Attachment I IRB Approval letters

Date:

July 31st, 2014

To:

Terisa Davis, Project Director

From:

Kerry Levin, Chair Westat IRB

Subject:

Expedited Approval of FDA-NCI Health Communications Survey as part of the Health
Information National Trend Survey (HINTS) 4, Project Number 8861
FWA 00005551

As Chair of the Westat Institutional Review Board (IRB), I reviewed the materials submitted for the following:
FDA-NCI Health Communications Survey as part of HINTS 4, Project Number 8861. The Westat IRB
reviews all studies involving research on human subjects. This study is funded by National Cancer Institute and
Food and Drug Administration.
This review included a request to approve a specific cycle of the survey focused on FDA issues, such as tobacco
product use and beliefs, medication use, and food safety.
IRB regulations permit expedited review of certain activities involving minimal risk [45 CFR pt. 46.110]. This study
can be considered minimal risk and is approved under expedited authority. Per [45 CFR 46.116(d)], a waiver of
informed consent is approved as the research involves no more than minimal risk to the subjects; the waiver or
alteration will not adversely affect the rights and welfare of the subjects; the research could not practicably be
carried out without the waiver or alteration; and whenever appropriate, the subjects will be provided with additional
pertinent information after participation.
Per [45 CFR 46.117(c)], a waiver of documentation of informed consent is also approved as the research presents
no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally
conducted outside of the research context.
As the Project Director you are responsible for the following:



cc:

You are required to submit this study for a continuing review before November 11, 2014.
In the interim, notify the IRB Office as soon as possible if there are any injuries to subjects as well as
problems or changes with the study that relate to human subjects.
Institutional Review Board
Nancy Weinfield

Matose, Takunda (NIH/OD) [C]
From:
To:
Cc:
Subject:
Attachments:

OHSR (NIH/DDIR)
Hesse, Bradford (NIH/NCI) [E]
Blake, Kelly (NIH/NCI) [E]; Terisa Davis; Moser, Richard (NIH/NCI) [E]; Grant, Nicole
(NIH/NCI) [E]
Amendment Determination for OHSRP #5810
Request for Amendment OHSRP #____

Dear Dr. Hesse, 

Attached is the OHSRP determination of Excluded from IRB Review per 45 CFR 46 and NIH policy for the reception of 
additional data with your collaborators David Cantor, Terisa Davis, Westat, for your project Health Information National 
Trends Survey 4 (HINTS 4). You may proceed with the project. 

Please retain this documentation as you would other research records. Amendments and or changes to the research 
must be submitted to OHSRP for review as changes may affect the determination. Please refer to OHSRP #5810 for 
future amendments to this activity. To request future amendments, please use the attached email template modified to 
meet the specific changes needed for your project. If you have any questions or need further assistance, please feel free 
to contact us. 

Best, 

Takunda Matose 
OHSRP ‐ National Institutes of Health 
Bldg 10, Suite 2C146 
Bethesda, MD 20892 
Office Telephone: 301‐402‐3444 
Office Fax: 301‐402‐3443 

From: Hesse, Bradford (NIH/NCI) [E]
Sent: Wednesday, May 28, 2014 10:15 AM
To: OHSR (NIH/DDIR)
Cc: Blake, Kelly (NIH/NCI) [E]; Terisa Davis; Brentin, Christine (NIH/OD) [E]; Moser, Richard (NIH/NCI) [E]
Subject: Amendment Request for OHSR #5810

Dear OHSRP and Chris, 
Thank you for providing us with the email template to request an amendment to our exempt submission.  

Please amend OHSR #5810, Health Information National Trends Survey 4 (HINTS 4), OHSRP determination of exempt, to 
allow an additional data collection cycle as follows: To include a fifth survey cycle (FDA‐NCI Health Communication 
Survey) to field in November‐December 2014. 

NIH Senior Investigator: Bradford W. Hesse, Ph.D. 

