IRB Approval

Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Disease Control

and Prevention (CDC)

M emorandum

Date

d

December 4th, 2013November 30, 2017

From

Clarietha T. Washington, MSW, BSPH

IRB-C Administrator, Human Research Protection Office

Subject

IRB Approval of Amendment to CDC Protocol #22382238.0, "Assisted Reproductive Technology Database-Protocol for Epidemiologic ResearchAssisted Reproductive Technology Database-Protocol for Epidemiologic Research" (Expedited)

To

Dmitry Kissin, MD, MPH

NCCDPHP

CDC's IRB C has reviewed and approved your request to amend protocol #2238.0, “Assisted Reproductive Technology Database-Protocol for Epidemiologic Research.” The amendment will limit external access to only the Research Data Center (RDC) remote data analysis mechanism. 

The action was reviewed in accordance with the expedited review process outlined in 45 CFR 46.110(b)(2), minor changes to previously approved research during the period of one year for which approval is authorized.

Reminder: IRB approval of protocol #2238.0 will still expire on 12/19/2018.

Any problems of a serious nature must be brought to the immediate attention of the CDC IRB, and any proposed changes to the protocol 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: Joan Redmond Leonard, ONDIEH/NCCDPHP

Nicole (Nicky) Cohen, (CDC/OID/NCEZID)