Attach 12A-12D IRB Approvals for Phase III

ATTACHMENT 12

IRB Approvals for AHS Phase III
12A. Phase III NCI IRB (2009 approval attached. Application was
re-submitted in March 2010. New approval will be attached
upon receipt.)
12B. Phase III IRB Westat, the Coordinating Center for the Study
12C. Phase III IRB University of Iowa Field Station - Iowa
(includes separate approvals for Main Study, Phase III, and
Prostate Buccal Collection)
12D. Phase III IRB Batelle Centers for Public Health Research
and Evaluation - North Carolina

OL
CONTINUING
REVIEWAPPLICATION

=lt loq

(NlH

and email)

MichaelAlavanjaand Laura Beane Freeman,NCIIDCEG/OEEB3O'l
430-4720

PROTOCOL
TITLE:

Aprospectivestudyof cancerand otherdiseaseamongmenand womenin agricultural
(i.e.,the Agricultural
healthStudy)
g
D
E
E
D
E

Renew -Recruitmentof participantshas not yet begun.
-Participantsare currentlybeingrecruitedor entolled.
Renew
-No longerrecruitingor enrollingparticipants,subjectfollo$/-uponly.
Renew
-Participanlshavecompleledstudy;studyand dala analysesongoing.
Renew
-Clinic€lHold/Recruitment
Renew
or enrollmentof participantssuspended.
Terminate -Studyclosed.Parlicipar{shave completedstudy.Recruitmentand
data analysiscomplete.

(Aggregate):
SUMMARYOF PROTOCOL
ENROLLMENT
OntywhenrheNrHisthe

(X-rays,e.9., CT;
e.g
, etc.) check all
lhat apply:
E
None
Medicallyindicated
O
fl
Researchindicated.Sinc€thelastrevie\il,
fl ResearchusageHAS NOT changed.
0 ResearchusageHAS changed.(Explainin summaryreport)
INVESTIGATIONAL
NEW DRUG/DEVICE: I None E IND
D tDE
'lf reportingmorethan one IND/IDE,list
on attachedsheer.

c@rdinaling site, provide totals and enrcllm€nt tabl8 for oth€r site.

NIH Sile

0
000
0

OtherSites

FOA No.

Total

90.500

90.500

Accrualceilingby IRB
New subjeclsaccruedsincelast CR

Sponsor:

89.658

89.658

Aggregatelotal accrued

\Ivhois the manutacturerof the aboveentitv?

Name:

Are you currenllyrecruitinghealthyvolunteers?
8No
Wll the protocolinvolveadultsunableto give informedconsent? E No

E Yes
El Yes

Doesthe prolocolinvolvea Tech TransferAgre€ment?

ts No

O Yes

Doesthe protocolinvolvea drugy'device/produci
that may lead to you or the NIH
receivingpaymentandiorroyallies?
ENo
O
Yes (Appenda staiemenlof disclosure)

Have analysesby sex, racial/ethnicsubgroupsbeencondudedfor Phase3 Clinical
Trialsas required? B No
E Yes (answera and b) A N/A
a. Have analysesbeen reported?tr No (explainin narralive) 0 Yes
b. Have signiticantdifferencesbeenfound? B No tr Yes

Havethere been any amendmenlssincethe lasl review?
BNo
n
Yes (Describe briefly in the attached narrative.)

Have any non-NlHInvesligatorsor sites beenaddedsincethe lasl review'?
E! No
tr Yes (ld€ntifythe personsor sitesand desdibe the collaborationin the
summaryreport)

Ha\r'etherebeen any changegin the informedconsentprocessor documentationsince
the last review?
ANo
D
Yes (Describein Summaryreport)

WITHTHISREVIEWI AM REQUESTING
A CHANGETO THE FOLLOWING:

'lnclsde Name,InsvB€nch,Telgphone,Address,e-mail.Checkbox if an NIH Employeeand initial
lin6.Attachsheetif necessary.

l-lavethere beenany changesin the subjeclpopulation,recruitmentor selectioncrileria
sincethe lasl revie\i/?
8No
g
Yes (Explainchangesin the atlachednarrative.)

PRINCIPAL INVESTIGATOR:

Delele: LauraBeaneFreeman
Add.: El Co-principalinvestiqator

INVESTIGATOR:
EXTMMURALADJUNCTPRINCIPAL

Haveany unexpec{edcomplications
or side effec,tsbeen notedsinc€the last review?
8No
Yes (ldentifyand explainin the attachednarralive.)
tr

Delete:
MEDICALADVISORYINVESTIGATOR:

from this studysincethe last IRB approval?
Have any subjeciswithdra\rrn
ENo
Yes (Discussin the attachednarrati\€.)
tr

Oelete
Add.

Has any informationappearedin the literature,or evolvedfrom lhis or similarresearch,
that mightaffec{the IRB'Sevaluationof the risldbenefitanalysisof humansubjects
involvedin this protocol?
ENo
Yes (Discussin the altachednarali\re.)
tr

LEADASSOCIATEINVESTIGATOR:
Delete

Add.: E
RESEARCHCONTACT:

Hasthe NIH IRP COI Guidebeen distdbutedto new NIH investigators?
gN/A
EYes
ONo

Delete:
Add.

Has the NIH IRP COI Guidebeen distributedto new Non-NlHinvestigators?
trNo
DYes
8N/A

INVESTIGATOR(S):
ASSOCIATE
Delete:

CONFLICTSOF INTERESTREVIEVI/?

