Medical Research With Children

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.

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 considers whether the safeguards work, whether they are fair, and how they apply in actual research practice. She goes on to offer specific recommendations to modify current policies and guidelines. Ross examines the regulatory structures (e.g. federal regulations and institutional review boards), the ad hoc policies (e.g. payment in pediatric research and the role of schools as research venues), the actual practices of researchers (e.g. the race/ethnicity of enrolled research subjects or the decision to enroll newborns) as well as the decision-making process (both parental permission and the child's assent), in order to provide a broad critique. Some of her recommendations will break down current barriers to the enrolment of children (e.g. permitting the payment of child research subjects; allowing healthy children to be exposed to research that entails more than minimal risk without requiring recourse to 407 panels); whereas other recommendations may create new restrictions (e.g., the need for greater protection for research performed in schools; restrictions on what research should be done in the newborn nursery). The goal is to ensure that medical research is done in a way that promotes the health of current and future children without threatening, to use the words of Hans Jonas, 'the erosion of those moral values whose loss . . . would make its most dazzling triumphs not worth having'.

Practical Research with Children is designed to help the reader understand techniques for research with children, based on real world experience. The book describes a wide range of research methods, focusing equally on quantitative and qualitative approaches, and considers how different methods can be integrated. It highlights the benefits and challenges of each method and gives emphasis to best practice, with expert guidance on how to avoid potential pitfalls in order to obtain valuable insights into how children develop. The volume includes fifteen chapters arranged over three sections. Each chapter explores a particular method, or combination of methods, and discusses both theoretical and practical issues, using a diversity of domains, including different ages, cultures, populations and settings. Uniquely, the book includes newer methods (such as eye tracking and digital technologies) alongside well-established behavioural methods which are used for research with children. With contributions from internationally renowned researchers and practitioners from a range of disciplines, the book will be indispensable reading for a wide audience, including for students in psychology, education and nursing undertaking research projects with children, and also for anyone looking to understand the research behind current theories in child development.

Studies involving children with mental, emotional, or behavioral problems--or their families--have to meet certain standards of research ethics. This book contains chapters on the kinds of ethical dilemmas that typically occur in different types of studies of children, and then presents 65 real-world cases from experts who study children's mental health. These experts offer practical suggestions for how to handle these dilemmas. Chapters on the perspectives of parents, regulators, and bioethicists provide additional points of view on these issues. Written in down-to-earth language, this book will be useful for professionals who study children, for those who train students in research methods, and for parents who are thinking about participating in research studies. In attempting to bridge the apparent gap between ethics and science, the editors close this volume on a note commonly sounded by researchers: more research is needed. Yet in this area, a new kind of research is required. The science of scientific ethics must be developed and expanded, and better understanding of the determinants and circumstances under which children can comprehend and evaluate risks and benefits is needed. Likewise, fuller knowledge of the contextual factors affecting children's and families' consent to participate in research is essential. In particular, development of scales to assess children's ability to comprehend risk-benefit issues, studies of families' reactions to research procedures, and empirical data on the impact of various forms of participant reimbursement will advance both science and ethics. This volume should spur further research, serving as a guide for current investigators, participating families, institutional review boards, and policymakers who shape the research enterprise.

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.

Fundamental questions about the morality of pediatric medical research persist despite years of debate and the establishment of strict codes of ethics. Is it ever permissible to use a child as a means to an end? How much authority should parents have over decisions about research involving their children? Should children or their parents be paid for participation in research? Most importantly, how can the twin goals of access to the benefits of clinical research and protection from research risk be reconciled? 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. Each chapter begins with a unique case vignette, followed by rich discussion and incisive ethical analysis. Chapters represent a host of current controversies and are contributed by leading scholars from a variety of disciplines that must grapple with how to best protect children from research risk while driving innovation in the fight against childhood diseases. Chapters end with questions for discussion, providing faculty and students with accessible starting points from which to explore more in depth the thorny issues that are raised. In the final chapter, the editors provide a synthesis and summary that serve as a capstone and companion to the case-based chapters. Unique in its specific focus on research, Ethics and Research with Children provides a balanced and thorough account of the enduring dilemmas that arise when children become research subjects, and will be essential reading for those involved with pediatric research in any context.

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.

Research with Children is a unique resource book on the methodology of childhood research. Leading and new researchers within the social studies of childhood discuss central questions of epistemology and methodology, demonstrating the links between theory and practice. The theoretical and practical questions are set out in a clear and well-argued fashion and will therefore appeal both to the newcomer to childhood studies and to experienced researchers in the field.