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

Writing Clinical Research Protocols

Writing Clinical Research Protocols
Author: Evan G. DeRenzo,Joel Moss
Publsiher: Academic Press
Total Pages: 300
Release: 2006
ISBN 10: 9780122107511
ISBN 13: 0122107519
Language: EN, FR, DE, ES & NL

Writing Clinical Research Protocols Book Review:

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 Considerations When Preparing a Clinical Research Protocol Ethical Considerations

Ethical Considerations When Preparing a Clinical Research Protocol   Ethical Considerations
Author: Anonim
Publsiher: Unknown
Total Pages: 135
Release: 2020
ISBN 10: 1928374650XXX
ISBN 13: OCLC:1287871060
Language: EN, FR, DE, ES & NL

Ethical Considerations When Preparing a Clinical Research Protocol Ethical Considerations Book Review:

World Medical Association Declaration of Helsinki

World Medical Association Declaration of Helsinki
Author: Anonim
Publsiher: Unknown
Total Pages: 135
Release: 2004
ISBN 10: 1928374650XXX
ISBN 13: OCLC:225309868
Language: EN, FR, DE, ES & NL

World Medical Association Declaration of Helsinki Book Review:

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.

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.

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.

Tri council Policy Statement

Tri council Policy Statement
Author: Anonim
Publsiher: Unknown
Total Pages: 218
Release: 2014
ISBN 10: 9781100254739
ISBN 13: 1100254730
Language: EN, FR, DE, ES & NL

Tri council Policy Statement Book Review:

This document is a joint policy of Canada's three federal research agencies, the Canadian Institutes of Health Research, the Natural Sciences and Engineering Research Council of Canada, and the Social Sciences and Humanities Research Council of Canada. This updated version replaces the TCPS 2 (2010) as the official human research ethics policy of these agencies.

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.

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 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.

Casebook on Ethical Issues in International Health Research

Casebook on Ethical Issues in International Health Research
Author: World Health Organization
Publsiher: World Health Organization
Total Pages: 209
Release: 2009
ISBN 10: 9241547723
ISBN 13: 9789241547727
Language: EN, FR, DE, ES & NL

Casebook on Ethical Issues in International Health Research Book Review:

I. Defining "research"--II. Issues in study design . -- III. Harm and benefit -- IV. Voluntary informed consent -- V. Standard of care -- VI. Obligations to participants and communities -- VII. Privacy and confidentiality -- VIII. Professional ethics.

Writing Clinical Research Protocols

Writing Clinical Research Protocols
Author: Evan DeRenzo,Joel Moss
Publsiher: Academic Press
Total Pages: 320
Release: 2005-08-18
ISBN 10: 9780122107511
ISBN 13: 0122107519
Language: EN, FR, DE, ES & NL

Writing Clinical Research Protocols Book Review:

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

Rethinking the Ethics of Clinical Research

Rethinking the Ethics of Clinical Research
Author: Alan Wertheimer
Publsiher: Oxford University Press
Total Pages: 356
Release: 2011
ISBN 10: 0199743517
ISBN 13: 9780199743513
Language: EN, FR, DE, ES & NL

Rethinking the Ethics of Clinical Research Book Review:

Introduction -- Facing up to paternalism in research ethics -- Preface to a theory of consent transactions in research : beyond valid consent -- Should we worry about money? -- Exploitation in clinical research -- The interaction principle.

Systematic Reviews in Educational Research

Systematic Reviews in Educational Research
Author: Olaf Zawacki-Richter,Michael Kerres,Svenja Bedenlier,Melissa Bond,Katja Buntins
Publsiher: Springer Nature
Total Pages: 161
Release: 2019-11-21
ISBN 10: 3658276029
ISBN 13: 9783658276027
Language: EN, FR, DE, ES & NL

Systematic Reviews in Educational Research Book Review:

In this open access edited volume, international researchers of the field describe and discuss the systematic review method in its application to research in education. Alongside fundamental methodical considerations, reflections and practice examples are included and provide an introduction and overview on systematic reviews in education research.

Ethics and Epidemiology

Ethics and Epidemiology
Author: Steven S. Coughlin,Angus Dawson
Publsiher: Oxford University Press
Total Pages: 276
Release: 2021-07-02
ISBN 10: 0197587070
ISBN 13: 9780197587072
Language: EN, FR, DE, ES & NL

Ethics and Epidemiology Book Review:

Since its first publication in 1996, Ethics and Epidemiology has been an invaluable resource for practicing public health professionals and MPH students around the world. This third edition presents an international perspective of prominent epidemiologists, ethicists, and legal scholars to address important ethical developments in epidemiology and related public health fields from the last decade, including the rise of public health ethics and the complex inter-relations between professional ethics in epidemiology, public health ethics, and research ethics. Ethics and Epidemiology, Third Edition is organized topically and divided into four parts covering "Foundations," "Key Values and Principles," "Methods," and "Issues." New or updated chapters include ethical issues in public health practice, ethical issues in genetic epidemiology, and ethical issues in international health research and epidemiology. Now updated with timely global examples, Ethics and Epidemiology, Third Edition provides an in-depth account to the theoretical and practical moral problems confronting public health students and professionals and offers guidance for how justified moral conclusions can be reached.

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.

Ethical and Regulatory Aspects of Clinical Research

Ethical and Regulatory Aspects of Clinical Research
Author: Ezekiel J. Emanuel,Robert A. Crouch,John D. Arras,Jonathan D. Moreno
Publsiher: Unknown
Total Pages: 532
Release: 2003
ISBN 10: 1928374650XXX
ISBN 13: UOM:39015058788673
Language: EN, FR, DE, ES & NL

Ethical and Regulatory Aspects of Clinical Research Book Review:

Professionals in need of such training and bioethicists will be interested.

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.

Fundamentals of Clinical Research

Fundamentals of Clinical Research
Author: Antonella Bacchieri,Giovanni Della Cioppa
Publsiher: Springer Science & Business Media
Total Pages: 343
Release: 2007-04-29
ISBN 10: 8847004926
ISBN 13: 9788847004924
Language: EN, FR, DE, ES & NL

Fundamentals of Clinical Research Book Review:

Here is a new book on methods and issues in clinical research. Its objectives can be summarized in three points. 1. Integrate medical and statistical components of clinical research. 2. Do justice to the operational and practical requirements of clinical research. 3. Give space to the ethical implications of methodological issues in clinical research. The book ends with a brief description of the drug development process and the phases of clinical development.