New consent process for using newborn screening samples in research
Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening in Hospitals Serving Diverse Patients
NA · University of Utah · NCT06192511
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 5980 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Utah (other) |
| Locations | 2 sites (Salt Lake City, Utah and 1 other locations) |
| Trial ID | NCT06192511 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults who have just given birth and are currently patients in the Mother & Baby Unit at participating hospitals.
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.
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 performed: Other studies have shown success in improving informed consent processes through educational interventions, suggesting potential for positive outcomes in this approach.
Eligibility criteria
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 this trial is running
Salt Lake City, Utah and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Implementation Science, Informed Consent, Neonatal Screening, newborn screening, informed consent, biobanking