NCT01704560

Improving Measurement Of Parents' Understanding Of Research Permission

IMPROVING MEASUREMENT OF PARENTS' UNDERSTANDING OF RESEARCH PERMISSION

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Well-informed potential subjects are presumably better able to make autonomous decisions about the risks and benefits of participating in a research study than those in possession of less information. In actuality, prior research into consent understanding suggests that longer forms offering exhaustive information may inhibit rather than promote understanding. Moreover, technical wording in tools used to measure parent understanding of research permission may also lead to inhibition of understanding. This study will test the hypothesis that, among parents of potential subjects for greater-than-minimal-risk research, two modified and simplified subset of questions from the Deaconess Informed Consent Comprehension Test (DICCT), one oral and open-ended and one written and multiple choice, will increase subject understanding of the nature and risks of the research. The study will enroll the parents of 40 potential neonatal research subjects with an interim analysis of data at 20 subjects. Subjects will review a sham research permission form and will be randomized 1:1 to complete one of the two modified comprehension tests in addition to the DICCT (gold-standard) test. Parents will be given an open-ended survey after the tests in order to qualitatively describe their opinions of each test. A subset of parents who have received the written form will also undergo a cognitive interview about the form. A similar subset will also be given an open-ended survey about a proposed permission form cover sheet. The primary outcome will be the correlation of scores between the DICCT and modified comprehension tests, following the sham informed consent process.

Conditions

• Improve Parent Understanding of Research Permission

Interventions

Type	Name	Description
OTHER	Coversheet to Informed Consent	The intervention is a one page cover sheet to be affixed to the front of the standard permission form for the trial for which permission is being sought (attached to application). The form will identify the study as research and contain sections that include investigator contact information, the purpose of the study, a brief description of the study procedures, the alternatives, the voluntary nature, the risks, the potential benefits, a discussion of privacy and confidentiality, the costs and the payments. Each topic will also contain a reference to the page in the consent containing the full description of the topic. The form is designed to have a reading level no higher than 6th to 8th grade. Parents will also receive the full permission form, and all required signatures will still be collected on the permission form.

Timeline

• Start date: 2012-03-30
• Primary completion: 2017-12-31
• Completion: 2019-04-30
• First posted: 2012-10-11
• Last updated: 2019-07-08

Locations

2 sites across 1 country: United States