IRB Approval

Institutional Review Board Certification

Notice of Renewal – Expedited Review

Principal Investigator/Project Director: David Rein
Department: Public Health Research
IRB Protocol Number: 13.05.12
Project Number: 7411
Protocol Title: Formative Research to Assess Injection Behaviors Among Young Persons
Who Inject Drugs in Rural and Suburban Settings
Expiration Date: 12/5/2014

This notification certifies that the research protocol and consent documents described above
have been renewed by the NORC Institutional Review Board (IRB00000967), under its
Federalwide Assurance #FWA00000142, which is valid through July 10, 2018.
The IRB has approved continuation of your research for a period of one year. To avoid a
lapse in IRB approval, please submit your continuing review materials to the IRB at least 2
weeks prior to the expiration date listed above. Although the IRB will provide reminders to
you about renewing your study’s approval as you near the expiration date, it is the
responsibility of the principal investigator and project director to ensure that IRB
approval does not lapse and that continuing review materials are submitted before
a study’s approval expires. If a study’s IRB approval lapses, all human subjects
research activities must stop until IRB approval is renewed.
Any amendments or other changes to this protocol must be submitted for review by the
IRB, and all adverse events must be reported to the IRB.
This protocol was reviewed and renewed pursuant to Expedited Review Category 8, under
which an expedited review procedure may be used for continuing review of research
previously approved by the IRB at a convened meeting where no subjects have been
enrolled and no additional risks have been identified.

__________________________
Karen H. Grigorian, IRB Chair

55 East Monroe Street, Chicago, Illinois 60603

12.5.2013
Date

Phone: 773-256-6000

www.norc.uchicago.edu