O SURE ! D ISC L T he g o a l o f this we b ina r is to g ive yo - - PowerPoint PPT Presentation

NEW IRB SUBMISSIO NS

T ips fo r g e tting yo ur sub missio ns pro c e sse d mo re e ffic ie ntly

IRB We b inar- Fe b ruary 12, 2015

DISC L

O SURE!

T he g o a l o f this we b ina r is to g ive yo u a dditio na l info rma tio n yo u ma y ne e d during yo ur sub missio n pro c e ss. F

• r a de ta ile d g uide o f ho w

to na vig a te e I RB ple a se re fe r to o ur instruc tio na l vide o s a t: http:/ / www.irb .e mo ry.e du/ tra ining / vide o s.html

O VERVIEW O F T

HE PRO C ESS

I nve stig a to r sub mits a ne w study in e I RB F a c ulty Adviso r o r De pa rtme nt re vie ws a study a nd sub mits it to the I RB I RB re c e ive s the study a nd it is a ssig ne d to a n a na lyst T he a na lyst re vie ws the study a nd se nds it b a c k fo r c ha ng e s a s ne c e ssa ry T he study is re vie we d b y a n e xpe dite d re vie we r o r b y the full b o a rd T he study is a ppro ve d a nd a le tte r is se nt to the inve stig a to r.

T

IPS T O G ET FRO M SUBMISSIO N T O APPRO VAL

 I

n a dditio n to the do c ume nts pro vide d, yo u sho uld b e a wa re o f o the r E mo ry re q uire me nts.

 Whe n wo rking with the Atla nta VA, Childre n’ s

Ho spita l o f Atla nta (CHOA) , St. Jo se ph’ s o r Gra dy, ple a se c o nside r tha t the y ma y ha ve e xtra re q uire me nts tha t must b e c o mple te d b e fo re yo u ma y sta rt yo ur study, e ve n if a ppro ve d b y the E mo ry I RB.

 I

f wo rking o n a n inte rna tio na l CT , yo u ma y ne e d to lo o k fo r o the r info rma tio n prio r to sub missio n. L e t’ s lo o k a t diffe re nt sc e na rio s….

MAYBE YO U DO NO T NEED IRB REVIEW!

 We ha d a pre vio us we b ina r a b o ut this pro c e ss.

Yo u c a n a c c e ss it a t this link:

http:/ / e mo ry.a do b e c o nne c t.c o m/ p2q lo yc zz48/

 BUT

! We just wa nt to g ive yo u a link to o ur to o l tha t he lps yo u de te rmine if yo u ne e d I RB re vie w o r no t.

 Yo u c a n find the to o l he re :

http:/ / www.irb .e mo ry.e du/ fo rms/ NHSRfo rm.php

C O L

L ABO RAT IVE INST IT UT IO NS

 F

• r situa tio ns whe re o ne o f the site s is fro m a n

E mo ry c o lla b o ra tive institutio n, suc h a s the VA, CHOA, St. Jo se ph’ s, o r Gra dy ple a se no te the fo llo wing …

G RADY ST

UDIES

 I

RB a ppro ve d studie s c o nduc te d a t Gra dy ne e d to b e a ppro ve d b y the Re se a rc h Ove rsig ht Co mmitte e (ROC) b e fo re yo u ma y sta rt the pro je c t.

 I

f this is a n e xpe dite d study, a nd yo u wa nt to ma ke the ROC me e ting o n time , ple a se le t us kno w a nd we mig ht b e a b le to re vie w yo ur study b e fo re the me e ting ta ke s pla c e .

 F

• rms fo r ROC c a n b e fo und he re :

http:/ / www.g ra dyhe a lth.o rg / sta tic / o ffic e -o f- re se a rc h-a dministra tio n

VA ST

UDIES

 Simila r a s in Gra dy studie s, VA studie s sho uld b e

a ppro ve d b y the Re se a rc h De ve lo pme nt Co mmitte e (RDC) a fte r a ppro va l b y the E mo ry I RB.

 T

• c o nduc t a study a t the Atla nta VA, yo u will ne e d

to ha ve in yo ur te a m a PI (o r Co -I )with a VA a ppo intme nt.

