2005
DOI: 10.1188/05.onf.751-755
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Quality of Informed Consent: Measuring Understanding Among Participants in Oncology Clinical Trials

Abstract: The Quality of Informed Consent questionnaire may provide valuable feedback regarding clinical trial participants' understanding of clinical trials and the research process. Individual responses to questions on the questionnaire may be used to aid personalized patient education and validation of the informed consent throughout trial enrollment. Future research efforts need to focus on the development of reliable tools to measure participants' understanding of informed consent and nursing interventions that imp… Show more

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Cited by 53 publications
(50 citation statements)
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“…En cualquier caso, sin embargo, dichas alternativas requieren que el investigador sea capaz de tomar la perspectiva del otro y de ponerse en los zapatos de sus participantes potenciales. Finalmente, es necesario que esfuerzos especiales se realicen para el caso de pacientes en condiciones de vulnerabilidad (e.g., pacientes psiquiátricos, pacientes con altos niveles de estrés, miembros de comunidades vulnerables, menores de edad) 41,42,43 . La dificultad conceptual de una proporción importante de los formatos de consentimiento analizados sugiere que los investigadores requieren cambiar su apreciación del propósito mismo del proceso de consentimiento informado y de los medios empleados para tales fines.…”
Section: Discussionunclassified
See 1 more Smart Citation
“…En cualquier caso, sin embargo, dichas alternativas requieren que el investigador sea capaz de tomar la perspectiva del otro y de ponerse en los zapatos de sus participantes potenciales. Finalmente, es necesario que esfuerzos especiales se realicen para el caso de pacientes en condiciones de vulnerabilidad (e.g., pacientes psiquiátricos, pacientes con altos niveles de estrés, miembros de comunidades vulnerables, menores de edad) 41,42,43 . La dificultad conceptual de una proporción importante de los formatos de consentimiento analizados sugiere que los investigadores requieren cambiar su apreciación del propósito mismo del proceso de consentimiento informado y de los medios empleados para tales fines.…”
Section: Discussionunclassified
“…Historiadores de la medicina coinciden en afirmar que, con anterioridad al siglo XX, la ética de la investigación con sujetos humanos estuvo gobernada por códigos particulares de conducta profesional 1,2 . En la historiografía especializada se reconocen algunos antecedentes de las modernas legislaciones gubernamentales sobre aspectos éticos del ejercicio y la investigación, como es el caso de las referencias a la mala práctica de la medicina en el código de Hammurabi y la interdicción en la Edad Media de prácticas con cadáveres, sobre la base de argumentos religiosos 3 .…”
Section: Introducción Y Planteamiento Del Problemaunclassified
“…Staff members also should address patient expectations of its risks and benefits. This is especially important for patients who may be more likely to misunderstand the details presented and have difficulty making an informed decision because of age, educational background, ethnicity, or language [8,52,79]. Clinicians must utilize formal standards, guidelines, and proven education resources aimed at promoting "cultural competence" and be aware of their patients' needs and preferences [71].…”
Section: Ensuring That Clinicians Communicate Effectively With Their mentioning
confidence: 98%
“…If communication is to be effective, clinicians must be trained to facilitate positive experiences and educated about the importance of being supportive and accessible in helping patients clarify their decision paths [69]. Staff members must help patients fully understand their treatment options and validate patients' understanding of the differences between trial treatments and standard treatments [8]. Staff members also should address patient expectations of its risks and benefits.…”
Section: Ensuring That Clinicians Communicate Effectively With Their mentioning
confidence: 99%
“…One such challenge is a lack of general understanding of the research and important concepts [1,7]. Participants also struggle to understand potential risks and benefits of research [7], and to understand their rights, the treatment they may receive [7], and the purpose of the research for which they are being asked to provide their consent [8,9]. Informed consent documents and informational materials for patients focus more on meeting minimal ethical requirements than facilitating the decision-making process [10].…”
Section: Introduction Digital Health and Decision Supportmentioning
confidence: 99%