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 o 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, o 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 o 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 NOT inc 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 o 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 o 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 o 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 o utc o me .  T o 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 Re po rts o n mo re tha n 5 sub je c ts sub je c ts No t me a nt to b e a Dra ws c o nc lusio ns a b o ut re pre se nta tive sa mple 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’ No t a s spe c ific to c o nditio ns o r tre a tme nts 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 Re po rte d/ pub lishe d in a info rma tio n spe c ific a lly wa y tha t sug g e sts b ro a d no te s c a se re po rts 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 : o 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 : o 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