Attachment 5 Westat & NCI IRB Approvals_8 July 2008

Attachment 5
Westat and NCI IRB Approval’s

TO:

Carolyn McLeod
Project Director

April 15, 2008

FROM:

Kerry Levin
Acting Chair, Institutional Review Board

SUBJECT:

Expedited Review and Approval for new activity
Survey of Physicians Regarding the Care of Cancer Survivors (SPARCCS), Project
8137.06,

As Acting Chair of the Westat Institutional Review Board (IRB), I have reviewed the
materials submitted for the following: Survey of Physicians Regarding the Care of Cancer
Survivors (SPARCCS), Project 8137.06. The IRB reviews all studies involving research on
human subjects.
SPARCCS is sponsored by the National Cancer Institute (NCI) from the National
Institutes of Health. Westat’s role will be to identify the sampling frame, finalize the sample
design, determine survey methods, develop survey materials, conduct the evaluation, enter and
clean the data and conduct data linkages and analyses.
The IRB previously approved a Waiver of Standard Informed Consent and study
instruments to conduct nine cognitive interviews among Primary Care Physicians and Medical
Oncologists. The purpose of that testing was to examine how well question items measured
knowledge, attitudes, and practices of primary care physicians and medical oncologists. This
request is for approval to screen physicians in the sampling frame and to send a self-administered
interview to approximately 4,400 physicians. The eligibility screener, mailings and follow up
activities will be conducted from Westat’s Rockville offices.
A random sample of primary care physicians belonging to primary care specialties
(Family Practice, Obstetrics/Gynecology, General Internal Medicine, and Pediatrics) will be
drawn from the Master File of the American Medical Association. Additionally, a second sample
will be drawn from the Medical Oncology specialty category. Surveys will be sent via FedEx to
physicians determined eligible at the screener with the hope that 1,100 completed surveys from
Primary Care Physicians (PCPs) and 2,200 completed surveys from Medical Oncologists.
The physicians will be sampled from the American Medical Association Master File so
that only non-Federal physicians currently practicing in office settings and belonging to the
aforementioned specialties will be included. Because the sample frame includes outdated
information, specialty and practice location will be verified along with address during
verification calls conducted before the first mailing. Cases not meeting these criteria will be
excluded. Separate screeners will be used for the primary care specialties. To participate, the
oncologists must treat primarily breast and colon cancer patients.

Page 2 – Westat Project 8137.06

Physicians will also have the choice to complete the questionnaire over the telephone.
The time to complete the questionnaire is estimated at 20 minutes. Similar instruments will be
used for primary care physicians and medical oncology physicians. Questionnaires will be
shipped by Federal Express beginning in January 2009. The shipping envelope will have a return
address label in the left hand corner of the envelope informing the recipient that the package is
“From the National Institutes of Health”. The package will contain a cover letter from NCI
including a list of Frequently Asked Questions, the questionnaire, a check for $50 as incentive
for participation, a postage paid, pre-addressed return envelope to Westat, a document describing
background details about the study, and a letter of support from a specialty organization
corresponding to the specialty of the physician respondent. There are no sensitive questions in
the survey instruments. Questions about patient characteristics are of a general nature and
information is collected in the aggregate rather than on specific individuals.
Completed questionnaires will be receipted and checked for completeness and legibility
of answers. The questionnaires have been designed to be electronically scannable and as noted
above, there is no identifying information in the questionnaires. Each will be identified by a
unique identification number. Each participant’s name and contact information will be stored in a
secure database at the Westat offices in Rockville, Maryland. Information will be stored
separately from information provided by the participant on the survey, and the only identifier on
the survey will be a unique number. Only staff members from Westat who have signed
confidentiality pledges will have access to the physician names and contact information. Very
few staff will have access to files linking names/identifiers to survey responses. Names and
contact information will be used only for follow-up purposes and purposes of payment by check.
Linking information will be retained by Westat and NCI will receive only the data file with
identification numbers. Identifiable data will be secure-shredded 6 months after the final report is
submitted to NCI.
IRB regulations permit expedited review of certain activities involving minimal risk [45
CFR pt. 46.110 (b) (1)]. This study can be considered minimal risk. I am therefore approving the
study under expedited authority.
A waiver of documentation of informed consent is also granted under 45 CFR 46.116
because the research involves no more than minimal risk to subjects and could not practicably be
carried out without the waiver.
You obligation to submit the study for an annual review on or before January 17th, 2009
remains unchanged. In the interim, you are responsible for notifying the Office of Research
Administration as soon as possible if there are any injuries to the subjects, problems with the
study, or changes to the study design that relate to human subjects.
cc:

