Informed Consent: Time for More Transparency
Arthritis research & therapy 2010; 12(3): 121
Informed consent is not only for documenting a patient's acceptance of enrolling in a clinical trial. It currently is the patient's and, we propose, should also be the public's main source of information regarding the reasons for the planned study, what is known in the field about the proposed trial, and what to expect as far as efficacy and harm. Informed consent is not currently part of the clinical trial registries. For purposes of full disclosure to the patients and the public, the informed consent should be part of the required documents for such registries.
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Using Formative Research to Develop a Context-Specific Approach to Informed Consent for Clinical Trials Corneli, Amy L.; Bentley, Margaret E.; Sorenson, James R.; Henderson, Gail E.; van der Horst, Charles; Moses, Agnes; Nkhoma, Jacqueline; Tenthani, Lyson; Ahmed, Yusuf; Heilig, Charles M.; Jamieson, Denise J. (2006-12)PARTICIPANT UNDERSTANDING is of particular concern when obtaining informed consent. Recommendations for improving understanding include disclosing information using culturallyappropriate and innovative approaches. To ...
The Influence of Informed Consent Content on Study Participants' Contraceptive Knowledge and Concerns Stephenson, Rob; Grabbe, Kristina; Vwalika, Bellington; Ahmed, Yusuf; Vwalika, Cheswa; Haworth, Alan; Fuller, Laurie; Liu, Fong; Chomba, Elwyn; Allen, Susan (2010-09)Little is known about how the information presented in the informed consent process influences study outcomes among participants. This study examines the influence of informed consent content on reported baseline contraceptive ...