Additional Recipients of Amendment determination: Kelly D. Blake, Richard Moser 

Collaborator:   
David Cantor, Westat, email: cantord1@westat.com 
Terisa Davis, Westat, email: terisadavis@westat.com 
1

Collaborator’s FWA#: 5551 

IRB/EC Approval:   Granted June 9, 2011. Documentation attached. 

Original Protocol Title and ID# that Specimens are sourced from:  Health Information National Trends Survey 4 (HINTS 
4), exemption #5810. Active protocol. 

Repository: N/A 

Identifiability of Specimens/data:  De‐identified 

De‐identification agreement:  N/A (use only if receiving coded specimens see Specimen/Data request form item #10 for 
sample language) 

Conflicts of Interest by NIH employees:  No conflicts of interest. 

Special Instructions or questions: As is outlined in our original, approved request for review (attached), HINTS 4 is a 
nationally‐representative mail survey sampled using addresses selected from a file of residential addresses based on the 
US Postal Service Computerized Delivery Sequence File. The purpose of HINTS 4 is to assess the ways in which the 
general population uses communication channels to obtain information about health and cancer. The survey monitors 
the use of information resources while collecting information about respondents’ knowledge, attitudes and behaviors 
related to health and cancer. HINTS 4 was to contain four data collection cycles to be fielded over three years. We’ve 
recently been given the opportunity to add a fifth data collection cycle of HINTS to be funded by the FDA. In preparing 
for the fielding of the FDA‐funded instrument, we would like to secure documentation from OHSRP that this fifth HINTS 
cycle (referred to as the FDA‐NCI Health Communication Survey) is exempt following the spirit of the original HINTS 4 IRB
approval. Please note that all data collection procedures and considerations for the protection of human subjects are 
exactly the same for all cycles of HINTS 4, including this forthcoming FDA‐funded cycle. The FDA‐NCI module is an 
extension of the previously approved research. 

Please let us know if we can provide you with further information or documentation to expedite the approval of this 
amendment. 
Thank you, 
Brad 

2

OHSR RESPONSE TO REQUEST FOR REVIEW OF RESEARCH ACTIVITY

INVOLVING HUMAN SUBJECTS

FAX:

301-480-2198

To:

Hesse, Bradford

Exempt: #:

5810

NCI
EPN 4068
From :

Office of Human Subjects Research (OHSR)

Nature of Research Activity:
The Division of Cancer Control and Population Sciences, Behavior Research Program of the National Cancer
Institute (NCI) is planning to conduct data collection for the Health Information National Trends Survey 4
(HI NTS 4) over the course of three years starting in 2011 . The purpose of HINTS is to assess the ways in
which the general population uses communication channels to obtain information about health and cancer.
ThA SI JrvAV mnnitnrs thA IJSA nf infnrmrltinn rASnlJrr.AS whilA r.nilAr.tinCl infnrmrltinn rlhnlJt rAsnnnrlAnts'

Original Request Received in OHSR on :

6/9/2011

Responsible NIH Research Investigator(s):

Bradford Hesse, PhD NCI

OHSR review of your request dated Wed , Jun 1, 2011 has determined that:

I:8J

o

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
Invo lving 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 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.

o 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 .

o Confidentiality Agreement
o Reliance

o Amendment
o Other
Admin Assist. CB

Office Person SPC

6/21/2011
Date

OHSR Use On ly
Human Subjects Data: Yes
Biologic Material:

No

01

02

03

04

05

06

J~~[D

REQUEST FOR REVIEW OF RESEARCH ACTIVITY INVOLVING HUMAN

SUBJECTS

INSTRUCTIONS: Please type directly on this fonn. You can expand the document if
you need more space. If your research involves a surveyor questionnaire, please attach it
to this completed fonn.
Completed fonns (with all required signatures) may be sent to OHSR by FAX (301-402­
3443), email to ohsr nih ddir@od.nih.gov, or by mail (2C146). If you have any
questions, call OHSR at (301) 402-3444.
Date:

June 1,2011

To:

