The Influence of Brand and Prinicple Display for Safe Consumer Use of OTC Drugs - Advancing the Science

Institutional Review Board Office
Northwestern University
Biomedical IRB
750 North Lake Shore Drive
Rubloff Building, Suite 700
Chicago, Illinois 60611
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Social and Behavioral Sciences IRB
600 Foster Street
Chambers Hall, Second Floor
Evanston, Illinois 60208
847-467-1723

APPROVAL OF MODIFICATION
DATE: June 21, 2016
TO:

Dr. Michael Wolf

FROM: Office of the IRB
DETERMINATION DATE: 6/21/2016
APPROVAL DATE:

6/21/2016

EFFECTIVE DATE:

6/21/2016

EXPIRATION DATE:

12/20/2016

The Northwestern University IRB has reviewed and approved the submission described below:
Type of Submission: Modification
Review Level: Expedited
Expedited Category: - (mm) Minor modification
Title of Study: The Influence of Brand and Principle Display for Safe Consumer use of
Over the Counter Drugs-Advancing the Science
Principal Investigator: Michael Wolf
IRB ID: STU00202120-MOD0002
Funding Source: Food and Drug Administration, Funding Source ID:
HHSF223201510126C
Documents Reviewed: • FDA Umbrella Branding Protocol V2 tracked changes, Category: IRB
Protocol;
• Verbal Recruitment Script, Category: Recruitment Materials;
• FDA BE Project - Craigslist recruitment post 6-7-16.docx, Category:
Recruitment Materials;
• Task (changes tracked in study battery file), Category:
Questionnaire/Survey;
• Consent V3 5-25-16 tracked changes.pdf, Category: Consent Form;
• Study Battery v3 (changes highlighted), Category:
Questionnaire/Survey;
Description of the modification:
 We have made some changes to the protocol and battery. We have written a craigslist ad. No
subjects have been enrolled.
________________________________________________________________________________________________________
Northwestern University has an approved Federalwide Assurance with the Department of Health and Human Services:
FWA00001549.
HRP-702 / v070115

Michael Wolf
STU00202120-MOD0002
Page 2 of 2

In conducting this study, you are required to follow the requirements listed in the Northwestern
University (NU) Investigator Manual (HRP-103), which can be found by navigating to the IRB Library
within the eIRB+ system.
NU IRB approval does not constitute or guarantee institutional approval and/or support. Investigators and
study team members must comply with all applicable federal, state, and local laws, as well as NU Policies
and Procedures, which may include obtaining approval for your research activities from other individuals
or entities.
For IRB-related questions, please consult the NU IRB website at http://irb.northwestern.edu. For general
research questions, please consult the NU Office for Research website at www.research.northwestern.edu.

________________________________________________________________________________________________________
Northwestern University has an approved Federalwide Assurance with the Department of Health and Human Services:
FWA00001549.
HRP-702 / v070115