CDC IRB Approval

Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES

Centers for Disease Control
and Prevention (CDC)

Memorandum
Date

December 19, 2017

From

Clarietha T. Washington, MSW, BSPH
IRB Administrator, Human Research Protection Office

Subject

IRB Approval of CDC New Protocol #7072, "The Data to Care (D2C) Public Health Strategy:
Successes, Challenges, and Lessons Learned in Identifying, Linking, and Reengaging Persons
Diagnosed with HIV to Medical Care.” (Expedited).

To

James W. Carey, PhD, MPH
NCHHSTP/DHAP/IRS
CDC’s IRB-Committee I has reviewed the request for approval of new protocol #7072, "The
Data to Care (D2C) Public Health Strategy: Successes, Challenges, and Lessons Learned in
Identifying, Linking, and Reengaging Persons Diagnosed with HIV to Medical Care” and has
approved the new protocol for the maximum allowable period of one year. CDC IRB approval
will expire on 12/18/2018. The protocol was reviewed in accordance with the expedited review
process outlined in 45 CFR 46.110(b)(1), category 9. The IRB determined the study to be not
greater than minimal risk to subjects.
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 12/18/2018.
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].

Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES

Cc: NCHHSTP Human Subjects (CDC)
Nicole (Nicky) Cohen, MD

Centers for Disease Control
and Prevention (CDC)