Attach 12D_IRB NC Knott

March 4. 2008

Charles Knott, MPA
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 reviewed the
continuing review submission dated 3/3/2008 for the study entitled The Agricultural
Health Study - Field Stations" (FG004905) and grant expedited approval to continue
with this study. This 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. The current approval expires 3/3/2009. 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.
ce

Christopher W. L u, MPA, CIP
Acting IRB Chair

cc:

Brigette Brevard
Contracts
Jan Jaeger

Battelle/Centers for Public Health Research and Evaluation
100 Capitola Drive, Suite 301
Durham, NC 27713
Federal-wide Assurance No. FWA00004696 (IRB No. 284)
INSTITUTIONAL REVIEW BOARD NOTICE OF APPROVAL
PROJECT DIRECTOR: Charles Knott, MPA
PROJECT TITLE: The Agricultural Health Study - Field Stations
CLIENT: NCI

PROTOCOL DATE: 3/3/08

BATTELLE PROJECT CODE: FG004905-Y1 02

or PROPOSAL NUMBER: _(fpreaward)

NATURE OF REVIEW: (check one)

FULL MEETING DATE:
X EXPEDITED
EXEMPT

_______

(speci reason):

minimal risk; no problems

(spec/j 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.
AMENDMENT DATED

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.

Christopher W. Lyu, MPA, CIP
Print or Type Name
X Copy of approved Informed Consent on file.
cc: Prçject Director
IRB Administrator