Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening

Recruiting now · Not applicable

Conditions studied: Implementation Science, Informed Consent, Neonatal Screening

In brief

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.

Key facts

Study ID

NCT06192511

Run by

Erin Rothwell

People needed

5980

Starts

2024-05-15

Expected to finish

2028-04-30

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Adult (> 18 years)
• English, Spanish or Arabic speaking
• Just gave birth and currently a patient in the Mother \& Baby Unit in the hospital

You may not qualify if…

• 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 is running

• University of Utah Hospital and Clinics — Salt Lake City, Utah, United States (enrolling)
• University of Utah, Department of Obstetrics & Gynecology — Salt Lake City, Utah, United States (enrolling)

Full record on ClinicalTrials.gov

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