New consent process for using newborn screening samples in research
Official title: Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening in Hospitals Serving Diverse Patients
Run by University of Utah · NCT06192511 · Data updated 2026-11-12
This study is testing a new online consent process to see if it helps new mothers better understand and accept how their babies' newborn screening samples can be used for research.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 5980 (estimated) |
| Sponsor | University of Utah Academic / other |
| Locations | 2 sites (Salt Lake City, Utah and 1 other locations) |
| Status | Recruiting |
| Started | May 15, 2024 |
| Main results expected | November 15, 2027 |
| Study ends | April 30, 2028 |
| Registry record updated | July 31, 2026 |
| Trial ID | NCT06192511 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults who have just given birth and are currently patients in the Mother & Baby Unit at participating hospitals.
✕Probably not a fit
Patients with infants born pre-term, in the Neonatal Intensive Care Unit, or in uncertain legal guardianship situations may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to implement an electronic consent education process for the retention and research use of residual dried bloodspots collected during newborn screening at four hospitals in Michigan. The research team will recruit new mothers to complete surveys assessing their understanding and acceptance of the Michigan BioTrust consent process before and after the implementation of the new educational materials. The study will compare responses from participants before and after the introduction of an educational website and video, which will supplement the existing consent process. Additionally, hospital staff will also provide feedback on the sustainability of the new consent process.
Why it matters
Potential benefit: If successful, this study could enhance informed consent practices and improve patient understanding regarding the use of newborn screening samples in research.
How similar studies have gone: Other studies have shown success in improving informed consent processes through educational interventions, suggesting potential for positive outcomes in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult (\> 18 years) * English, Spanish or Arabic speaking * Just gave birth and currently a patient in the Mother \& Baby Unit in the hospital Exclusion Criteria: * Parents of infants who are born pre-term (\< 37 weeks gestation) * Parents of infants in the Neonatal Intensive Care Unit * Parents of infants being put up for adoption or in situations where legal guardianship is unknown at the time of birth
Where it's running
-
University of Utah Hospital and Clinics
Salt Lake City, Utah, United States Recruiting -
University of Utah, Department of Obstetrics & Gynecology
Salt Lake City, Utah, United States Recruiting
Study contacts
- Principal investigator: Erin Rothwell, MD — University of Utah
- Study coordinator: Erin Johnson, PhD
- Email: erin.p.johnson@hsc.utah.edu
- Phone: 801-587-8578
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.