The Michigan Department of Community Health (MDCH) currently maintains a collection of dried blood spots that are left over after newborn screening. We would like to make these samples available and more useful for medical and public health research. However, the transition to a more formal specimen biobank, called the Michigan BioTrust for Health, brings up certain public policy issues. In addition to consulting with experts in research and ethics, MDCH is seeking input from Michigan citizens. This will help assure development of operating policies for the BioTrust that are acceptable to the public. We are currently surveying residents and your participation is very important. Please read the following quick facts about newborn screening, dried blood spots, biobanks, and privacy for important background information before you fill out the survey. You may also want to read the FAQ booklet or view a slideshow about newborn screening and the proposed BioTrust.
Newborn Screening Dried Blood Spots Michigan's BioTrust Project
Quick Facts: Newborn Screening
-
Newborn screening is a public health program to find rare but serious disorders that benefit from early treatment.
-
Newborn screening is mandated for all Michigan newborns by
law
. All babies need to be tested in order to find the small number of babies who look healthy but have a rare health problem.
-
Usually between 24 and 36 hours after birth, a small sample of blood is taken from a baby's heel and placed on a filter paper card (shown on right). These samples are called dried blood spots (DBS). The dried blood spot card is sent to the MDCH, Bureau of Laboratories, where it is tested for 49 disorders.
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About 1 out of every 530 babies born each year is found to have a disorder detected by newborn screening.
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In 2008, Michigan's newborn screening program identified 225 affected babies.
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Read more about newborn screening
Quick Facts: Dried Blood Spots 
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After newborn screening is complete, there are usually blood spots left over, as depicted above.
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In 1999, the Michigan Commission on Genetic Privacy and Progress recommended saving leftover spots because of their value for future research. Read the press release or full report.
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Technology is now to the point where the samples are likely to be more useful for research than in the past.
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Michigan law allows leftover dried blood spots to be used for medical research, as long as privacy is maintained. Privacy is maintained by removing all identifiable information, such as name and address, so researchers don't know whose sample was used.
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Until now, leftover dried blood spots from newborn screening have been stored in a warehouse at room temperature. The Michigan BioTrust will improve the storage conditions for these samples.
-
The
BioTrust will also promote and expand the use of newborn dried blood spot samples for health research.
Read more about dried blood spots and research
Quick Facts: Biobanking
-
A Biobank is a place that collects, stores, processes and distributes biological samples and the data associated with those materials.
- Biobanks may be used for clinical care or health research.
- In the United States, research biobanks are governed by ethical principles for human subject research established by federal guidelines.
Read more about
biobanks
Quick Facts: Safeguarding privacy
-
To assure protection of human subjects, every proposed study using Michigan dried blood spots is reviewed by the Michigan Department of Community Health Institutional Review
Board
(IRB). An IRB is a committee that approves, monitors, and reviews biomedical and behavioral research involving human subjects to protect their rights and welfare. All institutions that perform research involving human subjects are required to have an IRB.
-
Once the
BioTrust
is established, a scientific review panel will also review proposals requesting dried blood spots for their scientific value.
-
A Community Values Advisory Board will be appointed to provide guidance on the types of research that are, or are not, acceptable uses of the dried blood spots. The Community Values Advisory Board will base its recommendations to MDCH on input obtained from the public through community engagement efforts (such as this survey).
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Parents who do not want their child's leftover dried blood spots used for research may contact the Michigan Newborn Screening Program to request (1) that their child's sample be saved but not used for research
,
or (2) that their child's sample be destroyed after screening is completed.
-
Since Michigan law requires confidentiality, MDCH will remove all directly identifying information (name, address, etc.) about the person and label the sample with a code before it is placed in the Biobank, and made available for research.
Read more about Michigan's BioTrust project
Take the
BioTrust
survey!
More information about newborn screening:
Q.
What is Newborn Screening?
Newborn Screening (NBS) is a public health program to find babies with rare but serious conditions that benefit from early treatment.
Q.
When did NBS begin?
Newborn screening for a rare metabolic disease called PKU (phenylketonuria) began in 1965. PKU causes severe mental retardation, but can be treated by limiting the amount of protein in the diet. Today, a child with PKU can have normal development when detected by NBS and treated early.
Q.
How many disorders can be found today?
The number of disorders on the NBS panel has increased over the years as new technologies and treatments became available. The screening panel now includes 49 diseases. If these disorders are not found and treated soon after birth, permanent disability, illness or death may result.
Q.