Institutional Review Board
Jeanne Rosenthal

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

FAX:

301-435-3710

To:

Potosky, Arnold
NCI
EPN - Exec Plz North, 4005

From:

Office of Human Subjects Research (OHSR)

Nature of Research Activity:
The overall goal of the Survey of Physician Attitudes Regarding the Care of Cancer Survivors (SPARCCS) is
to identify perceptions, knowledge, and practices of primary care and oncology specialist physicians regarding
post-treatment follow up care of adult cancer survivors. There is little evidence regarding optimal follow up
care practices as well as limited understanding of current practices. There is consensus, however, from IOM
reports that the care of survivors is fragmented and poorly coordinated, and that considerable practice
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Original Request Received in OHSR on:
Responsible NIH Research Investigator(s):

Arnold Potosky, NCI

OHSR review of your request dated Thu, Apr 17, 2008 has determined that:

1

Federal regulations for the protection of human subjects do not apply to above named
activity. No further action is necessary.
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.
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.

Confidentiality Agreement

q Reliance
Amendment
Other
Note:

Office Person

IJS

Admin Asst.

This research is exempt under 45 CFR 46 101 (b) (2).

G

f;r

errv Menikoff. MD. JD

Director, OHSR

Signature

Date

Title

Domesticllnternational:
Domestic
Human Subjects Data: Yes
Biologic Material:

No

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

REQUEST FOR REVIEW O F RESEARCH ACTIVITY INVOLVING HUMAN
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 questionnaire, please attach it
to this completed form.
Completed forms (with all required signatures) may be sent to OHSR by FAX (301-4023443) or by mail (2C146). If you have any questions, call OHSR at (301) 3444.
Date: April 11,2008
To:

OFFICE OF

JECTS RESEARCH, Building 10, Room 2C- 146

From:
Through:
e.g., LabIBranch Chief)
Name of NIH Principal Investigator(s): Arnold L. Potoskv
IC NCI
LaboratoryIBranch Health Services and Economics Branch
Building & Room No. EPN/Rm. 41 10 Tel. No. 301-496-5662 FAX No.301-435-3710
Is the Principal investigator an NIH employee?

X

Yes

No

If no, please explain:
1. What is the proposed research activity that you intend to perform at NIH (please
use lay terms):
The overall goal of the Survey of Physician Attitudes Regarding the Care of Cancer
Survivors (SPARCCS) is to identify perceptions, knowledge, and practices of primary
care and oncologv specialist physicians regarding post-treatment follow-up care of adult
cancer survivors. There is little evidence regarding optimal follow up care practices as
well as limited understanding of current practices. There is consensus, however, from
IOM reports that the care of survivors is fragmented and poorly coordinated, and that
considerable practice variation exists in survivorship care. Thus, the goal of the survey
will be to obtain more information concerning the reasons for this fragmentation in care
by exploring limitations in knowled~e,confusion about roles, and the key barriers to
perceived "best practices" from the unique perspective of the practicing physicians. This
is directly responsive to specific IOM and PCP report recommendations.

