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  1. Experimental Design: Ethics, Integrity and the Scientific Method.Jonathan Lewis - 2020 - In Ron Iphofen (ed.), Handbook of Research Ethics and Scientific Integrity. Springer. pp. 459-474.
    Experimental design is one aspect of a scientific method. A well-designed, properly conducted experiment aims to control variables in order to isolate and manipulate causal effects and thereby maximize internal validity, support causal inferences, and guarantee reliable results. Traditionally employed in the natural sciences, experimental design has become an important part of research in the social and behavioral sciences. Experimental methods are also endorsed as the most reliable guides to policy effectiveness. Through a discussion of some of the central concepts (...)
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  • Improving understanding of clinical trial procedures among low literacy populations: an intervention within a microbicide trial in Malawi. [REVIEW]Paul M. Ndebele, Douglas Wassenaar, Esther Munalula & Francis Masiye - 2012 - BMC Medical Ethics 13 (1):29-.
    Background The intervention reported in this paper was a follow up to an empirical study conducted in Malawi with the aim of assessing trial participants’ understanding of randomisation, double-blinding and placebo use. In the empirical study, the majority of respondents (61.1%; n= 124) obtained low scores (lower than 75%) on understanding of all three concepts under study. Based on these findings, an intervention based on a narrative which included all three concepts and their personal implications was designed. The narrative used (...)
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  • Enrolling adolescents in HIV vaccine trials: reflections on legal complexities from South Africa.Catherine Slack, Ann Strode, Theodore Fleischer, Glenda Gray & Chitra Ranchod - 2007 - BMC Medical Ethics 8 (1):1-8.
    Background South Africa is likely to be the first country in the world to host an adolescent HIV vaccine trial. Adolescents may be enrolled in late 2007. In the development and review of adolescent HIV vaccine trial protocols there are many complexities to consider, and much work to be done if these important trials are to become a reality. Discussion This article sets out essential requirements for the lawful conduct of adolescent research in South Africa including compliance with consent requirements, (...)
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  • Comprehension Testing in Informed Consent.Wilson T. King & James E. Heubi - 2014 - AJOB Empirical Bioethics 5 (3):39-54.
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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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  • Improving protection for human research subjects: Better oversight, not just more oversight.Neil W. Schluger - 2008 - American Journal of Bioethics 8 (11):13 – 15.
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  • Neuropsychological functioning and recall of research consent information among drug court clients.David S. Festinger, Kattiya Ratanadilok, Douglas B. Marlowe, Karen L. Dugosh, Nicholas S. Patapis & David S. DeMatteo - 2007 - Ethics and Behavior 17 (2):163 – 186.
    Evidence suggests that research participants often fail to recall much of the information provided during the informed consent process. This study was conducted to determine the proportion of consent information recalled by drug court participants following a structured informed consent procedure and the neuropsychological factors that were related to recall. Eighty-five participants completed a standard informed consent procedure to participate in an ongoing research study, followed by a 17-item consent quiz and a brief neuropsychological battery 2 weeks later. Participants performed (...)
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  • Achieving new levels of recall in consent to research by combining remedial and motivational techniques: Table 1.David S. Festinger, Karen L. Dugosh, Douglas B. Marlowe & Nicolle T. Clements - 2014 - Journal of Medical Ethics 40 (4):264-268.
    Introduction Research supports the efficacy of both a remedial consent procedure ) and a motivational consent procedure for improving recall of informed consent to research. Although these strategies were statistically superior to standard consent, effects were modest and not clinically significant. This study examines a combined incentivised consent and CF procedure that simplifies the cognitive task and increases motivation to learn consent information.Methods We randomly assigned 104 individuals consenting to an unrelated host study to a consent as usual condition or (...)
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