Attachment 3b SmithA_NCI_Exempt_3827_CY2007

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

FAX:

Exempt: #:

301 435-3710
Smith, Ashley

To:

3827

NCI
EPN 4090
Office of Human Subjects Research (OHSR)

From:

Nature of Research Activity:
The National Physician Survey on Diet. Physical Activity, and Weight Control is a mail survey to be sent to a
national sample of 2.000 primary care physicians and their adminitrators. The purpose of this survey is to
obtain current, national data on physician knowledge, attitudes, recommendations, and practivces related to
diet, physical activiuty and weight among patient populations from infants to older adults. The survey will
identify factors that aid or hinder the dissemination of information about diet, physical activity, and weight
-,...-:-:-..-, -=---'-'L. --..---,--.:--.
.L

0.

O..!-.

Original Request Received in OHSR on:

8/1/2007

Responsible NIH Research Investigator(s):

Ashley Smith, NCI

OHSR review of your request dated Tue, Jul 31. 2007 has determined that:
era1 regulations for the protection of human subjects do not apply to above named
No further action is necessary.
The activity is designated EXEMPT, and has been entered in the OHSR database.
PLEASE NOTlPl 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 appropriate.

q Confidentiality Agreement
Reliance

0 Amendment
Other
Note:

Q

Office

Person

Admin Asst.

Domestidlnternational:
Domestic
OHSR Use Only
Human Subjects Data: Yes
Biologic Material:

No

0 1 'pq2 0 3 0 4 0 5 0 6

REOUEST FOR REVIEW OF RESEARCH ACTIVITY INVOLVING H U M A N
SUBJECTS

INSTRUCTIONS: Please type directly on this form. You can expand the document if
you need more space. If your research involves a survey or questiomaire, please attach it
to this completed form.
Completed forms (with all required signatures) may be sent to OHSR by FAX (3014023443)or by mail (2C146). If you have any questions, call OHSR at (301)3444.
Date: July 3 1,2007
To:

OFFICE OF HUMAN SUBJECTS RESEARCH, Building- 10,Room 2C-146

From:

fl/J&

(kfluy

d.~ u m )

Name of NJH Principal Investigator(s): Ashlev Wilder Smith
IC: NCI
- ~aborato$Branch:Outcomes Research Branch
Building & Room: EPN 4090 Tcl: /301451-1843)
FAX:D01-435-3710)

Is the Principal invastigator an NIH employee?

X Yes

No

If no, please explain:
1. What is the proposed rerearch activity that you intend to perform at NIH (please

use lay terms): The National Physician Survey on Diet, Physical Activity, and Weight
Control is a mail survey to be sent to a national sample of 2,000 primary care physicians
and their administrators. The purpose of this survey is to obtain current, national data on
physician knowledge, attitudes,recommendations, and practices related to diet, physical
activity and weight among patient populations from infants to older adults. The W e y
will identify f~ctorsthat aid or hinder the dissemination of information about diet,
physical activity, and weight through physicians' offices to the general patient
population.

Last revised 1 1/7/05

;,

6'
'

1,

2. If applicable, list your non-NLH Collaborating Invwtigator(s).

1

k,
I

r

Name

,

Address

Institution

Tel. # FAX #

I

I.

4. Deborah Galuska CDC
Centers for Disease Control and Prevention
4770 Buford Highway NE
MS 24
Phone: 770-488-6017
Fax: 770-488-6500

e-

. :,

2. Caroline McLrod, PhD

t

z

.t

P..
.

,

Westat
1650 Research Blvd.
Rockville, h4D 20850
Phone: (240) 453-2786
Fax: (301) 610-5140
3. Proposed start date of your rerearch: November 2007
Proposed completion date: August 2008
4. Will you be

thwe rampler or data?

Collecting Yes 1
Receiving
1No
Sending
Yes 11Yp
A contractor will be collecting and receiving survey data, and will send us data files
without subject identifiers.

5. Do the samplw or data:
(a) Alieady exist?-Yes

&No

(b) Or are they being collected for the express purpose of this study? &Yes

If "yes," please describe: Thii is a mailed survey to 2,000 physicians and their
adrnlmhtors.

..

(c) Or a combination of (a) and (b)?

-Yes

x N o

6. Wbat role will you have in thio research project? (Cheek aU that apply)
~ A d y z sunpleddata
e
only.

Last revised 1 li7105

N

o

-Consultant/advisor to collaborator(s) listed above.

