Att I_Battelle IRB letter

Baltelle
Th

Buines of Innovation

Centers for Public Health Research and Evaluation

January

27,

2009

Diane Manninen, PhD
Battelle CPHRE
1100 Dexter Avenue North
Suite 400
Seattle, WA 98109-3598
Dear Dr. Manninen:
As Chair of the Battelle/CPHRE Institutional Review Board (IRB) I have reviewed the
continuing review/modifications submission with revised material and responses to the
Board's January 31, 2008 review of the study entitled "Developing a Protocol for a
Follow-up Study of HPV Testing Among Women Undergoing Routine Cervical Cancer
Screening" (FG6O 1906-01) and grant final approval contingent upon obtaining a
Certificate of Confidentiality to provided added protections to the provider survey data.
Please forward a copy of the Certificate of Confidentiality to the Board when it is
received.
As with all Battelle/CPHRE studies, this study will be subject to continuing review again
next year. The current approval expires 1/26/20 10. We will send you notification at the
appropriate time. In the meantime, should any additional 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

100 Cepitola Drive, Suite: 200

Durham, North Carolina 27713

9195443717 fax 9195440830

wwwbattelieorg

BatteHe/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: Diane Manninen, PhD
PROJECT TITLE: Developing a Protocol for a Follow-up Study of HPV Testing Among Women
Undergoing Routine Cervical Cancer Screening
CLIENT: CDC

PROTOCOL DATE: 1/3/08

BATTELLE PROJECT CODE: FG6O 1906-01
NATURE OF REVIEW:

or PROPOSAL NUMBER:

(,fpreawar

(check one)

FULL MEETING DATE: 1/31/2008; final approval by Chair 1/27/09
EXPEDITED

(cpec

reason):

EXEMPT (spec/.i' 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.
X FULL IMPLEMENTATION.
X RENEWAL/CONTINUING REVIEW.
x

AMENDMENT DATED 1/22/2009

Please note the following requirements:
PROBLEMS OR ADVERSE REACTIONS: If any problems in treatment of human subjects or unexpected
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 1/26/2010.
t4/

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1.

••

IRB Chairperson

/

/ /

Date

Margaret R. Pennybacker, PhD
Print or Type Name
X Copy of approved Informed Consent on file.
cc: Proiect D

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