Waiver of Human Subjects Committee

Attachment 6
Waiver of Human Subjects Committee

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January 3, 2005

Centers for Public Health
Research and Evaluation
100 Capitola Drve, Suite 301
Durham, North Carolina 27713-4411
Telephone (919) 544-3717
Fax (9 9) 544-0830

Ping Yu, PhD
Battelle/CPHRE
2101 Wilson Boulevard
Suite 800
Arlington, VA 22201-3008
Dear Dr. Yu:
As chair of the Battelle/CPHRE Institutional Review Board (IRB) I have reviewed the
request for exemption dated 12/23/2004 for the study entitled "Drug-Free Communities
Support Program National Evaluation" (FG467191-01) and grant an exemption for this
study. This study is exempt per 45 CFR 46. 101(b)(5).
Should any changes occur in your protocol that would change the scope of this project,
please inform the IRB and submit a revised protocol for review. Similarly, the IRB needs
to be notified in the event of any injury or unexpected outcome arising from this study.
Sincerely,
/AaMargaret4. Pennybacker, PhD, CII'
IRB Chair
cc:

Brigette Brevard
Lynda Huffines
Pamela Sutherland

Battelle/Centers for Public Health Research and Evaluation
100 Capitola Drive, Suite 301
Durham, NC 27713
Federal-wide Assurance No. FWA00004696
INSTITUTIONAL REVIEW BOARD NOTICE OF APPROVAL
PROJECT DIRECTOR: Ping Yu, PhD
PROJECT TITLE: Drug-Free Communities Support Program National Evaluation
PROTOCOL DATE: 12/23/04

CLIENT: Office of National Drug Control Policy
BATTELLE PROJECT CODE: FG467191-0l

NATURE OF REVIEW:

or PROPOSAL NUMBER:

(fpreaward)

(check one)

FULL MEETING DATE:

______

EXPEDITED (specify reason):__________________

X EXEMPT (specify reason)Government programequired by Congress; 45 CFR 46.10 I(b)(5)

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.
RENEWAL.
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 lRB Chairperson immediately,
then complete an Adverse Event/Incident Report and forward it to the CPHRE IRB Administrator.
CHANGES IN PROTOCOL: If there are significant 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. Your next continuing review date should be on or beforejj.

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£

IRB Chairperson
Margaret A. Pennybacker. PhD,I
Print or Type Name
N/A

Copy of approved Informed Consent on file.

cc: Project Director
IRB Administrator

Date