IRB Approval

Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Disease Control

and Prevention (CDC)

M emorandum

Date

d

July 23, 2019

From

Denise M. Marshall, BS

IRB Administrator, Human Research Protection Office

Subject

CDC IRB Approval of new Protocol #7224, “Quantitative research to understand consumer opinions and preferences for emerging HIV prevention products among MSM in Atlanta”

To

Ayana Stanley, DrPH
NCHHSTP/DHAP

CDC's IRB Committee 1 has reviewed and approved the request of new protocol 7224.0, "Quantitative research to understand consumer opinions and preferences for emerging HIV prevention products among MSM in Atlanta." The protocol was reviewed in accordance with the expedited review process outlined in 45 CFR 46.110(b)(1), category 7. NOTE: HRPO may request an administrative check-in every two years from the date of approval to determine the status of this protocol.

If other institutions involved in this protocol are being awarded CDC funds through the CDC Office Financial Resources (OFR), you are required to send a copy of this IRB approval to the CDC OFR award specialist handling the award. You are also required to verify with the award specialist that the awardee has provided OFR with the required documentation and has approval to begin or continue research involving human subjects as described in this protocol.

• Please submit form 0.1257, Review of Changes to IRB-Approved Protocol, for any proposed changes to the protocol. Include with submission clean and tracked versions of all amended documents. Changes must be approved by the IRB before they are implemented.

• Please submit form 0.1254, Incident Report, for incidents, adverse events, unanticipated problems involving risks to subjects or others and serious or continuing noncompliance.

• Please submit form 0.1260, End of Human Subjects Review when the study has ended.

Any problems of a serious nature should be brought to the immediate attention of the Human Research Protection Office.

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

cc:

NCHHSTP Human Subjects (CDC)

Nicole “Nicky” Cohen, MD