IRB Letter of Approval

Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Disease Control

and Prevention (CDC)

Memorandum

Date

d

J

Fromm

une 7, 2018

Clarietha T. Washington, MSW, BSPH

I

Subject

RB Administrator, Human Research Protection Office

IRB Approval of CDC New Protocol #7118, "Women’s Experience with Congenital Syphilis: Qualitative Interviews with Post-Partum Women Associated with Congenital Syphilis Cases (Case Mothers)” (Expedited).

To

Monique Carry, PhD

NCHHSTP/DSTDP

CDC’s IRB-Committee I has reviewed the request for approval of new protocol #7118, “Women’s Experience with Congenital Syphilis: Qualitative Interviews with Post-Partum Women Associated with Congenital Syphilis Cases (Case Mothers) and has approved the new protocol for the maximum allowable period of one year. The IRB approved the inclusion of pregnant women and the request for waiver of documentation of consent. CDC IRB approval will expire on 06/06/19. The protocol was reviewed in accordance with the expedited review process outlined in 45 CFR 46.110(b)(1), categories 6 and 7. 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 06/06/2019.

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 Studies (CDC)

Nicole (Nicky) Cohen, MD