Ethical Considerations When Preparing a Clinical Research Protocol
  • Author : Evan DeRenzo
  • Release Date : 12 June 2020
  • Publisher : Academic Press
  • Genre : Medical
  • Pages : 370
  • ISBN 13 : 9780123869548

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Book excerpt: Ethical Considerations When Preparing a Clinical Research Protocol, Second Edition, provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. It includes practical information on ethical principles in clinical research, how to design appropriate research studies, how to consent and assent documents, how to get protocols approved, special populations, confidentiality issues, and the reporting of adverse events. The book's valuable appendix includes a listing of web resources about research ethics, along with a glossary, making it an invaluable resource for scientists collaborating in clinical trials, physician investigators, clinical research fellows, and more. 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
Publisher : Academic Press
Genre : Medical
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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 ...

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 : National Academies Press
Genre : Medical
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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 ...

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
Genre : Clinical trials
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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 ...

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 : National Academies Press
Genre : Social Science
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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 ...

The Belmont Report

The Belmont Report

Author : United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Publisher : Unknown
Genre : Human experimentation in medicine
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Returning Individual Research Results to Participants

Returning Individual Research Results to Participants

Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Committee on the Return of Individual-Specific Research Results Generated in Research Laboratories
Publisher : National Academies Press
Genre : Medical
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When is it appropriate to return individual research results to participants? The immense interest in this question has been fostered by the growing movement toward greater transparency and participant engagement in the research enterprise. Yet, the risks of returning individual research resultsâ€"such as results with unknown validityâ€"and the ...

Responsible Research

Responsible Research

Author : Institute of Medicine,Committee on Assessing the System for Protecting Human Research Participants
Publisher : National Academies Press
Genre : Medical
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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 ...

Tri council Policy Statement

Tri council Policy Statement

Author : Anonim
Publisher : Unknown
Genre : Human experimentation in medicine
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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 ...

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
Publisher : National Academies Press
Genre : Medical
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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 ...

How to Practice Academic Medicine and Publish from Developing Countries

How to Practice Academic Medicine and Publish from Developing Countries

Author : Samiran Nundy,Atul Kakar,Zulfiqar A. Bhutta
Publisher : Springer Nature
Genre : Medical
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This is an open access book. The book provides an overview of the state of research in developing countries – Africa, Latin America, and Asia (especially India) and why research and publications are important in these regions. It addresses budding but struggling academics in low and middle-income countries. It is written ...

Research Ethics in Africa

Research Ethics in Africa

Author : Mariana Kruger,Paul Ndebele,Lyn Horn
Publisher : AFRICAN SUN MeDIA
Genre : Science
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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 ...

A Practical Guide for Health Researchers

A Practical Guide for Health Researchers

Author : M. F. Fathalla,Mahmoud F. Fathalla
Publisher : WHOROEM
Genre : Medical
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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 ...

Field Trials of Health Interventions

Field Trials of Health Interventions

Author : Richard H. Morrow,David A. Ross
Publisher : Oxford University Press, USA
Genre : Tropical medicine
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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. ...

Casebook on Ethical Issues in International Health Research

Casebook on Ethical Issues in International Health Research

Author : World Health Organization
Publisher : World Health Organization
Genre : Medical
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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....