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

Conse nt at the Cr

• ssr
• ads

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

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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

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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?

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16 11 8 3 8 6

2 4 6 8 10 12 14 16 18 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

NUMBE R OF ST AT E S

Drie d Blo o d Spo t Re te ntio n T im e

F ro m: Ne wST E PS, So nta g , Aug ust 2015

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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

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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

• 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 SCRE E NING RE SE ARCH.

• (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

• 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 Re g ulatio ns, shall no t apply.

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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

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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

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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

• 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?

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F e de r a l Notic e of Pr

• pose 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

• 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

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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.”

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COGR Bo a rd o f Dire c to rs, De c e mb e r 8, 2015

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
• w risk

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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

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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

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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

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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

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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

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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

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Public Attitude s

 K

a ufma n e t a l Pr

e fe r e nc e s for

• pt- in and opt- out e nr
• llme nt

and c onse nt mode ls in biobank r e se ar c h: a national sur ve y

• f Ve te r

ans Administr ation patie nts. Ge ne t Me d. 2012

• 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 ne wbor n sc r e e ning spe c ime ns for r e se ar c h Pe dia tric s 2012

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

Public Attitude s

 Bhima ra o CN, Ro thwe ll E

, Ha rt K , L a time r S, Sc hiffma n JD, Bo tkin JR.

Attitude s of par e nts of c hildr e n with se r ious he alth c onditions r e gar ding the use of r e sidual ne wbor n sc r e e ning spe c ime ns for r e se ar c h. Pub lic He a lth

Ge no mic s. 2014;17(3):141-8.

• 27 pa re nts o f a c hild with le uke mia
• 22 pa re nts o f a c hild with PK

U

• 1927 me mb e rs o f the g e ne ra l pub lic
• Re sults:
• Pa re nts o f c hildre n with a se rio us he a lth c o nditio n ha d hig he r le ve ls
• f suppo rt tha n the g e ne ra l pub lic to wa rd the use o f re sidua l drie d

b lo o d spo ts

• Gro ups ha d simila r a ttitude s re g a rding o pt-in vs o pt-o ut a ppro a c h

to pa re nta l pe rmissio n (o pt-in> o pt-o ut)

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Summar y of the L ite r atur e

T

he ma jo rity o f individua ls suppo rt the se c o nda ry use o f c linic a l b io spe c ime ns fo r re se a rc h use

Pe o ple wa nt to kno w a b o ut this pra c tic e

• So me wa nt to b e info rme d a b o ut e ac h use

Pe o ple wa nt a c ho ic e a b o ut whe the r the ir

b io spe c ime ns a re use d

• Opt-in > o pt-o ut

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Conse nt L e ve ls

F ull I C w/ fo rm Simple I C + fo rm Bro a d I C w/ fo rm Wa ive r o f I C

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Conse nt L e ve ls

F ull I C w/ fo rm Simple I C + fo rm Bro a d I C w/ fo rm Wa ive r o f I C

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Infor me d Conse nt Challe nge s

Pro c e ss a nd c o nte nt o f info rme d c o nse nt in

45CF R46 a re no t e vide nc e -b a se d

• T

he y do no t re fle c t the c o nte nt o r prio rity

• f wha t pe o ple wa nt to kno w in c o nte xt

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Infor me d Conse nt Challe nge s

Co mpre he nsio n

• Co nte nt is intrinsic a lly diffic ult fo r po pula tio ns with:
• L
• w sc ie ntific lite ra c y
• L

a c k o f fa milia rity

• Hig hly va ria b le lite ra c y
• Hig hly va ria b le nume ra c y
• Co nte nt is diffic ult fo r inve stig a to rs
• F
• rms a re c ra fte d with limite d a tte ntio n to

c o mpre he nsio n

• L
• ng , hig h re a ding le ve ls, de nse , limite d use o f

g ra phic s

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Infor me d Conse nt Challe nge s

Co mpre he nsio n (c o nt)

• Psyc ho lo g ic a l o rie nta tio n o f pa tie nts fo ste rs

misc o nc e ptio ns

• “T

he ra pe utic misc o nc e ptio n”

• F

e w inc e ntive s fo r a ny o f the sta ke ho lde rs to impro ve c o mpre he nsio n o f the I C fo rm a nd pro c e ss

• Spo nso rs, inve stig a to rs, I

RBs: a ll g a in b e ne fits

• r a vo id b urde ns thro ug h hig h c o mple xity

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Compr e he nsion

De spite e xte nsive e vide nc e tha t re se a rc h

pa rtic ipa nts o fte n ha ve a ve ry limite d unde rsta nding o f ke y e le me nts o f re se a rc h pro to c o ls:

PE OPL E CONSE NT T O PART ICIPAT E IN RE SE ARCH ANYHOW!