How many babies with disorders are found?
Each year, more than 200 babies, or about 1 in 530 births, are found to have one of the disorders. Over the years, nearly 4,000 Michigan babies have been diagnosed and received treatment as a result of NBS.
Q.
How is NBS done?
When a baby is 24-36 hours old, a few drops of blood are drawn from the baby's heel. The sample is put on a filter paper card and allowed to dry. It is then sent to the state public health laboratory at the Michigan Department of Community Health (MDCH) for testing.
Q. What is a dried blood spot?
The NBS blood samples on the filter paper card are often called "dried blood spots" (DBS).
Q. Are blood spots ever left over after testing?
Yes, one or two spots are often left because most babies have normal results. Five spots of blood are usually collected to be sure there is enough for all the tests. Sometimes not all the spots are suitable for testing, so it helps to have more than are needed. In the event there is a positive (abnormal) test, the lab can double check the result with the extra spots. Having five spots available lowers the number of newborns who need to have their blood drawn again.
Q. What is Michigan's newborn screening law?
Michigan's newborn screening law is part of the public health
code
. This law designates the state public health laboratory as a centralized site to perform NBS, and establishes a fee for testing. It allows blood specimens to be used for medical research under certain conditions, and also lets parents ask the hospital to draw a second specimen to keep for themselves.
Q. How do parents learn about newborn screening?
Every hospital receives newborn screening brochures that should be given to parents when a baby is born. Efforts are also underway to enhance outreach education about newborn screening for expectant parents, so they will be aware of newborn screening before delivery.
Q. How much does newborn screening cost?
The current cost is $88.18 per baby. This fee supports the laboratory costs of screening, follow-up, and medical management for infants and children affected by the disorders.
Q. Where can I find more information about newborn screening?
More information can be obtained at the following websites:
More information about dried blood spots:
Q.
Why are dried blood spots stored?
Good laboratory practice requires that samples be kept for a period of time after testing is done. Also, federal regulations of laboratories require that documents related to testing be retained for two years. During the 1980's, the State of Michigan Attorney General concluded that the DBS should be held in storage by the state laboratory until a child reaches 21.5 years. In 1999, a governor's task force on genetic privacy, seeing the potential for DBS to add to health research, recommended the samples be retained indefinitely. State law allows MDCH to set the retention schedule, and in 2008, the policy was changed to save samples indefinitely.
Q. Are the blood spots currently used for anything else after NBS?
There are several possible uses:
♦
The
state laboratory uses stored blood spots for developing new NBS tests, and to make sure screening equipment is working as it should be.
♦
To
help ensure the health of all Michigan residents, the state laboratory may use blood spots to investigate the spread of infectious diseases or public health epidemics. For example, anonymous samples were used in the 1990s to find out how many newborns were exposed to HIV.
♦ Parents may request that their own child's identifiable sample be used to assist in investigating crimes like a missing child. Also, if a child is enrolled in a research study, parents may request that their child's spot be sent to the researcher.
♦ State law allows punches from leftover samples to be used for medical research after newborn screening is complete. However, the sample is separated from all directly identifying information, so the researcher does not know whose dried blood spot is being used.
Q. Why use leftover dried blood spots for research?
Studying DBS may lead to new screening tests. Research may also provide important clues about different factors that impact health or cause diseases not only in Michigan but worldwide. The samples are no longer needed after NBS is complete. Because many DBS samples 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. This can help speed up the chance of new discoveries, improve quality, and possibly reduce the cost of research.
Q. What kind of research has been done, and would be allowed in the future?
So far, only a few research studies using Michigan DBS have been conducted. Examples include: (1) studying the incidence of different gene variants for an inherited condition ( hereditary
hemochromatosis
); (2) developing additional laboratory screening methods ( sickle cell diseases); and (3) searching for new disease markers ( childhood leukemia). In the future, the only studies that will be allowed are for medical or public health research conducted in accordance with guidelines established by the Community Values Advisory Board.
Q. Are dried blood spots used for cloning or stem cell research?
No. Dried blood spots cannot be used for cloning or stem cell research.
Q. Has my child's (or my own) dried blood spot been used for medical research or public health investigations?
Currently it is not possible to tell exactly which spots have been used, because all identifying information is removed. In the future, new procedures will be put in place so it is possible to track the samples that are used, but still retain privacy. It should also be noted that lab policy states at least one full spot will always be saved for use by the child or his/her family in case it is ever needed.
More information about Michigan's BioTrust project:
Q.
