Improving Measurement Of Parents' Understanding Of Research Permission

Completed · Not applicable

Conditions studied: Improve Parent Understanding of Research Permission

In brief

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.

Key facts

Study ID

NCT01704560

Run by

University of Rochester

People needed

32

Starts

2012-03-30

Expected to finish

2019-04-30

Last updated by the study team

2019-07-08

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Parents of potential subjects eligible for a NICHD Neonatal Research Network (NRN) interventional trial ("Hydrocortisone/Extubation") or greater-than-minimal risk observational trial ("PROP")
• Permission being sought for a qualifying study
• English speaking

You may not qualify if…

• Permission has not been previously sought for another qualifying study
• Illiteracy (unable to read simple forms)

Where it is running

• Women and Children's Hospital of Buffalo — Buffalo, New York, United States
• Ann Marie Scorsone — Rochester, New York, United States

Full record on ClinicalTrials.gov

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