SSA Attachment 4 IRBs

W

3r,l UY_o^fi/a

fnstltr¡llonnl Rq'lcrv Buard (fRB) AuthorlznlIo¡t Agt'acntcnt
Nnrns of It¡sfltullon Provitllrrg IRB Revlervl

Nnn¡s of Institullon Rolytug on tlreDeslgrtnlod IRB¡

Ter¡trs ofl Aglce¡llonl

l.

'fhe Offici¡ls siguing belorv ngree tlrntBWI,a mç¡nbsr instililfior¡ of Pattners HenlthCare Systettr,.ltto,
üãy}çty n¡r tttã Fgcltc IRB for rcviçw nnd conlinuiug ovelsight-of its htunnn subject

ß;RTNËR!1,

resertrch doscrìbecl l¡olorv:

(WHD Extcnslon Stutly
Name of Reseuch ProjecÍ lTbmelt's Henlth Inltlnflva
'Protocolll: FI{CRC tRB Í,3467EXT

;.ñ;(r) ;f prirrcipal

Investlgator{s) st €açh Sito: Ro,ss P-r'entlce, PlrÐ

G'HCRC)

&

Gnr¡ret .Anrlerso¡t' PIrD

Jsnnn Mnnsott, MDr Dr PH

OtlilÐ

sporrso'orFrrndìngSourcçnnrlArv¿rlrl#(ifnny); Resenrchrtoundnllo¡rofslntellniverslçofNeruYorlt
2,

3,

rvill uteot tlto hu¡¡rll.TlF:tt proteotion
The revle$,&rrd corrthruing ovorsiglrt per.fornred by the FI'ICRC.lllB
to the FHCIIC
is
availnble
of
l'hich
copy
a
FWA,
o=ltRn-o¡r-pr*ed
*qrir"ii""ts orBt\rH'u

ilü'

'l.he PHCRC IIÌB rvill perform lny rtetennirtalion requlred by the Henlth Insumuce Portabllityand
uncler this Agreentont,
Áor tgipÀÀl arretÍts regulntions rvitlirespectlo therç¡en¡'ch includod
for use nrxl tllsclosu¡ç for researth of subjeots'
authorizotion
of
,uoii"tr
to
r"iátø
ilild1,.ñ;iå,,ni-,tutlonr
rlefined in the HIPAA regnlations. FHCRC rvill Provide a foru of
i;*údã u*ltn nrronr*ii"it tÉHl¡ ns pHI
if such authorìzation is requircd' Dotslrniuatíous as to the legal
of
ar¡tborjzntion for usç uo.i'ãi*rfrutá
HIP A shnll l¡s mads by thoentity or organlzation florrt
r¡nclel
forms
authàrization
suoh
of

À;;;;;tltit
;üif¡;t;i;y

rvl¡ioh PI'II is obtaillod fol tho ¡çsenrcl¡'
4.

5.

nud rvlll otlwnvlse accept
The FHCRC IlìB rvill allorv represonr¿tives of BWH to aflend ils rrreetings
¡recessary to ensuresufflclent
thc
extenl
to
study,
;il;r;,f;;õw-Hü;;i".osäumtivus in thc reyierv of
knorvledge of the loonl rosenrch sontext'
ancl tl¡e rosponsibie BttrFr PI in
The FHCRC IRB, or lhe Wo¡¡len,s Health lrritiativo cCC, rvill uotify,B\l'H
r:cquirod to secure npproval of
or
of
modlfications
study
the
dlsapprove
,*ú1,ü;¡ ¡i, ffiirirt i" opprour or
¡'esçarch
activity, nnnrcl¡ by
ìu
thç
ohnnges
approved
arrd
lRB"rçviärvecl
rãlii,unr
irr" ,t ?v, ns rvell
of the rovierv
PI
Bs¡H
"it
the
Agreen,"¡1g{to
rc trt. iifurì oif*ials deslgnated in thìé
,""¡iüC
penåhriilg to the
nreefings
IllB
of
FFICRC
n¡imtes
Relevaut
invcstig¡rto¡'s.
ir"iif,"ã'$",i letteÌs it *"turr to
reqttost'
rvdtfen
upon
BtVl{
to
avnilable
stucly rvill be madc

*pi*

*

il councctlon rvlth the strdy lor cnsuring compliàrce rviih the dbtomrinations of
6..
-' B\ilFI rornainstngrosponsible
rhe
relrns ofBT[H's Ol-IRP-apprnved FWA.
$,irh
oï¿
rüFI{Cnc
IRB rvill proniptly notifl BWH in rvritilgof any991!o,us or contittuittg non'conrplianæ by
4issoverçd úy the FHCRC IRB or FHCRC, atty suspotrsion.orte¡'mlnntio¡r of IRB
investlgotors
Brîfl o,. its
involvirrg rlsks to subjeots or others
aporov¡rl, arrd any irrjurìos to subjects or unanticipnted problenls
sludy. BwH u'ìll prornptly reporl to
rvith
the
in
cor¡ncotion
FI{cRc
IRB
õr
äiä;o[J ùtìliá nf¡ònC

7,
'' The FHCRC

FHcRc nuy
äiü,li¡.1,

rirc;Cð

iiir

*y

set'iou$

ol co¡tinçir¡g ¡ron-oo¡npliance

arvnle, arld

by

BwH or its invostigalors in connectiott rvilh the study

will ¡¡ln[e allrcasonnble effoûs to ensruç tl¡nt lts investign{o¡s p¡o¡t¡plly repoú to

li¡,',V io subjects or.unanticipnterl

problcrn involvhrg risks lo subjecls ot'others in connection

rvilh the study ofrvhioh they ate nrvate'
suoh ntntîors, If tho
FHCRC rvlll be lesponsible for any investigation of tton-cont¡rliallce ol' other
OI{RP)' I'HCRC
bu-T{?
extornall¡'(0.g.
lrill
of
ropot't
thût
n
the
pro6t*
includes
þroductlon
inuutìigori.,u
sltRll prevent
h copy of snoh repor.inrade to oxternal organízatior¡s, Nothing h this rlgreontont
"liniipioui¿,
g\,üifro,n rontlucthrg its ou,n inqr¡iry ol invesllgation hrto arry snolr ¡tmlter pnrsuant to its. orvn policles and
ploçedtr¡es, or fiorn rnakirrg its own reporl lo sxtCmal autholitles, or fiortl taking additiot¡al, lnore.resh'ictivc
by B'WH investigalots irt
if,lïrdi;iñ ,i"p, irs orvñ institutiori inoluding the ter'mlnatlorr of partìcipntlonallothôt"s
olrc
lrlqulries or'
with
to
coopemle
efiorts
*nay, Eacli paLty agrces to use flll r'€nson¿rbie
nnd tnceling
hlformation
related
ancl
rpsenroh
reooxls
ûeçÊssnÌy
to
pr.oviFile Typeapplication/pdfFile Modified2016-05-31File Created2015-12-02