Ethical Conduct of Clinical Research Involving Children

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Publisher : National Academies Press
ISBN 13 : 0309133386
Total Pages : 445 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Ethical Conduct of Clinical Research Involving Children by : Institute of Medicine

Download or read book Ethical Conduct of Clinical Research Involving Children written by Institute of Medicine and published by National Academies Press. This book was released on 2004-07-09 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Women and Health Research

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Publisher : National Academies Press
ISBN 13 : 030904992X
Total Pages : 286 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis Women and Health Research by : Institute of Medicine

Download or read book Women and Health Research written by Institute of Medicine and published by National Academies Press. This book was released on 1994-02-01 with total page 286 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the nineteenth century some scientists argued that women should not be educated because thinking would use energy needed by the uterus for reproduction. The proof? Educated women had a lower birth rate. Today's researchers can only shake their heads at such reasoning. Yet professional journals and the popular press are increasingly criticizing medical research for ignoring women's health issues. Women and Health Research examines the facts behind the public's perceptions about women participating as subjects in medical research. With the goal of increasing researchers' awareness of this important topic, the book explores issues related to maintaining justice (in its ethical sense) in clinical studies. Leading experts present general principles for the ethical conduct of research on womenâ€"principles that are especially important in the light of recent changes in federal policy on the inclusion of women in clinical research. Women and Health Research documents the historical shift from a paternalistic approach by researchers toward women and a disproportionate reliance on certain groups for research to one that emphasizes proper access for women as subjects in clinical studies in order to ensure that women receive the benefits of research. The book addresses present-day challenges to equity in four areas: Scientificâ€"Do practical aspects of scientific research work at cross-purposes to gender equity? Focusing on drug trials, the authors identify rationales for excluding people from research based on demographics. Social and Ethicalâ€"The authors offer compelling discussions on subjectivity in science, the evidence for male bias, and issues related to race and ethnicity, as well as the recruitment, retention, and protection of research participants. Legalâ€"Women and Health Research reviews federal research policies that affect the inclusion of women and evaluates the basis for researchers' fears about liability, citing court cases. Riskâ€"The authors focus on risks to reproduction and offspring in clinical drug trials, exploring how risks can be identified for study participants, who should make the assessment of risk and benefit for participation in a clinical study, and how legal implications could be addressed. This landmark study will be of immediate use to the research community, policymakers, women's health advocates, attorneys, and individuals.

Ethical and Policy Issues in International Research

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Publisher :
ISBN 13 :
Total Pages : 388 pages
Book Rating : 4.3/5 ( download)

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Book Synopsis Ethical and Policy Issues in International Research by : United States. National Bioethics Advisory Commission

Download or read book Ethical and Policy Issues in International Research written by United States. National Bioethics Advisory Commission and published by . This book was released on 2001 with total page 388 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Field Trials of Health Interventions

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Publisher :
ISBN 13 : 0198732864
Total Pages : 479 pages
Book Rating : 4.1/5 (987 download)

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Book Synopsis Field Trials of Health Interventions by : Peter G. Smith

Download or read book Field Trials of Health Interventions written by Peter G. Smith and published by . This book was released on 2015 with total page 479 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is an open access title available under the terms of a CC BY-NC 4.0 International licence. It is free to read at Oxford Scholarship Online and offered as a free PDF download from OUP and selected open access locations. Before new interventions are released into disease control programmes, it is essential that they are carefully evaluated in field trials'. These may be complex and expensive undertakings, requiring the follow-up of hundreds, or thousands, of individuals, often for long periods. Descriptions of the detailed procedures and methods used in the trials that have been conducted have rarely been published. A consequence of this, individuals planning such trials have few guidelines available and little access to knowledge accumulated previously, other than their own. In this manual, practical issues in trial design and conduct are discussed fully and in sufficient detail, that Field Trials of Health Interventions may be used as a toolbox' by field investigators. It has been compiled by an international group of over 30 authors with direct experience in the design, conduct, and analysis of field trials in low and middle income countries and is based on their accumulated knowledge and experience. Available as an open access book via Oxford Medicine Online, this new edition is a comprehensive revision, incorporating the new developments that have taken place in recent years with respect to trials, including seven new chapters on subjects ranging from trial governance, and preliminary studies to pilot testing.

