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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01704560|
Recruitment Status : Recruiting
First Posted : October 11, 2012
Last Update Posted : April 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Improve Parent Understanding of Research Permission||Other: Coversheet to Informed Consent||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||IMPROVING MEASUREMENT OF PARENTS' UNDERSTANDING OF RESEARCH PERMISSION|
|Study Start Date :||March 2012|
|Estimated Primary Completion Date :||December 31, 2017|
|Estimated Study Completion Date :||January 2019|
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01704560
|United States, New York|
|Women and Children's Hospital of Buffalo||Recruiting|
|Buffalo, New York, United States, 14222|
|Contact: Michael G Sacilowski, MAT, CCRC 716-878-7140 mailto:email@example.com|
|Principal Investigator: Satyan Lakshminrusimha, MD|
|Sub-Investigator: Anne Marie Reynolds, MPH, MD|
|Ann Marie Scorsone||Enrolling by invitation|
|Rochester, New York, United States, 14642|
|Principal Investigator:||Carl T D'Angio, MD||University of Rochester|