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Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309133386 Category : Medical Languages : en Pages : 445
Book Description
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.
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309133386 Category : Medical Languages : en Pages : 445
Book Description
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.
Author: Klaus Rose Publisher: Karger Medical and Scientific Publishers ISBN: 3805582013 Category : Medical Languages : en Pages : 164
Book Description
As off-label use of medicines in children is no longer acceptable today, paediatric drug development is currently in transition from an almost exclusive academic specialty towards an integrated part of the global process that drives the development of new pharmaceuticals. US and EU governments have made it mandatory for the pharmaceutical industry to investigate medicines in children, thus exposing a multitude of different institutions to paediatric research. Written by exponents of the academia as well as the pharmaceutical industry, regulators and patient advocacy groups, this book explains the background of the US and EU paediatric legislations, gives an analysis of their probable short-, mid- and long-term impact, addresses key operational challenges in paediatric research, and develops a tentative vision where paediatric drug development needs to go. Helping to understand the role of the different stakeholders, the spectrum of readers to profit from this book ranges from paediatricians, general medical personnel and pharmacologists to those involved in regulatory affairs and clinical trials, pharmaceutical company management, patient advocacy groups, ethical committees, politicians and interested lay persons.
Author: Anne D Greig Publisher: SAGE ISBN: 1446289850 Category : Education Languages : en Pages : 559
Book Description
This Third Edition of Doing Research with Children is practical introduction to the process of designing, doing and writing up research with children and young people. At the centre is a commitment to engaging with children and young people as active research participants rather than as passive subjects. In the new edition, you′ll find up to date information on the fast-changing political and ethical debates around research with children and young people as well as guidance on how to carry out research yourself. Divided into three sections, the new edition covers: -the main theories and approaches of research with children and young people -expanded guidance on research ethics -techniques for conducting both qualitative and quantitative research -more on analysing your research -a brand new chapter on communicating your research findings. This is a must-have guide for students and practitioners who are engaging in research with children and young people.
Author: Christina A. Di Bartolo Publisher: Springer ISBN: 331949547X Category : Medical Languages : en Pages : 260
Book Description
With the proliferation of research studies posted online, media outlets scrambling to pick up stories, and individuals posting unverified information via social media, the landscape for parents trying to understand the latest science as it pertains to their children has never been more challenging to navigate. This book is intended to assist pediatricians when discussing research findings with parents. It provides an overview of research practices and terminology, clarifies misconceptions about studies and findings, and explains the limitations of research when applied to medical decision making. Through this framework, physicians can explain their reasoning behind specific clinical recommendations. In addition to examining the broad concepts comprising research literacy, this book reviews the current findings in topics that pediatricians report discussing most often with parents, such as vaccines, diet, medications, and sleep. Pediatrician’s Guide to Discussing Research with Patients is a unique resource for pediatricians in encouraging the development of research literacy in their patients.
Author: World Health Organization Publisher: World Health Organization ISBN: 9241548371 Category : Business & Economics Languages : en Pages : 442
Book Description
The Pocket Book is for use by doctors nurses and other health workers who are responsible for the care of young children at the first level referral hospitals. This second edition is based on evidence from several WHO updated and published clinical guidelines. It is for use in both inpatient and outpatient care in small hospitals with basic laboratory facilities and essential medicines. In some settings these guidelines can be used in any facilities where sick children are admitted for inpatient care. The Pocket Book is one of a series of documents and tools that support the Integrated Managem.
Author: Bernard Lo Publisher: Lippincott Williams & Wilkins ISBN: 1451152779 Category : Medical Languages : en Pages : 302
Book Description
This book teaches researchers how to resolve the ethical dilemmas that can arise at any stage in clinical research. In addition to explaining pertinent regulations and laws, Dr. Lo helps investigators understand the gaps and uncertainties in regulations, as well as situations in which merely complying with the law may not fulfill ethical responsibilities. Most chapters include real-life examples that the author walks through, discussing the salient issues and how to approach them. This book can be used in courses on research ethics that are required or encouraged by major National Institutes of Health grants in academic health centers.
Author: Angela C. Mattke Publisher: Rosetta Books ISBN: 0795352298 Category : Health & Fitness Languages : en Pages : 546
Book Description
A parent’s guide from“one of the most reliable, respected health resources that Americans have” (Publishers Weekly). Drawing from the collective wisdom of pediatric experts at Mayo Clinic, ranked #1 on US News & World Report’s 2020-2021 Best Hospitals Honor Roll, Mayo Clinic Guide to Raising a Healthy Child addresses key questions and concerns many parents have about the preschool and school-age years. In this book, parents learn what to expect in the lively, wonder-filled time between ages 3 and 11. They’ll find answers to family dilemmas such as feeding a picky eater, resolving sleep problems, addressing bullying, treating common injuries and illnesses, and coping with complex health care needs. Experts discuss what it takes to prepare a child for a rich and meaningful adult experience. This book is intended to be a companion manual for navigating those early to middle childhood years, offering encouragement and trusted advice from some of the best experts around, and helping your family find success. The book is divided into 6 sections: · Section 1 addresses growth and development · Section 2 focuses on health and safety · Section 3 discusses important topics related to emotional wellbeing · Section 4 covers common illnesses and concerns · Section 5 is devoted to special circumstances in raising a child · Section 6 provides tips and guidance creating a healthy family unit
Author: JoAnn Pfeiffer Publisher: CRC Press ISBN: 1315299771 Category : Mathematics Languages : en Pages : 292
Book Description
A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application. Unique to this book is "A View from India," a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials.
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309316324 Category : Medical Languages : en Pages : 236
Book Description
Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Author: Institute of Medicine
Author: Institute of Medicine
Author: B. M. Ansari
Author: Klaus Rose
Author: Anne D Greig
Author: Christina A. Di Bartolo
Author: World Health Organization
Author: Bernard Lo
Author: Angela C. Mattke
Author: JoAnn Pfeiffer
Author: Institute of Medicine