Modified Consent Form Utility
| Status: | Terminated |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | November 2007 |
| End Date: | December 2008 |
CTSA Utility of Modified Consent Forms in Clinical Research: Fraga Tea Study
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.
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.
Inclusion Criteria:
- participation in parent study, English speaking
Exclusion Criteria:
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