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

What this Trial Is About

Researchers are evaluating a new electronic consent education process for the retention and research use of leftover dried bloodspots collected after newborn screening at four hospitals in Michigan. The study aims to assess how this new education approach impacts both patients and hospital staff. Women who have just given birth will be invited to participate in surveys about the Michigan BioTrust consent process before and after the new education is implemented. The study compares two groups: one group receives the current standard education, which includes a brief verbal description and a brochure about the Michigan BioTrust, and the other group receives standard education plus access to a website with detailed written information and a 4-minute video available in English, Spanish, or Arabic. Hospital staff will provide these educational materials, and surveys will be collected from patients both during their hospital stay and about four weeks later. Hospital employees involved in the new education process will also complete surveys immediately after training and several months after implementation. Participants will complete surveys shortly after the BioTrust consent process and again four weeks later via email, text, or phone. The research team will measure knowledge about consent and biobanking, decisional regret, decisional conflict, and consenting and biobanking rates obtained from state records six months after data collection ends. The study involves adult women who have just given birth and lasts through follow-up surveys and data collection for consenting rates.

Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening