Ethical Challenges In Study Design And Informed Consent For Health Research In Resource Poor Settings
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| Author | : Patricia A. Marshall |
| Publisher | : World Health Organization |
| Total Pages | : 89 |
| Release | : 2007 |
| Genre | : Medical |
| ISBN | : 9241563389 |
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 | : |
| Total Pages | : 79 |
| Release | : 2007 |
| Genre | : Developing countries |
| ISBN | : 9789241563383 |
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 | : Franklin G. Miller |
| Publisher | : Oxford University Press |
| Total Pages | : 336 |
| Release | : 2012-06-01 |
| Genre | : Medical |
| ISBN | : 0199896216 |
The use of human beings as research subjects poses distinctive ethical issues. Subjects of medical research are exposed to risks of harm for the sake of generating scientific knowledge that can benefit future patients and society. Ethical analysis of the challenges posed by research involving human subjects requires careful attention to the contextual details of scientific experimentation. This book contains 22 essays by Franklin G. Miller on research ethics written over a 15-year period. With the exception of the first essay, all have been previously published in bioethics and medical journals. The book is arranged into four parts. Part One addresses a general ethical perspective on the protection of human subjects in clinical research, including paternalism in research regulation and acceptable limits to research risks. The essays in Part Two examine ethical issues in study design. It includes ethical analyses of controversial types of medical experimentation-studies that provoke psychiatric symptoms, induce infections, provide patients with placebos that withhold proven effective treatments or administer fake invasive procedures, test experimental treatments in cancer patients who have exhausted all standard treatment options, and employ the use of deception to generate scientifically valid data. Part Three offers a systematic critique of "the therapeutic orientation" to clinical trials and the principle of clinical equipoise, which is widely regarded as a fundamental norm for randomized treatment studies. Part Four takes up a range of ethical issues relating to informed consent for research participation, including examination of "the therapeutic misconception" and presentation of a novel approach to the validity of consent: "the fair transaction model." An abiding theme, developed in many of the essays is that the ethics of clinical research is importantly different from the ethics of medical care.
| Author | : Peter G. Smith |
| Publisher | : |
| Total Pages | : 479 |
| Release | : 2015 |
| Genre | : Health & Fitness |
| ISBN | : 0198732864 |
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.
| Author | : Evan DeRenzo |
| Publisher | : Academic Press |
| Total Pages | : 370 |
| Release | : 2020-06-12 |
| Genre | : Medical |
| ISBN | : 0123869544 |
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
| Author | : Council for International Organizations of Medical Sciences (CIOMS) |
| Publisher | : World Health Organization |
| Total Pages | : 0 |
| Release | : 2017-01-31 |
| Genre | : Bioethics |
| ISBN | : 9789290360889 |
"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 |
| Total Pages | : 212 |
| Release | : 2009 |
| Genre | : Medical |
| ISBN | : 9241547723 |
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 | : Bernard Dickens |
| Publisher | : |
| Total Pages | : 8 |
| Release | : 2014 |
| Genre | : |
| ISBN | : |
The disparity in resources between economically developed and developing countries presents ethical concerns when commercial sponsors of studies and investigators propose to conduct them with subjects in developing countries. Vulnerable people may be recruited into studies of little health benefit to themselves or their communities and, under undue inducements, may accept disproportionate risks. Reproductive health studies may present women with undue risks. Guidelines have been developed to protect exploitable populations in resource-poor settings, although guarding their right to make informed and voluntary choices poses special challenges. Guidelines pay special attention to pregnant women as research subjects, and may approve and even require their enrollment in studies of products not known to be harmful. Placebo-controlled studies are addressed in contexts where no recognized treatments are routinely accessible. The structure and functions of research ethics review committees present difficult challenges, but they may be mitigated by enlightened international collaboration.
| Author | : Bernard Lo |
| Publisher | : Lippincott Williams & Wilkins |
| Total Pages | : 302 |
| Release | : 2012-03-28 |
| Genre | : Medical |
| ISBN | : 1451152779 |
This book teaches researchers how to resolve the ethical dilemmas that can arise at any stage in clinical research. In addition to explaining pertinent regulations and laws, Dr. Lo helps investigators understand the gaps and uncertainties in regulations, as well as situations in which merely complying with the law may not fulfill ethical responsibilities. Most chapters include real-life examples that the author walks through, discussing the salient issues and how to approach them. This book can be used in courses on research ethics that are required or encouraged by major National Institutes of Health grants in academic health centers.
| Author | : Marion Danis MD |
| Publisher | : Oxford University Press |
| Total Pages | : 274 |
| Release | : 2012-04-17 |
| Genre | : Medical |
| ISBN | : 0199930651 |
Interesting and important ethical questions confront researchers, regulators, institutional review boards, support personnel, and research participants committed to the ethical conduct of human subjects research at all stages of research. Questions encompass - but are not limited to - study design, enrolling participants, balancing the clinical needs of participants against the research agenda, ending trials, discharging post-trial obligations, and resolving conflicts. Straightforward solutions to these types of questions are often not found in regulations, ethics codes, or the bioethics literature. These resources may leave room for interpretation, offer conflicting guidance, or simply fail to address particular questions. Ethics consultation, which has been offered in clinical care settings with regularity since the 1980s, has since the turn of the century increasingly been sought in the clinical research context. Because there has only lately been recognition that ethics consultants can play a valuable role helping the research community conduct research in the most ethically informed way, there are many open questions in the field of research ethics consultation including the appropriate role of consultants and the best methods of consultation. The Clinical Center Bioethics Consultation Service has been serving the NIH community of researchers, administrators, healthcare providers, and research participants for more than a decade, conducting nearly 1,000 consultations in that time. In this book, members of the Bioethics Consultation Service reflect on this long track-record and unparalleled range of research ethics consultations to share a collection of their most interesting and informative research ethics consultations and to start a dialogue on remaining open questions. Although the NIH experience is unique, this book focuses on cases - and associated lessons - that are generalizable and valuable for the entire clinical research community. This book will be valuable to ethics consultants, clinical investigators, students and teachers, and others desiring insight into clinical research ethics and ethics consultation.
