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Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening

Erin Rothwell · with Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NCT06192511

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
5980
US sites recruiting
2
Study start
May 15, 2024
Record last updated
July 31, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

The purpose of this study is to implement an electronic consent education process for the retention and research use of residual dried bloodspots at four hospitals in Michigan and assess the impact of the new education, both on patients and hospital staff. The research team will recruit women who have just given birth to answer surveys about the Michigan BioTrust consent process. Surveys will be collected from participants in the hospital and again four weeks later. The research team will collect survey data from patient participants at each hospital prior to hospital staff implementation of the new education process and again after staff implementation.

Being studied: Educational Website and Video

Conditions: Implementation Science; Informed Consent; Neonatal Screening

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • University of Utah Hospital and Clinics

    Salt Lake City, UT 84132

    Site contact: Erin Johnson, PhD · 801-587-0975 · erin.p.johnson@hsc.utah.edu

  • University of Utah, Department of Obstetrics & Gynecology

    Salt Lake City, UT 84132

    Site contact: Erin Johnson, PhD · erin.p.johnson@hsc.utah.edu

Study contacts (from the official record)

  • Erin Johnson, PhD · 801-587-8578 · erin.p.johnson@hsc.utah.edu
  • Valerie Joseph · 801-587-2249 · valerie.joseph@hsc.utah.edu
Implementing a Novel Consent Process for Biospecimen Research… (NCT06192511) | Bored Studies