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Invvestiga
Dated: Fe
ator M
ebruary 27
Manua
7, 2017
al
Table oScope .What isWhat isWhat isWho mWhat trWhat fHow doHow doWhat IWhen cWhen cHow doShouldHow doHow dorepositHow doHow doWhen sWhat ifWhat aWhat aHow doWhat wWhat aHow doHow doHow doHow doHow loWhat ifHow doAppendAppendAppendHarmoAppendAppendAppend
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AppendAppendixAppendix
dix A-8 Adx A-9 Unx A-10 Inve
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PAGE28 of 53
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PAGE31 of 53
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PAGE32 of 53
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PAGE33 of 53
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PAGE34 of 53
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ses, if any, t
icipation in tate or withdrefits to whichauditors, th
ss to the subjl trial procedsubject, to thand that, by sect's legally
ng the subjece applicablele. If the resremain conf
e subject's legmanner if inf's willingnes
V17
d: 09/04/2014
was freely ge. d the written ded to subjec
bility for ran
d, including
experimentaor inconvenitus, or nursin When thereshould be marses of treatmotential benent available t
, if any, to th
to the subjec
the trial is voraw from theh the subjecte IRB, and t
bject's origindures and/or he extent persigning a wracceptable r
ct will be ke laws and/orults of the trfidential. gally acceptformation bess to continu
Version # 2
given by the
informed cocts should in
ndom assign
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al. iences to the ng infant.
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he subject fo
ct for particip
oluntary ande trial, at anyt is otherwisthe regulatoral medical redata, withou
rmitted by thritten informrepresentativ
ept confidentr regulationsrial are publi
table represeecomes availue participati
PAGE35 of 53
subject or th
onsent form nclude
nment to each
e procedures
subject and
ded clinical f this. ay be availab
ks. ct in the even
or participatin
pating in the
d that the suby time, withose entitled. ry authoritiesecords for ut violating the applicable
med consent fve is authoriz
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3
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xvii.
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ht on the inclspect. Such tnts having a dded. Subjectsd be withdraergency situnt of the substed. When py authorizedrch is not perthe followinses of experimental rese
tigator MMBER P-103
des Previous ve
ns to contactrial subjects,
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cted durationximate numbion in the tri
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ation in the tould receive y amendmentrial (therapeun the trial wg., minors, ot the trial to d, if capable,consent. ed above, a nclinical bene
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d representatrmissible pung: "a patienrimental research."
anual DATE
2/27/201
ersion(s) dated
t for further , and whom
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n of the subjeber of subjecial, the subjea copy of th
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V17
d: 09/04/2014
informationto contact in
d/or reasons rminated. ect's participcts involvedect or the subhe signed andmation proviject or the su
he signed andtten informatherapeutic) ent of the suith severe deompatible w should sign
utic trial (i.eubject), shoun and date th
in subjects wllowing cond
means of a triaseeable risksl-being is mioval opinionand the writton is justifiedwhich the ine particularlunduly distrent of the su
d representatject is not povailable, enroe Florida Pat
ght to know iconsent prio
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n regarding thn the event o
under which
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ubject’s legalementia), the
with the subjen and persona
e. a trial in wuld be conduhe written in
with consentditions are fual in subjects to the subjeinimized andn of the IRB ten approvald, should benvestigationaly closely moressed. ubject is not ptive, if presenossible, and tollment of thtient Bill of if medical treor to particip
PAGE36 of 53
he trial and tof trial-relate
h the subject
trial.
