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.

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'.

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.

Sexual abuse of children and adolescents is a gross violation of their rights and a global public health problem. It adversely affects the health of children and adolescents. Health care providers are in a unique position to provide an empathetic response to children and adolescents who have been sexually abused. Such a response can go a long way in helping survivors recover from the trauma of sexual abuse. WHO has published new clinical guidelines Responding to Children and Adolescents Who Have Been Sexually Abused aimed at helping front-line health workers, primarily from low resource settings, in providing evidence-based, quality, trauma-informed care to survivors. The guidelines emphasize the importance of promoting safety, offering choices and respecting the wishes and autonomy of children and adolescents. They cover recommendations for post-rape care and mental health; and approaches to minimizing distress in the process of taking medical history, conducting examination and documenting findings.

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 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.