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Ethical Considerations When Preparing a Clinical Research Protocol

Ethical Considerations When Preparing a Clinical Research Protocol
  • Author : Evan DeRenzo,Eric A. Singer,Joel Moss
  • Publisher :Unknown
  • Release Date :2020-07-10
  • Total pages :370
  • ISBN : 0123869358
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Summary : 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. Walks investigators and trainees through the identification of the ethical aspects of each section of a clinical research protocol Includes case histories that illustrate key points Contains information on conducting clinical research within the pharmaceutical industry Includes internet resources and worldwide web addresses for important research ethics documents and regulations Contains a chapter on Study Design and Methodology that is purposely expanded to explicitly address biostatistical considerations

Writing Clinical Research Protocols

Writing Clinical Research Protocols
  • Author : Evan DeRenzo,Joel Moss
  • Publisher :Unknown
  • Release Date :2005-09-08
  • Total pages :320
  • ISBN : 9780080454207
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Summary : This highly engaging guide for clinical researchers provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. Writing Clinical Research Protocols includes practical information on ethical principles in clinical research, designing appropriate research studies, writing consent and assent documents, getting protocols approved, special populations, confidentiality issues, and the reporting of adverse events. A valuable appendix includes a listing of web resources about research ethics as well as a glossary. This is an invaluable resource for basic scientists collaborating in clinical trials, physician investigators, clinical research fellows, research nurse coordinators, residents, and anyone who wants a better understanding of the clinical trials process. Walks investigators and trainees through identification of the ethical aspects of each section of a clinical research protocol Includes a chapter containing Case Histories Contains information on conducting clinical research within the pharmaceutical industry An appendix includes internet resources and world wide web addresses for important research ethics documents and regulations Chapter on 'Study Design and Methodology' purposely expanded to explicitly address biostatistical considerations

Ethical and Regulatory Aspects of Clinical Research

Ethical and Regulatory Aspects of Clinical Research
  • Author : Ezekiel J. Emanuel,Chair of the Department of Clinical Bioethics Ezekiel J Emanuel,Christine Grady,The Poynter Center for the Study of Ethics and American Institutions Robert A Crouch,Robert A. Crouch,John D. Arras,David and Lyn Silfen University Professor Jonathan D Moreno, PhD,Jonathan D. Moreno
  • Publisher :Unknown
  • Release Date :2003
  • Total pages :490
  • ISBN : 09876543XX
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Summary : Professionals in need of such training and bioethicists will be interested.

Principles and Practice of Clinical Research

Principles and Practice of Clinical Research
  • Author : John I. Gallin,Frederick P. Ognibene
  • Publisher :Unknown
  • Release Date :2007
  • Total pages :430
  • ISBN : 9780123694409
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Summary : The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers. *Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research *Delves into data management and addresses how to collect data and use it for discovery *Contains valuable, up-to-date information on how to obtain funding from the federal government

Reviewing Clinical Trials

Reviewing Clinical Trials
  • Author : Chinese University of Hong Kong,Chinese University of Hong Kong. Clinical Trials Centre,Washington, DC. Association for the Accreditation of Human research Protection Programs, Inc
  • Publisher :Unknown
  • Release Date :2010
  • Total pages :153
  • ISBN : 9789881904119
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Summary : The idea for this manual came from Pfizer in the US, which provided the Clinical Trials Centre at The University of Hong Kong, Hong Kong SAR, PR China with a nonbinding grant for its development. The general project layout protocol was accepted by Pfizer in July 2009. Pfizer has not in any way interfered with the project, except for providing nonbinding comments to the final product. The entire text of this manual was written by Johan PE Karlberg. Marjorie A Speers provided considerable and essential comments on the contents and the first and subsequent drafts. A group of international human research protection experts mostly working in non-profit institutions or organisations - see Contributors for details - reviewed and provided important comments on the contents and final draft. It was solely created with the intention to promote human research protection of participants in clinical trials. This manual will be translated into numerous languages and is provided free of charge as an electronic file over the Internet (http://www.ClinicalTrialMagnifier.com) and offered in print for a fee. The objective beyond this project is to establish educational activities, developed around the manual, and jointly organised with leading academic institutions worldwide.

The Oxford Textbook of Clinical Research Ethics

The Oxford Textbook of Clinical Research Ethics
  • Author : Ezekiel J. Emanuel,Christine C. Grady,Robert A. Crouch,Reidar K. Lie,Franklin G. Miller,David D. Wendler
  • Publisher :Unknown
  • Release Date :2011-02
  • Total pages :848
  • ISBN : 0199768633
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Summary : 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.

