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Michigan BioTrust For Health: Frequently Asked Questions
Frequently Asked QuestionsPlease explore this page to learn the answers to the most asked questions about the Michigan BioTrust for Health. If you cannot find the answer to your question, you can reach out to BioTrust staff at BioTrust@Michigan.gov.
To access a PDF version of the BioTrust Frequently Asked Questions, please click here.
What are blood spots?Soon after birth a few drops of blood are taken from a newborn’s heel. The drops fill five or six spots on a filter paper card. These “blood spots” are used for newborn screening. Newborn screening ensures babies with rare diseases such as phenylketonuria (PKU), cystic fibrosis and sickle cell disease are found early for treatment. To learn more about newborn screening please visit www.michigan.gov/newbornscreening.
What do I need to know about blood spots?Five or six blood spots are collected to ensure there is enough for all of the newborn screening tests. If there is an abnormal testing value, the lab has enough spots to double check the result. This reduces the need to perform a second blood draw and helps ensure that newborns who need care get it as soon as possible. Once newborn screening is done, any unused blood spots are stored by the Michigan Department of Health and Human Services (MDHHS). Blood spots are de-identified before being sent for long term storage at a secure site called the Michigan Neonatal Biobank (www.mnbb.org).
How long are Michigan blood spots stored?
Blood spots dating back to January of 1987 are currently in storage. Any blood spots received by the state lab on infants born before January of 1987 have been destroyed. According to MDHHS policy, dried blood spots can be stored for up to 100 years, with current MDHHS practice indicating that blood spots will be destroyed after 35-years.
Why have blood spots been stored?
Good lab practice requires that blood spots be kept for a length of time after newborn screening is done. The state lab has always stored blood spots after newborn screening, but the length of time has changed over the years. In the 1970s, blood spots were stored for 7 years and then destroyed. In the 1980s, the State of Michigan stored blood spots until a child reached 21.5 years. In 1999, a Governor’s task force called the Michigan Commission on Genetic Privacy and Progress recommended storing leftover blood spots indefinitely because of their value for future research. State law allows the Department of Health and Human Services to set the period for storage. Current MDHHS policy indicates that dried blood spots can be stored for up to 100 years, with our current practice being 35-year storage. Here are some important reasons to store blood spots:
- Blood spots are used to ensure quality newborn screening.
- Blood spots may be used by families in the future if needed. Parents have asked that their own child’s blood spot be sent to researchers for studies, to help diagnose a disorder or find reasons for a child’s untimely death.
- Blood spots may also help researchers better understand diseases or find ways to improve health.
How have stored blood spots been used?
Blood spots may be used for the following reasons:
- To improve newborn screening. The state lab may use blood spots to make sure that all tests are working or to add new tests to the newborn screening disease panel. The state lab used blood spots in 2022 to test and implement an improved screening method for lysosomal storage disorders.
- Parents have asked that their own child’s blood spot be sent to researchers for studies, to help diagnose a disorder or find reasons for a child’s untimely death.
- Blood spots may be used for de-identified medical and public health research through the Michigan BioTrust for Health program. Researchers have used blood spots to look for better ways to diagnose leukemia and to test for mercury levels to find out if pregnant mothers were eating safe amounts of fish.
Who oversees how blood spots are used while in storage?The MDHHS Newborn Screening Program is responsible for both storing blood spots after newborn screening is completed and overseeing how those residual spots are used. MDHHS created and runs the Michigan BioTrust for Health Program, also called the “BioTrust”, specifically to oversee the research use of the residual blood spots. BioTrust program components include outreach and community engagement, policy development, and coordination of medical and public health research studies using blood spots.
Who helps MDHHS guide the BioTrust program?
Four different advisory boards help guide BioTrust policies and operations. Board members represent the major state universities, research institutions, disease and advocacy organizations, community groups and the public. Below is a visual that shows the governance structure of the BioTrust.
What are the goals of the BioTrust program at MDHHS?The primary goals are to: (1) make blood spots more useful for medical and public health research while protecting privacy, (2) store blood spots to better preserve the samples, (3) encourage research, (4) engage and inform the public and (5) allow personal decision-making.
What is the Michigan Neonatal Biobank (MNB)?The Michigan Neonatal Biobank (MNB) is a 501(c)3 non-profit organization serving as the repository for storage and management of Michigan’s newborn screening blood spot samples. The MNB is a temperature controlled, secure facility at Wayne State University’s Biobanking Center of Excellence in Tech Town (www.mnbb.org). The only samples currently stored at the MNB are blood spots left-over from Michigan’s newborn screening program. The MNB cannot access data and only receives blood spots and linked data that have been labeled with a code. The MNB is not permitted to use or release DBS except for as directed by MDHHS.
Who oversees the Michigan Neonatal Biobank?Oversight of the MNB is provided by a board of directors. One board member is appointed from each of the institutions that collaborated to establish the MNB– the Michigan Department of Health and Human Services, Van Andel Institute, Michigan State University and the University of Michigan.
What is the difference between the Michigan BioTrust for Health and the MNB?
The BioTrust is a program run by the Department of Health and Human Services to oversee Michigan’s stored blood spots and their use in health research. The BioTrust encompasses outreach and community engagement, policy development as well as coordination and approval of research requesting blood spots.
The MNB is the contracted storage repository for Michigan’s residual newborn screening blood spot samples. The MNB is responsible for securely storing and optimally preserving blood spots and only releases them when directed by MDHHS. They also work to promote the use of these samples in health research.
How are dried blood spots made available for research?Dried blood spots are valuable for public health research because they provide information about environmental and biological factors that can affect human health. MDHHS created the Michigan BioTrust for Health, a program designed to oversee and facilitate researcher access to dried blood spots following careful review of each proposed study. At MDHHS’s direction, the Michigan Neonatal Biobank makes de-identified dried blood spots available to public health researchers.
Michigan was the first state to seek consent from all new parents for de-identified medical research using newborn screening dried blood spots. Beginning on May 1, 2010, hospitals and midwives began providing a consent form to new parents. Parents are empowered to choose whether or not they want their baby’s residual dried blood spots to be used for deidentified medical research benefitting public health. Spots collected prior to May 1, 2010, can be used for deidentified medical research unless a parent submits a request to mark their child’s spots as unavailable for research. Parents who do not want their child’s spots to be kept by MDHHS can submit a request to have those spots destroyed. Adults can make these requests on their own behalf.
Why use left-over blood spots for research?There are many reasons why blood spots are a unique resource for medical and public health research studies. Because these samples are collected when babies are about 1 day old, they provide a snapshot of biological functions shortly after birth that researchers can study to gain insight into newborn health. Blood spots contain genetic and other kinds of biomarkers that may be useful for studying birth defects or chronic diseases. Blood spots may also show if there was exposure to infections or toxins (such as pesticides or lead) before birth. Because many blood spots can be provided at one time, it is easier for researchers to study very large numbers of people from all over the state. This is simpler than trying to collect a new sample from each person and may help speed up the chance of new discoveries, improve quality, and possibly reduce the cost of research.
Research performed using Michigan’s dried blood spots has helped improve newborn screening techniques. For example, research using dried blood spots through the BioTrust has been instrumental in developing newborn screening tests for the debilitating disorders Spinal Muscular Atrophy and Niemann-Pick C Disease. Research facilitated by the BioTrust has also contributed to advancements in the study of cancers and environmental exposure.
What kind of research does the BioTrust allow?The only studies allowed are for medical and public health research. Guiding principles were developed with input from the Community Values Advisory Board. For more details and a list of studies using Michigan blood spots, please visit the “Blood Spot Research” page on the BioTrust website (www.michigan.gov/biotrust).
Who reviews requests from researchers for de-identified dried blood spot research?Research requests to use de-identified blood spots are submitted to the BioTrust, where they undergo multiple levels of review by the Bureau of Laboratories, Bureau of Epidemiology and Population Health, the MDHHS Institutional Review Board, and a panel of three Scientific Advisory Board members. The review process ensures that the proposed research study has scientific merit; that the research complies with departmental policy; that the researchers are qualified to conduct the research; and that human subjects and data are protected.
Are Michigan's blood spots used for cloning or stem cell research?No. Blood spots cannot be used for cloning. Michigan law also prohibits human cloning for any purpose and prohibits the use of state funds for human cloning. Therefore, blood spots cannot be used for cloning. Stem cells are specialized cells that currently can only be isolated from certain types of tissues which do not include left-over blood spots from newborn screening. Thus, Michigan’s blood spots are not stored for stem cell research.
Are dried blood spots sold to anyone?No. Both MDHHS and the Michigan Neonatal Biobank charge researchers administrative fees when using blood spots in research. MDHHS fees are charged to recuperate costs associated with staff time invested in getting projects through the multi-step review process and selecting which blood spots should be used for each project. The Michigan Neonatal Biobank charges an administrative fee to fulfill researcher requests for de-identified dried blood spots in MDHHS-approved research projects, but not for the blood spot itself. The fee helps offset the cost of storage, labor, and shipping. Neither the Biobank nor MDHHS receives a profit from the BioTrust program.