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

3.-JiLO/,~

~
____
. _ _ _ _ _ _ _ _ _ _ _ _ _ Bradford Hesse
From:
___
(Signature)

VA.. ~k . ­
Through:
William Klein
(Signature of appropriate Official for IC, e.g., LabIBranch Chief)
Protocol Title: "Health Information National Trends Survey 4 (HINTS 4)
Name of NIH Principal Investigator(s): _Bradford Hesse_ _ _ _ _ _ _ __

IC NCI Laboratory/Branch Health Communication & Infonnatics Research Branch,
Behavioral Research Program, Division of Cancer Control and Population Sciences
Building & Room No. EPN 4068 Tel. No. 301-594-9904 FAX No. 301-480-2198
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 Division of Cancer Control and Population Sciences, Behavior Research
Program of the National Cancer Institute (NCI) is planning to conduct data collection for
the Health Infonnation National Trends Survey 4 (HINTS 4) over the course of three
years starting in 2011. The purpose of HINTS is to assess the ways in which the general
population uses communication channels to obtain infonnation about health and cancer.
The survey monitors the use of infonnation resources while collecting infonnation about
respondents' knowledge, attitudes and behaviors related to health and cancer. There have
been three previous rounds of HINTS data collection (2003,2005 and 2007). HINTS 4

Last revised 8/4/09

1

draws upon the lessons learned from prior iterations of HINTS and continues the work of
the previous rounds of HINTS, while employing some new strategies. Based on the
higher response rates for the mail survey(overtheRDDsurvey)inHINTS3.asingle­
mode mail survey will be implemented with the inclusion ofthe $2 incentive. The use of
express mail, which was shown to be effective in HINTS 3 follow-up mailings, will also
be employed. To try to increase participation by Hispanic respondents, all materials will
be translated and respondents will have the option of completing the mail questionnaire
in Spanish. To more quickly address emerging issues in the field of health
communication while still maintaining the ongoing measurement of trends, HINTS 4 will
include four data collection cycles over the course of 3 years. The instrument for each
data collection cycle will include a core module of trended items in addition to special
topic modules to be implemented in only some of the cycles, increasing capacity of the
HINTS instruments to include additional topics and measures. The overall sample size
for all four cycles of HINTS 4 combined will be approximately 14,000 respondents
which is about twice the size ofprevious rounds of HINTS data collections.
2. If applicable, list your non-NIH Collaborating Investigator(s).
Name
David Cantor

Institution
Westat

Address Tel. # FAX #
1650 Research Boulevard
Rockville, MD 20850
tel: 301-294-2080 fax:301-610-4886

Terisa Davis

Westat

1650 Research Boulevard
Rockville, MD 20850
tel: 301-294-2864 fax: 240-314-2344

Wendy Hicks

Westat

1650 Research Boulevard
Rockville, MD 20850
tel: 301-251-2299 fax: 301-294-2034

3. Proposed start date of your research October 1, 2011

Proposed completion date May 1,2014

4. Will you be _ _ _ _these samples or data?
Collecting
Receiving
Sending

No

Yes

No

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

Last revised 8/4/09

2

(b) Or are they being collected for the express purpose of this study? Yes
If''yes,'' please describe: The goal of this research is to comprehensively assess the
American public's current access to, and use of, information about cancer, that will
include cancer prevention, early detection, diagnosis, treatment, and prognosis. The
content of the survey will focus on understanding the degree to which members of the
general population understand vital cancer prevention messages. More importantly, this
NCI survey will couple knowledge-related questions with inquiries into the
communication channels through which understanding is being obtained, and assessment
of cancer-related behavior. HINTS 4 is intended to be the foundation ofNCl's effort to
build on the opportunities presented by a national shift in communication context, and by
so doing, improve the Nation's ability to reduce the national cancer burden.

(c) Or a combination of (a) and (b)? No

6. What role will you have in this research project? (Check all that apply)
X Analyze samples/data only.
X Consultant/advisor to collaborator(s) listed above.
_ Author of the protocol that is being implemented by your collaborating investigator
(identified in question #2).
_

Co-authorship on publication(s)/manuscript(s) pertaining to this research.
You or NIH hold an IND for this research.

