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

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.

Ethics, Medical Research, and Medicine

Ethics, Medical Research, and Medicine
Author: Andrew Thompson
Publisher: Springer Science & Business Media
Total Pages: 205
Release: 2011-06-27
Genre: Philosophy
ISBN: 9401007942

Andrew Thompson, Norman J. Temple We humans are an extraordinary species. One of our finest achievements is the development of morality, of a sense of right and wrong. We articulate and then impose this sensitivity upon ourselves in the form of ethical guidelines, rules, regulations, and laws. We have, regrettably, also developed marvelously clever ways of justifying our behavior whenever it runs afoul of these prescriptions. We have, for example, developed the concept of objectivity to guide scientific pursuits and subsequently established rights which undermine the possibility of ever coming close to attaining the goal of being objective -- rights which entitle participating scientists to gain personal, tangible profits from scientific discoveries. Formerly, we envisaged gods who kept us in place, who reminded us that we were not all-powerful or especially wise. Now we tend to worship our achievements, especially our technological ones, and ourselves. Mary Midgley' aptly names this phenomenon, "humanolatry." We have lost our respect for nature in our enthusiasm for changing it to that which suits our shortsighted ends. We must, as she says, "unlearn" this way of thinking.

How to Practice Academic Medicine and Publish from Developing Countries?

How to Practice Academic Medicine and Publish from Developing Countries?
Author: Samiran Nundy
Publisher: Springer Nature
Total Pages: 475
Release: 2021-10-23
Genre: Medical
ISBN: 9811652481

This is an open access book. The book provides an overview of the state of research in developing countries – Africa, Latin America, and Asia (especially India) and why research and publications are important in these regions. It addresses budding but struggling academics in low and middle-income countries. It is written mainly by senior colleagues who have experienced and recognized the challenges with design, documentation, and publication of health research in the developing world. The book includes short chapters providing insight into planning research at the undergraduate or postgraduate level, issues related to research ethics, and conduct of clinical trials. It also serves as a guide towards establishing a research question and research methodology. It covers important concepts such as writing a paper, the submission process, dealing with rejection and revisions, and covers additional topics such as planning lectures and presentations. The book will be useful for graduates, postgraduates, teachers as well as physicians and practitioners all over the developing world who are interested in academic medicine and wish to do medical research.

Rethinking Health Care Ethics

Rethinking Health Care Ethics
Author: Stephen Scher
Publisher: Springer
Total Pages: 177
Release: 2018-08-02
Genre: Philosophy
ISBN: 9811308306

​The goal of this open access book is to develop an approach to clinical health care ethics that is more accessible to, and usable by, health professionals than the now-dominant approaches that focus, for example, on the application of ethical principles. The book elaborates the view that health professionals have the emotional and intellectual resources to discuss and address ethical issues in clinical health care without needing to rely on the expertise of bioethicists. The early chapters review the history of bioethics and explain how academics from outside health care came to dominate the field of health care ethics, both in professional schools and in clinical health care. The middle chapters elaborate a series of concepts, drawn from philosophy and the social sciences, that set the stage for developing a framework that builds upon the individual moral experience of health professionals, that explains the discontinuities between the demands of bioethics and the experience and perceptions of health professionals, and that enables the articulation of a full theory of clinical ethics with clinicians themselves as the foundation. Against that background, the first of three chapters on professional education presents a general framework for teaching clinical ethics; the second discusses how to integrate ethics into formal health care curricula; and the third addresses the opportunities for teaching available in clinical settings. The final chapter, "Empowering Clinicians", brings together the various dimensions of the argument and anticipates potential questions about the framework developed in earlier chapters.

Medical Ethics in Clinical Practice

Medical Ethics in Clinical Practice
Author: Matjaž Zwitter
Publisher: Springer
Total Pages: 216
Release: 2019-01-04
Genre: Medical
ISBN: 3030007197

This book discusses medicine from an ethical perspective, whereas books on medical ethics more commonly present ethics from a bio-medical standpoint. The book is divided into 23 chapters. The introductory chapters present some basic concepts of medical ethics, such as the relation between the legal system and ethics, ethical documents, ethical theories, and ethical analysis. The following chapters address issues of importance in all fields of medicine: respecting autonomy, communication, relations within a healthcare team, professional malpractice, limited resources, and the portrait of a physician. In turn, the third part of the book focuses on ethical aspects in a broad range of medical activities – preventive medicine, human reproduction, genetics, pediatrics, intensive care, palliative medicine, clinical research, unproven methods in diagnostics and treatment, and the role of physicians who aren’t directly responsible for patient care. The last part presents students’ seminars with case stories. The book offers a valuable resource for physicians of all specialties, students of medicine, professionals, and students from other fields devoted to human health, journalists, and general readers with an interest in medicine.

