IRB Approval Letter

Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES

Centers for Disease Control
and Prevention (CDC)

Memorandum
Date
d

February 18, 2016

From

Felecia Peterson
IRB-G Administrator, Human Research Protection Office

Subject

Site-Restriction CDC IRB Approval of New CDC Protocol 6817, "Cohort study of HIV,
Sexually Transmitted Infections and preventive interventions among young men who have sex
with men (YMSM) in Thailand" (Expedited)

To

Eileen Dunne
NCHHSTP/DHAP
CDC’s IRB-G has reviewed the request for approval of new protocol #6817, “Cohort study of
HIV, Sexually Transmitted Infections and preventive interventions among young men who have
sex with men (YMSM) in Thailand.” The IRB determined that the study involves no greater than
minimal risk to subjects. The protocol was reviewed in accordance with the expedited review
process outlined in 45 CFR 46.110(b)(1), under categories 2, 3, 4 and 7. Additional protections
for children involved in research, as described in 45 CFR 46 subpart D were considered when
reviewing this protocol and determined to be adequately addressed. A request for a waiver of
parental permission was reviewed and approved. The protocol has been approved for the
maximum allowable period of one year and CDC IRB approval will expire on 2/17/2017.
COLLABORATOR/SITE RESTRICTIONS:
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:
1. Local IRB Approvals pending for Dept. of Disease Control Thailand and Mahidol
University in Bangkok, Thailand
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 have
approval to begin or continue research involving human subjects as described in this protocol.

Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES

Centers for Disease Control
and Prevention (CDC)

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 2/17/2017.
Any problems of a serious nature must be brought to the immediate attention of the CDC
IRB, and any proposed changes to the protocol should 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 HS mailbox (CDC)
Jon Baio