Initial Approval Memo Lifting Site Restriction 2017 Att F

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service
Centers for Disease Control
and Prevention (CDC)

Memorandum
Date

December 28, 2017

From

Gail L. McConnell
Co-Chair, NIOSH Institutional Review Board

Subject

IRB Approval of New NIOSH Protocol 17-DSR-05XP, “Assessment of Occupational Injury
among Fire Fighters Using a Follow-back Survey” (Expedited)

To

Suzanne Marsh
Project Officer, NIOSH/DSR
The NIOSH IRB reviewed the request for approval of new protocol 17-DSR-05XP, “Assessment of
Occupational Injury among Fire Fighters Using a Follow-back Survey” and approved the protocol for the
maximum allowable period of one year. NIOSH IRB approval will expire on December 14, 2018. The
protocol was reviewed in accordance with the expedited review process outlined in 45 CFR 46.110(b)(1),
category (7).
The IRB determined the study poses minimal risk to subjects.
The CDC Form 0.1372A, IRB Authorization Agreement for an outside institution relying on a
CDC/NIOSH IRB was approved. As of December 28, 2017 the site restriction is lifted. NIOSH study
activities may begin with the following collaborator/site:
US Consumer Product Safety Commission (CPSC)
If other institutions involved in this protocol are being awarded NIOSH 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 December 14,
2018.
Any problems of a serious nature must be brought to the immediate attention of the NIOSH IRB, and
any proposed changes to the protocol should be submitted as an amendment to the protocol for
NIOSH IRB approval before they are implemented.
If you have any questions, please contact the NIOSH Human Research Protection Program (513) 533-8591
or e-mail: [email protected].