Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06192511

Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening

Led by Erin Rothwell · Updated on 2025-06-19

5980

Participants Needed

2

Research Sites

206 weeks

Total Duration

On this page

Sponsors

E

Erin Rothwell

Lead Sponsor

E

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborating Sponsor

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult (over 18 years old)
  • Speaks English, Spanish, or Arabic
  • Just gave birth and is currently a patient in the Mother & Baby Unit in the hospital
Not Eligible

You will not qualify if you...

  • Parent of an infant born pre-term (less than 37 weeks gestation)
  • Parent of an infant admitted to the Neonatal Intensive Care Unit
  • Parent of an infant being put up for adoption or with unknown legal guardianship at birth

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

University of Utah Hospital and Clinics

Salt Lake City, Utah, United States, 84132

Actively Recruiting

2

University of Utah, Department of Obstetrics & Gynecology

Salt Lake City, Utah, United States, 84132

Actively Recruiting

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Research Team

E

Erin Johnson, PhD

CONTACT

V

Valerie Joseph

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

SCREENING

Number of Arms

2

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