Modified Consent Form Utility

University of California (UC) Davis

Status: Terminated

Conditions: Healthy

Treatments: Other: Modified consent form; Other: Standard consent form

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00715923

200715802

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• participation in parent study, English speaking

Exclusion criteria

• none

Trial design

30 participants in 2 patient groups

1

Experimental group

Description:

Modified consent form

Treatment:

Other: Modified consent form

2

Active Comparator group

Description:

Standard consent form

Treatment:

Other: Standard consent form