Conse nt at the Cr ossr oads A Disc ussion with COGR F e br ua - PowerPoint PPT Presentation

Conse nt at the Cr ossr oads A Disc ussion with COGR F e br ua r y 25, 2016 Je ffre y R. Bo tkin, M.D., M.P.H. Pro fe sso r o f Pe dia tric s Chie f, Divisio n o f Me dic a l E thic s a nd Huma nitie s Asso c ia te Vic e Pre side nt fo r Re se a rc h Unive rsity o f Uta h

Conflic ts of Inte r e st  I ha ve no fina nc ia l re la tio nships tha t mig ht c re a te a COI fo r this pre se nta tio n Bo tkin 2016

Obje c tive s  Re vie w the fe de ra l re g ula tio ns a nd pro po se d c ha ng e s re g a rding info rme d c o nse nt, spe c ific a lly se c o nda ry re se a rc h use s o f c linic a l b io spe c ime ns  Hig hlig ht the c ha lle ng e s with info rme d c o nse nt  Disc uss a n a ppro a c h to tra nspa re nc y a nd c ho ic e re g a rding b io spe c ime ns a nd c o nse nt in o the r c o nte xts Bo tkin 2016

One Conte xt  I s it e thic a lly a ppro pria te fo r sta te he a lth de pa rtme nts to sa ve re sidua l b lo o dspo ts a fte r ne wb o rn sc re e ning fo r b io me dic a l re se a rc h?  Ho w muc h sho uld pa re nts kno w a b o ut this pra c tic e ?  Sho uld pa re nts b e a ske d the ir pe rmissio n? Bo tkin 2016

Drie d Blo o d Spo t Re te ntio n T im e 18 16 16 14 S 12 E AT ST 10 11 R OF NUMBE 8 8 8 6 6 4 2 3 0 1-6 Mo nths 7-12 Mo nths 2-5 Ye a rs 10-20 Ye a rs 21-30 Ye a rs I nd e finite ly F ro m: Ne wST E PS, So nta g , Aug ust 2015 Bo tkin 2016

Bloodspot Re te ntion and Use  L a wsuits in two sta te s: Minne so ta (2009) a nd T e xa s (2009)  Minne so ta suit b a se d o n sta te g e ne tic priva c y la w  T e xa s suit b a se d o n c o nstitutio na l c la ims re g a rding ille g a l se a rc h a nd se izure  Re fle c ts pub lic dissa tisfa c tio n with c urre nt a ppro a c he s Bo tkin 2016

F e de r al Polic y Change  Ne wb o rn Sc re e ning Save s L ive s Re autho rizatio n Ac t o f 2014 (Pub lic L a w No : 113-240)  T E XT OF SE C. 12. INF ORME D CONSE NT F OR NE WBORN ARCH. SCRE E NING RE SE  (a) I N GE NE RAL .—Re se arc h o n ne wb o rn drie d b lo o d spo ts shall b e c o nside re d re se arc h c arrie d o ut o n human sub je c ts me e ting the de finitio n o f se c tio n 46.102(f)(2) o f title 45, Co de o f F e de ral Re g ulatio ns, fo r purpo se s o f F e de rally funde d re se arc h c o nduc te d pursuant to the Pub lic He alth Se rvic e Ac t until suc h time as update s to the F e de ral Po lic y fo r the Pro te c tio n o f Human Sub je c ts (the Co mmo n Rule ) are pro mulg ate d pursuant to sub se c tio n (c ). F o r purpo se s o f this sub se c tio n, se c tio ns 46.116(c ) and 46.116(d) o f title 45, Co de o f F e de ral Bo tkin 2016 Re g ulatio ns, shall no t apply.

Ne wbor n Sc r e e ning Save s L ive s Re author ization Ac t  I nte rpre ta tio n  Re se a rc h with ne wb o rn sc re e ning drie d b lo o dspo ts is huma ns sub je c ts re se a rc h whe the r o r no t the y a re de - ide ntifie d  Wa ive r o f pa re nta l c o nse nt fo r re se a rc h use is no t pe rmissib le  T his la w will b e supe rse de d b y a ntic ipa te d c ha ng e s in the Co mmo n Rule Bo tkin 2016

NBS Save s L ive s Ac t  Ne w c o nse nt pro visio ns diffic ult to imple me nt b e c a use no c o nse nt fo r NBS  Po st pa rtum pe rio d is sho rt, he c tic , a nd with ma ny c linic a l prio ritie s  Co nse nt pro c e ss like ly to re sult in a sub sta ntia l de c re a se in a va ila b le DBS fo r re se a rc h Bo tkin 2016

NBS Save s L ive s Ac t  T a rg e te d intrusio n o f Co ng re ss into the b ro a d do ma in o f huma n sub je c ts pro te c tio ns  F o c use d o n o ne do ma in (NBS) b ut po te ntia lly a pplic a b le to a b ro a d ra ng e o f se c o nda ry re se a rc h with b io spe c ime ns  Sug g e sts se rio us disa g re e me nt with c urre nt re g ula to ry a ppro a c h  Are we a t a c ro ssro a d fo r c o nse nt? Bo tkin 2016

F e de r a l Notic e of Pr opose d Rule ma king (NPRM) for Huma n Subje c ts Re g ula tions  NPRM pro po se d to e xte nd the de finitio n o f “huma n sub je c t” to b io spe c ime ns whe the r o r no t the y a re ide ntifia b le  Bro a d c o nse nt fro m individua ls wo uld b e ne c e ssa ry b e fo re b io spe c ime ns c o uld b e use d fo r re se a rc h  Crite ria fo r wa ive r o f c o nse nt wo uld b e limite d Bo tkin 2016