X Decisional authority over the design or implementation of the research at the IRB
approved site? If so, please explain. Dr. Hesse was hired by NCI to supervise
administration of the Health Information Trends Survey. Consequently, he has direct
program responsibility over all major facets of the survey.
_Other (If necessary, use this space to describe your role in this research).

7. Where are the subjects of this research activity located? The HINTS target
population is all adults aged 18 or older in the civilian non-institutionalized population of
the United States. The sample design for HINTS 4 will consist of a series of four single
stage stratified samples of addresses selected from a file of residential addresses based on
the United States Postal Service (USPS) Computerized Delivery Sequence File (CDSF).
Each sample will be selected just prior to the data collection cycle in which it is to be
used. The frame will cover addresses from all zip codes in the 50 states and the District of
Columbia. Addresses in the frame will be grouped into two strata: one containing a high

Last revised 8/4/09

3

concentration of minority adults and the other containing a low concentration. The
number of addresses to be sampled at each cycle is 6,150 for the first two cycles and
6,121 for the last two cycles. The total number of addresses sampled over all four cycles
is 24,602. The samples from each stratum will be selected independently and addresses
within each stratum will be selected with equal probability. The expected number of
completed questionnaires for each cycle is 3,533 for the first two cycles and 3,500 for the
last two cycles. The number of completed questionnaires expected over the four cycles is
14,066. The difference in the sample sizes among the cycles is due to a modest
oversample planned for Central Appalachia in cycles 1 and 2 described in the next
section. The expected overall response rate for the HINTS 4 sample is 40 percent.
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?) No

Last revised 8/4/09

4

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?
CONFIDENTIALITY
No names will be used in the main data collection. At the close of each field period,

address information will be destroyed.

DATA OWNERSHIP

The data will be owned by NCI but NCI will not receive the data until it has been de­

identified.

DATA SECURITY

Paper forms will be processed in a locked field room and stored in a locked file cabinet.

DATA DESTRUCTION

All address information will be destroyed at the end of each field period.

10. If the samples, data do not come from an IRB approved protocol, do they come
from:
(a) Repository No
(b) Pathological waste No

(c) Autopsy material No
(d) Publicly available source No
(e) Other_ Samples will be drawn from addresses selected from a file of residential

addresses based on the United States Postal Service (USPS) Computerized Delivery

Sequence File (CDSF).

11. Please check the box(es) that apply(ies) to the samples/data that you will receive.
(a)

Samples and/or data will be anonymized/unlinked. (The samples/data 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) X Samples and/or 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)?

Last revised 8/4/09

5

-----------------------------­

~~- .......

(a) _X_ No, I will not send results back to the provider{s).
(b)

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
13. Has the research activity that you are proposing in this form been approved by
an Institutional Review Board (IRB) elsewhere?
X Yes, the NIH research activity has been reviewed by the following IRB (s) (Please
provide the following infonnation for each IRB):
Westat
1650 Research Boulevard
Rockville, MD 20850
David Cantor- - - - - ­

Name of institution that provided the review

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

"Health Infonnation National Trends Survey 4 (HINTS 4)

( Project # 8861.01.04) Title of IRB approved protocol and protocol #

5551

Federal Wide Assurance (FWA) number**

_ _ _---'No IRB 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/searchlasearch.asp#ASUR

14. Per NIH guidance***, have conflicts of interest by NIH employees, if
any, been resolved?
XYes _ _No

Last revised 8/4/09

6

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
research conducted at NIH, http://ohsr.od.nih.govlNew/mpafWa docs.html

Last revised 8/4/09

7

OHSR (NIH/DDIR)
From:
Sent:
To:
Cc:
Subject:
Attachments:

