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Improving Measurement Of Parents' Understanding Of Research Permission

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01704560
Recruitment Status : Completed
First Posted : October 11, 2012
Last Update Posted : July 8, 2019
Information provided by (Responsible Party):
Carl D'Angio, 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.

Condition or disease Intervention/treatment Phase
Improve Parent Understanding of Research Permission Other: Coversheet to Informed Consent Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
Actual Study Start Date : March 30, 2012
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : April 30, 2019

Arm Intervention/treatment
Experimental: Coversheet to Informed Consent
Coversheet attached to Informed Consent.
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.

No Intervention: No Coversheet
Standard, full permission form, without the coversheet.

Primary Outcome Measures :
  1. DICCT Questionnaire [ Time Frame: 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01704560

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United States, New York
Women and Children's Hospital of Buffalo
Buffalo, New York, United States, 14222
Ann Marie Scorsone
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
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Principal Investigator: Carl T D'Angio, MD University of Rochester
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Carl D'Angio, Professor, University of Rochester Identifier: NCT01704560    
Other Study ID Numbers: 39377
First Posted: October 11, 2012    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019