IRB Approval

Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Disease Control

and Prevention (CDC)

M emorandum

Date

d

March 24, 2016

From

Marcus Fleming, MBA

IRB Administrator, Human Research Protection Office

Subject

CDC Approval of Reliance on a Non-CDC IRB for CDC Protocol #63256734.0, "Persistence of Ebola virus in body fluids of Ebola virus disease survivors in Sierra Leone Prospective cohort study of influenza viral shedding in HIV infected and uninfected individuals”.

To

BARBARA KNUST, DVM, MPH,DACVPM

NCZVED/DHCPP

CDC's Human Research Protection Office reviewed and approved the request to allow reliance on a non-CDC IRB for protocol #6734.0, “Persistence of Ebola virus in body fluids of Ebola virus disease survivors in Sierra Leone” in accordance with 45 CFR 46.114. The protocol has been reviewed and approved by the Ministry of Health and Sanitation Sierra Leone IRB for the maximum allowable period of twelve monthstwelve months and the IRB’s approval will expire on 3/30/201301/14/2017.

Please submit CDC form 0.1251, Request for Continuing Review of IRB-Approved Protocol, along with certification of current IRB review and approval at the relied-upon institution, approximately six weeks prior to the protocol’s expiration date, even if you do not yet have certification of continuation approval to include with your submission. Please state on the 0.1251 that certification of continuation approval will be forwarded as soon as it is received.

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:

NCIRD Human Studies (CDC)