Ethical Conduct of Clinical Research Involving Children

Ethical Conduct of Clinical Research Involving Children
  • Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children
  • Publisher :Unknown
  • Release Date :2004-07-09
  • Total pages :445
  • ISBN : 9780309133388
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Summary : 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.

Clinical Trials in Vulnerable Populations

Clinical Trials in Vulnerable Populations
  • Author : Milica Prostran
  • Publisher :Unknown
  • Release Date :2018-05-09
  • Total pages :224
  • ISBN : 1789232007
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Summary : 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.

Surviving Your Thesis

Surviving Your Thesis
  • Author : Suzan Burton,Peter Steane
  • Publisher :Unknown
  • Release Date :2004
  • Total pages :254
  • ISBN : 9780415322225
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Summary : For those undertaking a higher degree research qualification, 'How To Survive Your Thesis' describes clearly the challenges and complexities of successfully engaging in both the research process and thesis writing.

Current Topics in Public Health

Current Topics in Public Health
  • Author : Alfonso J. Rodriguez-Morales
  • Publisher :Unknown
  • Release Date :2013-05-15
  • Total pages :744
  • ISBN : 9535111213
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Summary : Public Health is regarded as the basis and cornerstone of health, generally and in medicine. Defined as the science and art of preventing disease, prolonging life and promoting health through the organized efforts and informed choices of society, organizations, public and private, communities and individuals, this discipline has been renewed by the incorporation of multiple actors, professions, knowledge areas and it has also been impacted and promoted by multiple technologies, particularly - the information technology. As a changing field of knowledge, Public Health requires evidence-based information and regular updates. Current Topics in Public Health presents updated information on multiple topics related to actual areas of interest in this growing and exciting medical science, with the conception and philosophy that we are working to improve the health of the population, rather than treating diseases of individual patients, taking decisions about collective health care that are based on the best available, current, valid and relevant evidence, and finally within the context of available resources. With participation of authors from multiple countries, many from developed and developing ones, this book offers a wide geographical perspective. Finally, all these characteristics make this book an excellent update on many subjects of world public health.

Handbook for Good Clinical Research Practice (GCP)

Handbook for Good Clinical Research Practice (GCP)
  • Author : World Health Organization
  • Publisher :Unknown
  • Release Date :2005
  • Total pages :125
  • ISBN : 9789241593922
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Summary :

Research Ethics in Africa

Research Ethics in Africa
  • Author : Mariana Kruger,Paul Ndebele,Lyn Horn
  • Publisher :Unknown
  • Release Date :2014-06-01
  • Total pages :224
  • ISBN : 1920689303
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Summary : The aim of this book is to provide research ethics committee members with a resource that focuses on research ethics issues in Africa. The authors are currently active in various aspects of research ethics in Africa and the majority have been trained in the past by either the Fogarty International Center or Europe and Developing Countries Clinical Trial Partnership (EDCTP) sponsored bioethics training programmes .

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,National Research Council,Division of Behavioral and Social Sciences and Education,Board on Children, Youth, and Families,Committee on Ethical Issues in Housing-Related Health Hazard Research Involving Children, Youth, and Families
  • Publisher :Unknown
  • Release Date :2005-12-10
  • Total pages :216
  • ISBN : 0309097266
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Summary : 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.

Innovation in Medical Technology

Innovation in Medical Technology
  • Author : Margaret L. Eaton,Donald Kennedy
  • Publisher :Unknown
  • Release Date :2007-02-28
  • Total pages :155
  • ISBN : 9780801885266
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Summary : This thought-provoking study examines the ethical, legal, and social problems that arise with cutting-edge medical technology. Using as examples four powerful and largely unregulated technologies—off-label use of drugs, innovative surgery, assisted reproduction, and neuroimaging—Margaret L. Eaton and Donald Kennedy illustrate the difficult challenges faced by clinicians, researchers, and policy makers who seek to advance the frontiers of medicine safely and responsibly. Supported by medical history and case studies and drawing on reports from dozens of experts, the authors address important practical, ethical, and policy issues. They consider topics such as the responsible introduction of new medical products and services, the importance of patient consent, the extent of the duty to mitigate harm, and the responsibility to facilitate access to new medical therapies. This work's insights into the nature and consequences of medical innovation contribute to the national debate on how best to protect patients while fostering innovation and securing benefits.

