Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorErin Rothwell

About this trial

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.

Eligibility criteria

Qualifiers

Adult (> 18 years)

English, Spanish or Arabic speaking

Just gave birth and currently a patient in the Mother & Baby Unit in the hospital

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Educational Website and Video

Treatment groups

5,980 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Erin Rothwell

Lead sponsor

University of Utah

Sponsor institution

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

Collaborator