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  1. Improving informed consent: Stakeholder views.Emily E. Anderson, Susan B. Newman & Alicia K. Matthews - 2017 - AJOB Empirical Bioethics 8 (3):178-188.
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  • Ethical Criteria for Human Challenge Studies in Infectious Diseases: Table 1.Ben Bambery, Michael Selgelid, Charles Weijer, Julian Savulescu & Andrew J. Pollard - 2016 - Public Health Ethics 9 (1):92-103.
    Purposeful infection of healthy volunteers with a microbial pathogen seems at odds with acceptable ethical standards, but is an important contemporary research avenue used to study infectious diseases and their treatments. Generally termed ‘controlled human infection studies’, this research is particularly useful for fast tracking the development of candidate vaccines and may provide unique insight into disease pathogenesis otherwise unavailable. However, scarce bioethical literature is currently available to assist researchers and research ethics committees in negotiating the distinct issues raised by (...)
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  • Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials. [REVIEW]Adam Nishimura, Jantey Carey, Patricia J. Erwin, Jon C. Tilburt, M. Hassan Murad & Jennifer B. McCormick - 2013 - BMC Medical Ethics 14 (1):28.
    Obtaining informed consent is a cornerstone of biomedical research, yet participants comprehension of presented information is often low. The most effective interventions to improve understanding rates have not been identified.
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  • Reshaping consent so we might improve participant choice (II) – helping people decide.Hugh Davies, Rosie Munday, Maeve O’Reilly, Catriona Gilmour Hamilton, Arzhang Ardahan, Simon E. Kolstoe & Katie Gillies - 2023 - Research Ethics 19 (4):466-473.
    Research consent processes must provide potential participants with the necessary information to help them decide if they wish to join a study. On the Oxford ‘A’ Research Ethics Committee we’ve found that current research proposals mostly provide adequate detail (even if not in an easily comprehensible format), but often fail to support decision making, a view supported by published evidence. In a previous paper, we described how consent might be structured, and here we develop the concept of an Information and (...)
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  • (1 other version)Reshaping the review of consent so we might improve participant choice.Hugh Davies - 2021 - Sage Publications Ltd: Research Ethics 18 (1):3-12.
    Research Ethics, Volume 18, Issue 1, Page 3-12, January 2022. Consent is one necessary foundation for ethical research and it’s one of the research ethics committee’s major roles to ensure that the consent process meets acceptable standards. Although on Oxford ‘A’ REC we’ve been impressed by the thought and work put into this aspect of research ethics, we’ve continued to have concerns about the suitability and effectiveness of consent processes in supporting decision making, particularly for clinical trials. There’s poor understanding (...)
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  • Assessing Clinical Trial Informed Consent Comprehension in Non-Cognitively-Impaired Adults: A Systematic Review of Instruments.Laura D. Buccini, Don Iverson, Peter Caputi, Caroline Jones & Sheridan Gho - 2009 - Research Ethics 5 (1):3-8.
    This systematic review identifies and critically evaluates instruments that have been developed to measure clinical trial informed consent comprehension in non-cognitively-impaired adults. Literature searches were carried out on Medline (Ovid), PsycInfo, CINHAL, ERIC, ScienceDirect, and Cochrane Library for English language articles published between January 1980 and September 2008. Instruments were excluded if they focused on consent onto paediatric trials, the construct under study was primarily capacity or competency, or the instrument was developed specifically for psychiatric or cognitively-impaired populations. Instruments selected (...)
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  • Assessment of the appropriateness of the i-CONSENT guidelines recommendations for improving understanding of the informed consent process in clinical studies.Javier Diez-Domingo, Cristina Ferrer-Albero & Jaime Fons-Martinez - 2021 - BMC Medical Ethics 22 (1):1-12.
    BackgroundThe H2020 i-CONSENT project has developed a set of guidelines that offer ethical recommendations and practical tools aimed at making the informed consent process in clinical studies more comprehensive, tailored, and inclusive. An analysis of the appropriateness of some of its novel recommendations was carried out by a group of experts representing different stakeholders.MethodsAn adaptation of the RAND/ucla Appropriateness Method was used to assess the level of agreement on the recommendations among 14 representatives of different stakeholders, including patients, regulators, investigators, (...)
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  • UK Research Ethics Committee’s review of the global first SARS-CoV-2 human infection challenge studies.Hugh Davies - 2023 - Journal of Medical Ethics 49 (5):322-324.
    This paper describes the UK Research Ethics Committee’s (REC) preparations and review of the global first SARS-CoV-2 human infection challenge studies. To frame our review, we used the WHO guidance and our UK Health Research Authority ethical review framework. The WHO criteria covered most issues we were concerned about, but we would recommend one further criterion directing RECs to consider alternative research designs. Could research questions be equally well answered by less intrusive studies? The committee met virtually, ensuring broad representation (...)
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