Ethical Conduct of Clinical Research Involving Children

Ethical Conduct of Clinical Research Involving Children
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 445
Release: 2004-07-09
Genre: Medical
ISBN: 0309133386

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.

Research Involving Children

Research Involving Children
Author: United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Publisher:
Total Pages: 184
Release: 1977
Genre: Children
ISBN:

Doing Research with Children and Young People

Doing Research with Children and Young People
Author: Sandy Fraser
Publisher: SAGE
Total Pages: 308
Release: 2004
Genre: Medical
ISBN: 9780761943815

Doing Research with Children and Young People introduces researchers to the key considerations involved in working with children and young people.

Ethical Considerations for Research on Housing-Related Health Hazards Involving Children

Ethical Considerations for Research on Housing-Related Health Hazards Involving Children
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 216
Release: 2005-11-10
Genre: Social Science
ISBN: 0309164923

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 conducted in the home and in communities. It is often conducted with children in low-income families given the disproportionate prevalence of housing-related conditions such as lead poisoning, asthma, and fatal injuries among these children. This book emphasizes five key elements to address the particular ethical concerns raised by these characteristics: involving the affected community in the research and responding to their concerns; ensuring that parents understand the essential elements of the research; adopting uniform federal guidelines for such research by all sponsors (Subpart D of 45 CFR 46); providing guidance on key terms in the regulations; and viewing research oversight as a system with important roles for researchers, IRBs and their research institutions, sponsors and regulators of research, and the community.

Safe and Effective Medicines for Children

Safe and Effective Medicines for Children
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 432
Release: 2012-10-13
Genre: Medical
ISBN: 0309225493

The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.

Ethics and Research with Children

Ethics and Research with Children
Author: Eric Kodish
Publisher: Paperbackshop UK Import
Total Pages: 345
Release: 2018-12-24
Genre: Medical
ISBN: 0190647256

Promoting more thoughtful attention to the complex ethical problems that arise when research involves children, this fully updated new edition of Ethics and Research with Children presents 14 case studies featuring some of the most challenging and fascinating ethical dilemmas in pediatric research.

Research Involving Children

Research Involving Children
Author: United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Publisher:
Total Pages: 630
Release: 1977
Genre: Children
ISBN:

Ethical Research with Children

Ethical Research with Children
Author: Sarah Richards
Publisher: Springer
Total Pages: 237
Release: 2015-10-26
Genre: Social Science
ISBN: 1137351314

An increasing interest in children's lives has tested the ethical and practical limits of research. Rather than making tricky ethical decisions, transparent researchers tend to gloss over stories that do not fit with sanitized narratives. This book aims to fill this gap by making explicit the lived experiences of research with children.

The National Children's Study Research Plan

The National Children's Study Research Plan
Author: National Research Council
Publisher: National Academies Press
Total Pages: 166
Release: 2008-08-16
Genre: Social Science
ISBN: 030912056X

The National Children's Study (NCS) is planned to be the largest long-term study of environmental and genetic effects on children's health ever conducted in the United States. It proposes to examine the effects of environmental influences on the health and development of approximately 100,000 children across the United States, following them from before birth until age 21. By archiving all of the data collected, the NCS is intended to provide a valuable resource for analyses conducted many years into the future. This book evaluates the research plan for the NCS, by assessing the scientific rigor of the study and the extent to which it is being carried out with methods, measures, and collection of data and specimens to maximize the scientific yield of the study. The book concludes that if the NCS is conducted as proposed, the database derived from the study should be valuable for investigating hypotheses described in the research plan as well as additional hypotheses that will evolve. Nevertheless, there are important weaknesses and shortcomings in the research plan that diminish the study's expected value below what it might be.

Doing Research with Children

Doing Research with Children
Author: Anne D Greig
Publisher: SAGE
Total Pages: 559
Release: 2012-11-16
Genre: Education
ISBN: 1446289850

This Third Edition of Doing Research with Children is practical introduction to the process of designing, doing and writing up research with children and young people. At the centre is a commitment to engaging with children and young people as active research participants rather than as passive subjects. In the new edition, you′ll find up to date information on the fast-changing political and ethical debates around research with children and young people as well as guidance on how to carry out research yourself. Divided into three sections, the new edition covers: -the main theories and approaches of research with children and young people -expanded guidance on research ethics -techniques for conducting both qualitative and quantitative research -more on analysing your research -a brand new chapter on communicating your research findings. This is a must-have guide for students and practitioners who are engaging in research with children and young people.