Add.: l-l

Date submittedto lC DEC: 3/6/09

Dateclearedby lC DEC: 3127109
Send to A@ntable

SIGNATURE

lnvestigator

tt

o"t" 3/fOl|Jf'l
r

RECOMMENDAT

r

crfiit'l
APPROVALS

Debra Silverman
PiyftnypeNamr/

Investigator

Sendto Clini€l Oir€ctor

(y'a,8/"LY-

Sendto Chair.Institutional
R€vi€wBosrd

NancyPotischman
PrinuTypeName

o","

Oepl Head of A@untebl€

/

Pnriu I yps Nams

COMPLETION

sendtoBmnchchief.orcc

-l'?'/;f

Prdo@l & Con

Send to Off@ of Prol@l S€ryi@s,
though IRB Prctocol C@rdinator

A#rcvad Effe

ClinicalResearchProtocolContinuingReviewApplication
NIH-1195-1(9-06)

Page 1 of 1

From:                              Marsha Dunn
Sent:                               Tuesday, August 18, 2009 10:46 AM
To:                                   Kate Torres
Subject:                          FW: IRB Continuing Approval Letter for Project #7874
fyi

From: Carol Dollarhide
Sent: Friday, August 14, 2009 4:29 PM
To: Marsha Dunn
Subject: FW: IRB Continuing Approval Letter for Project #7874

DATE: August 14, 2009 

TO: Marsha Dunn  
Project Director 
FROM: Kerry Levin 

Chair, Institutional Review Board 

SUBJECT: IRB Continuing Review and Approval 
Agricultural Health Study (AHS) 
Project #: 7874 
FWA 5551 

On August 12, 2009, the Westat Institutional Review Board conducted its continuing review of the following: Agricultural Health Study (AHS), 
Project #: 7874. Pursuant to 45 CFR pt 46.109(e), continuing review of research studies occurs at intervals appropriate to the degree of risk 
but not less frequently than once a year. 

In accordance with 45 CFR pt 46, the Board approved the continuation of this study. The next continuing review will be due on or before 
August 1, 2010. In the interim, you are responsible for notifying the Institutional Review Board (IRB) Office as soon as possible if there are 
any injuries to the subjects, problems with the study, or changes to study design that relate to human subjects 

cc: Institutional Review Board ‐ Sharon Zack 

file://K:\mhgrp\Marshac\Kate Torres Documents Consolidation\New Folder\Attach 12B_IR... 4/8/2010

Centers for Public Health Research and Evaluation

February 1, 2010

Charles E. Knott, MPA, PMP
Battelle CPHRE
100 Capitola Drive, Suite 200
Durham, NC 27713
Dear Mr. Knott:
As Chair of the Battelle/CPHRE Institutional Review Board (IRB) I have review
ed the
continuing review submission dated 1124/2010 for the study entitled "The Agricu
ltural Health
Study - Field Stations" (FG004905-Y 102) and grant expedited approval to continu
e with this
study. The study is minimal risk and no problems have been reported.
As with all Battelle/CPHRE studies, this study will be subject to continuing review
again next
year if it is still active. The current approval expires 1/31/2011. We will
send you
notification at the appropriate time. In the meantime, should any changes occur
in your
protocol or questionnaire, please inform the IRB and submit the changes for review
.
Similarly, the IRB needs to be notified in the event of any injury or unexpected
outcome
arising from this study.
Sincerely,

Margaret R. Pennybacker, PhD
IRB Chair

cc: Brigette Brevard
Contracts
Jan Jaeger

Battelle/ Centers for Public Health Research and Evaluation
100 Capitola Drive, Suite 200
Durham, NC 27713
Federal-wide Assurance No. FWA00004696 (IRB No. 284)
INSTITUTIONAL REVIEW BOARD NOTICE OF APPROVAL
PROJECT DIRECTOR: Charles Knott
PROJECT TITLE: The Agricultural Health Study - Field Stations
CLIENT: NCI

PROTOCOL DATE: 1/24/10

BATTELLE PROJECT CODE: FG004905-Y102
NATURE OF REVIEW:

or PROPOSAL NUMBER:

(check one)

FULL MEETING DATE:
EXPEDITED

(specify reason) :

no problems; minimal risk

EXEMPT (speck reason):

TYPE OF APPROVAL:

(check one)

PRELIMINARY. SCHEDULE NEXT REVIEW PRIOR TO INVOLVEMENT OF HUMAN SUBJECTS

.

PRETEST/PILOT TEST. SCHEDULE NEXT REVIEW PRIOR TO FULL IMPLEMENTATION.
FULL IMPLEMENTATION.

X

RENEWAUCONTINUING REVIEW.
AMENDMENT DATED

Please note the following requirements:
PROBLEMS OR ADVERSE REACTIONS: If any problems in treatment of human subjects or unexpect
ed
adverse reactions occur as a result of this study, you must notify the IRB Chairperson immediately,
then
complete an Adverse Event/incident Report and forward it to the CPHRE IRB Administrator.
CHANGES IN PROTOCOL: If there are any changes in procedures or study protocol, you must notify
the
IRB Chairperson and submit the revisions for review before they are implemented.
RENEWAL: You are required to apply for renewal of approval at least annually for as long as the study
is
active unless the Board finds it necessary to require more frequent reviews. Your next continuing
review
date should be on or before 1/31/11.

IRB Chairperson

Date

Margaret R. Pennybacker, PhD
Print or Type Name
X Copy of approved Informed Consent on file.
cc: Project Director
IRB Administrator