IRB Approval

Minimal Risk IRB (Health Sciences)
7/17/2017
Submission ID number: 2013-1357-CR004
Title:
ORegon CHild Absenteeism due to Respiratory Disease Study
Principal Investigator:
JONATHAN L TEMTE
Point-of-contact:
SHARI K BARLOW
IRB Staff Reviewer:
JESSICA JOHNSON
A designated MR IRB member conducted an expedited review of the above-referenced
continuing review progress report form. The study was approved by the IRB member for the
period of 12 months with the expiration date of 7/16/2018. The study qualified for expedited
review pursuant to 45 CFR 46.110 and, if applicable, 21 CFR 56.110 and 38 CFR 16.110:
Category 9: The study meets ALL of the following criteria: (i) Categories 2 through 8 do not
apply; (ii) The research is not conducted under an investigational new drug application or
investigational device exemption; AND (iii) The IRB has determined and documented at a
convened meeting that the research involves no greater than minimal risk and no additional risks
have been identified
IMPORTANT: This study falls under the criteria outlined in the Five Year Renewal Policy. As
a result, no further continuing review applications can be submitted for this study unless this
study qualifies for an exception as described in the Five Year Renewal Policy
[https://kb.wisc.edu/gsadminkb/page.php?id=29793]. If this study does not qualify for an
exception to the five year renewal policy, a replacement initial review application must be
submitted no later than 4.16.2018.
To access the materials approved by the IRB, including any stamped consent forms and
recruitment materials, please log in to your ARROW account and view the documents tab in the
submission's workspace.
Please review the Investigator Responsibilities guidance (http://go.wisc.edu/m0lovn) , which
includes a description of IRB requirements for submitting continuing review progress reports,
changes of protocol and reportable events.
Please contact the appropriate IRB office with general questions: Health Sciences IRBs at 608263-2362 or Education and Social/Behavioral Science IRB at 608-263-2320. For questions
related to this submission, contact the assigned staff reviewer.