Do e s my study ne e d I RB Re vie w? No n Huma n Sub je c ts Re - - PowerPoint PPT Presentation

Do e s my study ne e d I RB Re vie w?

No n Huma n Sub je c ts Re se a rc h De te rmina tio ns- With E xa mple s E mo ry Unive rsity I RB Ma y 12, 2016 Je ssic a Ba ke r

Ob je c tive s

 Re vie w the de finitio n o f re se a rc h with huma n sub je c ts  Go o ve r wha t q ua lifie s a s de -ide ntifie d da ta  De te rmine whe n a c a se study ne e ds I

RB re vie w

 De te rmine whe n a q ua lity impro ve me nt pro je c t ne e ds

I RB re vie w

 Go o ve r the diffe re nc e b e twe e n pub lic he a lth

pra c tic e a nd pub lic he a lth re se a rc h

 Re vie w whe n c la ssro o m a c tivitie s a re c o nside re d

re se a rc h a nd whe n the y a re no t

 Go o ve r ho w to sub mit a pro je c t fo r a n I

RB De te rmina tio n

Ba c k to Ba sic s…

 T

he I RB e xists to pro te c t huma n re se a rc h pa rtic ipa nts, b ut the re a re ma ny pro je c ts fo r whic h the re g ula tio ns do no t re q uire I RB re vie w

 We try to limit o ur sc o pe to wha t is re q uire d b y the

re g ula tio ns

 Pro je c ts tha t me e t the de finitio n o f re se a rc h with

huma n sub je c ts must b e re vie we d b y the I RB (tho ug h if “e xe mpt” pe r the re g ula tio ns, no furthe r I RB o ve rsig ht is re q uire d a fte r initia l re vie w)

“E xe mpt” o r No t Huma n Sub je c ts Re se a rc h?

 “E

xe mpt” is a te rm de fine d in the fe de ra l re g ula tio ns

 “E

xe mpt” re fe rs to re se a rc h with huma n sub je c ts tha t is so lo w-risk tha t the re g ula to rs e xe mpt it fro m I RB

• ve rsig ht

 “E

xe mpt” is o fte n use d mo re b ro a dly b y tho se no t fa milia r with the re g ula tio ns, to de sc rib e a ny pro je c t tha t do e s no t re q uire I RB re vie w

 No te : “E

xe mpt” re se a rc h re q uire s a full initia l I RB sub missio n a nd c a nno t b e re vie we d via e ma il o r o ur we b site to o l

Huma n Sub je c ts Re se ar

c h

 Re se a rc h is “a syste matic inve stigatio n de sig ne d to

c o ntrib ute to ge ne r

alizable kno wle dge .”

(paraphrase d fro m 45 CF R 46.102)

Huma n Sub je c ts Re se ar

c h

 Syste matic Inve stigatio n?

 NOT

b y itse lf a ha llma rk o f re se a rc h! Ma ny g o o d no n- re se a rc h pro je c ts invo lve syste ma tic inve stig a tio n

 Me tho dic a l e xplo ra tio n o f a q ue stio n o r the o ry (inc lude s

so c io b e ha vio ra l me tho ds)

 T

ypic a lly inc lude s da ta c o lle c tio n a nd a na lysis

 I

nc lude s de ve lo pme nt, de sig n, a nd te sting pha se s

 Ca n I

nc lude :

 I

nte rvie ws, surve ys, c ha rt re vie ws, e pide mio lo g ic a l studie s,

• b se rva tio na l studie s

 Ge ne ra lly do e s NOT

inc lude :

 T

ra ining pe o ple ho w to use re se a rc h me tho ds

Huma n Sub je c ts Re se ar

c h

 De signe d to be Ge ne r

alizable ?  Diffic ult to de fine , b ut typic a lly de sig ne d to b e g e ne ra liza b le if:

