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Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening

Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening in Hospitals Serving Diverse Patients

Who can join

Ages 18 and older · All sexes · Healthy volunteers welcome

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

About the study

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.

What is being tested

• Educational Website and Video (behavioral)

Sponsor: Erin Rothwell · Participants: 5,980 · Started: May 15, 2024

Contact the study team

• Erin Johnson, PhD · Phone: 801-587-8578
• Valerie Joseph · Phone: 801-587-2249

Official record on ClinicalTrials.gov — NCT06192511

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.