Ethical Considerations When Preparing A Clinical Research Protocol
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Ethical Considerations When Preparing A Clinical Research Protocol
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Author : Evan DeRenzo
language : en
Publisher: Academic Press
Release Date : 2020-06-25
Ethical Considerations When Preparing A Clinical Research Protocol written by Evan DeRenzo and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-06-25 with Medical categories.
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
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Author : Evan G. DeRenzo
language : en
Publisher: Academic Press
Release Date : 2006
Writing Clinical Research Protocols written by Evan G. DeRenzo and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006 with Medical categories.
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. It 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 will be 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 Issues In Clinical Research
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Author : Bernard Lo
language : en
Publisher: Lippincott Williams & Wilkins
Release Date : 2012-03-28
Ethical Issues In Clinical Research written by Bernard Lo and has been published by Lippincott Williams & Wilkins this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-03-28 with Medical categories.
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.
Ethical Conduct Of Clinical Research Involving Children
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2004-07-09
Ethical Conduct Of Clinical Research Involving Children written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004-07-09 with Medical categories.
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.
Ethical And Policy Issues In International Research
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Author : United States. National Bioethics Advisory Commission
language : en
Publisher:
Release Date : 2001
Ethical And Policy Issues In International Research written by United States. National Bioethics Advisory Commission and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2001 with Clinical trials categories.
Field Trials Of Health Interventions
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Author : Peter G. Smith
language : en
Publisher: Oxford University Press, USA
Release Date : 2015
Field Trials Of Health Interventions written by Peter G. Smith and has been published by Oxford University Press, USA this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015 with Medical categories.
"IEA, International Epidemiological Association, Welcome Trust."
Ethics In Clinical Research
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Author : Dr. Jane Barrett
language : en
Publisher: Inst of Clinical Research
Release Date : 2006
Ethics In Clinical Research written by Dr. Jane Barrett and has been published by Inst of Clinical Research this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006 with Clinical medicine categories.
Until recently there has been no formal law covering many aspects of clinical research, making the ethical and scientific guidelines more important. Rapidly changing law gives researchers challenges when deciding research policies. There is relatively little teaching on the ethics of clinical research and this monograph intends to trigger thought and discussion as well as provide guidance in decision-making.
Ethical And Policy Issues In International Research Commissioned Papers And Staff Analysis
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Author : United States. National Bioethics Advisory Commission
language : en
Publisher:
Release Date : 2001
Ethical And Policy Issues In International Research Commissioned Papers And Staff Analysis written by United States. National Bioethics Advisory Commission and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2001 with Bioethics categories.
Sharing Clinical Trial Data
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2015-04-20
Sharing Clinical Trial Data written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-04-20 with Medical categories.
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.
Ethical Challenges In Study Design And Informed Consent For Health Research In Resource Poor Settings
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Author : Patricia A. Marshall
language : en
Publisher: World Health Organization
Release Date : 2007
Ethical Challenges In Study Design And Informed Consent For Health Research In Resource Poor Settings written by Patricia A. Marshall and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007 with Medical categories.
This review considers ethical challenges to research design and informed consent in biomedical and behavioral studies conducted in resource-poor settings. A review of the literature explores relevant social, cultural, and ethical issues in the conduct of biomedical and social health research in developing countries. Ten case vignettes illustrate ethical challenges that arise in international research with culturally diverse populations. Recommendations for researchers and policy-makers concerned about ethical practices in multinational studies conducted in resource-poor settings are also listed.