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.

This book is the most comprehensive treatment available of one of the most urgent problems in bioethics: decision-making for incompetents.

What should happen when doctors and parents disagree about what would be best for a child? When should courts become involved? Should life support be stopped against parents' wishes? The case of Charlie Gard, reached global attention in 2017. It led to widespread debate about the ethics of disagreements between doctors and parents, about the place of the law in such disputes, and about the variation in approach between different parts of the world. In this book, medical ethicists Dominic Wilkinson and Julian Savulescu critically examine the ethical questions at the heart of disputes about medical treatment for children. They use the Gard case as a springboard to a wider discussion about the rights of parents, the harms of treatment, and the vital issue of limited resources. They discuss other prominent UK and international cases of disagreement and conflict. From opposite sides of the debate Wilkinson and Savulescu provocatively outline the strongest arguments in favour of and against treatment. They analyse some of the distinctive and challenging features of treatment disputes in the 21st century and argue that disagreement about controversial ethical questions is both inevitable and desirable. They outline a series of lessons from the Gard case and propose a radical new 'dissensus' framework for future cases of disagreement. - This new book critically examines the core ethical questions at the heart of disputes about medical treatment for children. - The contents review prominent cases of disagreement from the UK and internationally and analyse some of the distinctive and challenging features around treatment disputes in the 21st century. - The book proposes a radical new framework for future cases of disagreement around the care of gravely ill people.

The MacCAT-CR provides a structured format for capacity assessment that is adaptable to the particulars of any given research project. With the introduction of the MacCAT-CR, researchers enrolling human participants in their studieshave available for the first time a reliable and valid means of assessing their potential subject's capacity to consent to participation. The MacCAT-CR can typically be administered in 15-20 minutes. Beginning with project-specific disclosures to potential participants, the MacCAT-CR measures the four generally accepted components of decision-making competence: understanding, appreciation, reasoning, and the ability to express a choice. Quantification of subjects' responses permits comparisons across subjects and subject groups, and allows the MacCAT-CR to be used for not only for screening individual participants but also for conducting research on the characteristics of subject populations and for assessing the effectiveness of interventions designed to increase subjects' capacities.

Recommendations from this study include reviewing professional policies and guidance to ensure greater consistency; developing a “toolkit” for health professionals to use to assess children’s competence; introducing courses/seminars for children, parents and health professionals to raise awareness and knowledge of the law; and amending or introducing a new law to better embed the rights of competent children to consent, or refuse, treatment.

The book explains how assessments should be conducted and offers detailed, practice-tested interview guidelines to assist medical practitioners in this task. Numerous case studies illustrate real-life applications of the concepts and methods discussed. Grisso and Appelbaum also explore the often difficult process of making judgments about competence and describe what to do when patients' capacities are limited.".

The Narrative Approach to Informed Consent: Empowering Young Children’s Rights and Meaningful Participation is a practical guide for researchers who want to engage young children in rights-based, participatory research. This book presents the Narrative Approach, an original and innovative method to help children understand their participation in research. This approach moves away from traditional paper-based consent to tailor the informed consent process to the specific needs of young children. Through the Informing Story, which employs a combination of interaction, information and narrative, this method enables children to comprehend concepts through storytelling. Researchers are stepped through the development of an Informing Story so that they can deliver accurate information to young children about what their participation in research is likely to involve. To further inform practice, the book documents the implementation of the Narrative Approach in four case studies demonstrating the variety of settings in which the method can be applied. The Narrative Approach to Informed Consent addresses the rights of young children to be properly researched, expands opportunities for their active and engaged research participation, and creates a unique conceptual ethical space within which meaningful informed consent can occur. This book will be an invaluable tool for novice and experienced researchers and is applicable to a wide range of education and non-education contexts.