MDHHS_Pub_1216_Eng_07_26_PRINT.pdf
PDF 3 MB Posted
- Attached to
- MDHHS BIOTRUST PUB 1216
- Solicitation number
- RFQ 171 260000000436 1
- Issued by
- Michigan
About this file
This is an informational brochure published by the Michigan Department of Health and Human Services (MDHHS) regarding the Michigan BioTrust for Health program, which oversees the use of stored blood spots from newborn screening for medical research purposes. The brochure explains that blood spots collected during mandatory newborn screening are stored at the Michigan Neonatal Biobank at Wayne State University for 35 years before destruction, with the potential for extension to a maximum of 100 years if program changes occur. Families are provided with a consent form allowing them to opt in or opt out of having leftover blood spots used for de-identified health research. The program emphasizes that participation is voluntary and will not affect a child's newborn screening results. Blood spots are shared with approved researchers using anonymous codes, and researchers are legally restricted from attempting to identify individuals. The MDHHS approves only research intended to better understand diseases or improve public health, with prior studies examining genetic causes of cancer, birth defects, obesity, newborn screening test development, and mercury exposure levels in pregnant women.
Privacy protections are extensive and include the application of the highest level of state protection under the public health code and a federal Certificate of Confidentiality from the U.S. Department of Health and Human Services. The BioTrust implements additional safeguards such as double-checking consent before sharing blood spots, ensuring studies meet institutional review board policies, confirming researcher destruction of samples after studies conclude, and limiting data sharing to de-identified information. Individuals may contact MDHHS at any time to change their decision regarding blood spot use, request return of samples, or request destruction. For people born before May 2010 when BioTrust consent efforts began, blood spots may be available for research unless the family requests otherwise. The program provides no direct benefit or compensation to participants, though research results may benefit the broader population through advances in disease diagnosis, prevention, and treatment.
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Other files
| File | Type | Posted |
|---|---|---|
| Standard Contract Terms - Short Form.pdf | ||
| State of Michigan Print Mail Management Terms Conditions (1).docx | DOCX document | |
| MDHHS BIOTRUST PUB 1216 Bid Request.docx | DOCX document |
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Text version
W ha t s te ps d oe s
M
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ta ke to pr ot ec t b lo od s po ts a nd in fo rm at io n?
Yo ur p riv ac y is im po rt an t.
Bl oo d sp ot s a nd in fo rm ati on a re p ro te ct ed u sin g de
-id en tifi ed co de s, se cu re st or ag e an d st ric t r ul es a bo ut w ho ca n ac ce ss th em . T he B io Tr us t t ak es a dd iti on al st ep s t o pr ot ec t y ou r p riv ac y.
In cl ud g:
Do ub le c he ck in g w he th er y ou c on se nt re se ar ch b ef or e sh ar in g bl oo d sp ot s.
En su rin g st ud ie s m ee t B io Tr us t a
In sti tu tio na l R ev ie w B oa rd p ol ic ie s de sig ne d to p ro te ct y ou r i nf or m ati on
Sh ar in g on ly d e-id en tifi ed b lo od sp ot s an d in fo rm ati on w ith re se ar ch er s.
Co nfi rm in g re se ar ch er s d es tr oy b lo od sp s a fte r t he st ud y en ds
W ill y ou o r y ou r c hi ld b en efi t f ro m bl oo d sp ot re se ar ch
Bl oo d sp ot re se ar ch m ay n ot d ire ct ly h el p yo u, y ou r c hi ld o r y ou r f am ily
Yo u w ill n ot b e pa id if y ou r c hi ld ’s bl oo d sp ot s a re u se d.
Yo ur fa m ily w ill n ot g et m on ey if uc ts (s uc h as n ew d ru gs
) r es ul t fr om th e re se ar ch
Pe rs on al re se ar ch re su lts a re ov id ed b ec au se b lo od sp ot s u d r r es ea rc h ar e de -id en tifi ed
Th is ty pe o f r es ea rc h is do ne to im pr ov e th e pu bl ic ’s he al th . P op ul ati on s o f p eo pl e m ay be ne fit fr om re se ar ch lo ok in g at n ew w ay s to d ia gn os e, p re ve nt o r t re at d ise as e.
W ha t a re th e ris ks if y ou r b ab y’ s bl oo d sp ot s ar e us ed fo r r es ea rc h?
Th er e is a ve ry sm al l r isk y ou r b ab y co ul be id en tifi ed
. M an y st ep s a re ta ke ec t p riv ac y.
Th e
M ic hi ga n De pa rt m en t o f H ea lth an
Hu m an S er vi ce s (
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) d oe s n di sc rim in at e ag ai ns t a ny in di vi du al o r gr ou p on th e ba sis o f r ac e, n ati or ig in , c ol or
, s ex
, d isa bi lit y, re lig io n, a ge he ig ht , w ei gh t, fa m ili al st at us
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Se x-ba se d di sc rim in ati on in cl ud es
, b ut is no t l im ite d to
, d isc rim in ati on b as ed o n se xu al o rie nt ati on , g en de r i de nti ty
, g en de r ex pr es sio n, se x ch ar ac te ris tic s, a eg na nc y.
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W ha t d o yo u ne ed to d o?
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m or e ab ou t c on se nt o pti on s on th e
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if y ou sti ll qu es tio ns a bo ut b lo od sp ot s.
