Q. How is privacy protected?
Michigan law allows leftover dried blood spots to be used for medical research, as long as confidentiality of the subjects is maintained. Confidentiality is maintained by removing all directly identifiable information (name, address, birth date, etc.) about the person so researchers don't know whose sample was used.
Q. How is directly identifiable information removed from the samples?
All samples are double blinded. This means that after newborn screening is completed, the filter paper containing leftover blood spots is separated from the NBS (newborn screening) card that has the baby's directly identifiable information. A code is assigned to the remaining blood spot sample before it is transferred to the Michigan Neonatal Biobank for storage. Then, before that same sample is released to a researcher, the Biobank assigns another, different tracking number. Therefore, the tracking number the researcher sees is two steps removed from the original NBS case number. If a research project requires samples meeting certain criteria, such as a certain geographic region, sex, or condition, Michigan Department of Community Health will conduct a database linkage to select the right samples while still keeping them confidential.
Q. Do law enforcement officials or insurance companies have access to the BioTrust?
No. The BioTrust and the MDCH that sends samples to the Biobank have been designated as a medical research project. Under state law, the samples, data and any other information included as part of this medical research project are protected and are not subject to forced disclosure to third parties.
Q. What are the options if I do not want my child's or my own dried blood spot sample used for research?
If you or your child were born between July 1984 and 2010, there are two options. You may fill out a form to: (1) request that the sample be saved but not used for research, or (2) request that the sample be destroyed after newborn screening is completed. If you ask for the sample to be destroyed, the laboratory requires verification that you are the legal representative entitled to make the request. Call 1-866-673-9939 or email email@example.com to obtain a form, or download:
Starting later in 2010, new parents will be asked to give permission by signing a consent form after delivery if they want their child's remaining DBS sample made available for future medical research. Parents will still be able to change their mind after signing the consent form, using the directive forms listed above.