ATTACHMENT 9_ Letter of Exemption to 45 CFR 46

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

301-435-3710

To:

Hartman, Anne

Exempt: U:

4996

NCI
EPN 4005
From:

Office of Human Subjects Research (OHSR)

Nature of Research Activity:
The Current Population Survey (CPS) is a monthly survey of the civilian non-institutionalized population,
including a total of 55,000 household interviews conducted by the Census Bureau for the Bureau of Labor
Statistics. The CPS has been conducted for more than 50 years and is the primary source of information on
the labor force characteristics of the U.S. population. The purpose of the current research activity is to
conduct thR Tohcco tls SunnIrnnt to th Current Pnni,ltion Stirvov in 201 0-2011. which will h used for
Original Request Received in OHSR on:

12/1/2009

Responsible NIH Research Investigator(s):

Anne Hartrnan, MS NCI

OHSR review of your request dated Tue, Dec 1 2009 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 FXEMPT, 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.
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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Reliance
Amendment
Other
Person SPC

Admin Assist. CB

12/7/2009
Title

Date

Domestiâ/International:
Domestic
OHSR Use Only
Human Subjects Data: Yes
Biologic Material:

No

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