I_OHSRP Exemption

OHSR RESPONSE TO REQUEST FOR REVIEW OF RESEARCH ACTIVITY
INVOLVING HUMAN SUBJECTS
FAX:

Exempt:#:

To:

11642

Kaufman, Annette
NCI
EPN BG RM 4032
Office of Human Subjects Research (OHSR)

From:

Nature of Research Activity:
The purpose of this project is to understand how new tobacco product advertisements are perceived and
influence product beliefs. In recent years, the tobacco industry has strategically focused marketing efforts on
products that do not emit secondhand smoke (e.g. Snus). Under Food and Drug Administration regulation of
tobacco, claims such as 'reduced harm' and 'modified risk' are prohibited, so tobacco companies can not
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Original Request Received in OHSR on:

10/23/2012

Responsible NIH Research lnvestigator(s}:

Annette Kaufman, NCI

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OHSR review of your request dated Mon. Oct 22, 2012 has determined that:

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Federal regulations for the protection of human subjects do not apply to above named activity. The OHSR
determination of Not Human Subjects Research is based on the interpretation of 45 CFR 46 under "Research
Involving Coded Private Information or Biological Specimens" (OHRP, Revised October 16, 2008) and Guidance
on Engagement of Institutions in Human Subjects Research (October 16, 2008). NOTIFY OHSR VIA AN E-MAIL
AMENDMENT OF ANY CHANGES THAT MAY ALTER THIS RESEARCH ACTIVITY.
The activity is designated EXEMPT, and has been entered in the OHSR database. PLEASE NOTIFY OHSR
OF ANY SIGNIFICANT CHANGES THAT MAY ALTER THE EXEMPT STATUS OF THIS RESEARCH
ACTIVITY.

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NOT EXEMPT. OHSR recommends IRB review. Please forward your request to the Chair of your IRB, who
may ask you to provide additional information in order to determine whether expedited or full review is
aoorooriate.

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Confidentiality Agreement

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Amendment

Reliance

Other
Office Person H B

Admin Assist. CB

Note:

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Lynnette Nieman, MD
·

Director, OHSRP

10/25/2012

Signature

Title

Date

Domestic/1 nternational:
Domestic
OHSR Use Only
Human Subjects Data: Yes
Biologic Material:

No

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