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Michigan BioTrust for Health - Consent Options
Prior to making a decision about participation in the BioTrust, please make sure you read the Frequently Asked Questions section of this website and get all of your questions answered.
The consent process differs depending on your or your child's date of birth. It is important to take a moment to learn more about the opt-out process for "legacy" blood spots, those collected prior to May 1, 2010. Please also read more about the opt-in process for "prospective" blood spots, those collected after April 30, 2010 through present day.
Blood spots have always been stored for some period of time following newborn screening, but the length of time has changed over the years. In the 1970s, samples were saved for 7 years. In the 1980s, the Michigan Department of Health and Human Services (MDHHS) changed the policy to store each sample for 21.5 years following the receipt of legal advice. In 2008, the policy was revised for indefinite storage of blood spots to align with a recommendation from the Governor's Commission on Genetic Privacy and Progress. Today, blood spots are stored for up to 100 years once newborn screening is completed. The changes in storage policy have allowed for a collection of stored blood spots dating back to January 1987. Any samples received by the state laboratory on infants born before January 1987 have been destroyed.
Opt-Out Process for Births Between October 1987 and April 30, 2010
Blood spots collected between October 1987 and April 30, 2010 are stored for up to 100 years. Blood spots collected between January 1987 and September 1987 are scheduled to be destroyed per the MDHHS Bureau of Laboratories' retention schedule. These stored spots are de-identified and may be used in health research under a waiver of informed consent granted by the MDHHS Institutional Review Board. The stored blood spots may also be requested by a parent or person (>18y) for their own use. If you or your child were born between October 1987 and April 30, 2010, and you want to continue allowing the use of the de-identified blood spots in research, you do not need to do anything. If you do not want your or your child's stored blood spots used for future health research, there are two options to opt-out. You may fill out a form to: (1) request that the blood spots continue to be stored but not used for research, or (2) request that the blood spots be destroyed. If you ask for the blood spots 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:
Opt-In Process for Births After April 30, 2010
Blood spots from an infant born after April 30, 2010, will be stored for up to 100 years after newborn screening is done. However, the blood spots will not be used in research through the BioTrust unless a signed parental consent form is on file with the state laboratory. This new opt-in process began May 1, 2010. Currently, all birthing hospitals and midwives have been instructed to give new parents the option of signing a consent form after delivery if they want their child's remaining blood spots made available for future medical research. One full blood spot will also be saved for future use by the child or family, should it ever be needed. After signing the consent form, parents can still change their mind later using the directive forms above.
**Please note, if a parent declines participation in the BioTrust blood spots are still stored for up to 100 years unless a Residual Newborn Screening Blood Spot Directive requesting destruction is returned to the state laboratory.**
- After Newborn Screening Your Baby's Blood Spots - Michigan BioTrust For Health Consent Brochure (Spanish) (Arabic)
- Audio Recording of BioTrust Consent Brochure
- BioTrust Consent Form English
- BioTrust Alternate Consent Form
- Directive to use DBS for research English