Improving Measurement Of Parents' Understanding Of Research Permission
- Conditions
- Improve Parent Understanding of Research Permission
- Interventions
- Other: Coversheet to Informed Consent
- Registration Number
- NCT01704560
- Lead Sponsor
- University of Rochester
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- 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
- Permission has not been previously sought for another qualifying study
- Illiteracy (unable to read simple forms)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Coversheet to Informed Consent Coversheet to Informed Consent Coversheet attached to Informed Consent.
- Primary Outcome Measures
Name Time Method DICCT Questionnaire Within 2 weeks after being approached for participation. Score on the post-permission DICCT questionnaire. The DICCT is scored on a 28 point scale, with each of 14 parameters being scored as 0 = incorrect, 1 = partially correct, 2 = correct. The DICCT, in addition to being previously validated, has other advantages. It contains questions that are not directly addressed in the cover sheet, but addressed in the full permission form, such as compensation for injury. These items will serve as valuable internal controls. The DICCT is easily adaptable to written answers, which makes it ideal for further modification in future studies.
The DICCT will be administered during a structured interview, without a time limit. The parent will be allowed to refer to the permission form to answer the questions.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Ann Marie Scorsone
🇺🇸Rochester, New York, United States
Women and Children's Hospital of Buffalo
🇺🇸Buffalo, New York, United States