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  1. Clinical Trial Portfolios: A Critical Oversight in Human Research Ethics, Drug Regulation, and Policy.Alex John London & Jonathan Kimmelman - 2019 - Hastings Center Report 49 (4):31-41.
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  • Building an Opt-Out Model for Service-Level Consent in the Context of New Data Regulations.A. R. Howarth, C. S. Estcourt, R. E. Ashcroft & J. A. Cassell - forthcoming - Public Health Ethics.
    The General Data Protection Regulation was introduced in 2018 to harmonize data privacy and security laws across the European Union. It applies to any organization collecting personal data in the EU. To date, service-level consent has been used as a proportionate approach for clinical trials, which implement low-risk, routine, service-wide interventions for which individual consent is considered inappropriate. In the context of public health research, GDPR now requires that individuals have the option to choose whether their data may be used (...)
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  • The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials: A Short Report.Charles Weijer, Monica Taljaard, Jeremy M. Grimshaw, Sarah Jl Edwards & Martin P. Eccles - 2014 - Research Ethics 10 (2):77-85.
    Owing to unique features of their design, cluster randomized trials complicate the interpretation of standard ethics guidelines. The recently published Ottawa statement on the ethical design and conduct of cluster randomized trials provides researchers and research ethics committees with detailed guidance on the design, conduct and review of cluster trials. The Ottawa statement sets out 15 recommendations, including guidance on the justification of study design, the need for research ethics committee review, the identification of research participants, obtaining informed consent, the (...)
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  • Social Science and Ethics Review: A Question of Practice Not Principle.Stuart G. Nicholls, Jamie Brehaut & Raphae Saginur - 2012 - Research Ethics 8 (2):71-78.
    In his article ‘The case against ethics review in the social sciences’, Schrag asserts that the social sciences should not be subject to ethical review. He recounts a number of examples where ethical review has seemingly failed. He further suggests some alternative models for dealing with ethical review in the social sciences. Finally, he concludes, and we concur, that there is a lack of empirical evidence as to the benefit of research ethics review.
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  • The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials: A Short Report.Charles Weijer, Monica Taljaard, Jeremy M. Grimshaw, Sarah J. L. Edwards & Martin P. Eccles - 2015 - Research Ethics 11 (1):52-60.
    Owing to unique features of their design, cluster randomized trials complicate the interpretation of standard ethics guidelines. The recently published Ottawa statement on the ethical design and conduct of cluster randomized trials provides researchers and research ethics committees with detailed guidance on the design, conduct, and review of cluster trials. The Ottawa statement sets out 15 recommendations, including guidance on the justification of study design, the need for research ethics committee review, the identification of research participants, obtaining informed consent, the (...)
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  • Cluster Randomized Trials:Another Look.Ruth Macklin - 2014 - Hastings Center Report 44 (1):37-43.
  • Delaying and Withholding Interventions: Ethics and the Stepped Wedge Trial.Ariella Binik - 2019 - Journal of Medical Ethics 45 (10):662-667.
    Ethics has been identified as a central reason for choosing the stepped wedge trial over other kinds of trial designs. The potential advantage of the stepped wedge design is that it provides all arms of the trial with the active intervention over the course of the study. Some groups receive it later than others, but the study intervention is not withheld from any group. This feature of the stepped wedge design seems particularly ethically advantageous in two instances: when the study (...)
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  • Ethical Issues Raised by Cluster Randomised Trials Conducted in Low-Resource Settings: Identifying Gaps in the Ottawa Statement Through an Analysis of the PURE Malawi Trial.Tiwonge K. Mtande, Charles Weijer, Mina C. Hosseinipour, Monica Taljaard, Mitch Matoga, Cory E. Goldstein, Billy Nyambalo & Nora E. Rosenberg - 2019 - Journal of Medical Ethics 45 (6):388-393.
    The increasing use of cluster randomised trials in low-resource settings raises unique ethical issues. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomised Trials is the first international ethical guidance document specific to cluster trials, but it is unknown if it adequately addresses issues in low-resource settings. In this paper, we seek to identify any gaps in the Ottawa Statement relevant to cluster trials conducted in low-resource settings. Our method is to analyse a prototypical cluster trial conducted (...)
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  • Latent Variable Modeling and its Implications for Institutional Review Board Review: Variables That Delay the Reviewing Process.Dong-Sheng Tzeng, Yi-Chang Wu & Jane-Yi Hsu - 2015 - BMC Medical Ethics 16 (1):1-7.
    BackgroundTo investigate the factors related to approval after review by an Institutional Review Board, the structure equation model was used to analyze the latent variables ‘investigators’, ‘vulnerability’ and ‘review process’ for 221 proposals submitted to our IRB.MethodsThe vulnerability factor included vulnerable cases, and studies that involved drug tests and genetic analyses. The principal investigator factor included the license level of the PI and whether they belonged to our institution. The review factor included administration time, total review time, and revision frequency. (...)
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  • Cluster randomized trial assessing the effects of rapid ethical assessment on informed consent comprehension in a low-resource setting.Adamu Addissie, Serebe Abay, Yeweyenhareg Feleke, Melanie Newport, Bobbie Farsides & Gail Davey - 2016 - BMC Medical Ethics 17 (1):1.
    _BMC Medical Ethics_ is an open access journal publishing original peer-reviewed research articles in relation to the ethical aspects of biomedical research and clinical practice, including professional choices and conduct, medical technologies, healthcare systems and health policies. _BMC __Medical Ethics _is part of the _BMC_ series which publishes subject-specific journals focused on the needs of individual research communities across all areas of biology and medicine. We do not make editorial decisions on the basis of the interest of a study or (...)
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  • Exceptions to the Rule of Informed Consent for Research with an Intervention.Susanne Rebers, Neil K. Aaronson, Flora E. van Leeuwen & Marjanka K. Schmidt - 2016 - BMC Medical Ethics 17 (1):1-11.
    BackgroundIn specific situations it may be necessary to make an exception to the general rule of informed consent for scientific research with an intervention. Earlier reviews only described subsets of arguments for exceptions to waive consent.MethodsHere, we provide a more extensive literature review of possible exceptions to the rule of informed consent and the accompanying arguments based on literature from 1997 onwards, using both Pubmed and PsycINFO in our search strategy.ResultsWe identified three main categories of arguments for the acceptability of (...)
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  • Community perspectives on randomisation and fairness in a cluster randomised controlled trial in Zambia.Maureen Mupeta Kombe, Joseph Mumba Zulu, Charles Michelo & Ingvild F. Sandøy - 2019 - BMC Medical Ethics 20 (1):1-10.
    One important ethical issue in randomised controlled trials is randomisation. Relatively little is known about how participating individuals and communities understand and perceive central aspects of randomisation such as equality, fairness, transparency and accountability in community-based trials. The aim of this study was to understand and explore study communities’ perspectives of the randomisation process in a cluster RCT in rural Zambia studying the effectiveness of different support packages for adolescent girls on early childbearing. In this explorative study, in-depth semi-structured interviews (...)
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