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Pavadinimas: ETHICAL CONDUCT OF CLINICAL RESEARCH INVOLVING CHILDREN
Autoriai: MARILYN J. FIELD AND RICHARD E. BEHRMAN, EDITORS
Metai:
ISBN: 0-309-09181-0
Brūkšninis kodas: 003 07509772 2
Ieškoti VUB kataloge
Anotacija:

     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 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 recommends steps that researchers, government agencies, and others can take to improve research conduct. The book argues that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular. The report 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.


xiii Preface
xv Acknowledgments
xvii Reviewers
1 Summary
25 1 INTRODUCTION
30 Origins of Study and Overview of Report,
31 Definitions: Research, Clinical Research, and Human Subjects
or Research Participants,
35 A Systems Perspective on Protecting Human Participants in Research,
39 Ethical Principles for a System to Protect Human Research Participants,
44 Historical Evolution of Policies for Protecting Human Participants in Research,
58 2 THE NECESSITY AND CHALLENGES OF CLINICAL
RESEARCH INVOLVING CHILDREN
59 Context,
62 Definitions: Infants, Children, and Adolescents,
66 The Rationale for Pediatric Drug Research,
72 Implications for Pediatric Investigation,
74 Challenges of Designing and Conducting Pediatric Studies,
87 Data on the Extent of Children's Participation in Clinical Research,
89 Initiatives to Increase Involvement of Children in Research,
92 Conclusion,
93 REGULATORY FRAMEWORK FOR PROTECTING
CHILD PARTICIPANTS IN RESEARCH
95 Federal Regulations to Protect Child Participants in Research,
105 Additional Federal Policies for Monitoring Safety of
Participants in Clinical Research,
110 Federal Rules for Research Conducted in Other Countries,
112 Conclusion,
113 DEFINING, INTERPRETING, AND APPLYING CONCEPTS
OF RISK AND BENEFIT IN CLINICAL RESEARCH
INVOLVING CHILDREN
114 Basic Concepts of Risk, Harm, and Benefit,
117 Assessing the Level of Risk Posed by a Research Protocol,
136 Other Issues Related to the Assessment of Risk,
145 Conclusion,
146 UNDERSTANDING AND AGREEING TO CHILDREN'S
PARTICIPATION IN CLINICAL RESEARCH
147 Ethical Principles and Legal Requirements,
159 Research Relevant to Parents' Comprehension of Children's
Participation in Research,
178 Children's and Adolescents' Comprehension of
Research Participation,
193 IRB and Investigator Policies and Practices,
195 Improving Processes for Requesting Permission and Assent,
209 Conclusion,
211 PAYMENTS RELATED TO CHILDREN'S
PARTICIPATION IN CLINICAL RESEARCH
212 Types of Payments Related to Research Participation,
213 Ethical Principles and Regulatory Policies,
217 Use of Payments in Research Involving Children,
220 IRB Policies and Practices,
221 Statements of Professional Organizations,
221 Other Concerns About Payment Related to Children's
223 Research Participation, Improving Practices and Policies on Payment Related to Children's Participation in Research,
228 Conclusion,
229 7 REGULATORY COMPLIANCE, ACCREDITATION, AND QUALITY IMPROVEMENT
230 Continued Concern About Oversight of Research Involving Humans, 234 Government Oversight of Regulations Protecting Child Participants in Research, 239 Compliance in the Context of Voluntary Action, Quality
Improvement, and Accreditation,
245 Conclusion,
246 8 RESPONSIBLE RESEARCH INVOLVING CHILDREN
248 Roles and Responsibilities,
275 Conclusion,
277 REFERENCES
APPENDICES
311 A STUDY ORIGINS AND ACTIVITIES
320 B STATE REGULATION OF MEDICAL RESEARCH WITH
CHILDREN AND ADOLESCENTS: AN OVERVIEW AND ANALYSIS
Amy T. Campbell
388 C HEALTH CARE PRIVACY AND CONFLICT-OF-INTEREST
REGULATIONS RELEVANT TO PROTECTION OF
HUMAN PARTICIPANTS IN RESEARCH
394 D GLOSSARY, ACRONYMS, AND LAWS AND REGULATIONS
402 E COMMITTEE BIOGRAPHICAL STATEMENTS
409 INDEX

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