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Ethical Conduct of Clinical Research Involving Children

Ethical Conduct of Clinical Research Involving Children
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 445
Release: 2004-07-09
Genre: Medical
ISBN: 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.


The Age of Informed Consent

The Age of Informed Consent
Author: Octavian Buda
Publisher: Cambridge Scholars Publishing
Total Pages: 248
Release: 2019-01-22
Genre: Medical
ISBN: 1527526704

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This volume analyses the conceptualization and the practical application of the concept of informed consent in various parts of continental Europe, and identifies whether informed consent can be seen as a clearly identifiable concept. The focus here is on the evolution of informed consent in France, Germany, Croatia, Turkey and Romania, with comparisons being made to the “traditional” history of the concept, mainly constructed in the US and the UK. The book will appeal to physicians, bio-ethicists and historians, as it provides the answers to some practical difficulties in applying informed consent in everyday practice, difficulties mainly generated by an indiscriminate application of an imported concept, without a proper analysis of the local cultural, social, and medical background.


Children’s Competence to Consent

Children’s Competence to Consent
Author: Gary B. Melton
Publisher: Springer Science & Business Media
Total Pages: 364
Release: 2012-12-06
Genre: Psychology
ISBN: 1468442899

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Informed Consent and Health

Informed Consent and Health
Author: Thierry Vansweevelt
Publisher: Edward Elgar Publishing
Total Pages: 296
Release: 2020-04-24
Genre: Law
ISBN: 1788973429

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Informed consent is the legal instrument that purports to protect an individual’s autonomy and defends against medical arbitrariness. This illuminating book investigates our evolving understanding of informed consent from a range of comparative and international perspectives, demonstrating the diversity of its interpretations around the world. Chapters offer a nuanced analysis of the problems that impede the understanding and implementation of the concept of informed consent and explore the contemporary challenges that continue to hinder both the patient and the medical community.


Informed Consent and Health Literacy

Informed Consent and Health Literacy
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 228
Release: 2015-03-04
Genre: Medical
ISBN: 0309317304

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Informed consent - the process of communication between a patient or research subject and a physician or researcher that results in the explicit agreement to undergo a specific medical intervention - is an ethical concept based on the principle that all patients and research subjects should understand and agree to the potential consequences of the clinical care they receive. Regulations that govern the attainment of informed consent for treatment and research are crucial to ensuring that medical care and research are conducted in an ethical manner and with the utmost respect for individual preferences and dignity. These regulations, however, often require - or are perceived to require - that informed consent documents and related materials contain language that is beyond the comprehension level of most patients and study participants. To explore what actions can be taken to help close the gap between what is required in the informed consent process and communicating it in a health-literate and meaningful manner to individuals, the Institute of Medicine's Roundtable on Health Literacy convened a one-day public workshop featuring presentations and discussions that examine the implications of health literacy for informed consent for both research involving human subjects and treatment of patients. Topics covered in this workshop included an overview of the ethical imperative to gain informed consent from patients and research participants, a review of the current state and best practices for informed consent in research and treatment, the connection between poor informed consent processes and minority underrepresentation in research, new approaches to informed consent that reflect principles of health literacy, and the future of informed consent in the treatment and research settings. Informed Consent and Health Literacy is the summary of the presentations and discussion of the workshop.


Health Care and the Law

Health Care and the Law
Author: Rebecca Keenan
Publisher: Thomson Brookers
Total Pages: 569
Release: 2010-01-01
Genre: Medical care
ISBN: 9780864726858

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Health Care and the Law 4th Edition is recognised as one of the leading texts setting out the basic principles of health care law in New Zealand. This book is an easy-to- understand, practical and uncomplicated account of health care law, making it an essential text for health practitioners, lawyers and students. Since 2004 when the 3rd edition of this book was published, there have been a number of legislative changes in the area of health law. This edition keeps you current with these changes, with updates made to all chapters. The inclusion of relevant case law also provides readers a greater understanding of the practicalities of the law, how it has been applied and how it may relate to them.


Registries for Evaluating Patient Outcomes

Registries for Evaluating Patient Outcomes
Author: Agency for Healthcare Research and Quality/AHRQ
Publisher: Government Printing Office
Total Pages: 396
Release: 2014-04-01
Genre: Medical
ISBN: 1587634333

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This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.


By Birth or Consent

By Birth or Consent
Author: Holly Brewer
Publisher: UNC Press Books
Total Pages: 407
Release: 2012-12-01
Genre: History
ISBN: 0807839124

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In mid-sixteenth-century England, people were born into authority and responsibility based on their social status. Thus elite children could designate property or serve in Parliament, while children of the poorer sort might be forced to sign labor contracts or be hanged for arson or picking pockets. By the late eighteenth century, however, English and American law began to emphasize contractual relations based on informed consent rather than on birth status. In By Birth or Consent, Holly Brewer explores how the changing legal status of children illuminates the struggle over consent and status in England and America. As it emerged through religious, political, and legal debates, the concept of meaningful consent challenged the older order of birthright and became central to the development of democratic political theory. The struggle over meaningful consent had tremendous political and social consequences, affecting the whole order of society. It granted new powers to fathers and guardians at the same time that it challenged those of masters and kings. Brewer's analysis reshapes the debate about the origins of modern political ideology and makes connections between Reformation religious debates, Enlightenment philosophy, and democratic political theory.


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
Total Pages: 216
Release: 2005-11-10
Genre: Social Science
ISBN: 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.


Model Rules of Professional Conduct

Model Rules of Professional Conduct
Author: American Bar Association. House of Delegates
Publisher: American Bar Association
Total Pages: 216
Release: 2007
Genre: Law
ISBN: 9781590318737

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The Model Rules of Professional Conduct provides an up-to-date resource for information on legal ethics. Federal, state and local courts in all jurisdictions look to the Rules for guidance in solving lawyer malpractice cases, disciplinary actions, disqualification issues, sanctions questions and much more. In this volume, black-letter Rules of Professional Conduct are followed by numbered Comments that explain each Rule's purpose and provide suggestions for its practical application. The Rules will help you identify proper conduct in a variety of given situations, review those instances where discretionary action is possible, and define the nature of the relationship between you and your clients, colleagues and the courts.