Ethical Considerations When Preparing a Clinical Research Protocol

Ethical Considerations When Preparing a Clinical Research Protocol
Author: Evan DeRenzo,Eric A. Singer,Joel Moss
Publsiher: Academic Press
Total Pages: 370
Release: 2020-06-12
ISBN 10: 0123869544
ISBN 13: 9780123869548
Language: EN, FR, DE, ES & NL

Ethical Considerations When Preparing a Clinical Research Protocol Book Review:

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

Ethical Considerations When Preparing a Clinical Research Protocol

Ethical Considerations When Preparing a Clinical Research Protocol
Author: Evan DeRenzo,Eric A. Singer,Joel Moss
Publsiher: Academic Press
Total Pages: 370
Release: 2020-07-10
ISBN 10: 0123869358
ISBN 13: 9780123869357
Language: EN, FR, DE, ES & NL

Ethical Considerations When Preparing a Clinical Research Protocol Book Review:

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

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
Publsiher: Unknown
Total Pages: 153
Release: 2010
ISBN 10: 9789881904119
ISBN 13: 9881904110
Language: EN, FR, DE, ES & NL

Reviewing Clinical Trials Book Review:

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.

Sharing Clinical Trial Data

Sharing Clinical Trial Data
Author: Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Responsible Sharing of Clinical Trial Data
Publsiher: National Academies Press
Total Pages: 304
Release: 2015-04-20
ISBN 10: 0309316324
ISBN 13: 9780309316323
Language: EN, FR, DE, ES & NL

Sharing Clinical Trial Data Book Review:

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 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
Publsiher: National Academies Press
Total Pages: 445
Release: 2004-07-09
ISBN 10: 9780309133388
ISBN 13: 0309133386
Language: EN, FR, DE, ES & NL

Ethical Conduct of Clinical Research Involving Children Book Review:

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 Issues in Research

Ethical Issues in Research
Author: Darwin Cheney
Publsiher: Univ Publishing Group
Total Pages: 237
Release: 1993
ISBN 10: 1928374650XXX
ISBN 13: UOM:39015033117782
Language: EN, FR, DE, ES & NL

Ethical Issues in Research Book Review:

Responsible Research

Responsible Research
Author: Institute of Medicine,Committee on Assessing the System for Protecting Human Research Participants
Publsiher: National Academies Press
Total Pages: 312
Release: 2003-02-06
ISBN 10: 0309084881
ISBN 13: 9780309084888
Language: EN, FR, DE, ES & NL

Responsible Research Book Review:

When 18-year-old Jesse Gelsinger died in a gene transfer study at the University of Pennsylvania, the national spotlight focused on the procedures used to ensure research participants’ safety and their capacity to safeguard the well-being of those who volunteer for research studies. Responsible Research outlines a three-pronged approach to ensure the protection of every participant through the establishment of effective Human Research Participant Protection Programs (HRPPPs). The approach includes: Improved research review processes, Recognition and integration of research participants’ contributions to the system, and Vigilant maintenance of HRPPP performance. Issues addressed in the book include the need for in-depth, complimentary reviews of science, ethics, and conflict of interest reviews; desired qualifications for investigators and reviewers; the process of informed consent; federal and institutional oversight; and the role of accreditation. Recommendations for areas of key interest include suggestions for legislative approaches, compensation for research-related injury, and the refocusing of the mission of institutional review boards. Responsible Research will be important to anyone interested in the issues that are relevant to the practice of using human subjects as research participants, but especially so to policy makers, research administrators, investigators, and research sponsors â€" but also including volunteers who may agree to serve as research participants.