 Aims to dra w c o nc lusio ns a b o ut pe o ple o r pra c tic e s b e yo nd a

spe c ific individua l o r inte rna l pro g ra m

 T

he de sign and inte nt to g e ne ra lize ma ke s it re se a rc h

 Pub lic a tio n o r pre se nta tio n a lo ne do e s no t imply so me thing is

re se a rc h

Human Subje c ts Re se a rc h

DHHS De finitio n:

 A Huma n Sub je c t is a living individua l a b o ut who m a n

inve stig a to r o b ta ins:

1. Da ta thro ug h inte rve ntio n o r inte ra c tio n; o r 2. Id e ntifia b le priva te info rma tio n

 Ide ntifia b le if ide ntity c a n b e a sc e rta ine d (e .g . 18 HI

PAA ide ntifie rs if HI PAA a pplie s)

 Priva te me a ns a re a so na b le e xpe c ta tio n tha t no re c o rding is ta king

pla c e , a nd info rma tio n is use d fo r inte nde d purpo se s

45 CF R 46.102

Human Subje c ts Re se a rc h

F DA De finitio n:

 A Huma n Sub je c t is a n individua l

who is o r b e c o me s a pa rtic ipa nt in re se a rc h, e ithe r a s a re c ipie nt

• f the te st a rtic le o r a s a c o ntro l.

 Ma y b e e ithe r a he a lthy

vo lunte e r o r a pa tie nt

 Also human spe c ime ns in c linic a l

inve stig a tio ns, e .g . a ssa ys o r in vitro dia g no stic de vic e s 21 CF R 50.3(g )

Human Subje c ts Re se a rc h

 T

ypic a lly do e s NOTinc lude huma n sub je c ts:

 Ana lysis o f fully de ide ntifie d, de linke d da ta se t  Re se a rc h with de ide ntifie d sa mple s

 E

xc e ptio n fo r F DA de finitio n, whe n in a c linic a l inve stig a tio n invo lving huma n spe c ime ns

 De c e a se d individua ls

De ide ntifie d Da ta se ts: Whe n No t Huma n Sub je c ts?

 Ana lyzing da ta c o lle c te d pre vio usly, strippe d o f a ll po ssib le

ide ntifie rs

 No o ne o n study te a m strippe d the ide ntifie rs the mse lve s

fo r c urre nt study, no r c o uld the y a c c e ss a ke y linking c o de s to ide ntifie rs

 Othe rs ma y still b e a b le to link c o de s to ide ntifie rs, b ut

ha ve a g re e me nt no t to re le a se ke y to study te a m

 Ye s, it’ s re se a rc h, b ut No t huma n sub je c ts b e c a use the re is

no inte ra c tio n o r inte rve ntio n a nd no ide ntifia b le info rma tio n

No te o n “De ide ntifie d”

 T

• the IRB, de ide ntifie d

me a ns:

 No o ne o n stud y te a m

ha s a c c e ss to id e ntifie rs

at any time

 F

• r re se a rc h whe re

HIPAA a pplie s, a ll 18 HIPAA id e ntifie rs a re re mo ve d

 Whe re HIPAA d o e s no t

a pply, it me a ns tha t the re is no fe a sib le wa y to id e ntify so me o ne fro m the d a ta (d ire c tly

• r via c o d e )

“De ide ntifie d” Da ta se ts F ro m E xte rna l Da ta b a se s

 T

ypic a lly na tio na l-le ve l da ta b a se s ma y a ppe a r “de ide ntifie d” b ut a dministra to rs sta te tha t re - ide ntific a tio n is te c hnic a lly po ssib le

 Ma y re q uire se pa ra te da ta

use a g re e me nt

 T

he I RB will o fte n re vie w the se if da ta so urc e b e lie ve s re ide ntific a tio n po ssib le

Ca se Studie s



Ca se studie s invo lve the c o lle c tio n a nd pre se nta tio n o f de ta ile d info rma tio n a b o ut a pa rtic ula r pa rtic ipa nt o r sma ll g ro up to hig hlig ht a n inte re sting c o nditio n, tre a tme nt, pre se nta tio n o r

• utc o me .