Finney Rutten, Lila (NIH/Nel) [C]
Thursday, June 09, 2011 8:53 AM
OHSR (NIH/DDIR)
Hesse, Bradford (NIH/Nel) [E]; Blake, Kelly (NIH/Nel) [E]
requestforReview HINTS4_Main Study_6_1_11.doc
requestforReview HINTS4_Main StudL6_1_11.doc

Follow Up Flag:
Flag Status:

Follow up
Flagged

Please find the attached request for review for the HINTS 4 data collection. Please let us know if you require additional
documentation for this request.
Lila Rutten on behalf of
Bradford Hesse, PhD, Chief, Health Informatics Research Branch

lila J. Rutten, PhD, MPH [Contractor]
Behavioral Scientist
Clinical Monitoring Research Program
SAIC-Frederick, Inc.
National Cancer Institute at Frederick
5705 Industry Lane
Frederick, MD 21702
Phone: 301-947-4912
finneyl@mail.nih.gov

This e-mail and any attachments to it are intended only for the identified recipient. It may contain proprietary or otherwise legally
protected information for SAIC-Frederick. Any unauthorized use or disclosure of this communication is strictly prohibited. If you
have received this communication in error, please notify the sender and delete or otherwise destroy the e-mail and all attachments
immediately.

From: Alston, Monique (NIH/DO) [E]

Sent: Thursday, June 09, 2011 8:33 AI...,

To: Finney Rutten, Ula (NIH/NO) [C]

Cc: Klein, William (NIH/NO) [E]

Subject: requestforReview HINTS4_Main Study_6_Cl1.doc

Signed copy per Bill's request. If you have any questions please feel free to contact.

Monique Alston
Task Leader, Hub D (NCI & OGA)
6130 Executive Plaza, Room 4057 A
Bethesda, M D 20892
(301) 496-2242
(301) 435-7547 (f)
alstonm@od.nih.gov

1

OHSR (NIH/DDIR)

From:
Sent:
To:
Cc:
Subject:

Hesse, Bradford (NIH/NCI) [E]
Wednesday , June 15, 2011 7:25 AM
OHSR (NIHIDDIR)
Terisa Davis - Health Studies; Finney Rutten, Lila (NIH/NCI) [C]; Moser, Richard (NIH/NCI)
[E]; Blake, Kelly (NIH/NCI) [E]
RE: HesseB_NCI_581 0_CY2011

This correspondence is to confirm the fact that all activities related to the Health Information National Trends Survey
(HINTS) will conform to existing collaborative protocol. Moreover, I offer confirmation that no one from the National
Cancer Institute will be in a position to seek the identity of the subjects from whom we have collected data in the HINTS
program. All of the original data files, including data files with anything resembling personal identifiable information,
while be kept in a highly secure data location housed by our contractor Westat. Westat will maintain its usual high level
of data security as specified in its data security plan submitted to the NCI. Staff within the NCI have been briefed, and
have exercised their customarily high levels of protection for participant anonymity over the past ten years in which the
HINTS program has been collecting data.
To verify our mutual understanding, I will cc Terisa Davis, who is the Project Director at Westat . Ms . Davis will respond
with an email confirm Westat's adherence to privacy protocols as requested in your memorandum.
Thank you very much for your prompt review and concise request. If there is anything else I can do please do not
hesitate to ask.
-Brad Hesse
Bradford W. Hesse, Ph .D.
Chief, Health Comm & Informatics Research Branch
Behavioral Research Program
Division of Cancer Control and Population Sciences
National Ca ncer Institute
Executive Plaza North , Room 4068
6130 Executive Blvd ., MSC 7365
Bethesda, MD 20892-7365
> {for express mail , use Rockville, MD 20852}

Phone 301-594-9904
Email hesseb@mail.nih .gov

From: OHSR (i'JIH/DDIR)

Sent: Tuesday, June 14, 2011 3:17 PM

To: Hesse, Bradford (NIH/NCI) [E]

Subject: HesseB_NCC5810_CY2011

Good Afternoon Dr. Hesse:

Thank you for the opportunity to review your research project entitled "Health Information National Trends Survey 4

(HINTS 4)." Since the work you are doing at the NIH provides little or no risk to human subjects off-site, OHSR has

decided the appropriate action for you to take is the following:

1. Confirm that the work you are doing is consistent with the existing collaborative protocol.
2. Provide documentation that you will not seek the identity of the subjects who have provided the samples you will
receive.
3. Ask your collaborator to provide documentation that the identity of the subjects who have provided the samples you will
receive will not be released to you.

