Modified Consent Form Utility

NCT00715923 | Terminated

• 1 other identifier: 200715802
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

informed consent document; ethics

Outcome Measures

Primary Outcomes (1)

• Subject satisfaction

  close of parent study

Study Arms (2)

1

EXPERIMENTAL

Modified consent form

Other: Modified consent form

2

ACTIVE COMPARATOR

Standard consent form

Other: Standard consent form

Interventions

Modified consent form OTHER

modified consent form used

1

Standard consent form OTHER

standard consent form used

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• participation in parent study, English speaking

You may not qualify if:

• none

Sponsors & Collaborators

• University of California, Davis: lead
• National Center for Research Resources (NCRR): collaborator

Study Sites (1)

University of California Davis

Sacramento, California, 95817, United States

Location

Study Officials

• Alexander A Kon, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 11, 2008
• First Posted: July 15, 2008
• Study Start: November 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: December 1, 2008
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

US (1)