices
About the Author
Dr. Lainie Ross is a general pediatrician and a medical ethicist in the MacLean Center for Clinical Medical Ethics at the University of Chicago.
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Inside This Book
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First Sentence:
The phrase 'women and children first' refers to the rescue policy on a sinking ship. Read the first page Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
research ethics standards, access versus protection, paying research subjects, minor increase over minimal risk, specialized consent statutes, research involving children, nontherapeutic research, asthma trials, diabetes prediction, abatement research, parental waivers, minimal risk research, medical best interest, research involving patients, oncology trials, pediatric ethics, therapeutic misconception, intranasal insulin, pediatric research, mature minor doctrine, clinical research investigations, human subject protections, consent mechanisms, written parental consent, family life situations Key Phrases - Capitalized Phrases (CAPs): (learn more)
Lainie Friedman Ross, Federal Register, Department of Health, New York, New England Journal of Medicine, General Assembly, Common Rule, Belmont Report, Journal of Pediatrics, Japanese American, Declaration of Helsinki, Royal College of Physicians, Government Printing Office, Kennedy Krieger Institute, Institute of Medicine, National Institutes of Health, Determination Letter, Diabetes Care, American Academy of Pediatrics, United States, University of Washington, Regulations Amending Basic, Children's Health Act, National Heart, Oxford University Press New!
Books on Related Topics | Concordance | Text Stats Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
The phrase 'women and children first' refers to the rescue policy on a sinking ship. Read the first page Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
research ethics standards, access versus protection, paying research subjects, minor increase over minimal risk, specialized consent statutes, research involving children, nontherapeutic research, asthma trials, diabetes prediction, abatement research, parental waivers, minimal risk research, medical best interest, research involving patients, oncology trials, pediatric ethics, therapeutic misconception, intranasal insulin, pediatric research, mature minor doctrine, clinical research investigations, human subject protections, consent mechanisms, written parental consent, family life situations Key Phrases - Capitalized Phrases (CAPs): (learn more)
Lainie Friedman Ross, Federal Register, Department of Health, New York, New England Journal of Medicine, General Assembly, Common Rule, Belmont Report, Journal of Pediatrics, Japanese American, Declaration of Helsinki, Royal College of Physicians, Government Printing Office, Kennedy Krieger Institute, Institute of Medicine, National Institutes of Health, Determination Letter, Diabetes Care, American Academy of Pediatrics, United States, University of Washington, Regulations Amending Basic, Children's Health Act, National Heart, Oxford University Press New!
Books on Related Topics | Concordance | Text Stats Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
Citations (learn more)
This book cites 50
books:
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- The Ethical Conduct of Clinical Research Involving Children by Committee on Clinical Research Involving Children on 8 pages
- The Patient as Person: Exploration in Medical Ethics. by Paul Ramsey on 7 pages
- Experimentation With Human Subjects by Paul Abraham Freund on 4 pages
- Ethics and Regulation of Clinical Research: Second Edition by Robert J. Levine on page 38, page 84, and page 127
- Before the Best Interests of the Child by Joseph Goldstein on page 102, page 150, and page 219
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