1

An e-mail from you and from the investigator(s) holding the key to the code is sufficient documentation .
This action is based on guidance issued on Aug. 10, 2004 by the HHS Office of Human Research Protections, the
regulatory office for the protection of human subjects.

Best regards,

Office of Human Subjects Research
Office of Intramural Research
National Institutes of Health
Bldg 10 Room 2C146
Bethesda, MD 20892
Office Telephone: 301-402-3444
Office Fax: 301-402-3443

2

OHSR (NIHIDDIR)

From:
Sent:
To:
Cc:
Subject:

Terisa Davis - Health Studies [TerisaDavis@westat.com]

Wednesday, June 15, 2011 8:35 AM

Hesse, Bradford (NIH/NCI) [E]; OHSR (NIHIODIR)

Finney Rutten, Lila (NIH/NCI) [C]; Moser, Richard (NIH/NCI) [E]; Blake, Kelly (NIH/NCI) [EI

RE: HesseB_NCI_5810_CY2011

This email is to confirm that identifying information of respondents participating in the Health Information National

Trends Survey 4 (HINTS 4) will not be released to NCI at any time. The names, addresses and other identifying

information of the survey respondents will not be included in any data provided to NCI. Individual survey responses will

be identified by an assigned ID number only. Access to the code linking the ID numbers and the personal information

will be restricted to only a few Westat staff members. Once the study is complete, the personal information will be

destroyed.

If you have additional questions about the protection of HINTS subjects, please don't hesitate to contact me.

Thank you,

Terisa Davis, MPH

Project Director, HINTS

Westat

1600 Research Boulevard

Rockville, MD 20850

Tel: 301-294-2864

terisadavis@westat.com

From: Hesse, Bradford (NIH/Ncr) [E] [mailto:hesseb@mail.nih.qov]

Sent: Wednesday, June 15, 2011 7:25 AM

To: OHSR (NIH/DDIR)

Cc: Terisa Davis - Health Studies; Finney Rutten, Lila (NIH/Ncr) [C]; Moser, Richard (NIH/Ncr) [E]; Blake, Kelly

(NIH/Ncr) [E]

Subject: RE: HesseB_NCI_5810_CY2011

This correspondence is to confirm the fact that all activities related to the Health Information National Trends Survey

(HINTS) will conform to existing collaborative protocol. Moreover, I offer confirmation that no one from the National

Cancer Institute will be in a position to seek the identity of the subjects from whom we have collected data in the HINTS

program. All of the original data files, including data files with anything resembling personal identifiable information,

while be kept in a highly secure data location housed by our contractor Westat. Westat will maintain its usual high level

of data security as specified in it s data security plan submitted to the NCI. Staff within the NCI have been briefed, and

have exercised their customarily high levels of protection for participant anonymity over the past ten years in which the

HINTS program has been collecting data.

To verify our mutual understanding, I will cc Terisa Davis, who is the Project Director at Westat. Ms. Davis will respond

with an email confirm Westat's adherence to privacy protocols as requested in your memorandum.

Thank you very much for your prompt review and concise request. If there is anything else I can do please do not

hesitate to ask .

