IRB Approval

Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES

Centers for Disease Control
and Prevention (CDC)

Memorandum
Date

April 12, 2018

From

Jerrell Little
IRB-Committee 2 Administrator
Human Research Protection Office

Subject

CDC Approval of New Protocol 7100.0, "Long term sequela of Rocky Mountain spotted fever"
(Expedited)

To

Naomi Drexler, MPH
NCEZID/BVBD

CDC's IRB-Committee 2 has reviewed the request for approval of new protocol 7100.0, "Long
term sequela of Rocky Mountain spotted fever" and has approved the protocol for the maximum
allowable period of one year. CDC IRB approval will expire on 4/10/2019. The protocol was
reviewed in accordance with the expedited review process outlined in 45 CFR 46.110(b) (1) and
(2) under categories 4, 5, and 7.
The IRB determined that the study poses minimal risk to subjects. The IRB approves the
inclusion of children under 45 CFR 46.404. The inclusion of pregnant women was reviewed
under Subpart B and was found to be permissible under 45 CFR 46.204.
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 have
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. 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 at least six weeks
before the protocol's expiration date of 4/10/2019.
Any problems of a serious nature should be brought to the immediate attention of the IRB, and
any proposed changes to the protocol should be submitted as an amendment to the protocol for
IRB approval before they are implemented.

Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES

Centers for Disease Control
and Prevention (CDC)

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 email at [email protected]).

CC:
NCEZID Human Subjects