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Methodological Challenges in Biomedical HIV Prevention Trials

Methodological Challenges in Biomedical HIV Prevention Trials
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 270
Release: 2008-06-13
Genre: Medical
ISBN: 0309114306

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The number of people infected with HIV or living with AIDS is increasing at unprecedented rates as various scientists, organizations, and institutions search for innovative solutions to combating and preventing the disease. At the request of the Bill & Melinda Gates Foundation, Methodological Challenges in Biomedical HIV Prevention Trials addresses methodological challenges in late-stage nonvaccine biomedical HIV prevention trials with a specific focus on microbicide and pre-exposure prophylaxis trials. This book recommends a number of ways to improve the design, monitoring, and analysis of late-stage clinical trials that evaluate nonvaccine biomedical interventions. The objectives include identifying a beneficial method of intervention, enhancing quantification of the impact, properly assessing the effects of using such an intervention, and reducing biases that can lead to false positive trial results. According to Methodological Challenges in Biomedical HIV Prevention Trials, the need to identify a range of effective, practical, and affordable preventive strategies is critical. Although a large number of promising new HIV prevention strategies and products are currently being tested in late-stage clinical trials, these trials face a myriad of methodological challenges that slow the pace of research and limit the ability to identify and fully evaluate effective biomedical interventions.


Case Studies in Ethics and HIV Research

Case Studies in Ethics and HIV Research
Author: Sana Loue
Publisher: Springer Science & Business Media
Total Pages: 347
Release: 2007-10-05
Genre: Medical
ISBN: 038771362X

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This important work takes as its subject one of medicine’s most pressing arenas of ethical debate. There has been a consistent interest in ethical issues arising in the context of HIV research. Ongoing international and multi-site studies and the continuing search for an HIV vaccine continue to prompt examination of how this research is conducted. Also examined are how participants are engaged in the studies and the obligations of the researchers to individual participants and their communities during the course of and following the conclusion of the research. Each chapter of this book is authored primarily by one of the editors (secondarily by the other) and is accompanied by one to two case studies.


Ethical Issues in HIV Vaccine Trials

Ethical Issues in HIV Vaccine Trials
Author: T. Kerns
Publisher: Springer
Total Pages: 265
Release: 1996-12-11
Genre: Social Science
ISBN: 0230380018

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This book explores some of the complex ethical quandaries entailed by proposed phase III HIV preventive vaccine trials. The book argues that such trials must be initiated as soon as politically and ethically feasible on the one hand, and that no such trials should be undertaken until we can assure full compliance with the Nuremberg Code and the WHO/CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects on the other. The tension between these two positions is fully detailed and suggestions offered for how to think about possible resolutions.


Good Participatory Practice

Good Participatory Practice
Author:
Publisher: World Health Organization
Total Pages: 68
Release: 2007
Genre: Medical
ISBN:

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These Good Participatory Practice guidelines aim to provide systematic guidance on the roles and responsibilities of entities funding and conducting biomedical HIV prevention trials towards participants and their communities. Such entities include investigators, research staff, pharmaceutical industry sponsors, foundations, government-supported research networks, non-governmental research sponsors, and all others involved in designing, financing, and executing clinical trials research.


Innovation and Biomedicine

Innovation and Biomedicine
Author: M. Michael
Publisher: Springer
Total Pages: 321
Release: 2013-09-24
Genre: Social Science
ISBN: 1137316675

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With its focus on the offshore randomized control trials of a Pre-Exposure Prophylactic pill (PrEP) for preventing HIV infection, the volume develops a sustained analysis of the complex, virtual and topological dimensions of the expectations, ethics and evidence that surround the innovation of PrEP.


Ethical Issues in International Biomedical Research

Ethical Issues in International Biomedical Research
Author: James V. Lavery
Publisher:
Total Pages: 401
Release: 2007
Genre: Medical
ISBN: 0195179226

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Ethical Issues in International Biomedical Research is the definitive book on the ethics of research involving human subjects in developing countries. Using 21 actual case studies, it covers the most controversial topics, including the ethics of placebo research in Africa, what benefits should be provided to the community after completion of a research trial, how to address conflicts between IRBs in developed and developing countries, and undue inducement of poor people in developing countries. Each case is accompanied by two expert commentaries, written by many of the worlds leading experts in bioethics as well as new voices with research experience in developing countries. No other volume has this scope. Students in bioethics, public and international health, and ethics will find this book particularly useful.


Ethical Considerations in HIV Preventive Vaccine Research

Ethical Considerations in HIV Preventive Vaccine Research
Author:
Publisher:
Total Pages: 56
Release: 2000
Genre: AIDS vaccines
ISBN:

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This document highlights, from UNAID'S perspective, some of the critical elements that must be considered in HIV vaccine development activities.


Ethical Issues in HIV Vaccine Trials

Ethical Issues in HIV Vaccine Trials
Author: Thomas A. Kerns
Publisher:
Total Pages: 249
Release: 1997
Genre: AIDS vaccines
ISBN: 9780333674925

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This work explores some of the complex ethical quandaries entailed by proposed phase III HIV preventive vaccine trials. It argues that such trials must be initiated as soon as is politically and ethically feasible on the one hand, and, on the other, that no such trials should be undertaken until we can assure full compliance with the Nuremberg Code and the WHO/CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects. The tension between these two positions is documented, and suggestions offered for how to think about possible resolutions.