Modified Consent Form Utility

Healthy Clinical Trial

Official title:

CTSA Utility of Modified Consent Forms in Clinical Research: Fraga Tea Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00715923
• Other study ID #: 200715802
• Status: Terminated
• Phase: N/A
• First received: July 11, 2008
• Last updated: December 1, 2015
• Start date: November 2007
• Est. completion date: December 2008

Study information

• Verified date: December 2015
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: December 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• participation in parent study, English speaking

Exclusion Criteria:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Modified consent form
modified consent form used
• Standard consent form
standard consent form used

Locations

Country	Name	City	State
United States	University of California Davis	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject satisfaction		close of parent study	No