IRB Approval

Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES

Centers for Disease Control
and Prevention (CDC)

Memorandum
Date
d
From

March 17, 2015

Subject

IRB Approval of CDC Protocol #6701, "Evaluating a HIV/AIDS Focused Video Game for Young
People” (Expedited)

To

LEIGH WILLIS, PhD, MPH
NCHHSTP/DHAP

Jason Abel
IRB-A Administrator, Human Research Protection Office

CDC’s IRB-A has reviewed the request for approval of new protocol #6701, "Evaluating a HIV/AIDS
Focused Video Game for Young People” and has approved the protocol for the maximum allowable
period of one year. CDC IRB approval will expire on 03/16/2016. The protocol was reviewed in
accordance with the expedited review process outlined in 45 CFR 46.110(b)(1), Category 7. The IRB
determined the study to be not greater than minimal risk to subjects.
The IRB has approved the inclusion of pregnant women 45 CFR 46.204
The IRB has approved the inclusion of pregnant women 45 CFR 46.404
If other institutions involved in this protocol are being awarded CDC funds through the CDC
Procurement and Grants Office (PGO), you are required to send a copy of this IRB approval to the CDC
PGO award specialist handling the award. You are also required to verify with the award specialist that
the awardee has provided PGO with the required documentation and has approval to begin or continue
research involving human subjects as described in this protocol.
As a reminder, the IRB must review and approve all human subjects research protocols at intervals
appropriate to the degree of risk, but not less than once per year. There is no grace period beyond one
year from the last IRB approval date. It is ultimately your responsibility to submit your research protocol
for continuation review and approval by the IRB along with available IRB approvals from all
collaborators. Please keep this approval in your protocol file as proof of IRB approval and as a reminder
of the expiration date. To avoid lapses in approval of your research and the possible suspension of
subject enrollment and/or termination of the protocol, please submit your continuation request
along with all completed supporting documentation at least six weeks before the protocol's
expiration date of 03/16/2016.
Any problems of a serious nature must be brought to the immediate attention of the CDC IRB, and
any proposed changes to the protocol are required to be submitted as an amendment to the
protocol for CDC IRB approval before they are implemented.

If you have any questions, please contact your National Center Human Subjects Contact or the
CDC Human Research Protection Office (404) 639-7570 or e-mail: [email protected].
cc:
NCHHSTP Human Subjects (CDC)