Universtiy of Pittsburgh IRB Approval

University of Pittsburgh
Institutional Review Board

3500 Fifth Avenue
Pittsburgh, PA 15213
(412) 383-1480
(412) 383-1508 (fax)
http://www.irb.pitt.edu

Memorandum
To:

Shanta Zimmer

From:

Christopher Ryan PhD, Vice Chair

Date:

11/15/2013

IRB#:

PRO13100580

Subject: Surveillance, Monitoring Absenteeism and Respiratory Transmission
(SMART2)
The University of Pittsburgh Institutional Review Board reviewed and approved the above
referenced study by the expedited review procedure authorized under 45 CFR 46.110 and 21
CFR 56.110. Your research study was approved under:
45 CFR 46.110.(3)
45 CFR 46.110.(5)
45 CFR 46.110.(7)
The IRB has approved the advertisement that was submitted for review as written. As a
reminder, any changes to the approved advertisement would require IRB approval prior to
distribution.
Staff members who do not have the required child clearances are not permitted to interact with
children.
The signature of one parent is required on the consent document.
This study has been approved under 45 CFR 46.404 for the inclusion of children. The IRB has
determined that the written permission of one parent is sufficient.

The risk level designation is Minimal Risk.
Approval
11/15/2013
Date:
Expiration
11/14/2014
Date:
For studies being conducted in UPMC facilities, no clinical activities can be undertaken by
investigators until they have received approval from the UPMC Fiscal Review Office.

Please note that it is the investigator’s responsibility to report to the IRB any unanticipated
problems involving risks to subjects or others [see 45 CFR 46.103(b)(5) and 21 CFR
56.108(b)]. Refer to the IRB Policy and Procedure Manual regarding the reporting requirements
for unanticipated problems which include, but are not limited to, adverse events. If you have any
questions about this process, please contact the Adverse Events Coordinator at 412-383-1480.
The protocol and consent forms, along with a brief progress report must be resubmitted at least
one month prior to the renewal date noted above as required by FWA00006790 (University of
Pittsburgh), FWA00006735 (University of Pittsburgh Medical Center), FWA00000600
(Children’s Hospital of Pittsburgh), FWA00003567 (Magee-Womens Health Corporation),
FWA00003338 (University of Pittsburgh Medical Center Cancer Institute).
Please be advised that your research study may be audited periodically by the University of
Pittsburgh Research Conduct and Compliance Office.