Attach 8. Continuing Review IRB Approval Child Health Disparities

Attach 8. Continuing Review IRB Approval Child Health Disparities.pdf

Child Health Disparities Substudy for the National Children's Study (NCS)- Phase 1

Attach 8. Continuing Review IRB Approval Child Health Disparities

OMB: 0925-0673

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ATTACHMENT 8 CONTINUING REVIEW IRB APPROVAL
CHILD HEALTH DISPARITIES
Office of Human Subj e cts Re se arch
In s titu tio n a l Re v ie w Bo a rd s
1 620 Mc El der r y St r eet , Reed Hal l , Su i t e B-1 30
Bal t i mor e, Mar y l and 21 205-1 91 1
41 0-955-3008
41 0-955-4367 Fax
e-mai l : jh mi r b @jh mi .edu

Da t e: Ja n u a r y 4, 2013

CONTINUING REVIEW APPROVAL
Rev i ew Ty pe:

Ex pedi ted

PI Na me:

Ti n a Ch en g

St u dy #:

N A _00042617

St u dy Na me:

Mea su r i n g Ch i l d Hea l th Di spa r i ti es: Hea l th Li ter a cy , Di scr i m i n a ti on a n d Hea l th Ser v i ces (Th e Hea l th y
Beg i n n i n g s Stu dy )

Commi t t ee
Ch a i r:

Su sa n Ba ssett

Commi t t ee:

JHM-IR B X

Da t e of rev i ew: Decem ber 23, 2012
Da t e of a pprov a l : Decem ber 23, 2012
Da t e of ex pi ra t i on : Decem ber 22, 2013
Th e JHM IR B a ppr ov ed th e a bov e-r efer en ced Con ti n u i n g R ev i ew.
Da t e of Approv a l a n d Ex pi ra t i on Da t e: Th e a ppr ov a l a n d ex pi r a ti on da te for th i s r esea r ch a r e l i sted a bov e. If th e a ppr ov a l l a pses, th e
r esea r ch m u st stop a n d y ou m u st su bm i t a r equ est to th e IR B to deter m i n e wh eth er i t i s i n th e best i n ter ests of i n di v i du a l pa r ti ci pa n ts to
con ti n u e wi th tr ea tm en t i n ter v en ti on s.
Ch a n ges i n Resea rch : A l l pr oposed ch a n g es to th e r esea r ch m u st be su bm i tted u si n g a n eIR B Ch a n g e i n R esea r ch a ppl i ca ti on . Th e
ch a n g es m u st be a ppr ov ed by th e JHM IR B pr i or to i m pl em en ta ti on , wi th th e fol l owi n g ex cepti on : ch a n g es m a de to el i m i n a te a ppa r en t
i m m edi a te h a za r ds to pa r ti ci pa n ts m a y be m a de i m m edi a tel y , a n d pr om ptl y r epor ted to th e JHM IR B.
Con t i n u i n g Rev i ew: Con ti n u i n g R ev i ew A ppl i ca ti on s sh ou l d be su bm i tted a t l ea st 6 weeks pr i or to th e stu dy ex pi r a ti on da te. Fa i l u r e to
a l l ow su ffi ci en t ti m e for r ev i ew m a y r esu l t i n a l a pse of a ppr ov a l . If th e Con ti n u i n g R ev i ew A ppl i ca ti on i s n ot su bm i tted pr i or to th e
ex pi r a ti on da te, y ou r stu dy wi l l be ter m i n a ted a n d a N ew A ppl i ca ti on m u st be su bm i tted to r ei n i ti a te th e r esea r ch .
Un a n t i ci pa t ed Probl ems: Y ou m u st i n for m th e IR B of a n y u n a n ti ci pa ted pr obl em s i n v ol v i n g r i sks to pa r ti ci pa n ts or oth er s.
If th i s r esea r ch h a s a com m er ci a l spon sor , th e r esea r ch m a y n ot sta r t u n ti l th e spon sor a n d JHU h a v e si g n ed a con tr a ct.

Th e Joh n s Hopki n s In sti tu ti on s oper a tes u n der m u l ti pl e Feder a l -Wi de A ssu r a n ces: Th e Joh n s Hopki n s Un i v er si ty Sch ool of Medi ci n e FWA 000057 52, Th e Joh n s Hopki n s Un i v er si ty Sch ool of N u r si n g - FWA 00006088, Th e Joh n s Hopki n s Hospi ta l a n d Joh n s Hopki n s Hea l th
Sy stem s - FWA 00006087 , Joh n s Hopki n s Ba y v i ew Medi ca l Cen ter - FWA 00006089, Howa r d Cou n ty Gen er a l Hospi ta l - FWA 000057 43, Hu g o
W. Moser R esea r ch In sti tu te a t Ken n edy Kr i eg er , In c. - FWA 000057 19, Joh n s Hopki n s Com m u n i ty P h y si ci a n s - FWA 00002251, Su bu r ba n
Hospi ta l a n d Hea l th Sy stem - FWA 00005924

1/16/13

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