Last revised 11/7/05

2. If applicable, list your non-NIH Collaborating Investigator(s).
Institution
Name
Craig Earle
Dana Farber
44 Binney St.
Boston, MA 02 115
Phone: 6 17-632-5564
Fax: 617-532-2270
Patti Ganz
UCLA Jonsson Cancer Center
Box 956900, A2-125 CHS
Los Angeles, CA 90095-6900
Phone: 3 10-206-1404
Fax: 3 10-206-3566
Michael Stefanek
American Cancer Society
250 Williams St.
Atlanta, GA 30303
Phone: 404-3 15-1123
Fax: 404-3 15-9348
Tenbroeck Smith
American Cancer Society
250 Williams St.
Atlanta, GA 30303
Phone: 404-3 15-1 123
Fax: 404-3 15-9348
John Ayanian
Harvard Medical School
180 Longwood Ave.
Boston, MA 02 115
Phone: 617-432-3455
Fax: 616-432-01 73
3. Proposed start date of your research January 3,2009
Proposed completion date January 3,2012

Last revised 11/7/05

Address Tel. # FAX #

4. Will you be

these samples or data?

Collecting &/No
Receiving &/No
Sending
Yes/Nl
5. Do the samples or data:
(a) Already e x i s t ? Y e s

X No

(b) Or are they being collected for the express purpose of this study? &Yes
If "yes," please describe: This survey will be mailed to 2200 physicians.
(c) Or a combination of (a) and (b)?

Yes

No

X No

6. What role will you have in this research project? (Check all that apply)
-Analyze samplesldata only.
-~onsultantladvisorto collaborator(s) listed above.

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

X Co-authorship on publication(s)/manuscript(s)
-

pertaining to this research.

-You or NIH hold an lND for this research.

X Decisional authority over the design or implementation of the research at the IRB
approved site? If so, please explain. I am the Task Order Monitor for this proiect.
Other (If necessary, use this space to describe your role in this research).

7. Where are the subjects of this research activity located?
Participants will be recruited from physician offices and medical clinics across the United
States.

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 from the subject; by interviewing the subject?)
Yes X N o

Last revised 1 1/7/05

9. What kind of human samples (e.g., tissue, blood) or data (e.g., private
information, responses to questionnaires) will be involved in your research?
Responses to questionnaire items.

10. If the samples, data do not come from an IRB approved protocol, do they come
from:
(a) Repository

Yes X No

(b) Pathological waste -Yes

X No

(c) Autopsy material -Yes _1Z_ No
(d) Publicly available source Y e s 1(_No
(e) Other
11. Please check the box(es) that apply(ies) to the samplesldata that you will receive.

(a)

X Samples andor data will be anonymized/unlinked. (The samplesldata cannot
be linked to individual subjects by you or your collaborators at other sites.)

(b) -Samples and/or data will be coded, however that code cannot be used by
either the sender or the receiver to identify specific individuals.
(c) -Samples andor data will be coded so that the provider of the samples/data
can link them to specific individuals but the receiver will not be able to do so.

12.
Will you send results back to the provider(s) (listed in question 2 of this
form)?
(a)
(b)

X No, I will not send results back to the provider(s).
Yes, I will send aggregate results to the provider(s).

(c) -Yes, I will send results to the provider(s) that are linked to identifiable
individuals.
If yes, does the provider intend to link your data to identifiable individuals?
Yes
No

Last revised 11/7/05

13. Has the research activity that you are ~roposingin this form been approved by
an Institutional Review Board (IRB) elsewhere?
Yes, the NIH research activity has been reviewed by the following IRE3 (s)
X
(Please provide the following information for each IRE3):
Name of institution that provided the review
1650 Research Blvd..
Rockville, MD 20850
Arnold L. Potoskv

Address of reviewing institution
Name of PI for the IRE3 approved protocol

National Survey of Physician
Attitudes Regarding the Care of
Cancer Survivors Proiect#8 137.06 Title of IRE3 approved protocol and protocol #

FWA0000555 1

Federal Wide Assurance (FWA) number* *

No IRE3 review of the research activity described in question #1 above has
taken place
(**An FWA is a contract between the U.S. Department of Health and Human Services
(DHHS) and an entity receiving DHHS 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

http://ohrp.cit.nih.gov/search/asearch.asp#ASUR
14. Per NIH guidance***, have conflicts of interest by NIH employees, if any, been
resolved?
X Yes
--

No

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

***The January 5,2005 NIH Guide to Preventing Conflict of Interest applies to all
docs.htrn1
research conducted at NIH, http://ohsr.od.nih.~ov/New/mpafwa

Last revised 1 1/7/05