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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
Publisher: World Health Organization
Total Pages: 89
Release: 2007
Genre: Medical
ISBN: 9241563389

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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.


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 Loomis Marshall
Publisher:
Total Pages: 79
Release: 2007
Genre: Developing countries
ISBN: 9789241563383

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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.--Publisher's description.


Field Trials of Health Interventions

Field Trials of Health Interventions
Author: Peter G. Smith
Publisher:
Total Pages: 479
Release: 2015
Genre: Health & Fitness
ISBN: 0198732864

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This is an open access title available under the terms of a CC BY-NC 4.0 International licence. It is free to read at Oxford Scholarship Online and offered as a free PDF download from OUP and selected open access locations. Before new interventions are released into disease control programmes, it is essential that they are carefully evaluated in field trials'. These may be complex and expensive undertakings, requiring the follow-up of hundreds, or thousands, of individuals, often for long periods. Descriptions of the detailed procedures and methods used in the trials that have been conducted have rarely been published. A consequence of this, individuals planning such trials have few guidelines available and little access to knowledge accumulated previously, other than their own. In this manual, practical issues in trial design and conduct are discussed fully and in sufficient detail, that Field Trials of Health Interventions may be used as a toolbox' by field investigators. It has been compiled by an international group of over 30 authors with direct experience in the design, conduct, and analysis of field trials in low and middle income countries and is based on their accumulated knowledge and experience. Available as an open access book via Oxford Medicine Online, this new edition is a comprehensive revision, incorporating the new developments that have taken place in recent years with respect to trials, including seven new chapters on subjects ranging from trial governance, and preliminary studies to pilot testing.


Ethical Conduct of Clinical Research Involving Children

Ethical Conduct of Clinical Research Involving Children
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 445
Release: 2004-07-09
Genre: Medical
ISBN: 0309133386

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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 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.


Informed Consent and Health Literacy

Informed Consent and Health Literacy
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 228
Release: 2015-03-04
Genre: Medical
ISBN: 0309317304

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Informed consent - the process of communication between a patient or research subject and a physician or researcher that results in the explicit agreement to undergo a specific medical intervention - is an ethical concept based on the principle that all patients and research subjects should understand and agree to the potential consequences of the clinical care they receive. Regulations that govern the attainment of informed consent for treatment and research are crucial to ensuring that medical care and research are conducted in an ethical manner and with the utmost respect for individual preferences and dignity. These regulations, however, often require - or are perceived to require - that informed consent documents and related materials contain language that is beyond the comprehension level of most patients and study participants. To explore what actions can be taken to help close the gap between what is required in the informed consent process and communicating it in a health-literate and meaningful manner to individuals, the Institute of Medicine's Roundtable on Health Literacy convened a one-day public workshop featuring presentations and discussions that examine the implications of health literacy for informed consent for both research involving human subjects and treatment of patients. Topics covered in this workshop included an overview of the ethical imperative to gain informed consent from patients and research participants, a review of the current state and best practices for informed consent in research and treatment, the connection between poor informed consent processes and minority underrepresentation in research, new approaches to informed consent that reflect principles of health literacy, and the future of informed consent in the treatment and research settings. Informed Consent and Health Literacy is the summary of the presentations and discussion of the workshop.


Disease Control Priorities in Developing Countries

Disease Control Priorities in Developing Countries
Author: Dean T. Jamison
Publisher: World Bank Publications
Total Pages: 1449
Release: 2006-04-02
Genre: Medical
ISBN: 0821361805

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Based on careful analysis of burden of disease and the costs ofinterventions, this second edition of 'Disease Control Priorities in Developing Countries, 2nd edition' highlights achievable priorities; measures progresstoward providing efficient, equitable care; promotes cost-effectiveinterventions to targeted populations; and encourages integrated effortsto optimize health. Nearly 500 experts - scientists, epidemiologists, health economists,academicians, and public health practitioners - from around the worldcontributed to the data sources and methodologies, and identifiedchallenges and priorities, resulting in this integrated, comprehensivereference volume on the state of health in developing countries.


Public Health Ethics: Cases Spanning the Globe

Public Health Ethics: Cases Spanning the Globe
Author: Drue H. Barrett
Publisher: Springer
Total Pages: 0
Release: 2016-04-20
Genre: Medical
ISBN: 9783319238463

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This Open Access book highlights the ethical issues and dilemmas that arise in the practice of public health. It is also a tool to support instruction, debate, and dialogue regarding public health ethics. Although the practice of public health has always included consideration of ethical issues, the field of public health ethics as a discipline is a relatively new and emerging area. There are few practical training resources for public health practitioners, especially resources which include discussion of realistic cases which are likely to arise in the practice of public health. This work discusses these issues on a case to case basis and helps create awareness and understanding of the ethics of public health care. The main audience for the casebook is public health practitioners, including front-line workers, field epidemiology trainers and trainees, managers, planners, and decision makers who have an interest in learning about how to integrate ethical analysis into their day to day public health practice. The casebook is also useful to schools of public health and public health students as well as to academic ethicists who can use the book to teach public health ethics and distinguish it from clinical and research ethics.


Casebook on Ethical Issues in International Health Research

Casebook on Ethical Issues in International Health Research
Author: World Health Organization
Publisher: World Health Organization
Total Pages: 212
Release: 2009
Genre: Medical
ISBN: 9241547723

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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.


International Ethical Guidelines for Health-Related Research Involving Humans

International Ethical Guidelines for Health-Related Research Involving Humans
Author: Council for International Organizations of Medical Sciences (CIOMS)
Publisher: World Health Organization
Total Pages: 0
Release: 2017-01-31
Genre: Bioethics
ISBN: 9789290360889

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"In the new 2016 version of the ethical guidelines, CIOMS provides answers to a number of pressing issues in research ethics. The Council does so by stressing the need for research having scientific and social value, by providing special guidelines for health-related research in low-resource settings, by detailing the provisions for involving vulnerable groups in research and for describing under what conditions biological samples and health-related data can be used for research."--Page 4 de la couverture.


Ethical Considerations When Preparing a Clinical Research Protocol

Ethical Considerations When Preparing a Clinical Research Protocol
Author: Evan DeRenzo
Publisher: Academic Press
Total Pages: 370
Release: 2020-06-12
Genre: Medical
ISBN: 0123869544

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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 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