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NCT03141307 · ClinicalTrials.gov registry record · NA
The Effect of Electronic Informed Consent Information (EICI) on Residual Newborn Specimen Research
A NA study of Neonatal Screening, sponsored by University of Utah.
- Completed
- Registry status
- NA
- Development phase
- 711
- Enrollment target
- 1
- Study location
NCT03141307: Completed NA study of Neonatal Screening, sponsored by University of Utah.
NCT03141307 is a NA study of Neonatal Screening that has completed, run by University of Utah. The registered enrollment target is 711 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (49% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03141307, a NA study of Neonatal Screening, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- NA
- Development phase
- 711 participants
- Enrollment target
- 1
- Study location
Study Summary
Obtaining adequate informed consent from potential research participants is a significant challenge for biobank-dependent research. To maintain public trust and support, it is important to establish an informed decision-making process for the collection and use of biospecimens collected within clinical settings. For the majority of all infants born in the US, residual dried blood biospecimens are generated after newborn screening is completed. Some programs choose to store these specimens for several uses including biomedical research. Identifying ways to improve comprehension about broad consent for future biobank-dependent research is a national priority. Specific Aim 1: Identify the key information items necessary to make an informed decision about broad consent for the retention and future research use of residual biospecimens. Methods include focus groups with new parents to determine key information elements relevant to consent for use of residual biospecimens within the Michigan BioTrust. Additional meetings with IRB personnel within the participating hospitals, health departments and universities will also be conducted to ascertain their expectations and requirements for the consent process. Specific Aim 2: Based on the data collected in Aim 1, create a state-of-the-art electronic informed consent information (EICI) tool for use in the clinical setting about the retention and use of residual biospecimens. The award-winning Genetic Science Learning Center will develop the professional EICI in Spanish and English. Validation of the EICI will be completed using feedback from both community and scientific advisory boards for the Michigan BioTrust. Specific Aim 3: Evaluate the EICI consent approach by comparing it to: a) traditional consent delivered on an electronic tablet; and b) the current paper-based consent approach. Both Spanish and English speaking parents (n = 630) in the state of Michigan, where informed consent is required for biobank research during p
Primary Outcome
Questions based on the 16-item biobank checklist developed from consensus-based guidelines for adequate comprehension for biobanking (see Beskow et al. 2014). This measure assesses a person's understanding of the Michigan BioTrust program. Scale range: 0-1 The reported scale is derived from the number of correct answers divided by 20 for a percentage correct. Thus, a score of .6 indicates a 60% correct response rate. Higher values indicate more comprehension of the presented information. Lower
Conditions Studied
Interventions
- BEHAVIORAL Control
- BEHAVIORAL EICI Movie
- BEHAVIORAL EICI App
Study Locations (1)
Michigan
- Michigan Department of Health & Human Services - Lansing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 711 participants |
| Start Date | 2018-03-01 |
| Est. Completion | 2018-06-15 |
| Phase | NA |
What the finished NCT03141307 record still lists
NCT03141307 is an interventional study that assigns participants to a tested intervention. The registered 711 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (49% lower).
The record links to 1 condition, with Neonatal Screening appearing as the primary indexed condition, and to 3 interventions - of which Control is the first listed.
NCT03141307 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT03141307 about?
NCT03141307 is a clinical study titled "The Effect of Electronic Informed Consent Information (EICI) on Residual Newborn Specimen Research". Obtaining adequate informed consent from potential research participants is a significant challenge for biobank-dependent research. To maintain public trust and support, it is important to establish an informed decision-making process for the collection and use of biospecimens collected within clini...
What is the current status of trial NCT03141307?
This trial is currently completed. It is a NA study. The enrollment target is 711 participants. The study started on 2018-03-01. Estimated completion is 2018-06-15.
What conditions does trial NCT03141307 study?
This clinical trial studies the following conditions: Neonatal Screening.
What interventions are being tested in trial NCT03141307?
The interventions under investigation include: Control (BEHAVIORAL), EICI Movie (BEHAVIORAL), EICI App (BEHAVIORAL).
Who is sponsoring clinical trial NCT03141307?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03141307 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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711 147th of 2000 higher than 1,854 of 2,000 other NA trials
participants (enrollment target), bucketed by value
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