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Aiding Compr e he nsion

No ma g ic !

• Re vising fo rms fo r simplic ity, pro c e ssa b ility, a nd g ra phic a l

pre se nta tio ns sho ws so me e ffic a c y

• Use o f multime dia to o ls is pro mising
• “T

e a c h b a c k” a nd o ne -o n-o ne time a re pro mising

• T

he ra pe utic misc o nc e ptio n re ma ins a se rio us c o nc e rn witho ut a de q ua te re me die s

• T

RUST is a muc h g re a te r fa c to r in de c isio ns to pa rtic ipa te tha n is the na ture o f the disc lo sure

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Aiding Compr e he nsion

I

mpro ving c o mpre he nsio n is like ly to e nta il inc re a se d pe rso na l e ng a g e me nt b e twe e n inve stig a to rs a nd po te ntia l pa rtic ipa nts

T

• wha t e xte nt is this justifie d in the re se a rc h c o nte xt

if

• Co nse nt le ve ls a re hig h fo r b io b a nking ?
• Risk le ve ls a re ve ry lo w?

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Aiding Compr e he nsion

Wha t sho uld b e the na ture o f info rme d c o nse nt in

the c linic a l c o nte xt fo r se c o nda ry b io spe c ime n re se a rc h g ive n:

• A sub sta ntia l c o mmitme nt o f time fo r me a ning ful

dia lo g ue

• A ne e d fo r kno wle dg e a b le sta ff to o b ta in I

C

• T

he lo w prio rity o f se c o nda ry re se a rc h o ppo rtunitie s during c linic a l e nc o unte rs

• T

he ne e d fo r la rg e inve stme nts in tra c king da ta b a se s

• T

he la c k o f risk

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NPRM Pr

• posals Re gar

ding Infor me d Conse nt

“T

he info rmatio n must b e pre se nte d in suffic ie nt de tail re lating to the spe c ific re se arc h, and must b e

• rg anize d and pre se nte d in a way that do e s no t

me re ly pro vide lists o f iso late d fac ts, b ut rathe r fac ilitate s the pro spe c tive sub je c t’ s o r re pre se ntative ’ s unde rstanding o f the re aso ns why o ne mig ht o r mig ht no t want to partic ipate .” (e mphasis adde d)

• Will e na b le OHRP to re q uire e le me nts to pro mo te a nd a sse ss

c o mpre he nsio n

• SACHRP suppo rts this la ng ua g e

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Infor me d Conse nt

F

• unda tio na l princ iple in re se a rc h e thic s
• F

irst princ iple in the Nure mb urg Co de

• Prima ry e le me nt in “Re spe c t fo r Pe rso ns” in the Be lmo nt

Re po rt

F

• unde d o n the no tio n o f “a uto no mo us

a utho riza tio n” (F

a de n a nd Be a uc ha mp 1986)

• I

nte ntio na l

• With unde rsta nding
• Witho ut c o ntro lling influe nc e

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Infor me d Conse nt

Wha t if “a uto no mo us a utho riza tio n” is no t a re a listic

g o a l?

• Ca n we de fine mo re limite d g o a ls tha t pe rmit

re se a rc h whe n fully a uto no mo us a utho riza tio n c a nno t b e a c hie ve d?

• Are the re diffe re nt wa ys to think a b o ut the
• b lig a tio ns to so urc e s o f b io spe c ime ns?

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T he “F air T r ansac tion Mode l” of Infor me d Conse nt

F

ra nklin Mille r & Ala n We rthe ime r. “T

he E thic a l Cha lle ng e s o f Huma n Re se a rc h” Oxfo rd Pre ss 2012

• “T

he c rite ria fo r asse ssing the validity o f c o nse nt transac tio ns sho uld b e b ase d o n fair te rms o f c o o pe ratio n fo r the re spe c tive partie s that re fle c t the c o nte xt o f the ac tivity fo r whic h c o nse nt is g ive n.”

• F

a irne ss is re le va nt to b o th the pa rtic ipa nt a nd the re se a rc h te a m

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T he “F air T r ansac tion Mode l” of Infor me d Conse nt

F

ra nklin Mille r & Ala n We rthe ime r. “T

he E thic a l Cha lle ng e s o f Huma n Re se a rc h” Oxfo rd Pre ss 2012

• “What fairne ss e ntails will vary re aso nab ly de pe nding o n the

risk-b e ne fit pro file s pre se nte d b y diffe re nt c linic al trials.”

