Ethical Considerations for Research on Housing-Related Health Hazards Involving Children explores the ethical issues posed when conducting research designed to identify, understand, or ameliorate housing-related health hazards among children. Such research involves children as subjects and is conduc
Ethical conduct of clinical research involving children
β Scribed by Marilyn Jane Field, Richard E. Behrman
- Publisher
- National Academies Press
- Year
- 2004
- Tongue
- English
- Leaves
- 446
- Edition
- 1
- Category
- Library
No coin nor oath required. For personal study only.
β¦ Synopsis
In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. "Ethical Conduct of Clinical Research Involving Children" considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.
β¦ Table of Contents
Front Matter......Page 2
Contents......Page 8
Preface......Page 14
Acknowledgments......Page 16
Reviewers......Page 18
Summary......Page 22
1 Introduction......Page 46
2 The Necessity and Challenges of Clinical Research Involving Children......Page 79
3 Regulatory Framework for Protecting Child Participants in Research......Page 114
4 Defining, Interpreting, and Applying Concepts of Risk and Benefit in Clinical Research Involving Children......Page 134
5 Understanding and Agreeing to Childrenβs Participation in Clinical Research......Page 167
6 Payments Related to Childrenβs Participation in Clinical Research......Page 232
7 Regulatory Compliance, Accreditation, and Quality Improvement......Page 250
8 Responsible Research Involving Children......Page 267
References......Page 298
Appendices......Page 330
A Study Origins and Activities......Page 332
B State Regulation of Medical Research with Children and Adolescents: An Overview and Analysis......Page 341
C Health Care Privacy and Conflict-of-Interest Regulations Relevant to Protection of Human Participants in Research......Page 409
D Glossary, Acronyms, and Laws and Regulations......Page 415
E Committee Biographical Statements......Page 423
Index......Page 430
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