Integrating Clinical Research into Epidemic Response

Integrating Clinical Research into Epidemic Response
  • Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Board on Global Health,Committee on Clinical Trials During the 2014-2015 Ebola Outbreak
  • Publisher :Unknown
  • Release Date :2017-07-26
  • Total pages :342
  • ISBN : 0309457769
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Summary : The 2014â€"2015 Ebola epidemic in western Africa was the longest and most deadly Ebola epidemic in history, resulting in 28,616 cases and 11,310 deaths in Guinea, Liberia, and Sierra Leone. The Ebola virus has been known since 1976, when two separate outbreaks were identified in the Democratic Republic of Congo (then Zaire) and South Sudan (then Sudan). However, because all Ebola outbreaks prior to that in West Africa in 2014â€"2015 were relatively isolated and of short duration, little was known about how to best manage patients to improve survival, and there were no approved therapeutics or vaccines. When the World Heath Organization declared the 2014-2015 epidemic a public health emergency of international concern in August 2014, several teams began conducting formal clinical trials in the Ebola affected countries during the outbreak. Integrating Clinical Research into Epidemic Response: The Ebola Experience assesses the value of the clinical trials held during the 2014â€"2015 epidemic and makes recommendations about how the conduct of trials could be improved in the context of a future international emerging or re-emerging infectious disease events.

Oncology Clinical Trials

Oncology Clinical Trials
  • Author : Susan Halabi, PhD,Wm. Kevin Kelly, DO
  • Publisher :Unknown
  • Release Date :2009-12-22
  • Total pages :168
  • ISBN : 9781935281764
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Summary : Clinical trials are the engine of progress in the development of new drugs and devices for the detection, monitoring, prevention and treatment of cancer. A well conceived, carefully designed and efficiently conducted clinical trial can produce results that change clinical practice overnight, deliver new oncology drugs and diagnostics to the marketplace, and expand the horizon of contemporary thinking about cancer biology. A poorly done trial does little to advance the field or guide clinical practice, consumes precious clinical and financial resources and challenges the validity of the ethical contract between investigators and the volunteers who willingly give their time and effort to benefit future patients. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, Oncology Clinical Trials, provides a comprehensive guide for both early-career and senior oncology investigators into the successful design, conduct and analysis of an oncology clinical trial. Oncology Clinical Trials covers how to formulate a study question, selecting a study population, study design of Phase I, II, and III trials, toxicity monitoring, data analysis and reporting, use of genomics, cost-effectiveness analysis, systemic review and meta-analysis, and many other issues. Many examples of real-life flaws in clinical trials that have been reported in the literature are included throughout. The book discusses clinical trials from start to finish focusing on real-life examples in the development, design and analysis of clinical trials. Oncology Clinical Trials features: A systematic guide to all aspects of the design, conduct, analysis, and reporting of clinical trials in oncology Contributions from oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives Hot topics in oncology trials including multi-arm trials, meta-analysis and adaptive design, use of genomics, and cost-effectiveness analysis Real-life examples from reported clinical trials included throughout

Mixed Methods in Health Sciences Research

Mixed Methods in Health Sciences Research
  • Author : Leslie Curry,Marcella Nunez-Smith
  • Publisher :Unknown
  • Release Date :2014-09-30
  • Total pages :432
  • ISBN : 1483347141
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Summary : Mixed Methods in Health Sciences Research: A Practical Primer, by Leslie Curry and Marcella Nunez-Smith, presents key theories, concepts, and approaches in an accessible way. Packed with illustrations from the health sciences literature, this ready-to-use guidebook shows readers how to design, conduct, review, and use mixed methods research findings. Helpful checklists, figures, tables, templates, and much more give readers examples that will elevate the quality of their research, facilitate communication about their methods, and improve efficiency over the course of their projects. Real-world examples and insights from mixed methods researchers provide unique perspectives on every aspect of mixed methods research. This book successfully pulls together foundational mixed methods principles, synthesizes the knowledge base in the field, and translates it for a health science researcher audience. “The content is highly applicable to real life research teams in the areas of clinical research, health services research, and implementation science, providing sound content and practical advice. The authors have synthesized and pull key concepts from a variety of sources to provide a concise resource.” —Linda M. Herrick, South Dakota State University “Everything from the references, to the topics, checklists, conceptual graphic representations, and organizers, interviews, and resources, all contribute to the content and aid with understanding and/or application. … It addresses specific MM research as it pertains to health sciences in a way that other texts just do not even attempt.” —Denise L. Winsor, University of Memphis “[This text is] a very pragmatic approach to mixed methods research; excellent resources, tables, and figures [are] provided, along with cases and examples of value to researchers and grant reviewers. Its relevance to practice, education, and research, as well as to potential policy implications, is a strong focus that would make this a valued textbook for any researcher!” ? —Karen Devereaux Melillo, University of Massachusetts Lowell “The text is cutting edge. It leads the way with its focus on team dynamics. [The authors] succeed in making the book relevant and practical. They also articulate a number of key insights in the area of mixed methods that rarely get addressed, such as teams and conflict. Great read with a lot of good, practical information for mixed methods researchers at all levels. The practical approach of this text makes it an innovative and valuable resource.” —John G. Schumacher, University of Maryland