-Author of the protocol that is being implemented by your collaborating
investigator (identified in question #2).

xCo-authorship on publication(s)/manuscript(s) pertaining to this research.

-You or NIH hold an IND for this research.
-x- Decisional authority over the desiga o; implementation of the research at the IRB

approved site? If so, please explain.

I am the Tnsk Order Monitor for this Westat-condueted project.

-Other (Ifnecessary, use this space to describe your role in thii researoh).
7. Where are the subjects of this mearcb activity located?

Participants are located in physician offices and medical clinics across the counby.

8. If human subjects are located elsewhere (not at NIH), will you have direct
contact or intervention with them? (Examples: as subject's physician; in obtaining
samples directly fram the subject; by interviewing the subject?) -Y e s x N o
9. What kind of human sampled (e.g., tinsue, blood) or data (as,
private
Information, responaes to questionnaires) will be Involved in your research?

Respom to questionnaire items

10. If the samples, data do not come from an 1RB approved protocol, do they come
from:

(a) Repository Y e s -x- No
@) Pathological waste

Yes -x-

(c) Autopsy material -Yes -x-

No
No

(d) Publicly available s o m Y e s -x(0)

Obr

Last revised 1 1nB5

No

11. Please check the box(-) that apply(ies) to the samplesldata that you will receive.

(a) -x- Samples and/or data will be anonymidunlinked. (The sampleddata cannot
be linked to individual subjects by you or your collaborators at other sites.)
(b)

-Samples andlor data will be coded, however that code cannot be used by
either the sender or the receiver to identify specific individuals.

(c) -Samples andtor data will be coded so that the provider of the samplesJdata
can link them to specific individuals but the receiver will not be able to do so.
12. Willyou send results back to the provider(#) (listed in question 2 of this form)?

(a) -x-No, I will not send results back to the provider@).
(b) -Yes, I will send aggregate results to the provider(s).

(c) -Yes, I will send results to the provider@)that are linked to identifiable individuals.
If yes, does the provider intend to link your data to identifiable individuals?
Y e s
No
13. Has the rwearch activity #hat vou are ~roaosinnin this form been approved by
an Institutional Review Board (IRB) elsewhere?

X
Yes, the NU4 research activity has been reviewed by the following IRB (s)
(Please provide the following information for each IRB):

-Westat
-1650 Research Blvd.

Name of institution that provided the h e w

Rockville, MD 20850

A d h of reviewing institution

-Ashley Wilder Smith-

Name of PI for the IRB approved protocol

-National Survey of Energy

Balance Related Care Among
Primary Care Physicians
Project M357.05

-FWA 555 1

Title of IRB approved protocol and protocol #
Federal Wide Assurance (FWA) number*"

No IRB review of the msearch activity described in question #1 above has
taken place

Last revised 1 1/7/05

..

(**An FWA is a contract between the U.S. Department of Health and Human Services
(DMS) and an entity receiving D M S funds to conduct clinical research that the latter
will follow ethical guidelines and federal regulations for the protection of human
subjects. For a list of domestic and international institutions go to

14. Per MH pidance***, have conflicts of interest by NIH employw, if any, been
resolved?
No
X Yes

--

.

..-

-

If your answer i no, please see your Clinical Director about this matter before
proceeding with tbir research.

***The January 5,2005 NIH Guide to Preventing Conflict of Interest applies to all
research conducted at NM, httD:llohsr.od.nih.eovMewIrn~lrfwadocs.htm!

Last revised 1 117105

Page 1 of 1

Robinson, Kimberley (NIHIOD) [?I
From:

Sent:
To:

Subject:

Robinson, Kimberley (NIHIOD) [?I
Tuesday, August 07,20072:13 PM
Smlh. Ashley (CDC)
RESPONSE TO REQUEST FOR REVIEW # 3827

Attachments: SmithA-NCI-Exempt3827-CY2007.pdf

Good afternoon:
Attached please find the Response to Request for Review of Research Activity Involving
Human Subjects dated 07/31 107.
Any questions, feel free to contact OHSR.
Best Regards,

Kimberley V. Robinson
Administrative Assistant
OD/OHSR/NIH
10 Center Drive, Rm. 2C-146
Bethesda, MD 20892
301-402-8631 (Direct)
301-402-3443 (Fax)