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Ethical Considerations When Preparing A Clinical Research Protocol

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Ethical Considerations When Preparing a Clinical Research Protocol

Ethical Considerations When Preparing a Clinical Research Protocol Book
Author : Evan DeRenzo,Eric A. Singer,Joel Moss
Publisher : Academic Press
Release : 2020-06-12
ISBN : 0123869544
Language : En, Es, Fr & De

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Book Description :

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 Conduct of Clinical Research Involving Children

Ethical Conduct of Clinical Research Involving Children Book
Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children
Publisher : National Academies Press
Release : 2004-07-09
ISBN : 9780309133388
Language : En, Es, Fr & De

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Book Description :

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.

World Medical Association Declaration of Helsinki

World Medical Association Declaration of Helsinki Book
Author : Anonim
Publisher : Unknown
Release : 2004
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download World Medical Association Declaration of Helsinki book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Reviewing Clinical Trials

Reviewing Clinical Trials Book
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 : 2010
ISBN : 9789881904119
Language : En, Es, Fr & De

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Book Description :

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.

Ethical Considerations for Research on Housing Related Health Hazards Involving Children

Ethical Considerations for Research on Housing Related Health Hazards Involving Children Book
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
Release : 2005-12-10
ISBN : 0309097266
Language : En, Es, Fr & De

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Book Description :

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.

The Belmont Report

The Belmont Report Book
Author : United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Publisher : Unknown
Release : 1978
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download The Belmont Report book written by United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Responsible Research

Responsible Research Book
Author : Institute of Medicine,Committee on Assessing the System for Protecting Human Research Participants
Publisher : National Academies Press
Release : 2003-02-06
ISBN : 0309084881
Language : En, Es, Fr & De

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Book Description :

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.

Returning Individual Research Results to Participants

Returning Individual Research Results to Participants Book
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
Release : 2018-09-23
ISBN : 0309475171
Language : En, Es, Fr & De

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Book Description :

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 associated burdens on the research enterprise are competing considerations. Returning Individual Research Results to Participants reviews the current evidence on the benefits, harms, and costs of returning individual research results, while also considering the ethical, social, operational, and regulatory aspects of the practice. This report includes 12 recommendations directed to various stakeholdersâ€"investigators, sponsors, research institutions, institutional review boards (IRBs), regulators, and participantsâ€"and are designed to help (1) support decision making regarding the return of results on a study-by-study basis, (2) promote high-quality individual research results, (3) foster participant understanding of individual research results, and (4) revise and harmonize current regulations.

Research Ethics in Africa

Research Ethics in Africa Book
Author : Mariana Kruger,Paul Ndebele,Lyn Horn
Publisher : AFRICAN SUN MeDIA
Release : 2014-06-01
ISBN : 1920689303
Language : En, Es, Fr & De

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Book Description :

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 .

A Practical Guide for Health Researchers

A Practical Guide for Health Researchers Book
Author : M. F. Fathalla,Mahmoud F. Fathalla
Publisher : WHOROEM
Release : 2004
ISBN : 9789290213635
Language : En, Es, Fr & De

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Book Description :

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.

Tri council Policy Statement

Tri council Policy Statement Book
Author : Anonim
Publisher : Unknown
Release : 2014
ISBN : 9781100254739
Language : En, Es, Fr & De

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Book Description :

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.

Field Trials of Health Interventions

Field Trials of Health Interventions Book
Author : Richard H. Morrow,David A. Ross
Publisher : Oxford University Press, USA
Release : 2015-06-11
ISBN : 0198732864
Language : En, Es, Fr & De

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Book Description :

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.

Sharing Clinical Trial Data

Sharing Clinical Trial Data Book
Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Responsible Sharing of Clinical Trial Data
Publisher : National Academies Press
Release : 2015-04-20
ISBN : 0309316324
Language : En, Es, Fr & De

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Book Description :

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.

Casebook on Ethical Issues in International Health Research

Casebook on Ethical Issues in International Health Research Book
Author : World Health Organization
Publisher : World Health Organization
Release : 2009
ISBN : 9241547723
Language : En, Es, Fr & De

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Book Description :

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.

Ethics and Epidemiology

Ethics and Epidemiology Book
Author : Steven S. Coughlin,Angus Dawson
Publisher : Oxford University Press
Release : 2021-07-02
ISBN : 0197587070
Language : En, Es, Fr & De

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Book Description :

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.

Responsible Conduct of Research

Responsible Conduct of Research Book
Author : Adil E. Shamoo,David B. Resnik
Publisher : Oxford University Press
Release : 2009-02-12
ISBN : 0199709602
Language : En, Es, Fr & De

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Book Description :

Recent scandals and controversies, such as data fabrication in federally funded science, data manipulation and distortion in private industry, and human embryonic stem cell research, illustrate the importance of ethics in science. Responsible Conduct of Research, now in a completely updated second edition, provides an introduction to the social, ethical, and legal issues facing scientists today.

Systematic Reviews in Educational Research

Systematic Reviews in Educational Research Book
Author : Olaf Zawacki-Richter,Michael Kerres,Svenja Bedenlier,Melissa Bond,Katja Buntins
Publisher : Springer Nature
Release : 2019-11-21
ISBN : 3658276029
Language : En, Es, Fr & De

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Book Description :

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.

Clinical Trials in Vulnerable Populations

Clinical Trials in Vulnerable Populations Book
Author : Milica Prostran
Publisher : BoD – Books on Demand
Release : 2018-05-09
ISBN : 1789232007
Language : En, Es, Fr & De

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Book Description :

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.

Ethical Issues in Research

Ethical Issues in Research Book
Author : Darwin Cheney
Publisher : Univ Publishing Group
Release : 1993
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Ethical Issues in Research book written by Darwin Cheney, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Ethics in Scientific Research

Ethics in Scientific Research Book
Author : Cortney Weinbaum,Carlos Ignacio Gutierrez
Publisher : Unknown
Release : 2019-06-05
ISBN : 9781977402691
Language : En, Es, Fr & De

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Book Description :

Scientific research ethics vary by discipline and by country, and this analysis sought to understand those variations. The authors reviewed literature and conducted interviews to provide researchers, government officials, and others who create, modify, and enforce ethics in scientific research around the world with an understanding of how ethics are created, monitored, and enforced across scientific disciplines and across international borders.