Ethical Conduct of Clinical Research Involving Children

Ethical Conduct of Clinical Research Involving Children

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2004-07-09

Total Pages: 445

ISBN-13: 0309133386

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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.


Medical Response to Child Sexual Abuse

Medical Response to Child Sexual Abuse

Author: Randell Alexander

Publisher: STM Learning

Published: 2019-04

Total Pages: 439

ISBN-13: 9781936590742

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The second edition of Medical Response to Child Sexual Abuse is revised and updatedto reflect contemporary best practices for the pediatric approach to childhood sexualabuse. This text is specifically developed to equip physicians, nurses, and othermedical professionals with the necessary tools to identify cases of child sexual abuseand to effectively treat and examine sexually abused patients. Professionals who work with sexually abused children face a great challenge innot only treating the immediate outcomes of sexual abuse but also safeguardingtheir patients' long-term recovery. To meet their needs and the needs of those intheir care, Medical Response to Child Sexual Abuse, Second Edition offers a wealthof evidence-based research and practical guidelines to the evaluation of childhoodsexual abuse.


Medical Child Abuse

Medical Child Abuse

Author: Thomas A. Roesler

Publisher:

Published: 2009

Total Pages: 0

ISBN-13: 9781581101362

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Thomas A. Roesler, MD, FAAP and Carole Jenny, MD, MBA, FAAP make the case that the term Munchausen syndrome by proxy should be retired permanently and replaced with a commonsense appreciation that children can be abused by their parents in the medical environment. Physicians who find themselves providing unnecessary and harmful medical care can see the abuse for what it is, another way parents can harm children. the book offers the first detailed and comprehensive description of treatment for this form of child maltreatment.


New Directions in Child Abuse and Neglect Research

New Directions in Child Abuse and Neglect Research

Author: National Research Council

Publisher: National Academies Press

Published: 2014-03-25

Total Pages: 376

ISBN-13: 0309285151

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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.


Women Who Sexually Abuse Children

Women Who Sexually Abuse Children

Author: Jacqui Saradjian

Publisher:

Published: 1996

Total Pages: 310

ISBN-13:

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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.


Safe and Effective Medicines for Children

Safe and Effective Medicines for Children

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2012-10-13

Total Pages: 432

ISBN-13: 0309225493

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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.


Protecting Data Privacy in Health Services Research

Protecting Data Privacy in Health Services Research

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2001-01-13

Total Pages: 208

ISBN-13: 0309071879

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The need for quality improvement and for cost saving are driving both individual choices and health system dynamics. The health services research that we need to support informed choices depends on access to data, but at the same time, individual privacy and patient-health care provider confidentiality must be protected.


Combined Parent-Child Cognitive Behavioral Therapy

Combined Parent-Child Cognitive Behavioral Therapy

Author: Melissa K. Runyon

Publisher: Oxford University Press

Published: 2013-11

Total Pages: 330

ISBN-13: 0199916888

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Combined Parent-Child Cognitive Behavioral Therapy is an evidence-based intervention and prevention model for child physical abuse aimed at empowering families to develop optimistic outlooks on parenting and strengthen parent-child relationships.


Childhood Sexual Abuse

Childhood Sexual Abuse

Author: Paul E. Mullen

Publisher: SAGE Publications

Published: 1999-02-02

Total Pages: 147

ISBN-13: 1452221529

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Childhood Sexual Abuse critically reviews research into and provides a concise and clear guide to our current knowledge on the topic. The issues covered include: the prevalence of child sexual abuse; who molests children; the effects of such abuse, both immediate and long-term; the risk factors for abuse; and the influences and interventions that may amplify or ameliorate the impact of child sexual abuse on the victim. Areas of debate, such as the false memory syndrome, are approached in terms of the research data relevant to their resolution. This volume sets out to inform rather than advocate, discusses the methodologies of research as well as their results, highlights the limitations and the extent of current information, and points out how we can learn more about child sexual abuse.


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

Published: 2005-11-10

Total Pages: 216

ISBN-13: 0309164923

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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.