Ethics of alternative trial designs and methods in low-resource settings
Van Der Graaf, Rieke; Cheah, Phaik Yeong
(2019) Trials, volume 20
(Article)
Abstract
This editorial introduces articles in this Special Issue, which are based on presentations given at the 2017 meeting of the Global Forum of Bioethics in Research meeting. The main themes presented at the meeting were the use of cluster randomized trials, stepped-wedge cluster randomized trials, and controlled human infection models
... read more
in research conducted in low-resource settings. The editorial sets out which ethical issues may arise in the context of alternative trial designs and describes the articles in this issue that addresses some or more of the ethical issues, such as justification of the research design, risk-benefit evaluations and consent.
show less
Download/Full Text
Keywords: Adaptive trials, Alternative trial designs, Cluster randomized trials, Controlled human challenge studies, Ethics, Stepped wedge cluster randomized trials, Medicine (miscellaneous), Pharmacology (medical)
ISSN: 1745-6215
Publisher: BioMed Central
Note: Funding Information: These and other issues were discussed at the 2017 Global Forum on Bioethics in Research (GFBR) meeting, which took place in Bangkok, Thailand, on 28 and 29 November 2017. The GFBR, supported by the Wellcome Trust, the Bill & Melinda Gates Foundation, the National Institutes of Health, and the UK Medical Research Council, hosts annual meetings on contemporary bioethics topics, such as research with pregnant women (2016) [16] and data sharing and biobanking (2018). The 2017 meeting focused on the ethics of alternative trial designs, namely adaptive trials, CRTs, including SW-CRTs, and CHIMs in low-and middle-income country research. Some do not consider the designs discussed in this Special Issue as ”alternative,” but for practical reasons, we will use this term throughout this Special Issue [17]. Funding Information: Funds were provided by the Global Forum on Bioethics in Research (GFBR). GFBR funding is provided by the Wellcome Trust, the Bill & Melinda Gates Foundation [OPP1151904], the National Institutes of Health, and the UK Medical Research Council. The GFBR and its funders had no role in the conception of the research or in writing the manuscript. Funding Information: Thanks to all the planning committee members and Wellcome Trust staff members who have organized the 2017 GFBR meeting, to all presenters for sharing their cases, and to all attendants for their input. Thanks to Karla Hemming and Charles Weijer for helpful comments during the revision process. Funds were provided by the Global Forum on Bioethics in Research (GFBR). GFBR funding is provided by the Wellcome Trust, the Bill & Melinda Gates Foundation [OPP1151904], the National Institutes of Health, and the UK Medical Research Council. Publisher Copyright: © 2019 The Author(s).
(Peer reviewed)
