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pdfDEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Centers for Disease Control
and Prevention (CDC)
Memorandum
Date
September 27, 2017
From
Kathy Masterson, CIP
IRB Administrator, NIOSH Institutional Review Board
Subject
IRB Approval of Continuation of NIOSH Protocol 11-DSR-02XP, “Workplace Violence
Prevention Programs in NJ Healthcare Facilities” (Expedited)
To
Marilyn Ridenour, BSN, MBA, MPH, CPH
Project Officer, DSR, NIOSH
The NIOSH IRB has reviewed and approved your request to continue protocol 11-DSR02XP for the maximum allowable period of one year and it will expire on September 21,
2018. The protocol was reviewed in accordance with the expedited review process outlined
in 45 CFR 46.110(b)(1), Categories (7) and (5).
The IRB determined that the study poses no more than minimal risk to subjects.
A waiver of documentation of informed consent is granted per 45 CFR 46.117 (c)(2).
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 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 September 21, 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 CDC Human Research Protection Program
(513)533-8591 or e-mail: [email protected].
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| File Type | application/pdf |
| File Title | 11-DSR-02XP 092117 conap Ridenour 2017__.pdf |
| Author | kjm3 |
| File Modified | 2018-01-26 |
| File Created | 2017-09-27 |