Understanding Clinical Research

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Publisher : McGraw Hill Professional
ISBN 13 : 0071792651
Total Pages : 262 pages
Book Rating : 4.0/5 (717 download)

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Book Synopsis Understanding Clinical Research by : Renato D. Lopes

Download or read book Understanding Clinical Research written by Renato D. Lopes and published by McGraw Hill Professional. This book was released on 2013-05-22 with total page 262 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Double Standards in Medical Research in Developing Countries

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Publisher : Cambridge University Press
ISBN 13 : 9780521541701
Total Pages : 292 pages
Book Rating : 4.5/5 (417 download)

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Book Synopsis Double Standards in Medical Research in Developing Countries by : Ruth Macklin

Download or read book Double Standards in Medical Research in Developing Countries written by Ruth Macklin and published by Cambridge University Press. This book was released on 2004-05-27 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent international developments show that essential medications can be made affordable and accessible to developing countries, and that double standards need not prevail. This is the first book to examine these issues, drawing the bold conclusion that double standards in medical research are ethically unacceptable."--BOOK JACKET.

The Belmont Report

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Publisher :
ISBN 13 :
Total Pages : 614 pages
Book Rating : 4.:/5 (327 download)

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Book Synopsis The Belmont Report by : United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

Download or read book The Belmont Report written by United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and published by . This book was released on 1978 with total page 614 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Ethical Considerations When Preparing a Clinical Research Protocol

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Publisher : Academic Press
ISBN 13 : 0123869358
Total Pages : 368 pages
Book Rating : 4.1/5 (238 download)

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Book Synopsis Ethical Considerations When Preparing a Clinical Research Protocol by : Evan DeRenzo

Download or read book Ethical Considerations When Preparing a Clinical Research Protocol written by Evan DeRenzo and published by Academic Press. This book was released on 2020-06-11 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: Ethical Considerations When Preparing a Clinical Research Protocol, Second Edition, provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. It includes practical information on ethical principles in clinical research, how to design appropriate research studies, how to consent and assent documents, how to get protocols approved, special populations, confidentiality issues, and the reporting of adverse events. The book's valuable appendix includes a listing of web resources about research ethics, along with a glossary, making it an invaluable resource for scientists collaborating in clinical trials, physician investigators, clinical research fellows, and more.

Ethical Issues in International Biomedical Research

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Publisher :
ISBN 13 : 0195179226
Total Pages : 401 pages
Book Rating : 4.1/5 (951 download)

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Book Synopsis Ethical Issues in International Biomedical Research by : James V. Lavery

Download or read book Ethical Issues in International Biomedical Research written by James V. Lavery and published by . This book was released on 2007 with total page 401 pages. Available in PDF, EPUB and Kindle. Book excerpt: Ethical Issues in International Biomedical Research is the definitive book on the ethics of research involving human subjects in developing countries. Using 21 actual case studies, it covers the most controversial topics, including the ethics of placebo research in Africa, what benefits should be provided to the community after completion of a research trial, how to address conflicts between IRBs in developed and developing countries, and undue inducement of poor people in developing countries. Each case is accompanied by two expert commentaries, written by many of the worlds leading experts in bioethics as well as new voices with research experience in developing countries. No other volume has this scope. Students in bioethics, public and international health, and ethics will find this book particularly useful.

How to Practice Academic Medicine and Publish from Developing Countries?

