0539_Att J_IRB Approval 2010

7h. Business of Innovation
Centers for Public Health Research and Evaluation

December 30, 2009

Diane Manninen, PhD
Battelle CPHRE
1100 Dexter Avenue North
Suite 400
Seattle, WA 98109
Dear Dr. Manninen:
As Chair of the Battelle/CPHRE Institutional Review Board (IRB) I have reviewed the
continuing review and modifications submission dated 12/29/2009 for the study entitled
"Estimating the Capacity for National & State-level Colorectal Cancer Screening through a
Survey of Endoscopic Capacity" (FG929902-01) and grant expedited approval to continue
with the study and implement the changes. The study is minimal risk. The changes which
include increasing the number of facilities, adding questions to the survey and modifying
questions do not affect the risk/benefits ratio.
As with all Battelle/CPHRE studies, this study will be subject to continuing review again next
year. The current approval expires 12/29/2010. 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

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: Diane Manninen
PROJECT TITLE: Estimating the Capacity for National & State-level Colorectal Cancer Screening
through a Survey of Endoscopic Capacity
CLIENT: CDC

PROTOCOL DATE: 12/29/09

BATTELLE PROJECT CODE: FG929902-01
NATURE OF REVIEW:

or PROPOSAL NUMBER:

_(ifpremvard)

(check one)

FULL MEETING DATE:
X

EXPEDITED
EXEMPT

(sped reason):

minimal risk; no change to risk/benefits

(sped 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

RENEWAL/CONTINUING REVIEW.

X

AMENDMENT DATED 12/29/09

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 12/29/10.

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