 Physic ia ns ma y o b ta in a n a ppo intme nt b y b e ing

spo nso re d b y a c linic a l divisio n a nd privile g e s thro ug h the VA Me dic a l Ce nte r Chie f o f Sta ff’ s Offic e .

 F

• r mo re info rma tio n, visit this link:

http:/ / www.a tla nta .va .g o v/ se rvic e s/ re se a rc h/ I nve s tig a to rs.a sp

C HO A ST

UDIES

 CHOA ha s a n I

RB b ut we ma y re vie w studie s c o nduc te d a t CHOA pe r o ur a g re e me nt.

 T

he CHOA I RB will re vie w studie s unde r a CHOA PI (no E mo ry a ppo intme nt), e ve n if the study a lso ha s Co -I s a ffilia te d with E mo ry; o r studie s do ne with CHOA me dic a l re c o rds.

 Prio r to sub mitting , ma ke sure yo ur study ne e ds

E mo ry I RB re vie w, to a vo id de la ys.

ST . JO SEPH’S & JO HN’S C REEK

 I

f do ing re se a rc h in the se fa c ilitie s, ple a se c ho o se the m a s a site in yo ur I RB sub missio n.

 I

f using a le a se spa c e (like the E mo ry Clinic a t

• St. Jo se ph), se le c t o the r.

 Yo u ne e d a PI

• r Co -I

a sso c ia te d with this lo c a tio n a s pa rt o f yo ur study te a m.

 Yo u a re re q uire d to o b ta in SJHC ROC a ppro va l

to ve rify institutio na l a ppro pria te ne ss a nd/ o r c o mplia nc e with the Ca tho lic dire c tive s b e fo re study c a n b e g in a t SJHC/ Jo hn’ s Cre e k.

 We c a nno t a ppro ve yo ur study until SJHC ROC

a ppro ve s yo ur study.

C L INIC AL T RIAL S

 I

f yo ur CT is b e ing c o nduc te d a t E mo ry He a lthc a re , yo u ne e d to c o mply with the Offic e o f Qua lity sta nda rds.

 Yo u ma y ne e d to sub mit to the Oo Q a dditio na l

fo rms tha t c a n b e fo und he re : http:/ / irb .e mo ry.e du/ fo rms/ c linic a l.html

 T

he fo rms a re re q uire d so the I RB c a n re le a se yo ur a ppro va l do c ume nts.

 We do no t re vie w the se fo rms. F

• r q ue stio ns,

ple a se c o nta c t L a ura De a ne a t la ura .de a ne @ e mo ryhe a lthc a re .o rg

C L INIC AL T RIAL S

 I

f using a drug o r de vic e , the PI sho uld e nsure tha t the use is do ne unde r the c urre ntly F DA a ppro ve d indic a tio n.

 I

f no t, the drug o r de vic e ma y ne e d a n I ND o r I DE .

 An inve stig a to r ho lding a I

ND o r I DE is a “spo nso r” unde r fe de ra l re g ula tio ns, a nd the re fo re ne e d to c o mply with a dditio na l re q uire me nts.

 F

• r mo re info rma tio n, ple a se re fe r to this

g uida nc e : http:/ / www.irb .e mo ry.e du/ do c ume nts/ g uida n c e -E mo rySI .pdf

C L INIC AL T RIAL S

 F

• r inte rna tio na l c linic a l tria ls, ple a se ma ke sure

yo u a re fo llo wing the re se a rc h c o untry la ws.

 We re c o mme nd to c o nta c t K

ris We st, who c a n re fe r yo u to Ge ne ra l Co unse l. T he y will re vie w the inte rna tio na l la ws yo u ne e d to fo llo w fo r a fe e .

 I

n a dditio n, yo u ma y ne e d to hire a CRO (mo nito r).

 T

he E mo ry I RB ma y a ppro ve yo ur study a s lo ng a s it c o mplie s with a ll the a b o ve -e xpla ine d re q uire me nts.