T

• de te rmine whe the r a c a se study o r c a se se rie s re q uire s I

RB re vie w, re c a ll tha t huma n sub je c ts re se a rc h is de sig ne d to c o ntrib ute to g e ne ra liza b le kno wle dg e .

 A c a se study hig hlig hts a fe w pa rtic ula r c a se s fo r purpo se s o f

de mo nstra tio n ra the r tha n fo r purpo se s o f dra wing g e ne ra lize d c o nc lusio ns.

 HI

PAA re g ula tio ns sho uld still b e c o nside re d, if a pplic a b le

Ca se Study



Be lo w a re so me c rite ria tha t te nd to b e re pre se nta tive o f e ithe r c a se studie s o r re se a rc h Case Study Re se ar c h

Re po rts o n 5 o r fe we r sub je c ts Re po rts o n mo re tha n 5 sub je c ts No t me a nt to b e a re pre se nta tive sa mple Dra ws c o nc lusio ns a b o ut a b ro a de r po pula tio n b a se d o n the re po rte d c a se s Spe c ific to sub je c ts’ c o nditio ns o r tre a tme nts No t a s spe c ific to individua ls, inste a d fo c use d mo re o n c o nditio ns o r tre a tme nts Re po rte d/ pub lishe d info rma tio n spe c ific a lly no te s c a se re po rts Re po rte d/ pub lishe d in a wa y tha t sug g e sts b ro a d finding s o r re c o mme nda tio ns

Ca se Study E xa mple - No I RB Re vie w Re q uire d

 A pro file o f thre e pe o ple

with the sa me ra re dise a se

 Pro c e dure s inc lude :

• b ta ining histo ric a l he a lth

info rma tio n, in-de pth inte rvie ws, c o mpa ring diffe re nt tre a tme nts, c o lle c ting o utc o me da ta

 I

nte nt is to hig hlig ht diffe re nc e s a nd simila ritie s in the c a se s

 Not me a nt to be

g e ne ra liza ble !

Ca se Study E xa mple - I RB Re vie w Re q uire d

 A pro file o f te n pe o ple

with the sa me dise a se

 Pro c e dure s inc lude :

• b ta ining histo ric a l he a lth

info rma tio n, in-de pth inte rvie ws, c o mpa ring diffe re nt tre a tme nts, c o lle c ting o utc o me da ta

 I

nte nt is to de te rmine the b e st tre a tme nt

 Me a nt to be g e ne ra liza ble !

Qua ity I mpro ve me nt

 QA/ QI

pro je c ts o fte n inc lude a c tivitie s suc h a s c o nduc ting surve ys, re vie wing ide ntifia b le da ta , a nd imple me nting me tho ds fo r impro ve me nt.



T he ke y is de te rmining whe the r this type o f pro je c t is de signe d

to be ge ne r alizable

 QA/ QI

pro je c ts fo c us o n impro ving the pe rfo rma nc e o f a n institutio na l pra c tic e in c o mpa riso n with a n e stablishe d sta nda rd o r g o a l. T he re sults o f the pro je c t a re no t inte nde d to a pply to a nyo ne b e yo nd the sc o pe o f the pro je c t, a nd c o nc lusio ns a re dra wn o nly in re la tio n to the pa rtic ula r pra c tic e a t the institutio n.