ly acceptableten informedubjects. Durially acceptabsent form uped to subjectbjects who clly acceptable subject shoect’s ally date the
which there isucted in subjenformed cons
t of a legallyulfilled: a) Tts who can gects are low.d low. d) Theis expressly
l opinion cov conducted ial product isonitored and
possible, thent, should bethe subject’she subject inRights whiceatment is fo
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3
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ntial Documecable regulatures to prevential documenmarketing appmplated mared since the ftigational prover if requirethe sponsor. tigator/instituinancial aspe
ponsor and threquest of th
tigator/institud records. orts nvestigator sally, or morenvestigator swhere applicuct of the triating
erious adverst for those S
hure) identifi
tigator MMBER P-103
des Previous ve
should ensurdata reported
the CRF, thae source docrrection to aould not obsapplies to boprovide guidentatives on s to assure thted represennvestigator. T
nstitution shents for the Ctory requirement accidentants should bplication in rketing appliformal discooduct. Theseed by the appIt is the respution as to wects of the trhe investigathe monitor, ution should
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se events (SASAEs that theies as not ne
anual DATE
2/27/201
ersion(s) dated
re the accurad to the spon
at are derivedcuments or tha CRF shouldscure the origoth written adance to inve
making suchat changes tatives are dThe investig
hould maintaConduct of aments. The inal or prematue retained unan ICH regioications in anontinuation oe documentsplicable regu
ponsibility ofwhen these drial should betor/institutionauditor, IRB
d make avail
mit written suif requestedptly provide
stitution on acreasing the
AEs) should e protocol oreding immed
V17
d: 09/04/2014
acy, completensor in the C
d from sourche discrepand be dated, iginal entry (
and electroniestigators anh correctionor correctio
documented, gator should
ain the trial da Clinical Trnvestigator/iure destructintil at least 2on and until n ICH regionof clinical des should be rulatory requf the sponso
documents noe documenten.
B, or regulatoable for dire
ummaries of d by the IRB.e written repoany changes risk to subje
d be reportedr other documdiate reporti
Version # 2
eness, legibiCRFs and in a
ce documentncies should initialed, and(i.e. an auditic changes ord/or the inve
ns. Sponsors ns in CRFs mare necessaretain recor
documents arial and as reinstitution shion of these d2 years afterthere are no
n or at least evelopment oretained for auirements or or to inform to longer neeed in an agre
ory authorityect access all
the trial stat. orts to the spsignificantly
ects.
d immediatelment (e.g., Iing. The imm
PAGE37 of 53
ility, and all required
ts, should bebe explaine
d explained (t trail shouldr correctionsestigators' should havemade by
ary, and are ds of the cha
as specified iequired by thhould take documents.
r the last appo pending or 2 years haveof the a longer periby an agreemthe ed to be retaieement betw
y, the l requested t
tus to the IRB
ponsor, the Iy affecting th
ly to the sponInvestigator'smediate repo
3
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anges
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iod ment
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i.
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iii.
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InvestNUMHRP
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If the inveof the sponapplicablesponsor andetailed wIf the sponpromptly iinvestigatoIRB a detaIf the IRB investigatoinvestigatosponsor wsuspension
s by Investighould informummary of thred.
tigator MMBER P-103
des Previous ve
ed promptly bshould iden
er than by thThe investig
ements relatethe regulatornd/or laboratevaluations sments and wi
hs, the invesquested infor
nation or Suspended for athe trial subjs, and, where
e regulatory aestigator termnsor, the inv
e, and the invnd the IRB, a
written explannsor terminatinform the inor/institutionailed writtenterminates o
or should infor/institution
with a detailedn.
gator: Upon cm the instituti
he trial’s out
anual DATE
2/27/201
ersion(s) dated
by detailed, ntify subjectshe subjects' ngator should ed to the repory authoritietory abnormshould be repithin the tim
tigator shourmation (e.g.
spension of aany reason, thects, shoulde required byauthorities. I
minates or suvestigator shovestigator/insand should pnation of thetes or suspennstitution whn should promn explanationor suspends form the instn should promd written exp
completion oion; the invetcome, and t
V17
d: 09/04/2014
written repos by unique cnames, persod also complyorting of une
es and the IRmalities identi
ported to theme periods sp
uld supply th., autopsy re
a Trial: If thhe investigat
d assure appry the applicaIn addition:uspends a triaould inform stitution sho
provide the se terminationnds a trial, thhere applicabmptly inform
n of the termits approvaltitution whermptly notifyplanation of
of the trial, testigator/instthe regulator
Version # 2
orts. The immcode numberonal identificy with the apexpected ser
RB. ified in the p
e sponsor accpecified by th
e sponsor aneports and ter
he trial is preator/institutioropriate theraable regulato
al without prthe institutio
ould promptlsponsor and n or suspensihe investigatble and the m the IRB an
mination or sul opinion of are applicable
y the sponsorf the termina
the investigatitution shoury authoritie
PAGE38 of 53
mediate and rs assigned tcation numbepplicable rious adverse
protocol as cording to thhe sponsor in
nd the IRB wrminal medi
ematurely on should apy and folloory requirem
rior agreemeon where ly inform thethe IRB a ion. tor should
nd provide thuspension. a trial, the e and the r and provid
ation or
ator, where uld provide ths with any
3
to the ers,
e
he n the
with ical
ow-ments,
ent
e
he
de the
he
Append
1. Wthco
2. EinreEon
3. Sobon
4. Cre
5. T
6. Winedre
7. Thu
8. Wre
9. Wli
dix A-4
When approphe Departmeomponent to
Employees ofntermittent aesearch and
Employees ofn active dutyervice membbtain comman-duty or of
Components elated injury
There may bea. Initial
condub. The IR
awareregula318 Wabout
When assessinvolving humducation andesearch base
The followinguman resear
a. resultsb. changc. when d. when
organa DoD
When conducequired to sp
When researcimitations on
a. Prohibduty h
InvestNUMHRP
Supersed
Additionresearch
priate, researent of Defenso see whethef the Departm
appointmentsshould checkf the Departmy. bers must foand permiss
ff-duty. of the Depar
y than the DHe specific edul and continuuct, review, aRB staff, chae of the speciations via the
WORKSHEEthese requir
ing whether man subjectsd training poed on the comg shall be prrch protectios of IRB con
ge of reviewisignificant cthe Organizizations that
D-supported cting multi-specify the roch involves Un dual compebit an individhours.
