Attachment 3 - OHSR Exemption

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NIH N C I
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WOUEST FOR W V m W OF RESEARCH ACTIVITY INVOLVING m

N

SUBJECTS_

.lNS'lXUICTIONS: Please type direct1.y on this form. You can expand the docu.ment if
you need more space. If your rescarch involves a survey or questionnaiw, please attach it
to this completed form.

Completed forms (with 111.1 required signatures) may be sent to OFSR by FAX (301-4023443), em.a.ilto ohsr nih ddir@od.nihm,or by .mail (2C146). If you.have any
questions, call OHSR at (301.)402-3444.
1Da.b: April 1,201.0

To:

OFFICE OF HUMAN SUBJECTS RESEARCH, ~ u i l d i n10,
~ Room 2C-346
L %

na5-h-n-b-

(si,giiturc)
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Through:
(Signature o# appropriate 0 l f i c i . d for 1C. e.g., LabIBranch Chief)

Protocol Title: The Survey of Health Cam Professionals' ~woienessand
Perceptions of the National Cancer 1,nstitut.e'~
Intramural Clinical Trials (NCI)
Name of NM[ Principal Investigator(s):
Susan.McMullen, RN, Director, Office of Patient Outreach and Recruitment
Center for Cancer Research,
NCI
Bloch Bui.l&ng 82, Room 101, MSC 8200,
9030 Old\Georgetown Road, Bethesda, Maryl.and 20892
mcrnulles@mari.l.ni
h.gov
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Tel. No: (30.2)402-5931
FAX No: (301.)480-0278
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Is the Principal investigator an NIB employee? Yes

If no, please explain:

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1. What is the proposed research activity that you intend to perform at NIll
(please use lay terms):
The purpose of this rescarch i s to gain understanding of the awareness level and
knowledge of NCI, incS.udingthe services NCl provides, the activities it conducts,
and its 1,ocation.The survey also asks about clinical trial, referral practices and
how th.esc physician.^ find out about clinical research opport~niti~es
for their
patients.

Last revised 8/4/09

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02/06

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2. If appli.cable,list your aon-NM Collaborating J,nveatigator(s).

Jean Walmsl.ey

MMG
600 Kings Farm Boulevard
5rhFl.oor
Rockville MD 20850
jwalmsley @.mmgct.com
Phone: 301-348- I. 627
Fax: 30 1-92 I. -4405

September 203.0,
3. Proposed start date of your research
Proposed completion date O c t o b e r 2010- and then yearly for 3 years
'

4. WilI you be

these samples or data?

Collecting

Yes

Receiving

No
No

Sending

5. Do the sample or data:
(a) Already exist? No

(b) Or are they being collected for the express purpose of this study? Yes
If "yes," please describc: The purpose of this research is to gain understanding of the
awareness level and knowledge of NCI, including the services NCT provides, the
activities it conducts, and its location. The survey also asks about clinical trial referral
practices and how these physicians find out about clinical rcsewch opportunities for
their patients. The survey results are collected anew each time the survey i s sent out.
(c) Or a combination of (a) and (b)?

Yes

d

No

6. What role will yon have in this research project? (Check all &at apply)
-'I_ Analyze samplesldata only.

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Consultantladvisor to collaborator(s) listed above.

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

-C+authorship on p&blication(s)/manuscript(s) pcrtain,ingto this research.

-You or NIH hold an TND for th.isresearch.

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4 Decisional authority over the design or implementation of h e research at the IRB
!
approved site? If so, please explain.
-Other

(If necessary, use this space to describe your role in this research).

7. Where are the subjects of this research activity located?

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E-mai.1.survey sent out nationwide by AMA to mernbe,rswho have opted in to receive emails

8. If human subjects are located elsewhere (not at NIEI), will you have direct
contact or intervention with them? (Examp1,es; as subjwt's physician; in obtaining
samples directly from the subject.; by interviewing the subject?) No
9. What kind of human samples (e.g., tissue, blood) or data (e!,g., private
information, responses to questionnaires) will be involved in your 'msearch?
No human,samples wi.11 be involved. Respondents will be asked,toianswer qu.estions
about t.heei experience and opinion.^ on NCI and the services the institute provides.

