Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening

Launched by ERIN ROTHWELL · Jan 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to educate parents about giving consent for the use of leftover blood samples from newborn screening tests. The research is taking place at four hospitals in Michigan, and it aims to see how well this new electronic consent process works for both parents and hospital staff. The study is looking for women who have just given birth, can speak English, Spanish, or Arabic, and are currently in the Mother & Baby Unit of the hospital. However, parents of premature infants, those in the Neonatal Intensive Care Unit, or those in uncertain legal situations regarding guardianship cannot participate.

Participants in the study will be asked to complete surveys about their understanding and feelings regarding the consent process, both while they are still in the hospital and again four weeks later. This feedback will help the researchers understand how effective the new education method is and how it impacts everyone involved. Your participation could help improve how hospitals communicate important information about newborn screening and consent for future research.

Gender

ALL

Eligibility 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