tigator MMBER P-103
des Previous ve
nal Requireh rch protocolsse approval.
er this is a reqment of Defes) may not bk with their ment of Defe
ollow their coion to partic
rtment of DeHHS regulatiucational requing researchapprove, oveair, and memific requireme trainings cET: Additiorements wheto support os, the Departolicies to ensmplexity andromptly repon officer:
ntinuing reviing IRB changes to thzation is notit any part of research pro
site research,les and respoU.S. militaryensation: dual from re
anual DATE
2/27/201
ersion(s) dated
ements for
s must be revConsult witquirement.
fense (includbe able to leg
supervisor bfense cannot
ommand polcipate in rese
efense mightions. quirements oh ethics educersee, suppormbers; and rements containonducted ononal Federaen appropriatr collaboratetment of Defsure the persod risk of the rorted (no lon
iew
he research pfied by any Fthe HRPP is
otocol , a formal agonsibilities oy personnel,
eceiving pay
V17
d: 09/04/2014
r Departme
viewed and ath the Depar
ding temporagally accept pbefore accepbe paid for
licies regardearch involvi
t have stricte
or certificatication is reqrt, or managesearchers anned in Deparn the HRPP tal Agency Cte. e with this infense may evonnel are quresearch.
nger than wit
protocol are Federal depas under inve
greement betof each partypolicies and
of compens
Version # 2
ent of Defe
approved byrtment of De
ary, part-timepayments to
pting such paconducting r
ding the requing human s
er requireme
ion required.quired for all ge Human Rend research rtment of Detoolkit (spec
Criteria) and
nstitution forvaluate this ualified to pe
thin 30 days)
approved byartment, age
estigation for
tween organy. d procedures
sation for res
PAGE39 of 53
fense (DOD
y the IRB priefense fundin
e, and o participate ayments. research whi
uirement to subjects whil
ents for resea
. personnel w
esearch. staff becomeefense cifically, HRd are educate
r research institution’serform the
) to the DOD
y the IRB ency, or natior cause invol
nizations is
s require
search durin
3
D)
ior to ng
in
ile
le
arch-
who
e
RP-ed
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onal lving
g
10. O“A3
b. An indthe re
c. Federfor blo
d. Non-Fblood prevai
Other specificAdditional R18 WORKS
InvestNUMHRP
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dividual maysearch whenal employeeood draws foFederal persodraws in a r
iling rates anc requiremenRequirementSHEET: Ad
tigator MMBER P-103
des Previous ve
y be compenn not on dutyes while on dor research uons may be creasonable and the naturents of the Dets for Departdditional Fe
anual DATE
2/27/201
ersion(s) dated
nsated for rey. duty and nonup to $50 forcompensated
amount as ape of the reseaepartment oftment of Defderal Criter
V17
d: 09/04/2014
search if the
n-Federal perr each bloodd for researc
pproved by tharch. f Defense resfense (DOD)ria.