COGR Comme nts on NPRM  “COGR stro ng ly o ppo se s the pro po sa l to e xpa nd the de finitio n o f a “huma n sub je c t” to c o ve r re se a rc h with no n-ide ntifie d b io spe c ime ns a s pro po se d a t .102(e )(1) a nd to re q uire info rme d c o nse nt fo r re se a rc h invo lving b io spe c ime ns in a ll b ut a limite d numb e r o f c irc umsta nc e s. We b e lie ve no n- ide ntifia b le b io spe c ime ns sho uld re ma in e xc lude d fro m the re g ula tio ns a nd no t sub je c t to c o nse nt.” COGR Bo a rd o f Dire c to rs, De c e mb e r 8, 2015 Bo tkin 2016

Biospe c ime n- base d r e se ar c h  E thic a l a nd re g ula to ry issue s a rise b e c a use  Re se a rc h with b io spe c ime ns is re mo ve d in time a nd pla c e fro m the so urc e individua l  Pub lic se nsitivitie s a b o ut the pe rso na l na ture o f b io spe c ime ns (“I ts pa rt o f me .”)  Hig h sc ie ntific yie ld  L o w risk Bo tkin 2016

Biospe c ime n- base d r e se ar c h  Co ntro ve rsie s fo c us o n se c o nda ry use s o f b io spe c ime ns o b ta ine d fo r o the r purpo se s  Se c o nda ry use s o f c linic a l spe c ime ns fo r whic h no c o nse nt is o b ta ine d fo r re se a rc h  Se c o nda ry use s o f re se a rc h spe c ime ns fo r whic h se c o nda ry use s c a nno t b e pre dic te d Bo tkin 2016

Risks Assoc iate d with Biospe c ime n Re se ar c h  E sse ntia lly no ne : No insta nc e s o f we lfa re ha rms fro m b io spe c ime n re se a rc h  I nsta nc e s o f “dig nita ry ha rms”  Ha va supa i T rib a l c a se  T he Mo o re Ca se  He nrie tta L a c ks c a se  Ne wb o rn sc re e ning la wsuits Bo tkin 2016

F e de r a l Re g ula tions Gove r ning Biospe c ime ns  I f b io spe c ime ns a re no t re a dily ide ntifia b le to the inve stig a to r, the re se a rc h is no t c o nside re d huma n sub je c ts re se a rc h a nd fa lls o utside the re g ula tio ns  HI PAA ma y a pply in c o ve re d e ntitie s unle ss de - ide ntifie d b y HI PAA sta nda rds  I de ntifia b le spe c ime ns: c o nse nt c a n o fte n b e wa ive d if a n I RB de te rmine s tha t the c rite ria a re me t  Co nse nt c a n b e simplifie d/ a lte re d if re se a rc h me e ts the wa ive r c rite ria Bo tkin 2016

Waive r / Alte r ation Cr ite r ia (45CF R46.116(d)  Minima l risk re se a rc h  Will no t a dve rse ly a ffe c t the rig hts o r we lfa re o f sub je c ts  No t pra c tic a b le to o b ta in c o nse nt  Whe n a ppro pria te , sub je c ts g ive n pe rtine nt info rma tio n a fte r pa rtic ipa tio n Bo tkin 2016

Waive r / Alte r ation Cr ite r ia (45CF R46.116(d)  Minimal r isk r e se ar c h  Will no t a dve rse ly a ffe c t the rig hts o r we lfa re o f sub je c ts  Not pr ac tic able to obtain c onse nt  Whe n a ppro pria te , sub je c ts g ive n pe rtine nt info rma tio n a fte r pa rtic ipa tio n Bo tkin 2016

Public Attitude s a bout Conse nt  Hull e t a l Pa tie nts' vie ws on ide ntifia bility of sa mple s a nd informe d c onse nt for g e ne tic re se a rc h Am J Bio e th. 2008 Oc t;8(10):62-70  1395 a dult pa tie nts in 5 a c a de mic me dic a l c e nte rs a c ro ss the c o untry  Hypo the tic a l issue s surve y  86% wo uld pe rmit use if a no nymo us, 84% if de -ide ntifie d  71% wa nte d to b e info rme d a b o ut re se a rc h use o f c linic a l sa mple s e ve n whe n de -ide ntifie d  Of tho se who wa nte d to b e info rme d a b o ut re se a rc h use s, 57% wo uld re q uire pe rmissio n b e fo re use  T he re ma inde r we re sa tisfie d with no tific a tio n Bo tkin 2016

Public Attitude s  K a ufma n e t a l Pr e fe r e nc e s for opt- in and opt- out e nr ollme nt and c onse nt mode ls in biobank r e se ar c h: a national sur ve y ation patie nts . Ge ne t Me d. 2012 of Ve te r ans Administr  451 ve te ra ns in o nline surve y with hypo the tic a l c ho ic e s  80% willing to pa rtic ipa te in b io b a nk with a n o pt-in a ppro a c h  69% willing to pa rtic ipa te with a n o pt-o ut a ppro a c h Bo tkin 2016

Public Attitude s  Bo tkin e t a l Public attitude s r e gar ding the use of r e sidual c h Pe dia tric s 2012 ne wbor n sc r e e ning spe c ime ns for r e se ar F e b ;129(2):231-8  3855 a dult re spo nde nts in na tio na l surve y  81.5% suppo rtive o f re te ntio n a nd re se a rc h use o f re sidua l drie d b lo o dspo ts  62% o f re spo nde nts wo uld wa nt pa re nta l pe rmissio n fo r se c o nda ry use o f spe c ime ns (o pt-in) c o mpa re d to 38% fo r a no tific a tio n a nd o pt-o ut Bo tkin 2016