 QI

pro je c ts ma inly imple me nt pro ve n o r te ste d pro c e dure s; the y a re no t de sig ne d to e va lua te the sa fe ty o r e ffic a c y o f a ne w pro c e dure , o nly to se e ho w we ll it wo rks a t the institutio n

Qua lity I mpro ve me nt

QA/ QI Re se ar c h

F

• c us is lo c a l a nd spe c ific ,

me a nt to impro ve institutio na l pra c tic e E xplo re s a hypo the sis o r the o ry to dra w g e ne ra l c o nc lusio ns b e yo nd the sc o pe o f institutio n Pa rtic ipa nts a re no t me a nt to b e re pre se nta tive o f a b ro a de r po pula tio n Re sults o r da ta ma y b e g e ne ra lize d a s b e ing re pre se nta tive o f po pula tio n a t la rg e Co nc lusio ns dire c tly a pplic a b le to institutio n, no c la im tha t the y a re g e ne ra liza b le Co nc lusio ns me a nt to b e g e ne ra liza b le a nd a pply to institutio ns b e yo nd site whe re pro je c t to o k pla c e Pub lic a tio ns fo c us o n impro ve me nt a t institutio n, a llo ws e xte rna l institutio ns to dra w o wn c o nc lusio ns a b o ut a pplic a b ility Pub lic a tio ns me a nt to b e g e ne ra liza b le , sug g e sts a pplic a b ility to o the r institutio ns

Qua lity I mpro ve me nt-No I RB re vie w re q uire d

 A study o f a sta te priso n

he a lth syste m is unde rta ke n to impro ve pa tie nt sa tisfa c tio n

 Pro c e d ure s inc lud e :

c ha rt re vie w, inte rvie ws with priso ne rs, sa tisfa c tio n surve ys, imple me nta tio n o f ne w inte rve ntio n a nd c o lle c tio n o f d a ta b e fo re a nd a fte r the ne w inte rve ntio n

 Re sults will b e pro vid e d

to the priso n he a lth a utho rity with re c o mme nd a tio ns fo r the syste m

 Not inte nde d to be

g e ne r a liza ble outside of the pr ison syste m studie d

Qua lity I mpro ve me nt- I RB Re vie w Re q uire d

 A study o f a sta te priso n

he a lth syste m is unde rta ke n to impro ve pa tie nt sa tisfa c tio n

 Pro c e d ure s inc lud e :

c ha rt re vie w, imple me nta tio n o f ne w inte rve ntio n a nd c o lle c tio n o f d a ta b e fo re a nd a fte r the ne w inte rve ntio n

 Re sults will ma ke

re c o mme nd a tio ns fo r

• the r priso n he a lth

syste ms

 Inte nde d to be

g e ne r a liza ble

Pub lic He a lth Pra c tic e vs. Pub lic He a lth Re se a rc h

 Sc ie ntific me tho ds a re use d in b o th pub lic he a lth

pr ac tic e a c tivitie s a nd pub lic he a lth r e se ar c h pro je c ts.

 K

no wle dg e g a ine d ma y b e ge ne r

alizable in b o th

c a se s.

 T

he purpo se o f pub lic he a lth r

e se ar c h is to g e ne ra te

• r c o ntrib ute to g e ne ra liza b le kno wle dg e .

 T

he prima ry inte nt o f pub lic he a lth pr

ac tic e is

pra c tic a l:

 to pre ve nt o r c o ntro l dise a se o r injury a nd impro ve

he a lth, to impro ve a pub lic he a lth pro g ra m o r se rvic e , o r to e va lua te a pro g ra m.

Pub lic He a lth Pra c tic e vs. Pub lic He a lth Re se a rc h

Public He alth Pr ac tic e Re se ar c h

Dire c t pe rfo rma nc e o r o ve rsig ht b y g o ve rnme nta l he a lth a utho rity Co nduc te d b y a c a de mic c e nte rs with e xpe rie nc e in c o nduc ting re se a rc h Prima ry inte nt is to pre ve nt o r c o ntro l a dise a se o r injury Aims to dra w c o nc lusio ns a b o ut a hypo the sis to c o ntrib ute to the fie ld a t la rg e F