Design and Analysis of Clinical Trials

Design and Analysis of Clinical Trials
  • Author : Shein-Chung Chow,Jen-Pei Liu
  • Publisher :Unknown
  • Release Date :2004
  • Total pages :729
  • ISBN : 09876543XX
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Summary : Presentation of principles and methodologies for various clinical trials, and a well-balanced summary of current regulatory requirements. Emphasizes real-life examples and illustrations from clinical case studies, as well as numerous references.

Field Trials of Health Interventions

Field Trials of Health Interventions
  • Author : Richard H. Morrow,David A. Ross
  • Publisher :Unknown
  • Release Date :2015-06-11
  • Total pages :480
  • ISBN : 0198732864
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Summary : Before new interventions can be used in disease control programmes, it is essential that they are carefully evaluated in "field trials", which may be complex and expensive undertakings. Descriptions of the detailed procedures and methods used in trials that have been conducted in the past have generally not been published. As a consequence, those planning such trials have few guidelines available and little access to previously accumulated knowledge. In this book the practical issues of trial design and conduct are discussed fully and in sufficient detail for the text to be used as a "toolbox" by field investigators. The toolbox has now been extensively tested through use of the first two editions and this third edition is a comprehensive revision, incorporating the many developments that have taken place with respect to trials since 1996 and involving more than 30 contributors. Most of the chapters have been extensively revised and 7 new chapters have been added.

Exploitation and Developing Countries

Exploitation and Developing Countries
  • Author : Jennifer S. Hawkins,Ezekiel J. Emanuel
  • Publisher :Unknown
  • Release Date :2008-08-04
  • Total pages :320
  • ISBN : 1400837324
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Summary : When is clinical research in developing countries exploitation? Exploitation is a concept in ordinary moral thought that has not often been analyzed outside the Marxist tradition. Yet it is commonly used to describe interactions that seem morally suspect in some way. A case in point is clinical research sponsored by developed countries and carried out in developing countries, with participants who are poor and sick, and lack education. Such individuals seem vulnerable to abuse. But does this, by itself, make such research exploitative? Exploitation and Developing Countries is an attempt by philosophers and bioethicists to reflect on the meaning of exploitation, to ask whether and when clinical research in developing countries counts as exploitative, and to consider what can be done to minimize the possibility of exploitation in such circumstances. These reflections should interest clinical researchers, since locating the line between appropriate and inappropriate use of subjects--the line between exploitation and fair use--is the central question at the heart of research ethics. Reflection on this rich and important moral concept should also interest normative moral philosophers of a non-Marxist bent. In addition to the editors, the contributors are Richard J. Arneson, Alisa L. Carse, Margaret Olivia Little, Thomas Pogge, Andrew W. Siegel, and Alan Wertheimer.

Running Behavioral Studies With Human Participants

Running Behavioral Studies With Human Participants
  • Author : Frank E. Ritter,Jong W. Kim,Jonathan H. Morgan,Richard A. Carlson
  • Publisher :Unknown
  • Release Date :2013
  • Total pages :183
  • ISBN : 1452217424
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Summary : Running Behavioral Experiments With Human Participants: A Practical Guide, by Frank E. Ritter, Jong W. Kim, Jonathan H. Morgan, and Richard A. Carlson, provides a concrete, practical roadmap for the implementation of experiments and controlled observation using human participants. Ideal for those with little or no practical experience in research methodology, the text covers both conceptual and practical issues that are critical to implementing an experiment. The book is organized to follow a standard process in experiment-based research, covering such issues as potential ethical problems, risks to validity, experimental setup, running a study, and concluding a study.