• Hig h-risk tria ls re q uire a hig h le ve l o f a uto no mo us a utho riza tio n
• T

he e xa mple o f sig ning fo rms fo r mo rtg a g e s, c a r re nta ls, so ftwa re purc ha se s, e tc .

• T

he va lidity o f the se c o nse nt a g re e me nts is he a vily de pe nde nt o n institutio na l pro te c tio ns tha t c a n justify suc h a g re e me nts in the fa c e o f limite d unde rsta nding

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T he F air T r ansac tion Mode l

Se e ms to a llo w a limite d disc lo sure o f info rma tio n

whe n risk a re lo w a nd institutio na l pro te c tio ns a re in pla c e fo r the pa rtic ipa nt

Se e ms to a llo w a limite d o r no a sse ssme nt o f whe the r

c o mpre he nsio n ha s b e e n a c hie ve d whe n risks a re lo w a nd institutio na l pro te c tio ns a re in pla c e

Unc e rta in whe the r this mo de l pe rmits re se a rc h whe n

a la c k o f c o mpre he nsio n, o r misc o nc e ptio ns, a re ide ntifie d

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T he F air T r ansac tion Mode l with Biospe c ime n Re se ar c h

 Se c o nda ry re se a rc h with b io spe c ime ns is e xtre me ly lo w

risk/ lo w b urde n fo r so urc e s

• Stro ng institutio na l struc ture s in pla c e to pro te c t so urc e s

 Suc h re se a rc h ha s hig h sc ie ntific va lue  A hig hly b urde nso me syste ms to a tte mpt to o b ta in fully

a uto no mo us a utho riza tio n fo r se c o nda ry use s is no t “fa ir” to the re se a rc h e nte rprise

 A mo de st le ve l o f a utho riza tio n is a c c e pta b le  No a sse ssme nt o f c o mpre he nsio n is a c c e pta b le  BUT

: A c o mple te la c k o f tra nspa re nc y is no t a c c e pta b le

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Conse nt L e ve ls

F ull I C w/ fo rm Simple I C + fo rm Bro a d I C w/ fo rm Wa ive r o f I C

Bo tkin 2016

SACHRP Pr

• posal on the NPRM

 Pro po sa l re le va nt to se c o nda ry re se a rc h use s o f c linic a l

b io spe c ime ns

 Notic e with opt- out

• “SACHRP re c o mme nds tha t the re q uire me nt fo r b ro a d c o nse nt unde r

§_.104(f) b e re pla c e d with a re q uire me nt fo r pro visio n o f no tic e o f re se a rc h pra c tic e s, with a n o pt-o ut me c ha nism fo r tho se individua ls who de sire no t to a llo w the ir b io spe c ime ns o r ide ntifie d da ta to b e use d fo r future re se a rc h. Suc h a no tic e a nd o ppo rtunity to o pt o ut do no t c o nstitute info rme d c o nse nt, b ut a re mo re info rma tive a nd re spe c tful tha n c urre nt re g ula to ry re q uire me nts a nd a vo id ma ny o f the pro b le ms a sso c ia te d with a “b ro a d c o nse nt.”

• “SACHRP re c o mme nds tha t g uida nc e sug g e st tha t no sig na ture b e

re q uire d to a c kno wle dg e the pro visio n o r re c e ipt o f no tic e o f re se a rc h pra c tic e s.”

• “SACHRP re c o mme nds tha t the g uida nc e to b e pro mulg a te d b y HHS

a dva nc e the no tio n o f a ro b ust syste m whe re b y individua ls a re ma de a wa re o f the ir o ptio ns, ha ve a n o ppo rtunity to a sk q ue stio ns a nd g e t a nswe rs, a nd b e a b le to e xe rc ise re a dily the ir o pt o ut rig hts.”

• I

nstitutio na l tra c king o f tho se who o pt-o ut; no wa ive r o f o pt-o ut a va ila b le

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SACHRP Pr

• posals on the NPRM

“SACHRP b e lie ve s tha t the mo st a ppro pria te a nd

e ffe c tive me tho d o f pre ve nting a nd de te rring una utho rize d re -ide ntific a tio n o f sub je c t da ta a nd b io spe c ime ns lie s in re g ula to ry, a dministra tive , c ivil, a nd c rimina l pe na ltie s a g a inst inve stig a to rs a nd e ntitie s tha t wo uld se e k to re -ide ntify a ny de - ide ntifie d b io spe c ime ns a nd da ta tha t ha ve b e e n distrib ute d fo r re se a rc h use s.”

