CSTE IRB Workgroup

Document Opinion from US District Court Related to MI Newborn Screening and Research.pdf (274 KB)

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Michigan is currently defending its newborn screening program and the Michigan BioTrust for Health (an IRB approved program to make residual newborn screening dried blood spots available for a limited scope of health research) in federal court. This opinion is not favorable to the use of residual dried blood spots for research where express consent has not been obtained. Additionally, the opinion is critical of a waiver of informed consent granted by the Michigan Department of Health and Human Services IRB. I thought this issue may be of interest to this group.

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Ian H. posted this on · Download ↓
Ian Horste
If anyone has any thoughts they are interested in sharing, or questions about Michigan's programs, please let me know. If any of your departments may be interested in filing an amicus brief related to this case, I'm happy to put you or your legal staff in touch with people better positioned to assist with that than I am.