Does MDHHS ever provide a dried blood spot to law enforcement?MDHHS will only provide a dried blood spot to law enforcement if MDHHS receives consent from the individual, a parent, a guardian, or another authorized representative to do so.
What has been done with my child's (or my own) blood spots and what are my options?
While all blood spots may be used for quality improvement and test development by the newborn screening lab, MDHHS is committed to ensuring that families have opportunities to make decisions about the use of these left over blood spots in research studies. The consent process differs depending on your or your child’s date of birth. For information about your options, please refer to the birth date sections below that applies to you or your child:
- Before January of 1987: Blood spots received by the State Laboratory on infants born before January of 1987 have been destroyed.
- Between January of 1987 and April of 2010: Blood spots collected in this time period are coded and may be used in health research under a waiver of informed consent granted by the MDHHS Institutional Review Board. If you want to continue to allow the use of coded blood spots in health research, you do not need to do anything. If you do not want your or your child’s blood spots made available for future health research, you have two options to opt-out. You may fill out a form to: (1) request that blood spots remain stored but not used in future research, or (2) request that blood spots be destroyed. The lab requires verification that you are the legal representative entitled to make the request to destroy blood spots. You must submit your State ID or driver’s license as well as a copy of your or your child’s birth certificate.
- After May 1, 2010: Blood spots from an infant born in or after May of 2010 may 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 MDHHS. New parents are given a BioTrust consent form around the time that blood spots are collected for newborn screening to record whether “yes” they want blood spots made available for research or “no” they do not. Please note, if a parent declines participation in the BioTrust, blood spots are still stored unless a form to destroy the blood spots is returned to the newborn screening program.
For more information, visit the “Consent Options” of the BioTrust website.
How does the BioTrust protect your privacy?
MDHHS and MNB take many steps to securely store blood spots and protect your privacy. There are many levels of security at the Michigan Neonatal Biobank, where blood spots are stored. Blood spots are stored using a code and not a person’s name. Details that could pinpoint a child or family are removed before blood spots are sent to MNB for storage. Only authorized employees are permitted to access the dried blood spots.
When blood spots are used in medical and public health research projects, researchers are only provided dried blood spots in a deidentified form. This means researchers don’t know whose blood spots they are using. The only exception is if you specifically grant permission to a researcher to use your dried blood spots in an identified form. Click here to read more about how your privacy is protected in the BioTrust research process.
The dried blood spots are also protected under the law. The BioTrust has been designated a Medical Research Project (MRP), which adds privacy protections. As outlined in the MRP, MDHHS is only permitted to use dried blood spots for quality improvement and test development of NBS disorders, parent- or guardian-directed medical research, crime victim identification, and de-identified medical research. MDHHS has been granted the highest level of federal protection, a Certificate of Confidentiality from the United States Department of Health and Human Services.
How can I access my or my child's leftover blood spots for personal use?
The Newborn Screening Follow-Up Program serves to facilitate the release of blood spots for parent or personal use. However, the Newborn Screening Follow-Up Program is not responsible for the actual testing of the released blood spot, nor does it provide clinical guidance on the use of the blood spot. In the past, families have used blood spots to diagnose a child’s untimely death, for further genetic testing, or for research projects outside of the BioTrust that they are participating in.
To access blood spots for further personal use, an Authorization to Disclose Protected Health Information (Form DCH-1183) must be completed and returned to the Newborn Screening Program at the MDHHS. This request can be made by a parent or legal guardian for a child or directly by an individual 18 years or older. The newborn screening program requires verification that you are the legal representative entitled to make the request to destroy blood spots. You must submit your State ID or driver’s license as well as a copy of your or your child’s birth certificate with your request.For more information on this process, please email newbornscreening@Michigan.gov.
Can I request that blood spots be destroyed?Yes, if you would like to request your or your child’s blood spots be destroyed, you must complete a Residual Newborn Screening Directive form and return it to MDHHS. The lab requires verification that you are the legal representative entitled to make the request to destroy blood spots. You must submit your State ID or driver’s license as well as a copy of your or your child’s birth certificate with your request. MDHHS will not process any destruction requests unless all necessary paperwork is provided. Once blood stops have been destroyed, you will receive a letter in the mail to confirm completion of the request.