• c use d o n impro ving he a lth o f a

spe c ific po pula tio n o r g ro up Ge ne ra te s kno wle dg e tha t c a n b e a pplie d Be ne fits a nd risks prima rily de sig ne d to a c c rue to pa rtic ipa ting c o mmunity Be ne fits a pply b e yo nd pa rtic ipa ting c o mmunity tha t b e a rs risks Ma y invo lve pe o ple who did no t spe c ific a lly vo lunte e r to pa rtic ipa te (no info rme d c o nse nt) I nvo lve s re se a rc h sub je c ts who vo lunta rily c o nse nt to pa rtic ipa te (tho ug h c o nse nt ma y b e wa ive d b y the I RB)

Pub lic He a lth Pra c tic e - No I RB Re vie w Re q uire d

 E

mo ry fa c ulty he lp a n NGO imple me nt a ne w pre ve ntio n

• utre a c h pro g ra m

 Pro c e d ure s inc lud e : c o lle c tio n

• f d a ta prio r to a nd a fte r

imple me nta tio n o f the ne w pro g ra m a nd surve ys to g a ug e pa rtic ipa nt re spo nse

 Re po rts will b e g e ne ra te d to

info rm NGO a d ministra to rs a nd Ministry o f He a lth

 Not me a nt to infor

m the lite r a tur e , or impa c t pr a c tic e s

• utside the ta r

g e t c ommunity

 Ca n still d isse mina te e xpe rie nc e

a t c o nfe re nc e s a s a c a se re po rt

Qua lity I mpro ve me nt E xa mple - I RB Re vie w Re q uire d

 E

mo ry fa c ulty wo rking o n c le a n wa te r wo rk with inte rna tio na l

• rg a niza tio n to distrib ute a nd

e va lua te ne w pro duc ts a nd e duc a tio na l to o ls to impro ve a c c e ss to c le a n wa te r

 Pro c e d ure s inc lud e : c o lle c tio n

• f d a ta a nd surve y re spo nse s

prio r to a nd a fte r imple me nta tio n o f the ne w pro c e d ure in two pilo t a re a s

 Re po rte d re sults will ma ke

re c o mme nd a tio ns fo r ro lling o ut the inte rve ntio ns to o the r a re a s a lo ng with id e ntifying b a rrie rs to c le a n wa te r in simila r a re a s

 Inte nt is to be g e ne r

a liza ble - IRB r e vie w is r e quir e d!

Cla ssro o m Ac tivitie s

 So me re se a rc h me tho ds a nd re se a rc h de sig n c la sse s

inc lude ha nds-o n pro je c ts tha t ma y se e m like re se a rc h.

 Cla ssro o m a c tivitie s a re o fte n me a nt to sa tisfy a c o urse

re q uire me nt o r to te a c h a pa rtic ula r le sso n, no t to spre a d b e yo nd the c la ssro o m in a wa y tha t wo uld sug g e st g e ne ra liza b le re se a rc h.

 So me instruc to rs unde rta ke pro je c ts to impro ve

stude nt pe rfo rma nc e . No I RB re vie w is re q uire d whe n the inte ntio n is so le ly to impro ve the te a c he r’ s o r a de pa rtme nt’ s te a c hing me tho ds.



Howe ve r, if a n instruc to r ha s a n a c a de mic inte re st is

pe da g o g y, a nd is using the c la ssro o m to te st inno va tio ns in pe da g o g y, I RB sub missio n wo uld like ly b e re q uire d

Cla ssro o m a c tivitie s- No I RB Re vie w Re q uire d

 I

mpro ving te st sc o re s in a ma th c la ss b y utilizing te c hno lo g y

 Pro c e dure s inc lude : surve ys

with stude nts, re vie w o f te st sc o re s b e fo re a nd a fte r imple me nta tio n

 I

nte nt is to impro ve o ne de pa rtme nt’ s stude nts’ te st sc o re s

 Not me a nt to be g e ne ra liza ble

Cla ssro o m a c tivitie s- I RB Re vie w Re q uire d (Ma y Be E xe mpt)