What is the BioTrust project?
The BioTrust is a way to make dried blood spots more useful by storing them under conditions that better preserve the leftover samples. Once created, the BioTrust would actively promote use of leftover DBS for important medical and public health research studies.
Q. What are the goals of the BioTrust project?
The four primary goals are to:
Ø
Make
the DBS more useful for medical and public health research
Ø
Store
DBS under conditions that better preserve the samples
Ø
Let
researchers know samples are available
Ø
Engage
the public to ensure that the BioTrust is used in an acceptable manner
Q. If newborn screening has been done since 1965, why is there interest in using the dried blood spots for research now?
The idea is not really new. In 1999, the Michigan Commission on Genetic Privacy and Progress recommended saving leftover spots because of their value for future research. In 2000, the Michigan Legislature passed a law allowing them to be used for research. Technology is now to the point where the samples are likely to be more useful than in the past.
Q. Who will be in charge of the
BioTrust?
MDCH will continue to be responsible for the samples, holding them "in trust" for future research. The laboratory will contract with the Michigan Neonatal Biobank, a nonprofit charitable organization, for storage and day-to-day management of the collection after samples are de-identified. The Biobank is part of the Biobanking Center of Excellence at Wayne State University's Tech Town. MDCH and the Neonatal Biobank will not do all the research, but make the samples available to qualified medical and public health researchers who follow the proper steps for using them.
Q. Who will oversee the
BioTrust?
MDCH will appoint three different advisory and review boards with members representing the major state universities, research institutions, disease organizations, community groups and the general public.
(1) A
Community Values Advisory Board will provide guidance on ethical issues including what types of research are, or are not, acceptable uses of the dried blood spots. The Community Values Advisory Board will also be responsible for assisting with public education about the BioTrust, and engaging the public to obtain valuable feedback.
(2) A Scientific Review Board will approve requests for specific research studies based on scientific merit. In addition, the MDCH, Institutional Review Board (IRB) will review and approve all proposals to assure human subject protections before any samples are released to a researcher.
(3) A Board of Directors will oversee operations of the
Michigan Neonatal Biobank as a non-profit organization.
Q. How will identifying information be removed from the samples?
All samples will be double blinded. This means that after newborn screening is completed, the filter paper containing leftover blood spots will be separated from the NBS card that has the baby's identifying information. A code will be assigned to the remaining blood spot sample before it is transferred to the
Biobank.
Then, before that same sample is released to a researcher, the Biobank will assign 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, MDCH will conduct a database linkage to select the right samples while still keeping them de-identified.
For example, consider the situation where a researcher wants to study dried blood spots from children who later developed a certain kind of cancer. The following process would occur:
-
Researcher submits a detailed proposal that outlines the study and describes the types of
samples
that are needed.
-
The BioTrust Scientific Review Board examines the proposal to make sure it has scientific value and is in accordance with the
BioTrust's
guiding principles for medical research.
-
The MDCH Institutional Review Board reviews the proposal to assure protection of human subjects.
-
MDCH identifies a list of samples (by code number) for the
Michigan Neonatal Biobank to release to the researcher. Neither
Biobank
staff nor the researcher can tell the identity of these samples.
-
Information that could be helpful to the researcher, but does not identify an individual, may be transmitted with the blood spot samples. For instance, the researcher's study protocol might ask for 50 samples from babies born in southern Michigan who weighed over 6 pounds and developed a certain type of cancer tumor after age 3; and 50 samples from babies born in northern Michigan who weighed less than 6 pounds and developed the tumor before age 3.
-
Before it is released to the researcher, the
Biobank
assigns a new tracking number to each sample and the corresponding data which consists only of the birth weight, designation as a northern or southern county, and age when the tumor was diagnosed, but no other identifying information.
Q. Will law enforcement officials or insurance companies have access to the
BioTrust
?
No. The
BioTrust
will be designated as a medical research project by the MDCH Chief Medical Executive. Under state law, the samples, data and any other information included as part of this medical research project are protected and cannot be released to third parties.
Q. How will the
BioTrust
be different from the way dried blood spots are currently used?
Some things are different, but others remain the same. While the
BioTrust
will promote dried blood spots more widely for use in research, there will also be increased privacy protections and more intensive scientific review of proposed studies. This chart summarizes some of the differences and similarities between the use of dried blood spots now, and under the
BioTrust
.
Newborn Screening Dried Blood Spots Michigan's BioTrust Project
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BioTrust
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