10. If the samples, data do not come from an XRB approved prbtocol, do they come
from:

-

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(a) Reposi.toryNo N/A
(b) Pathological waste No - N/A

-

(c) Autopsy material No N/A

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(d) Publicly available source No - N/A
(e) Other

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11. Please check the box(es) that apply(ies) to the samples/data tha.t you will reaive.

(a)

4 Samples and/or data will be anonymizedlunlinked. (Tbe samples/datq,

cannot be linked to indivi,dualsubjects by you or your coUaborators at other sites.)

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(b)

-Samp1.e~and/or data will be coded, however that code cannot be used by
either th.e sender or the receiver t.o i.dentifyspecific individuals.

(c)

-Samples and/or data will be coded so that the provider of th.e smples/data
can link 'themto specific individuals but the receiver will not be able to do so.

12. Will you send results back to the provider($) (listed in question 2 of this
form)?
'
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r'

(a) -No, 1 will not send results back to the provid.cr(s).

(b)

,

Yes, 1 will send aggregate results to the provider($).

(c) -Yes, I will send results to the provider(s) that ace linked to identifiable
individuals.
If yes, does the provider Wend to link yous data to jden.tifiableindi,uiduals?
Yes
No
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Last revised 8/4/09

05/06

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N I H HCI

13. Has the research activity that vou are vronosiw in this f ! o q been appmwd by
an Institutional Review Board (IRB)dsewhere?
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Yes, the NM research activity has been reviewed by the following IRB (s)
(Please provide the fo1lowin.g information for each IRB):
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Name of institution :thatprovided the review
Address of ,reviewi& institntion

Name of PI for the IRB approved protocol

Title of IRB approveh protocol and protocol #

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Fedcral Wi.de Assurance (FWA) nambcr*"

N

O TRB rcview of the rescarch acti.vitydescribed in question #I,

taken place

above has

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(**An W A is a contract between the U.S. Department of Healtly and Human Services
(,DHHS)and an entity receiving DHHS funds to conduct cli.ni.ca1rpsearch,that the latter
will follow ethical guidelines and federal,regulations for the prote&tionof hum,an

subjects. For a list of domestic and international instituti0n.sgo to i
httn://ohrp.ci.t.ni
h,.novlsea~Masearch.a~#ASUR
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14. Per NRI guidance***, have conflicts of interest by NIH emplo$ees, if any, been

resolved?
No

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If your answer is no, please see your Clinical Director about this matter beforc
pmcding with this &search.,
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***The January 5,2005 NIH Guide to Preventing Conflict of Interest applies to all.
research conducted at NZH,h~://o.hsr.od.nih.~ov/NewlmDafwa
docs-html
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Last revised 8/4/09

NIH NCI

Tb:

From:

OHSR

PAGE 01/06

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Susan McMullen
Office of patient Outreach and Recruitment
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CCR
Fax:

301-402-3443

Pagegr

6 ( including hver )
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Request for review

0 Urgent

For Review

1

CC:

III Please Comment

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0 Please Reply
.

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Comments:

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Please Recycle

Page 1 of 1
OHSR (NIHIDDIR)
From:

OHSR (NIHIDDIR)

Sent:

Thursday, June 10,2010 9:37AM

To:

McMullen, Susan (NIHINCI) [El

Subject: Request for Review Rec'd-OHSR 5260

Good morning Ms. McMullen,
This email is to verify that OHSR has received your Request for Review of Research and it is currently being
processed as W S R #5260. Please use this number in any future correspondence regarding this study. We will contact
you via email if any additional information is needed. If you have not heard from OHSR within 7 business days, .
please contact us.

Protocol Title: The Survey of Health Care Professionals' Awareness and Perceptions of the National Cancer
Institute's Intramural Clinical Trials (NCI)
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Thank you.
Sincerely,

~

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OHSR - National Institutes of Health
Bldg 10, Suite 2C146
Bethesda, MD 20892
Office Telephone: 301-402-3444
Office Fax: 301-402-3443

The NIH is committed to maintaining the highest standards for the protection of human subjects.

&

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