Appendix 5 OHSR Clearance

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

Exempt: #:

FAX:
To:

Bright, Maw Anne
NCI

build in^ 6116 - 6116 Executive Boulevard, 3049
From:

Office of Human Subjects Research (OHSR)

Nature of Research Activity:
The NCI currently collects: 1. Customer service and demographic information from clients who contact NCl's
Cancer Information Service (CIS) in order to properly plan, implement, and evaluate cancer education efforts,
including assessing the extent by which the CIS impacts under served populations; 2. Smoking/tobacco use
behavior of individuals seeking NCl's smoking cessation assistance in order to provide smoking cessation
services tailored to the individ~~al
client's needs and track their smokinn behavior at follow Iln
Original Request Received in OHSR on:

511812009

Responsible NIH Research Investigator(s):

Mary Anne Bright, NCI

OHSR review of vour request dated Fri, Mav 15,2009 has determined that:
Federal regulations for the protection of human subjects do not apply to above named
activity. No further action is necessary.

q

The activity is designated EXEMPT. and has been entered in the OHSR database.
SE NOTIFY OHSR OF ANY SIGNIFICANT CHANGES THAT MAY Al TFR THF
EMPT STATUS OF THIS RESFARCH ACTIVITY,

q

NOT EX-.
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 appropriate.

q
q

Confidentiality Agreement
Reliance
Amendment

q

Other
Office Person SPC

Note:

Admin Assist. CB

5/27/2009
Date

Human Subjects Data: Yes
Biologic Material:

No

OHSR Use Only
0 1 0 2 0 3 0 4 0 5 0 6

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OHSR (NIHIDDIR)
-

-

--

-

From:

Bright, Mary Anne (NIHINCI) [El

Sent:

Wednesday, May 27,2009 11:32 AM

To:

OHSR (NIHIDDIR)

Subject: RE: BrightM-NCI-4695-CY2009
Good morning.
Yes, this is a service activity and is not research. Thank you for your review. Much appreciated.
Mary Anne

Mary Anne Bright
Associate Director, Office of Public Information and Resource Management
Office of Communications and Education
National Cancer Institute
phone - 301-594-9048
fax - 301-402-0555
[email protected]
This e-mail message may contain privileged and confidential information intended for the use of the individual(s)
or entity named above. If you are not the intended recipient, you are hereby notified that any use,
dissemination, distribution, or copying of this message or its content is strictly prohibited. I f you have received
this message in error, please notify the sender immediately and delete or destroy the message without making a
copy. Thank you.

From: OHSR (NIHIDDIR)
Sent: Wednesday, May 27,2009 10:07 AM
To: Bright, Mary Anne (NIHINCI) [El
Subject: BrightM-NU-4695-CY2009
Good Morning Ms. Bright:
Thank you for the opportunity to review your project to collect customer service and demographic information from
clients who contact NCl's Cancer lnformation Service (CIS) and smoking cessation services tailored to the client's
needs. OHSR has one point of clarification. Based on the information you have provided, it appears that this is a
service activity; not a research activity. Please confirm this for OHSR records,
Best regards,

s w P-%y-&maku44, PCD;m
Office of Human Subjects Research
Office of Intramural Research
National Institutes of Health
Bldg 10 Room 2C146
Bethesda, MD 20892

Page 2 of 2

Office Telephone: 301-402-3444
Office Fax: 301-402-3443