Version # 2
e participant
rsons may bd draw. ch participatihe IRB acco
search be fo) Research”
PAGE40 of 53
is involved
e compensat
ing other thaording to loca
und in the section in H
3
in
ted
an al
HRP-
Append
1. Yhu
2. Yhu
3. O“A3
dix A-5
You must repuman subjec
a. Any sresear
b. Any sc. Any s
You must repuman subjec
a. Any cimme
Other specificAdditional R18 WORKS
InvestNUMHRP
Supersed
AdditionResearch
port the folloct research psignificant adrch, with a dsuspension osignificant noport the folloct research pcompromise diately. c requiremenRequirementSHEET: Ad
tigator MMBER P-103
des Previous ve
nal Requireh owing withinprogram mandverse eventescription of
or terminationon-complian
owing withinprogram man
of personall
nts of the Dets for Departdditional Fe
anual DATE
2/27/201
ersion(s) dated
ements for
n ten businesnager ts, unanticipaf any correctn of IRB app
nce with HRPn three businnager ly identifiabl
epartment oftment of Enederal Criter
V17
d: 09/04/2014
r Departme
ss days to the
ated risks; antive actions proval of resPP procedur
ness days to t
le informatio
f Energy (DOergy (DOE) ria.
Version # 2
ent of Ene
e Departmen
nd complaintaken or to bsearch. res or other rthe Departm
on must be r
OE) researchResearch” s
PAGE41 of 53
ergy (DOE)
nt of Energy
nts about thebe taken.
requirementsment of Energ
reported
h be found inection in HR
3
E)
e
s. gy
n the RP-
Append
AdditioPrisons
1. Impr
2. Tph
3. Tpr
4. Inco
5. Ain
6. T7. In
soacocuco
8. Aidas
9. Eincopacco
10. Erem
11. IfbubdTo
dix A-6
nal Requir
mplementatirojects is no
The project mharmaceutic
The research rotection of nvestigators onducted.
Any investigan which the i
The research ncentives canoft drinks anccommodatiffered to nonustody. Partiontractors.
A non-emplodentifiable ws a statistica
Except as notnformation thonsent to relarticular indction, suit, oonsent of the
Except for coecords that c
may not be stf you are conut the study e asked to prata, not iden
These arrangef the project
InvestNUMHRP
Supersed
AdditionResearch
rements for
ion of Bureaut considered
must not invocal testing. design musthuman subjemust observ
ator who is ainvestigator must be revnnot be offe
nd snacks to ions such as n-confined ricipating in a
yee of the Bwhen advancl research orted in the conhat identifielease the info
dividual cannor other judice individual
omputerized contain non-dtored in, or innducting a stis not a joinrovide Offic
ntifiable to inements mustt.
tigator MMBER P-103
des Previous ve
nal Requireh
r DOJ Rese
u programmd to be researolve medical
t be compatiects.
ve the rules o
a non-emploagrees to adiewed and apred to help pbe consumenominal mo
research subjauthorized r
Bureau may re adequate wr reporting rensent statems a subject toormation. Fonot be admittcial, administo whom thedata recordsdisclosable introduced intudy of speci
nt project invce of Researcndividual subt be negotiat
anual DATE
2/27/201
ersion(s) dated
ements for
earch cond
matic or operarch. l experiment
ble with bot
of the institu
yee of the Bdhere to the rpproved by tpersuade inmed at the test onetary recomjects who areesearch bein
receive recorwritten assurecord is prov
ment to the suo any personor example, rted as evidenstrative, or lee data pertais maintainedinformation nto, an electrial interest to
volving Officch and Evalubjects, accomted prior to th
V17
d: 09/04/2014
r Departme
ducted in th
ational initia
tation, cosm
th the operat
ution or offic
Bureau of Prirequirementsthe Bureau R
mate subjectssetting may
mpense for te both: No lo
ng conducted
rds in a formrance that thevided to the ubject, you mn without tharesearch infonce or used fegislative proin. d at an officiadirectly tracronic retrievo the Office ce of Researuation with tmpanied by he beginning
Version # 2
ent of Just
he Federal
atives made
etic research
tion of prison
ce in which t
isoners musts of 28 CFRResearch Res to participa
y be offered. time and effoonger in Burd by Bureau
m not individe record wilagency.
must not proat subject’s p
formation idefor any purpoceeding wi
al Departmeceable to a spal system. of Research
rch and Evaluthe computerdetailed docg of the data
PAGE42 of 53
tice (DOJ)
Bureau of
through pilo
h, or
n facilities a
the research
t sign a stateR §512. eview Boardate. HoweveReasonable
fort may be reau of Prisoemployees o
dually l be used sol
vide researcprior writtenentifiable to pose in any ithout the wr
ent of Justicepecific perso
h and Evaluauation, you mrized researc
cumentation.a collection p
3
)
f
ot
and
is
ement
d. er,
ons or
lely
ch n a
ritten
e site, on
ation may ch . phase
12. R
13. Yre
14. T
15. T
Required elema. Identib. Anticic. A stat
withdror prejas soo
d. A statexcepFor exindicasomeowithou
e. A statinmat
You must havesearch.
