Modified Consent Form Utility
This trial is active, not recruiting.
|Treatments||modified consent form, standard consent form|
|Sponsor||University of California, Davis|
|Collaborator||National Center for Research Resources (NCRR)|
|Start date||November 2007|
|End date||September 2008|
|Trial size||30 participants|
|Trial identifier||NCT00715923, 200715802|
Subjects enrolling into a nutrition study of the effects of tea on fat absorption will be randomized to receive either a standard informed consent document or a modified document that is shorter and more easily understood than the standard document. The hypothesis is that using a shorter form that is more easily understood and more visually simple will lead to greater subject satisfaction in the consent process and will not compromise subject comprehension of key study aspects. Consent for study inclusion has been waived by the IRB because informing subjects of the nature and process of the study would likely affect the findings, and both the standard and modified consent forms were approved for use in the nutrition study.
|Intervention model||parallel assignment|
|Masking||single blind (subject)|
Modified consent form
Standard consent form
time frame: close of parent study
Male or female participants at least 18 years old.
Inclusion Criteria: - participation in parent study, English speaking Exclusion Criteria: - none
|Official title||CTSA Utility of Modified Consent Forms in Clinical Research: Fraga Tea Study|
|Principal investigator||Alexander A Kon, MD|
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