IRB Approval

Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES

Centers for Disease Control
and Prevention (CDC)

Memorandum
Date
d
From

July 21, 2014

Subject

IRB Approval of CDC Protocol #6531, "Context Matters: Measuring Provider and Community
Factors in The Sustainable Health Center Implementation PrEP Pilot (SHIPP) Study”
(Expedited)

To

Dawn Smith, MD,MS, 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 #6531, "Context Matters:
Measuring Provider and Community Factors in The Sustainable Health Center Implementation
PrEP Pilot (SHIPP) Study” and has approved the protocol for the maximum allowable period of
one year. CDC IRB approval will expire on 07/20/2015. 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 woment under 45 CFR 46.204
The IRB has approved the waiver of documentation of consent under 45 CFR 46.117(c)(2)
Institutions that receive federal support who are engaged in human subjects research are
required to obtain and provide documentation of IRB approval. CDC investigators who
interact with institutions that have failed to meet these requirements are collaborating with
noncompliant institutions. Study activities may not begin with the collaborators listed
below until documentation indicating current IRB approval has been received by CDC’s
Human Research Protection Office (HRPO) and the PI has been notified by HRPO that
this restriction has been lifted and study activities may begin:
-

Access Community Health Network
Newark Community Health Centers
Central Care Community Health Center

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

Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES

Centers for Disease Control
and Prevention (CDC)

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 07/20/2015.
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: huma@cdc.gov.
cc:
NCHHSTP Human Subjects (CDC)