The IRB appla. Nameb. Title oc. Purpod. Locate. Methof. Anticig. Durath. Numb
each. i. Indica
The IRB appla. Revieb. Detailc. Signif
knowld. Specife. Descr
or a cldiscom
f. Descrg. Descr
securih. Destro
when
InvestNUMHRP
Supersed
ments of discification of thipated uses otement that praw consent
ejudice (the ion as practicatement regartions to any
xample, an inates intent toone else, or, ut authorizattement that pe subject's reve academic
lication muses and currenof the study.
ose of the stuion of the stuods to be emipated resultion of the stu
ber of subjec
ation of risk lication musw of relatedled descriptificance of anledge. fic resourcesription of all lass of subjemforts will aription of steription of phyity of any indoy research rthe research
tigator MMBER P-103
des Previous ve
closure addithe investigatof the resultsparticipationt and end parinmate will bable).
rding the conguarantees o
nvestigator mo commit futu
if the subjection. participationelease date o preparation
t include a snt affiliations
udy. udy.
mployed. ts. udy.
cts (staff or in
or discomfot include a c
d literature. on of the res
nticipated res
s required fropossible risk
ects, and a diactually occueps taken to mysical or admdividually idrecords or re
h has been co
anual DATE
2/27/201
ersion(s) dated
tionally incltors. s of the resea
n is completerticipation inbe returned t
nfidentiality of confidentmay not guaure criminalct is an inma
n in the reseaor parole elign or experien
summary stats of the inve
nmates) requ
ort involved acomprehensi
search methosults and the
om the Bureks, discomfoiscussion of ur. minimize anministrative dentifiable demove indiviompleted.
V17
d: 09/04/2014
lude:
arch. ely voluntaryn the project to regular as
of the researtiality requirarantee confil conduct or ate, indicates
arch project wgibility. nce in the are
tement, whicestigators.
uired and am
as a result ofve statemen
od. eir contributi
eau of Prisonorts, and benthe likelihoo
ny risks. procedures t
data that are bidual identif
Version # 2
y and that theat any time signment or
rch informatred by federaidentiality wharm himse
s intent to lea
will have no
ea of study o
ch includes:
mount of tim
f participationt, which incl
ion to the ad
ns. nefits to indivod that the ri
to be followbeing collectfiers from th
PAGE43 of 53
e subject mawithout pen
r activity by
tion and al or state law
when the subjlf or herself ave the facil
o effect on th
of the propos
me required fr
on. ludes:
dvancement o
vidual subjeisks and
wed to: Ensurted for the st
hose records
3
ay nalty staff
w. ject
f or lity
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sed
from
of
ects
re the tudy.
16. Tre
17. Yre
18. Aa
19. AdRpr
20. Y21. In
re22. Y
ex23. P
suth
24. OwRBC
AdditioJustice
1. TH
2. Ast
3. Ton
4. Uab
5. AJuin
i. Descrprogra
j. Relevstatem
The IRB applequired by fe
You must assesearch proje
At least once report on th
At least 12 wistribute one
Research Revrovided data
You must incn any publicesearch proje
You must expxpression ofrior to submubpart, You he Chief, Off
Other specificwithin the FeRequirementsBureau of PriCriteria.
nal Requir
The project mHuman SubjeAll investigattatements, w
The confidennly be broke
Under a privabuse unless t
A copy of all ustice Data, nstruments, s
InvestNUMHRP
Supersed
ription of anyams and ope
vant researchments, questilication musederal regulasume responect as an assa year, you
he progress oorking days
e copy of theview Board, a or assistancclude an abstation of resuect. pressly disclf the policies
mitting for pumust provid
ffice of Reseac requiremenderal Bureaus for Departmisons (BOP)”
rements for
must have a pects Protectiotors and rese
which are matiality statem
en if the subjacy certificatthe subject sdata must bincluding cosurveys, or o
tigator MMBER P-103
des Previous ve
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