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

> **NIH NIH R01** · UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH · 2022 · $693,250

## Abstract

PROJECT SUMMARY
Biobanks are an enormously valuable resource for genomic research. However, inadequate diversity among
specimen donors limits their generalization for translational research. The lack of representativeness of
biosamples has the potential to limit the application of precision medicine within underrepresented
communities and may inadvertently exacerbate health disparities. Biobanks created using stored newborn
screening bloodspots can be particularly valuable resources in efforts aimed at addressing the need for
samples from diverse populations: they represent virtually the whole population of infants in a given state, and
can be accessed by a wider range of researchers and institutions than smaller repositories with narrower
research goals. However, the storage and future research use of newborn bloodspots has itself experienced a
long history of national controversy given that state newborn screening programs do not obtain informed
consent for collection and testing, and only a few states have subsequently added consent for the research
use of leftover bloodspots. Ongoing lawsuits among some state programs and policy debates at both the state
and federal levels have further mired any progress to promote the use of newborn screening bloodspots for
important health research, including studies that assess health disparities. The implementation of consent
processes at the state level may become necessary for the continued utilization of this important resource. The
proposed renewal of our R01 will address these concerns by: identifying determinants, strategies,
mechanisms, barriers, and facilitators of consenting quality across hospitals serving diverse and underserved
populations for the retention and research use of residual dried bloodspots for the Michigan Biotrust of Health
(Aim 1); engaging members of underrepresented and non-English speaking communities in Michigan to
support implementation of an electronic informed consent intervention (EICI) in diverse hospital settings (Aim
2); and implementing and evaluating the EICI consent approach within four major hospitals across the state of
Michigan serving underrepresented persons, Spanish and Arabic speaking participants, and the general
population (Aim 3).

## Key facts

- **NIH application ID:** 10520786
- **Project number:** 2R01HD082148-05A1
- **Recipient organization:** UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH
- **Principal Investigator:** Aaron J Goldenberg
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $693,250
- **Award type:** 2
- **Project period:** 2022-09-15 → 2027-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10520786

## Citation

> US National Institutes of Health, RePORTER application 10520786, Implementing a Novel Consent Process for Biospecimen Research after Newborn Screening in Hospitals Serving Diverse Patients (2R01HD082148-05A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10520786. Licensed CC0.

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