Pharmaceutical Medicine and Translational Clinical Research

Pharmaceutical Medicine and Translational Clinical Research
Author: Divya Vohora,Gursharan Singh
Publsiher: Academic Press
Total Pages: 526
Release: 2017-11-14
ISBN 10: 0128020989
ISBN 13: 9780128020982
Language: EN, FR, DE, ES & NL

Pharmaceutical Medicine and Translational Clinical Research Book Review:

Pharmaceutical Medicine and Translational Clinical Research covers clinical testing of medicines and the translation of pharmaceutical drug research into new medicines, also focusing on the need to understand the safety profile of medicine and the benefit-risk balance. Pharmacoeconomics and the social impact of healthcare on patients and public health are also featured. It is written in a clear and straightforward manner to enable rapid review and assimilation of complex information and contains reader-friendly features. As a greater understanding of these aspects is critical for students in the areas of pharmaceutical medicine, clinical research, pharmacology and pharmacy, as well as professionals working in the pharmaceutical industry, this book is an ideal resource. Includes detailed coverage of current trends and key topics in pharmaceutical medicine, including biosimilars, biobetters, super generics, and Provides a comprehensive look at current and important aspects of the science and regulation of drug and biologics discovery

Field Trials of Health Interventions

Field Trials of Health Interventions
Author: Richard H. Morrow,David A. Ross
Publsiher: Oxford University Press, USA
Total Pages: 480
Release: 2015-06-11
ISBN 10: 0198732864
ISBN 13: 9780198732860
Language: EN, FR, DE, ES & NL

Field Trials of Health Interventions Book Review:

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.

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
Publsiher: National Academies Press
Total Pages: 216
Release: 2005-12-10
ISBN 10: 0309097266
ISBN 13: 9780309097260
Language: EN, FR, DE, ES & NL

Ethical Considerations for Research on Housing Related Health Hazards Involving Children Book Review:

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.

Research Ethics in Africa

Research Ethics in Africa
Author: Mariana Kruger,Paul Ndebele,Lyn Horn
Publsiher: AFRICAN SUN MeDIA
Total Pages: 224
Release: 2014-06-01
ISBN 10: 1920689303
ISBN 13: 9781920689308
Language: EN, FR, DE, ES & NL

Research Ethics in Africa Book Review:

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 .

Principles and Practice of Clinical Research

Principles and Practice of Clinical Research
Author: John I. Gallin,Frederick P Ognibene
Publsiher: Elsevier
Total Pages: 448
Release: 2011-04-28
ISBN 10: 9780080489568
ISBN 13: 0080489567
Language: EN, FR, DE, ES & NL

Principles and Practice of Clinical Research Book Review:

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

Principles of Good Clinical Practice

Principles of Good Clinical Practice
Author: Michael J. McGraw,Shawn P. Shearn
Publsiher: Pharmaceutical Press
Total Pages: 256
Release: 2010
ISBN 10: 0853697906
ISBN 13: 9780853697909
Language: EN, FR, DE, ES & NL

Principles of Good Clinical Practice Book Review:

This text aims to be a one-stop source for guidance and checking the rules for proper conduct of clinical trials, as well as providing a historical perspective of the clinical research landscape. Good Clinical Practice guidelines provide an international quality standard for the regulation of clinical trials. They include standards on how clinical trials should be conducted, provide assurance of safety and efficacy of newly developed drugs and protect human rights. Principles of Good Clinical Practice describes the ethical principles and regulatory requirements that influence the current and future conduct of clinical research. As well as providing essential information on clinical trial design and pharmacovigilance, coverage also includes: informed consent; investigator and sponsor responsibilities; site monitoring; institutional review boards and dependent ethics committees; clinical trial registration and reporting; quality assurance; and future implications for good clinical practices. Principles of Good Clinical Practice will be a definitive text for Clinical Development personnel at pharmaceutical companies, Contract Research Organizations (CROs), PharmD and postgraduate pharmacy students, and medical, pharmacy and drug company libraries

Clinical Trials in Vulnerable Populations

Clinical Trials in Vulnerable Populations
Author: Milica Prostran
Publsiher: BoD – Books on Demand
Total Pages: 224
Release: 2018-05-09
ISBN 10: 1789232007
ISBN 13: 9781789232004
Language: EN, FR, DE, ES & NL

Clinical Trials in Vulnerable Populations Book Review:

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.

Children and Clinical Research

Children and Clinical Research
Author: Anonim
Publsiher: Unknown
Total Pages: 221
Release: 2015
ISBN 10: 9781904384311
ISBN 13: 1904384315
Language: EN, FR, DE, ES & NL

Children and Clinical Research Book Review:

A Practical Guide for Health Researchers

A Practical Guide for Health Researchers
Author: M. F. Fathalla,Mahmoud F. Fathalla
Publsiher: WHOROEM
Total Pages: 234
Release: 2004
ISBN 10: 9789290213635
ISBN 13: 9290213639
Language: EN, FR, DE, ES & NL

A Practical Guide for Health Researchers Book Review:

Health researchers, the intended audience of this book, are not limited to scientists pursuing a research career. They include health professionals, administrators, policymakers and non-governmental organizations, among others, who can and should use the scientific method to guide their work for improving the health of individuals and communities. Even if they do not pursue much research themselves, they need to grasp the principles of the scientific method, to understand the value and also the limitations of science, and to be able to assess and evaluate results of research before applying them. This book includes the following chapters: Introduction and overview; ethics in health research; what research to do; planning the research; writing the research protocol; submitting a research proposal; implementing the research project; describing and analysing the research results; communicating research; guidelines on writing a scientific paper; publishing a scientific paper; guidelines on making a scientific presentation; assessing and evaluating research.

Open Scientific Data

Open Scientific Data
Author: Vera Lipton
Publsiher: BoD – Books on Demand
Total Pages: 230
Release: 2020-01-22
ISBN 10: 1838809848
ISBN 13: 9781838809843
Language: EN, FR, DE, ES & NL

Open Scientific Data Book Review:

This book shows how the vision for open access to scientific data can be more readily achieved through a staged model that research funders, policy makers, scientists, and research organizations can adopt in their practice. Drawing on her own experiences with data processing, on early findings with open scientific data at CERN (the European Organization for Nuclear Research), and from case studies of shared clinical trial data, the author updates our understanding of research data - what it is; how it dynamically evolves across different scientific disciplines and across various stages of research practice; and how it can, and indeed should, be shared at any of those stages. The result is a flexible and pragmatic path for implementing open scientific data.

Ethical Challenges in Study Design and Informed Consent for Health Research in Resource poor Settings

Ethical Challenges in Study Design and Informed Consent for Health Research in Resource poor Settings
Author: Patricia A. Marshall,Patricia Loomis Marshall
Publsiher: World Health Organization
Total Pages: 79
Release: 2007
ISBN 10: 9241563389
ISBN 13: 9789241563383
Language: EN, FR, DE, ES & NL

Ethical Challenges in Study Design and Informed Consent for Health Research in Resource poor Settings Book Review:

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.

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
Publsiher: OUP USA
Total Pages: 848
Release: 2011-02
ISBN 10: 0199768633
ISBN 13: 9780199768639
Language: EN, FR, DE, ES & NL

The Oxford Textbook of Clinical Research Ethics Book Review:

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.

The Management of Clinical Trials

The Management of Clinical Trials
Author: Hesham Abdeldayem
Publsiher: BoD – Books on Demand
Total Pages: 90
Release: 2018-06-06
ISBN 10: 1789232384
ISBN 13: 9781789232387
Language: EN, FR, DE, ES & NL

The Management of Clinical Trials Book Review:

This concise book is addressed to researchers, clinical investigators, as well as practicing physicians and surgeons who are interested in the fields of clinical research and trials. It covers some important topics related to clinical trials including an introduction to clinical trials, some aspects concerning clinical trials in pediatric age group, and the unique aspects of the design of clinical trials on stem cell therapy.