Beyond the HIPAA Privacy Rule

Beyond the HIPAA Privacy Rule
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 334
Release: 2009-03-24
Genre: Computers
ISBN: 0309124999

In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.

The Oxford Textbook of Clinical Research Ethics

The Oxford Textbook of Clinical Research Ethics
Author: Ezekiel J. Emanuel
Publisher: OUP USA
Total Pages: 848
Release: 2011-02
Genre: Medical
ISBN: 0199768633

The Oxford Textbook of Clinical Research Ethics is the first comprehensive and systematic reference on clinical research ethics. Under the editorship of experts from the U.S. National Institutes of Health of the United States, the book's 73 chapters offer a wide-ranging and systematic examination of all aspects of research with human beings. Considering the historical triumphs of research as well as its tragedies, the textbook provides a framework for analyzing the ethical aspects of research studies with human beings. Through both conceptual analysis and systematic reviews of empirical data, the contributors examine issues ranging from scientific validity, fair subject selection, risk benefit ratio, independent review, and informed consent to focused consideration of international research ethics, conflicts of interests, and other aspects of responsible conduct of research. The editors of The Oxford Textbook of Clinical Research Ethics offer a work that critically assesses and advances scholarship in the field of human subjects research. Comprehensive in scope and depth, this book will be a crucial resource for researchers in the medical sciences, as well as teachers and students.

Understanding Clinical Research

Understanding Clinical Research
Author: Renato D. Lopes
Publisher: McGraw Hill Professional
Total Pages: 262
Release: 2013-05-22
Genre: Medical
ISBN: 0071792651

A complete guide to understanding and applying clinical research results Ideal for both researchers and healthcare providers Understanding Clinical Research addresses both the operational challenges of clinical trials and the needs of clinicians to comprehend the nuances of research methods to accurately analyze study results. This timely resource covers all aspects of clinical trials--from study design and statistics to regulatory oversight--and it delivers a detailed yet streamlined overview of must-know research topics. The text features an accessible three-part organization that traces the evolution of clinical research and explains the bedrock principles and unique challenges of clinical experimentation and observational research. Reinforcing this content are real-life case examples--drawn from the authors' broad experience--that put chapter concepts into action and contribute to a working knowledge of integral research techniques. FEATURES: The most definitive guide to promoting excellence in clinical research, designed to empower healthcare providers to assess a study's strengths and weaknesses with confidence and apply this knowledge to optimize patient outcomes In-depth coverage of fundamental research methods and protocols from preeminent authorities provides readers with an instructive primer and a springboard for ongoing clinical research education Clear, comprehensive three-part organization: Section One: Evolution of Clinical Research offers a succinct history of clinical trials, drug regulations, and the role of the FDA while covering the impact of information technology and academic research organizations Section Two: Principles of Clinical Experimentation takes you through the typical phases of clinical trials in the development of medical products, from initial human subject research to postapproval surveillance studies Section Three: Observational Research highlights the underlying principles, pitfalls, and methods for case-control studies, cohort studies, registries, and subgroup analyses within randomized trials

Issues in Medical Research Ethics

Issues in Medical Research Ethics
Author: Jürgen Boomgaarden
Publisher: Berghahn Books
Total Pages: 152
Release: 2003
Genre: Law
ISBN: 9781571816016

With the advances of medicine, questions of medical ethics have become more urgent and are now considered of great social and political significance. An innovatively designed, activity-based workbook, this text was prepared using papers and case studies collected from several countries in the European Union. It reflects the issues and concerns that confront clinical practitioners throughout Europe and elsewhere today and presents varying national responses in law and policy to these concerns, as identified by ethicists, lawyers, theologians and practitioners. The problems they examine include the relationship between medical research and medical practice, elementary regulations of medical research, the complexity of informed consent, and the role of the sponsor or scientific community.