Improving Measurement Of Parents' Understanding Of Research Permission
Status: | Active, not recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - 45 |
Updated: | 6/27/2018 |
Start Date: | March 30, 2012 |
End Date: | January 2019 |
IMPROVING MEASUREMENT OF PARENTS' UNDERSTANDING OF RESEARCH PERMISSION
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- Permission has not been previously sought for another qualifying study
- Illiteracy (unable to read simple forms)
We found this trial at
2
sites
Buffalo, New York 14222
Principal Investigator: Satyan Lakshminrusimha, MD
Phone: 716-878-7140
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