-Brad Hesse

Bradford W. Hesse, Ph .D.
Chief, Health Comm & Informatics Research Branch
Behavioral Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
Executive Plaza North , Room 4068
6130 Executive Blvd, MSC 7365
Bethesda , MD 20892-7365
> {for express mail, use Rockville, MD 20852}

Phone: 301-594-9904
Email hesseb@mail.nih .gov

From: OHSR (NIH/DDIR)
Sent: Tuesday, June 14, 2011 3:17 PM
To: Hesse, Bradford (NIH/NCI) [EJ
Subject: HesseB_NCI_5810_CY2011
Good Afternoon Dr. Hesse:
Thank you for the opportunity to review your research project entitled "Health Information National Trends Survey 4
(HINTS 4)." Since the work you are doing at the NIH provides little or no risk to human subjects off-site, OHSR has
decided the appropriate action for you to take is the following:
1. Confirm that the work you are doing is consistent with the existing collaborative protocol.
2. Provide documentation that you will not seek the identity of the subjects who have provided the samples you will
receive.
3. Ask your collaborator to provide documentation that the identity of the subjects who have provided the samples you will
receive will not be released to you.

An e-mail from you and from the investigator(s) holding the key to the code is sufficient documentation.
This action is based on guidance issued on Aug. 10, 2004 by the HHS Office of Human Research Protections, the
regulatory office for the protection of human subjects

Best regards,

Office of Human Subjects Research
Office of Intramural Research
National Institutes of Health
Bldg 10 Room 2C146
Bethesda, MD 20892
Office Telephone: 301-402-3444
Office Fax: 301-402-3443

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------------------------...............

OHSR (NIH/DDIR)

From:
Sent:
To:
Subject:

OHSR (NIHIDDIR)

Tuesday, June 14, 2011 3:17 PM

Hesse, Bradford (NIH/NCI) [E]

HesseB_NCI_5810_CY2011

Good Afternoon Dr. Hesse:

Thank you for the opportunity to review your research project entitled "Health Information National Trends Survey 4

(HINTS 4)." Since the work you are doing at the NIH provides little or no risk to human subjects off-site, OHSR has

decided the appropriate action for you to take is the following:

1. Confirm that the work you are doing is consistent with the existing collaborative protocol.
2. Provide documentation that you will not seek the identity of the subjects who have provided the samples you will
receive.
3. Ask your collaborator to provide documentation that the identity of the subjects who have provided the samples you will
receive will not be released to you .
An e-mail from you and from the investigator(s) holding the key to the code is sufficient documentation.
This action is based on guidance issued on Aug. 10, 2004 by the HHS Office of Human Research Protections, the
.
regulatory office for the protection of human subjects.

Best regards,

Office of Human Subjects Research
Office of Intramural Research
National Institutes of Health
Bldg 10 Room 2C146
Bethesda, MD 20892
Office Telephone: 301-402-3444
Office Fax: 301-402-3443

OHSR (NIH/DDIR)
From:

Sent:
To:

Cc:
Subject:

OHSR (NIH/OOIR)
Monday, June 13, 2011 4:14 PM
Hesse, Bradford (NIH/NCI) [E]
Finney Rutten, Lila (NIH/NCI) [C]
Request for Review Rec'd-OHSRP 5810

Good afternoon Dr. Hesse,
This email is to verify that OHSR has received your Request for Review of Research and it is currently being processed as
OHSRP #5810. 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: Health Information National Trends Survey 4 (HINTS 4)
Thank you.
Sincerely,
OHSRP - National Institutes of Health
Bldg 10, Suite 2C146
Bethesda, IVID 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.

J;

Please consider the environment before printing this e-mail

1

OHSR (NIH/DDIR)

From :
Sent:

To:
Cc:
Subject:
Attachments:

OHSR (NIHIDDIR)

Thursday, June 23 , 2011 10:45 AM

Hesse, Bradford (NIH/NCI) [E]

Finney Rutten , Lila (NIH/NCI) [C] ; Grant, Nicole (NIH/NCI) [E]

Request for Review Determination_OHSRP # 5810

HesseB_NCI_5810_CY2011.pdf

Good morning Dr. Hesse,
Attached, please find OHSRP' s determination of your Request for Review of Research, OHSRP # 5810.
Please contact OHSRP with any questions.

Sincerely,
OHSRP - 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.

~ Please consider the environment before pri nllng th is e-mail

1