Abuse Of Minors In Clinical Studies

With the emergence of effective drugs and observed drug toxicities in babies, two mantras emerged: that children are therapeutic orphans, and that children are not small adults. US and EU laws demand pediatric studies as a condition for the approval of new drugs in adults. This is called “Pediatric Drug Development” (PDD). Although apparently reasonable, there are catches. Children are vulnerable at birth, but they grow and become bodily mature with puberty, well before coming of age. Minors are not another species. The 18th birthday, an administrative/ legal limit, does not correspond to a physiological change. Drugs treat the body, not the legal status. PDD results in pointless studies in bodily mature adolescents, and in exaggerated studies in younger minors. An originally well-intentioned concept results in thousands of questionable studies worldwide. This book draws attention to conflicts of interest and ethical dilemmas of PDD and questions its applicability for adolescents and minors that are no longer babies.

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.

This book serves as a comprehensive resource for researchers and regulatory bodies working to establish sound evidence bases through research for the care of children and families affected by abuse. Issues such as consent, anonymous research, and how to interface with the legal system in terms of disclosure and sharing of results are discussed in depth. Ethical Issues in Child Abuse Research also provides insights into questions of ethics in animal research, perpetrator and retrospective research, and balances the necessity of collecting this valuable information while protecting vulnerable populations, and respecting their privacy while interacting in a complex legal system. With input from many leaders in child abuse research, this book fills a critical need, providing readers with a pathway to apply these principles of ethics to their own research in this challenging field.

The causes of child abuse and neglect have been major topics of study since the 1960s, but treatment strategies, research, and legal issues have only received concentrated attention since the '80s. The leading figures in these efforts have contributed to this handbook, a state-of-the-art compilation of their findings that also includes writings on associated cultural issues , youth violence, sexual abuse, and child development. Both a text and a reference, the volume is uniquely founded on empirical research.

This work is based on in-depth research with more than fifty women who have sexually abused children and therapy that has been carried out with several such women. It describes many aspects of their lives: childhood; own abuse histories; and adult relationships with partners and peers.

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.

During the past decade, a dramatic increase in research and clinical interest has risen in child abuse and neglect. This recent growth in awareness isdue at leastpartly to thealarmingstatisticsdocumentingthe incidence of child maltreatment. Almost one million children are re ported to be abused and neglected each year, and many experts believe that this figure underestimates the true incidence. Indeed, recentsurveys suggest that almost 1. 5 million children are the targets of domestic vio lence every year. A significantproportion of these children die as a func tion of this maltreatment, whereas theremaindersuffera variety ofshort and long-term deleterious medicaland psychosocial consequences. Child maltreatment is a universal problem that has precipitated a mobilization of effort from a variety of disciplines, including psychology, medicine, psychiatry, social work, sociology, and criminology. Particular attention has been directed toward the prevention and treatment of childabuse and neglect. Such endeavors require the screen ing of large groups in order to identify families that are at high-risk for engaging in such behavior. Delineating those characteristics that differ entiate high- from low-risk families and children is one of the obvious priorities for researchers and clinicians in the future. This book, there fore, carefully considers the status of research on risk factors of abuse and neglect in children. Adduced data undoubtedly will have practical value for subsequent intervention efforts.

Each year, child protective services receive reports of child abuse and neglect involving six million children, and many more go unreported. The long-term human and fiscal consequences of child abuse and neglect are not relegated to the victims themselves -- they also impact their families, future relationships, and society. In 1993, the National Research Council (NRC) issued the report, Under-standing Child Abuse and Neglect, which provided an overview of the research on child abuse and neglect. New Directions in Child Abuse and Neglect Research updates the 1993 report and provides new recommendations to respond to this public health challenge. According to this report, while there has been great progress in child abuse and neglect research, a coordinated, national research infrastructure with high-level federal support needs to be established and implemented immediately. New Directions in Child Abuse and Neglect Research recommends an actionable framework to guide and support future child abuse and neglect research. This report calls for a comprehensive, multidisciplinary approach to child abuse and neglect research that examines factors related to both children and adults across physical, mental, and behavioral health domains--including those in child welfare, economic support, criminal justice, education, and health care systems--and assesses the needs of a variety of subpopulations. It should also clarify the causal pathways related to child abuse and neglect and, more importantly, assess efforts to interrupt these pathways. New Directions in Child Abuse and Neglect Research identifies four areas to look to in developing a coordinated research enterprise: a national strategic plan, a national surveillance system, a new generation of researchers, and changes in the federal and state programmatic and policy response.