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K yo ur c ho ic e fo r b lo od ar ch u se o n th e
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a pp lie s t he h ig he le l o f p ro te cti on to p riv ac y av ai la bl e un de r t he st at e pu bl ic h ea lth c od e.
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“y es or no to b re se ar ch
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If yo u sa y “y es le fto ve r bl oo d sp ot s m ay b e us r a pp ro ve d re se ro ug h th e Bi oT ru st
If yo u sa y "n o, bl oo d sp ot s w ill n ot b e r r es ea rc h th ro ug h
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Yo ur d ec isi on w ill n ot a ffe ct y ou r ba by
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W ha t a re th e st ep s fo r u si ng b s in re se ar ch
A fe w d ro ps o f b lo od a re ta ke n fr om y ou r ba by
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T hi s pr og ra m is re qu ire d by st at e la w a nd sc re en s al l b ab ie s f or ra re b ut se rio us d iso rd er s t o en su re e ar ly tr ea tm en t.
To le ar n m or e, v isi t M ic hi ga n.
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p ro gr am se ei ng u se o f s to re d bl oo d sp ot s f th re se ar ch . T he B io Tr us t c on se nt rm w s f am ili es to m ak e a de ci sio n ab ou t pa rti ci pa tin g in d e-id en tifi ed re se ar ch
De -id en tifi ed re se ar ch m ea ns rm ati on th at c ou ld id en tif y yo u or y ou r ch ild is re m ov ed b ef or e bl oo d sp ot sh ed . F or e xa m pl e, re se ar ch er s d o no t re ce iv e na m es o r b irt h da te s.
B lo od sp ot s sh ar ed w ith re se ar ch er s a re la be le d ith
-id en tifi ed c od e.
Bl oo d Sp ot S cr ee ni ng
W ha t h ap pe ns to b lo od s po ts a
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O fte n bl oo d sp ot s a re le ft ov er a fte r n ew bo rn en in g.
C ur re nt M
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p ol ic ie s s ta te d sp ot s w ill b e st or ed a t t he M ic hi ga n
N eo na ta l B io ba nk fo r 3 ye ar s a nd en ro ye d.
T he M ic hi ga n
N eo na ta l B io ba nk ca te d at W ay ne
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W hi le in st or ag e, b lo od sp ot s c an b e:
U se d to im pr ov e an d te st n ew bo rn en in g pr oc es se s.
Re tu rn ed fo r p er so na l u se , i f r eq ue by ou r f am ily
U se d, w ith y ou r c on se nt , f or m ed ic al pu ic h ea lth re se ar ch th ro ug h th e
Bi oT ru st fo r H ea lth
If ne w bo rn sc re en in g pr og ra m n ee ds c ha e, ag e m ay b e ex te nd ed to a m ax im um y ea rs . T hi s b ro ch ur e ex pl ai ns th e
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Ca n yo u ch an ge y ou r m in d?
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a t a ny ti m ge y ou r d ec isi on
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Tr us t re se ar ch , s to re d bu t n ot u se d fo r r es ea rc h, tu rn ed to y ou , o r d es tr oy ed . A fte r t ur ni
, y ou r c hi ld m us t m ak e th is re qu es t.
Bl oo d sp ot st or ag e an d Bi oT ru st c on ac tic es h av e ch an ge d ov er ti m e.
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a t
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St ud ie s a re o nl y ap pr ov if pa rti ci pa nt s’ ri gh ts a re p ro te ct qu al ity o f s ci en ce is e va lu by xp er ts a nd re se ar ch te am s a ee no t t o us e an y m et ho ds th at c ld en tif y so m eo ne a nd a ll re se ig ns w ith
B io
Tr us t p ol ic ie s.
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a pp ro ve s th e st ud y.
Bl oo d sp ot s m ay b e pi ck ed a t ra nd om to re pr es en t m an y di ffe ps , o r t he y m ay b e se le ct cu s o n on e sp ec ifi c gr ou p, su ch a s pe op le w ith c an ce r.
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s el ec ts b lo od s po ts
Bl oo d sp ot s a re u se d to st ud y ap pr ov ed re se ar ch to pi cs . W he n th e st ud y en ds , b lo od sp ot s a re d es tr oy ed
St ud y re su lts a re re po rt ed to M
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To re vi ew a li st o f a pp ro ve d st ud ie s, vi sit M ic hi ga n.
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Bi oT ru st
Re se ar ch er p er fo rm s st ud y.
Bl oo d sp ot s a re sh ar ed ith ar ch er s u sin g an a no ny m s
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to li nk d sp ot s t o so m e de -id en tifi rm ati on , s uc h as a d ia gn os ye o f b irt h.
R es ea rc he rs a re le ga lly ric te d fr om tr yi ng to id en tif ho b lo od sp ot s b el on g to
Re se ar ch er g et s bl oo d sp ot s.
W ha t t yp ar ch is d on e?
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o nl y ap pr ar ch th at in te nd s t o be tte r un rs ta nd d ise as es o r im ov e th e pu bl ic
’s he al th
Pr io r r es ea rc h st ud ie s h av e:
Lo ok ed fo r g en eti c ca c an ce r, bi rt h de fe ct ob ity
He lp ed d ev el op ew bo rn sc re en in g te st s.
Te st ed m er cu ry le ve ls to fi t i f p re gn an t m ot he rs tin g sa fe a m ou nt s o f fi sh
Re se ar ch er s m ay st ud e ra ng e of h ea lth to pi cs in cl ud in g on es n ot li st ed a bo ve
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