IRB Approval

Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES

Centers for Disease Control
and Prevention (CDC)

Memorandum
Date

July 1, 2015 (Updated 11/16/2015)

From

Marcus Fleming. MBA
IRB Administrator, Human Research Protection Office

Subject

CDC Approval of Continued Reliance on a Non-CDC IRB for CDC Protocol #6149 “A
Prospective Birth Cohort Study Involving Environmental Uranium Exposure in the Navajo
Nation”

To

Angela Ragin, PhD
NCEH/ATSDR/DTTHS
CDC's Human Research Protection Office reviewed and approved the request to continue
reliance on a non-CDC IRB for protocol #6149, “A Prospective Birth Cohort Study Involving
Environmental Uranium Exposure in the Navajo Nation” in accordance with 45 CFR 46.114.
The protocol has been reviewed and approved by the University of New Mexico IRB for twelve
months, and the IRB’s approval will expire on 06/02/2016.
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 huma@cdc.gov.

cc:
Candis Hunter, MS
NCEH/ATSDR Human Subjects