C L INIC AL T RIAL S

 I

f yo u a re c o nduc ting a ne w Pha se I I b / I I I / I V drug o r a na lo g o us de vic e studie s tha t a re industry-de sig ne d, industry-initia te d, a nd industry-spo nso re d, yo ur study will b e re vie we d b y WI RB

 WI

RB? WI RB is a c o mme rc ia l I RB tha t is no t a ffilia te d with E mo ry Unive rsity. L e a rn mo re a t www.wirb .c o m

 F

• r mo re info rma tio n a b o ut the pro c e ss o f

sub mitting yo ur study via WI RB, ple a se fo llo w this link: http:/ / www.irb .e mo ry.e du/ fo rms/ e xte rna l- irb s/ WI RB_fa q .html

SO C IO- BEHAVIO RAL ST

UDIES

 T

he ma jo rity fa ll unde r the e xpe dite d, e xe mpt

• r NHSR c a te g o rie s.

 F

• r info rma tio n a b o ut the se c a te g o rie s, ple a se

se e the fo llo wing : http:/ / www.irb .e mo ry.e du/ do c ume nts/ Pyra mi d%20shb .pdf

 I

f wo rking unde r the Sc ho o l o f Pub lic He a lth, yo u a re re q uire d to use a n info rme d c o nse nt fo rm inc luding HI PAA la ng ua g e .

INT

ERNAT IO NAL NO N- C L INIC AL T RIAL S

 F

• r inte rna tio na l re se a rc h (no t CT

), yo u ma y ne e d to sub mit pro o f o f the a ppro va l o f yo ur study fro m the lo c a l e thic s c o mmitte e o r a le tte r o f c ultura l c o nte xt.

 F

• r inte rna tio na l re se a rc h, HI

PAA rule s will no t a pply unle ss ide ntifia b le da ta will b e b ro ug ht b a c k to the US fo r a na lysis.

 F

ind te mpla te s fo r the do c ume nts we re q uire d a t this link: http:/ / www.irb .e mo ry.e du/ fo rms/ so c io .html

C HART REVIEW

 Re vie we d unde r the e xe mpt o r e xpe dite d

re vie w c a te g o rie s

 Co nside r if yo u re a lly ne e d to re c o rd na me s,

a ddre sse s, da te s, e tc . E xe mpt re vie w ma y b e a n

• ptio n if no t!

 Our re vie we rs will de c ide wha t c a te g o ry ma y

a pply fo r yo ur study

 F

• r pro spe c tive c ha rt re vie ws (re vie wing c ha rts

fo r sub je c ts e nro lle d a c tive ly), yo u ma y ne e d to o b ta in info rme d c o nse nt.

RESEARC H WIT

H E MO RY ST UDENT S DAT A

 As yo u ma y kno w, HI

PAA a pplie s fo r studie s do ne unde r the c o ve re d e ntity.

 I

f a study is do ne so le ly a t a stude nt c linic (no t unde r the c o ve re d e ntity), HI PAA ma y no t a pply b ut F E RPA.

 Wha t is F

E RPA? T he F a mily E duc a tio na l Rig hts a nd Priva c y Ac t is a F e de ra l la w tha t pro te c ts the priva c y o f stude nt e duc a tio n re c o rds.

 F

• r q ue stio ns, ple a se c o nta c t o ur o ffic e o r K

ris We st.

A WO RD ABO UT C O NSENT FO RMS!

 Ma ke sure yo u use a n E

mo ry I RB te mpla te . Witho ut o ur te mpla te , we will b e una b le to sta mp yo ur fo rm a fte r a ppro va l.

 I

f yo u a re c o nduc ting yo ur study a t CHOA, VA,

• St. Jo se phs o r Gra dy, yo u ne e d to use the

a ppro pria te I CF te mpla te .

 Yo u c a n find the se do c ume nts a t this link:

http:/ / www.irb .e mo ry.e du/ fo rms/ c o nse nt_to o lk it/ inde x.html

IRB C O NT

AC T INFO RMAT IO N

 Ma ria G. Da vila

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

 Sha ra K

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

 K

e vin Wa c k (404)712-5220 o r kwa c k@ e mo ry.e du

 Se a n K

iske l (404)712-0766 o r skiske l@ e mo ry.e du

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Q UEST

IO NS?

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