Western Institutional Review Board Approval Memo

Certificate
of
Approval

Western Institutional Review Board®
3535 7th Avenue SW | Olympia, WA 98502-5010
PO Box 12029 | Olympia, WA 98508-2029
Office: (360) 252-2500 | Toll Free: (800) 562-4789
www.wirb.com

THE FOLLOWING WERE APPROVED
INVESTIGATOR:

Jennie W. Wenger Ph.D.
4825 Mark Center Drive
Alexandria, Virginia 22311

BOARD ACTION DATE:
PANEL:
STUDY APPROVAL EXPIRES:
STUDY NUM:
WIRB PRO NUM:
INVEST NUM:
WO NUM:
CONTINUING REVIEW:
SITE STATUS REPORTING:

08/14/2012
2
07/17/2013
1133448
20121088
175562
1-735495-1
Annually
Annually

SPONSOR: Office of the Assistant Secretary of Defense (Reserve Affairs)
PROTOCOL NUM: A30500
AMD. PRO. NUM:
TITLE:
The Impact of ChalleNGe on Participants’ Noncognitive Skills
APPROVAL INCLUDES:
Assent Information Sheet [S0]
Consent Form [S0]
Revised Research Locations (07-23-2012)
WIRB APPROVAL IS GRANTED SUBJECT TO:
RE-CONSENTING INSTRUCTIONS: Subjects currently enrolled are not required to sign the enclosed version(s) of the consent
form(s). All subjects who will be enrolled in the future for this study must sign the most current WIRB-approved consent form(s).
WIRB HAS APPROVED THE FOLLOWING LOCATIONS TO BE USED IN THE RESEARCH:
CNA, 4825 Mark Center Drive, Alexandria, Virginia 22311
Freestate Challenge Academy, Building 4220, Aberdeen Proving Ground, Maryland 21005
Lincoln's Challenge Academy, 205 Dodge Avenue, Rantoul, Illinois 61866
Washington Youth Academy, 1207 Carver Street, Bremerton, Washington 98312
Grizzly Youth Academy, 10 Sonoma Avenue, San Luis Obispo, California 93403
Fort Gordon Youth Challenge, Building 4006, 40006 Brems Circle, Fort Gordon, Georgia 30905
Wisconsin Challenge Academy, 749 East 12th Avenue, Fort McCoy, Wisconsin 54656
Gillis Long Youth Challenge Center, 5445 Point Clair Road, Carville, Louisiana 70721
If the PI has an obligation to use another IRB for any site listed above and has not submitted a written statement from the
other IRB acknowledging WIRB's review of this research, please contact WIRB's Client Services department.

IF YOU HAVE ANY QUESTIONS, CONTACT WIRB AT 1-800-562-4789
This is to certify that the information contained herein is true and correct as reflected in the records of the Western Institutional Review
Board (WIRB), OHRP/FDA parent organization number IORG 0000432, IRB registration number IRB00000533. WE CERTIFY THAT
WIRB IS IN FULL COMPLIANCE WITH GOOD CLINICAL PRACTICES AS DEFINED UNDER THE U.S. FOOD AND DRUG
ADMINISTRATION (FDA) REGULATIONS, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) REGULATIONS, AND
THE INTERNATIONAL CONFERENCE ON HARMONISATION (ICH) GUIDELINES.

8/17/2012
Theodore D. Schultz, J.D., Chairman

(Date)

This document electronically reviewed and approved by Luk, Hsiang-Ning on 8/17/2012 2:21:55 PM PST. For more information call Client Services at 1-360-252-2500.
Board Action: 08/14/2012; Study: 1133448

Page 1 of 2

Copyright © 2011 Western Institutional Review Board, Inc. All rights reserved.

ALL WIRB APPROVED INVESTIGATORS MUST COMPLY WITH THE FOLLOWING:
1.

Conduct the research in accordance with the protocol, applicable laws and regulations, and the principles of research ethics as
set forth in the Belmont Report.

2.

Although a participant is not obliged to give his or her reasons for withdrawing prematurely from the clinical trial, the
investigator should make a reasonable effort to ascertain the reason, while fully respecting the participant’s rights.

3.

Unless consent has been waived, conduct the informed consent process without coercion or undue influence, and provide the
potential subject sufficient opportunity to consider whether or not to participate. (Due to the unique circumstances of
research conducted at international sites outside the United States and Canada where WIRB approved materials are translated
into the local language, the following requirements regarding consent forms bearing the WIRB approval stamp and regarding
certification of translations are not applicable.)
a. Use only the most current consent form bearing the WIRB "APPROVED" stamp.
b. Provide non-English speaking subjects with a certified translation of the approved consent form in the subject's first
language. The translation must be approved by WIRB.
c. Obtain pre-approval from WIRB for use of recruitment materials and other materials provided to subjects.

4.

Obtain pre-approval from WIRB for changes in research.

5.

Obtain pre-approval from WIRB for planned deviations and changes in research activity as follows:
If this research is federally funded or conducted under an FWA, obtain pre-approval from WIRB for all planned
deviations and changes in research activity, except where necessary to eliminate apparent immediate hazards to the
human subjects. OHRP considers all planned protocol deviations to be changes in research that need prior IRB review
and approval.
If this research is not federally funded and not conducted under an FWA, obtain pre-approval from WIRB for any
planned deviations that could adversely affect the rights, safety or welfare of subjects, or the integrity of the research
data and any changes in the research activity, except where necessary to eliminate apparent immediate hazards to the
human subjects. FDA has not adopted the policy that all planned protocol deviations are changes in research that need
prior IRB review and approval.
Deviations necessary to eliminate apparent immediate hazards to the human subjects should be reported within 10 days.

6.

Promptly report to WIRB all unanticipated problems (adverse events, protocol deviations and violations and other problems)
that meet all of the following criteria:
a. Unexpected (in terms of nature, severity or frequency);
b. Related or possibly related to participation in the research; and
c. Suggests that the research places subjects or others at a greater risk of harm than was previously known or
recognized.
Please go to www.wirb.com for complete definitions and forms for reporting.

7.

Provide reports to WIRB concerning the progress of the research, when requested.

8.

Ensure that prior to performing study-related duties, each member of the research study team has had training in the
protection of human subjects appropriate to the processes required in the approved protocol.

Federal regulations require that WIRB conduct continuing review of approved research. You will receive
Continuing Review Report forms from WIRB. These reports must be returned even though your study
may not have started.
DISTRIBUTION OF COPIES:
Contact, Company
WIRB Translations Department, WIRB USA
Jennifer Atkin, CNA
Jennie W. Wenger Ph.D., CNA
Ernie Gonzales, Department of Defense

Board Action: 08/14/2012; Study: 1133448

Page 2 of 2

Copyright © 2011 Western Institutional Review Board, Inc. All rights reserved.