From Newborn Screening to Population Health Research: Implementation of the Michigan BioTrust for Health

Abstract

In June 2009, the Michigan Department of Community Health launched the Michigan BioTrust for Health to improve preservation and utility of residual dried blood spots from newborn screening (NBS) for biomedical research while maintaining public support and integrity of NBS. In this article, we chronicle implementation of the BioTrust and document its impact on NBS. Overall, the percentage of new parents who consent to possible future research use of their children's dried blood spots through the BioTrust has remained consistent with previous public opinion surveys. No significant increase in refusal of NBS has been observed despite increased publicity. There was, however, a slight increase in requests to destroy samples following completion of NBS, indicating readily accessible opt-out information. Given adequate training and cooperation of birthing hospital staff, as well as outreach education for parents and health-care providers, we conclude it is possible to implement a biobanking initiative without adversely impacting NBS.

Public concerns regarding the storage and secondary uses of residual newborn bloodspots: an analysis of print media, legal cases, and public engagement activities

“…For example, in the UK, the use of extensive public consultation has been endorsed. In 2009, the Michigan Department of Community Health founded the Michigan BioTrust for Health to ensure the preservation of RBS for biomedical research (Langbo et al 2013). Findings from the Lansing, Michigan deliberative jury (Fleck et al 2008) informed the development of the BioTrust's ethical guidelines for the storage and additional use of RBS.…”

“…Findings from the Lansing, Michigan deliberative jury (Fleck et al 2008) informed the development of the BioTrust's ethical guidelines for the storage and additional use of RBS. Research has determined that the BioTrust has managed to maintain public support and integrity of the NBS program, while avoiding an increase in refusals of NBS (even with the increased negative publicity related to storage and additional research uses of RBS) (Langbo et al 2013). The BioTrust is a clear example of the benefit of incorporating the "public voice" into the development of policy for the storage and use of RBS.…”

Current status of newborn screening worldwide: 2015

“…55,56 As in other countries, researchers in both the U.S. and Canada have investigated parental attitudes and public perceptions concerning potential uses of residual NBS specimens in an effort to inform NBS programs and address any issues revealed. 57,58 In Michigan, a model NBS biobank has been developed, 59 and a Newborn Screening Translational Research Network (NBSTRN) has been funded by the National Institutes of Health as one way of providing researchers with improved knowledge and access to NBS specimens in participating state NBS programs. 60 In Canada, the federal government has no formal role in newborn screening.…”

Using Newborn Screening Bloodspots for Research: Public Preferences for Policy Options

“…Some evidence suggests that it is feasible to implement permission-based models. 17,20,[42][43][44] Of note, Charles et al 20 tested this approach by using a 2-stage written consent protocol. They allowed parents to provide separate consent for: (1) their infant to be screened; and (2) secondary use of the sample for research.…”

“…However, other consent-based biorepository models (eg, Michigan BioTrust for Health) achieve more moderate uptake (ie, 60%), raising questions about whether explicit consent compromises the ability of programs to conduct generalizable research. 44 A second option might be informed by the results of the logistic regression and the evidence of somewhat diminished enthusiasm for explicit consent among those exposed to the reasoning exercise. Such an approach would mobilize efforts 6 27 and be feasible to implement remains to be seen.…”