Bo tkin 2016

Notic e and Opt- out

Pro mo te s tra nspa re nc y a nd c ho ic e BUT

: e thic a l justific a tio n c o nting e nt o n ro b ust e ffo rts with the no tific a tio n e ffo rt a nd the fa c ilita tio n o f c ho ic e

• T

he we a kne ss o f a no tic e a nd o pt-o ut a ppro a c h is pe rfunc to ry e ffo rts to pro vide no tic e a nd/ o r hig h hurdle s to e ffe c tive c ho ic e

T

his a ppro a c h is a ppro pria te ly c a lib ra te d to the de g re e o f risk a nd c ha lle ng e s c o mpa re d to a mo re ro b ust syste m o f a c hie ve a uto no mo us a utho riza tio n

Bo tkin 2016

Public Attitude s

 Bo tkin e t a l. Public attitude s r

e gar ding the use of e le c tr

• nic

he alth infor mation and r e sidual c linic al tissue s for r e se ar c h

J Co mmunity Ge ne t. 2014 Jul; 5(3): 205–213

• 12 fo c us g ro ups (131 pa rtic ipa nts) in Uta h, Wa shing to n,

Arizo na a nd Minne so ta

• Pa rtic ipa nts info rme d o f c urre nt pra c tic e s re g a rding the

se c o nda ry re se a rc h use s o f c linic a l re c o rds a nd re sidua l b io spe c ime ns

• I

nfo rme d tha t the Unive rsity wa s c o nside ring a info rma tio n a nd o pt-o ut a ppro a c h a nd a ske d whe the r this wa s a c c e pta b le

• T

he la rg e ma jo rity o f pa rtic ipa nts suppo rte d the pro po se d a ppro a c h

Bo tkin 2016

Notic e and Opt- out

 Bo tkin JR Wa iving g o o db ye to wa ive rs o f c o nse nt. Ha sting s

Ce nte r Re po rt 2015 No v (45)6:b a c kc o ve r

 Bo tkin JR. Crushing c o nse nt unde r the we ig ht o f

e xpe c ta tio ns. Am J Bio e thic s 15(9): 1–3, 2015

 Ro thwe ll E

, Ande rso n RA, Swo b o da K J, Sta rk L , Bo tkin JR. Pub lic a ttitude s re g a rding a pilo t study o f ne wb o rn sc re e ning fo r spina l musc ula r a tro phy. Am J Me d Ge ne t A. 2013 Apr;161A(4):679-86.

 Bo tkin JR, Huc ka b y-L

e wis M, Wa tso n MS, Swo b o da K J, Ande rso n R, Bo nho mme N, Bro sc o JP, Co me a uy AM, Go lde nb e rg A, Go ldma n E , T he rre ll B, L e vy-F isc h, T a rini B, Wilfo nd B. Pa re nta l pe rmissio n fo r pilo t ne wb o rn sc re e ning re se a rc h: Guide line s o f the NBST

• RN. Pe dia tric s 2014;133:e 410-

e 417. (Ne wb o rn Sc re e ning T ra nsla tio na l Re se a rc h Ne two rk)

Bo tkin 2016

Conse nt at a Cr

• ssr
• ads

Se ve ra l o ptio ns to mo ve fo rwa rd (no t mutua lly

e xc lusive )

• Re do ub le e ffo rts to impro ve c o mpre he nsio n (a udio -visua ls,

mo re pe rso na l e ng a g e me nt, te a c h b a c k, o the rs? ) fo r so me c o nte xts

• E

sse ntia l fo r hig he r risk re se a rc h pro to c o ls

• De fine minimum le ve ls o f c o mpre he nsio n fo r re se a rc h

pro to c o ls tha t po se diffe re nt le ve ls o f risk

• Be tte r de fine whe n simply pro viding info rma tio n a nd
• ppo rtunitie s fo r c o mpre he nsio n a re suffic ie nt
• Risks a re lo w a nd institutio na l sa fe g ua rds a re in pla c e
• T

ra nspa re nc y is ke y

Bo tkin 2016

Conc lusions

 Co nse nt with b io spe c ime ns re pre se nts a c ha lle ng ing

c o nflic t in va lue s: re spe c t fo r a uto no mo us de c isio n- ma king a nd the pro mo tio n o f va lua b le re se a rc h

 De b a te is re le va nt to o the r re se a rc h c o nte xts tha t

a re re mo ve d fro m the “b e dside ”

• “Big da ta ”
• Cluste r ra ndo mize d tria ls

 No tic e a nd o pt-o ut ma y b e a ppro pria te whe n risks

a re lo w a nd institutio na l sa fe g ua rds a re in pla c e

 I

nno va tive ide a s a re ne c e ssa ry to de ve lo p ne w a ppro a c he s a nd sa fe g ua rds fo r the se do ma ins o f re se a rc h

Bo tkin 2016

Bo tkin 2016

T hank You!