 T

e sting a ne w te c hno lo g y in se ve ra l ma th c la sse s with a im

• f o b ta ining re pre se nta tive

sa mple

 Pro c e dure s inc lude :

a no nymo us surve ys with stude nts, re vie w o f te st sc o re s b e fo re a nd a fte r imple me nta tio n

 I

nte nt is to sho w tha t te c hno lo g y use impro ve s te st sc o re s

 If de sig ne d to be g e ne ra liza ble

• ne e ds IRB re vie w (ma y be

e xe mpt)

Ano the r L itmus T e st…

 Whe the r c la ssro o m inno va tio n, q ua lity impro ve me nt,

• r pub lic he a lth:

 if yo u a re a dding a dditio na l da ta c o lle c tio n o r

pro c e dure s to yo ur pro je c t in o rde r to ma ke the re sults mo re ro b ust fo r pub lic a tio n o r utility in g e ne ra lizing - b e yo nd wha t yo u wo uld do so le ly fo r yo ur

• wn/ institutio n’ s ne e ds - the n yo u a re like ly do ing so me

“re se a rc h”

No t T

• ta lly Cle a r? We

Ag re e !

 T

he re g ula tio ns le a ve ple nty o f a mb ig uity a nd whe the r a pa rtic ula r pro je c t ne e ds I RB o ve rsig ht is no t o b vio us

 De pe nds o n pa rtic ula ritie s, o fte n the re a re e xc e ptio ns

 T

AK E AWAY:

Sub mit yo ur pro je c t to the I

RB fo r a n o ffic ia l de te rmina tio n

 De te rmina tio n re q ue st fo rm o n the I

RB we b site is q uic k a nd c o nve nie nt, no t ne a rly a s invo lve d a s a n e I RB sub missio n.

 Re q ue st a De te rmina tio n to o l lo c a te d o n the E

mo ry I RB we b site unde r “F

• rms & Guida nc e ” ta b

Sub mitting a pro je c t to the I RB fo r a De te rmina tio n

 Yo u will b e a ske d to

a nswe r so me q ue stio ns a nd a tta c h a pro to c o l, pro po sa l, o r pro je c t summa ry.

 Onc e sub mitte d, yo ur

pro je c t is se nt to the IRB listse rve , whic h is mo nito re d b y a n IRB a na lyst o n a ro ta ting b a sis e a c h da y.

 Yo u sho uld imme dia te ly

re c e ive a re c e ipt no tifying yo u tha t yo ur sub missio n wa s re c e ive d.

 Yo u sho uld g e t so me

initia l re spo nse within thre e b usine ss da ys.

Sub mitting a pro je c t to the I RB fo r a De te rmina tio n

 Be sure to re spo nd to

a ny q ue stio ns yo ur re vie wing a na lyst ma y ha ve b y re plying to yo ur a na lyst dire c tly.

 Ma ke sure yo u a ddre ss

the c rite ria c o ve re d in this we b ina r.

 Yo ur a na lyst will pro vide

yo u with a n e ma il de te rmina tio n o nc e a ll q ue stio ns ha ve b e e n a nswe re d .

 I

f yo u re q uire a fo rma l de te rmina tio n le tte r, just le t yo ur a na lyst kno w!

Que stio ns?

I RB Co nta c ts o n the QA a nd E duc a tio n te a m:

Mar

ia Davila

(404)712-0724 o r ma ria .da vila @ e mo ry.e du

Shar

a Kar le bac h

(404)712-0727 o r sha ra .ka rle b a c h@ e mo ry.e du

Je ssic a Bake r

(404)712-9698 o r je ssic a .b a ke r@ e mo ry.e du

Anisha E

asle y

(404)712-8548 o r a nisha .e a sle y@ e mo ry.e du

33

T ha nk Yo u!

Ple ase c o nside r taking a mo me nt to c o mple te o ur surve y, link lo c ate d o n the we b inars pag e o f the we b site .