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

Author: Patricia A. Marshall
Publisher: World Health Organization
ISBN: 9241563389
Category : Medical
Languages : en
Pages : 89

View

Book Description
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.

Author: Patricia Loomis Marshall
Publisher:
ISBN: 9789241563383
Category : Developing countries
Languages : en
Pages : 79

View

Book Description
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.

Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309317304
Category : Medical
Languages : en
Pages : 192

View

Book Description
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.

Author: Council for International Organizations of Medical Sciences (CIOMS)
Publisher: World Health Organization
ISBN: 9789290360889
Category : Bioethics
Languages : en
Pages : 0

View

Book Description
"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.

Author: World Health Organization
Publisher: World Health Organization
ISBN: 9241547723
Category : Medical
Languages : en
Pages : 212

View

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.

Author: Peter G. Smith
Publisher: Oxford University Press, USA
ISBN: 0198732864
Category : Medical
Languages : en
Pages : 479

View

Book Description
"IEA, International Epidemiological Association, Welcome Trust."

Author: Jonathan Ives
Publisher: Cambridge University Press
ISBN: 1316849074
Category : Law
Languages : en
Pages : 416

View

Book Description
Bioethics has long been accepted as an interdisciplinary field. The recent 'empirical turn' in bioethics is, however, creating challenges that move beyond those of simple interdisciplinary collaboration, as researchers grapple with the methodological, empirical and meta-ethical challenges of combining the normative and the empirical, as well as navigating the difficulties that can arise from attempts to transcend traditional disciplinary boundaries. Empirical Bioethics: Theoretical and Practical Perspectives brings together contributions from leading experts in the field which speak to these challenges, providing insight into how they can be understood and suggestions for how they might be overcome. Combining discussions of meta-ethical challenges, examples of different methodologies for integrating empirical and normative research, and reflection on the challenges of conducting and publishing such work, this book will both introduce the novice to the field and challenge the expert.

Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309133386
Category : Medical
Languages : en
Pages : 445

View

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.

Author: Jill A. Fisher
Publisher:
ISBN:
Category : Clinical trials
Languages : en
Pages : 280

View

Book Description
Today, more than 75 percent of pharmaceutical drug trials in the United States are being conducted in the private sector. Once the sole province of academic researchers, these important studies are now being outsourced to non-academic physicians. According to Jill A. Fisher, this major change in the way medical research is performed is the outcome of two problems in U.S. health care: decreasing revenue for physicians and decreasing access to treatment for patients. As physicians report diminishing income due to restrictive relationships with insurers, increasing malpractice insurance premiums, and inflated overhead costs to operate private practices, they are attracted to pharmaceutical contract research for its lucrative return. Clinical trials also provide limited medical access to individuals who have no or inadequate health insurance because they offer "free" doctors' visits, diagnostic tests, and medications to participants. Focusing on the professional roles of those involved, as well as key research practices, Fisher assesses the risks and advantages for physicians and patients alike when pharmaceutical drug studies are used as an alternative to standard medical care. A volume in the Critical Issues in Health and Medicine series, edited by Rima D. Apple and Janet Golden

Author: Franklin G. Miller
Publisher: Oxford University Press
ISBN: 0199896208
Category : Law
Languages : en
Pages : 347

View

Book Description
This book contains 22 essays on the ethics of research involving human subjects written over a 15-year period. Topics addressed include the ethics of clinical trials, controversial study designs, and informed consent.