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Author :
Publisher : Springer Nature
ISBN 13 : 9811652481
Total Pages : 475 pages
Book Rating : 4.8/5 (116 download)

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Book Synopsis How to Practice Academic Medicine and Publish from Developing Countries? by : Samiran Nundy

Download or read book How to Practice Academic Medicine and Publish from Developing Countries? written by Samiran Nundy and published by Springer Nature. This book was released on 2021-10-23 with total page 475 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

The Oxford Textbook of Clinical Research Ethics

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Publisher : OUP USA
ISBN 13 : 0199768633
Total Pages : 848 pages
Book Rating : 4.1/5 (997 download)

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Book Synopsis The Oxford Textbook of Clinical Research Ethics by : Ezekiel J. Emanuel

Download or read book The Oxford Textbook of Clinical Research Ethics written by Ezekiel J. Emanuel and published by OUP USA. This book was released on 2011-02 with total page 848 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Sharing Clinical Trial Data

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Publisher : National Academies Press
ISBN 13 : 0309316324
Total Pages : 236 pages
Book Rating : 4.3/5 (93 download)

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Book Synopsis Sharing Clinical Trial Data by : Institute of Medicine

Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Issues in Medical Research Ethics

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Publisher : Berghahn Books
ISBN 13 : 9781571816016
Total Pages : 152 pages
Book Rating : 4.8/5 (16 download)

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Book Synopsis Issues in Medical Research Ethics by : Jürgen Boomgaarden

Download or read book Issues in Medical Research Ethics written by Jürgen Boomgaarden and published by Berghahn Books. This book was released on 2003 with total page 152 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Ethical and Regulatory Aspects of Clinical Research

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Publisher :
ISBN 13 :
Total Pages : 532 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Ethical and Regulatory Aspects of Clinical Research by : Ezekiel J. Emanuel

Download or read book Ethical and Regulatory Aspects of Clinical Research written by Ezekiel J. Emanuel and published by . This book was released on 2003 with total page 532 pages. Available in PDF, EPUB and Kindle. Book excerpt: Professionals in need of such training and bioethicists will be interested.

Clinical Trials in Vulnerable Populations

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Publisher : BoD – Books on Demand
ISBN 13 : 1789232007
Total Pages : 226 pages
Book Rating : 4.7/5 (892 download)

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Book Synopsis Clinical Trials in Vulnerable Populations by : Milica Prostran

Download or read book Clinical Trials in Vulnerable Populations written by Milica Prostran and published by BoD – Books on Demand. This book was released on 2018-05-09 with total page 226 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book Clinical Trials in Vulnerable Populations has 12 chapters divided into 4 sections: Minority Patients, Women, Medically Compromised Patients and Clinical Trials. Contributing authors came from several countries, from Serbia to Turkey. The book was edited by Professor Milica Prostran MD, Ph.D., specialist in Clinical Pharmacology. The potential reader is shown a modern approach to clinical trials in vulnerable populations, from different points of view. The chapters deal at length and clarity with their topics. Finally, I believe, that this book I edited and reviewed with dedication will capture the attention of many readers, from medical students to practicing doctors and pharmacists. All of whom must consider this very important field of medicine: clinical trials in vulnerable patients.

Ethics in Scientific Research

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Publisher :
ISBN 13 : 9781977402691
Total Pages : 118 pages
Book Rating : 4.4/5 (26 download)

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Book Synopsis Ethics in Scientific Research by : Cortney Weinbaum

Download or read book Ethics in Scientific Research written by Cortney Weinbaum and published by . This book was released on 2019-06-05 with total page 118 pages. Available in PDF, EPUB and Kindle. Book excerpt: Scientific research ethics vary by discipline and by country, and this analysis sought to understand those variations. The authors reviewed literature and conducted interviews to provide researchers, government officials, and others who create, modify, and enforce ethics in scientific research around the world with an understanding of how ethics are created, monitored, and enforced across scientific disciplines and across international borders.

Code of Ethics for Nurses with Interpretive Statements

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Publisher : Nursesbooks.org
ISBN 13 : 1558101764
Total Pages : 42 pages
Book Rating : 4.5/5 (581 download)

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Book Synopsis Code of Ethics for Nurses with Interpretive Statements by : American Nurses Association

Download or read book Code of Ethics for Nurses with Interpretive Statements written by American Nurses Association and published by Nursesbooks.org. This book was released on 2001 with total page 42 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pamphlet is a succinct statement of the ethical obligations and duties of individuals who enter the nursing profession, the profession's nonnegotiable ethical standard, and an expression of nursing's own understanding of its commitment to society. Provides a framework for nurses to use in ethical analysis and decision-making.