J1 NCI OHSR Determination

OHSRP #13204
OHSRP REQUEST FOR DETERMINATION FORM

9-11-2015

II.

SHOULD I STOP OR GO FORWARD WITH AN OHSRP SUBMISSION?

1.

Have you already started or completed your research activity
n Yes (Súop here. Please consult OHSRP.)

XNo

2.

a

ls the proposed activity a component of
,
e.g. the results of this activity will be used in support of the protocol?
n Yes (Sfop here. You will likely need to amend the NIH protocol for the proposed
activity. Please consult the IRB if you are unsure. Do not submit this request.)

XNo

3.

ls this a research collaboration in which the NIH investigator has access to
individually identifiable specimens/data (including coded specimens/data for which
the investigator has the code key), and wants to send specimensldata that are
either coded or anonymous to collaborators? lf the specimens/data are not
individually ídentifiable, but the identity of the sub7'ecfs may readily be ascertained
by the investigator or associated with the information because of a small sample
size or other reason, please answer "Yes" below.

n Yes (Sfop here. You must obtain IRB approval of an amendment to the original
protocol or IRB approval of a new protocol. Do not submit this request.)
XNo

4.

Does this activity involve prisoners?
flYes lSúop here. Please consult the lRB. Do not submit this request.)

XNo

5.

Please select the type of activity or materials involved in your project. (Select all
that apply.)

n

5a. Single Gase Report that does not contain any identifiable information
about the participant; and no changes were made to the participant's care for
the sake of reportability

¡

5b. Program Evaluation, the results of which will only be shared with the
relevant program or institution; and the participants have not been assigned to
groups for comparison; and no comparison of a standard versus non-standard
intervention is taking place

n

5c. Quality Assurance/Quality lmprovement activity with a clinical practice
focus, that does not introduce an untested clinical intervention or collect patient
outcomes for the purposes of collecting scientific evidence about how well the
intervention achieves its intended results, in which the sole purpose is to

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OHSRP REQUEST FOR DETERMINATION FORM

improve internal practice and not to also conduct research to develop or
contribute to generalizable knowledge

n

5d. Quality Assurance/Quality lmprovement activity with a non-clinical
practice focus, e.g. usability testing or evaluation of websites, workshops,
conferences, tools, policies, etc., in which the sole purpose is to improve a

product or service and not to also conduct research to develop or
contribute to generalizable knowledge

[
n

5e. Clinical Consulting
5f. Diagnostic Testing for Clinical Purposes (Other approvals may be
needed if investigationalfesfs are used. Please consult your lC FDA
representative or the FDA.)

n

Sg.Autopsy Materials, Specimens/Data from Deceased Persons (Please

n

5h. Specimens/data purchased from a commercial repository which will
contain no identifying information

n

5i. Derivatives of materials (e.9. DNA, RNA, cell fragments or sub-parts,
viruses or parasites) obtained from humans which will contain no identifying
information

n

5j. Established NIH Human Embryonic Stem Gell Lines that are available
to qualified investigators and require no ethical review according to the
registry. The cell line must be listed here:
http :/igrants. n ih.qov/stem cel ls/req istrv/cu rrent. htm and not be identifiable to

contact your privacy officer for further guidance.)

the NIH researchers.

lf 5a. - 5/. rs se/ected above, and your proposed project involves ONLY fhese
activities: SIOP answering questíons here. No submrssion or determination is
required from OHSRP or an lRB. However, other NIH policies or lC requirements
apply. Please retain this documentation for your files.

of these activities above and other activities
not listed here or involves none of these activities above, please continue with the
If your proposed project involves anv

request for determination form.

III. WHAT ADDITIONAL DOCUMENTATION MUST BE SUBMITTED TO OHSRP
WITH THE REQUEST FOR DETERMINATION FORM?
There are three categories of research that require additional documentation to be
submitted fo OHSRP wíth the request for determination form. The categories are:

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9-11-2015

OHSRP REQUEST FOR DETERMINATION FORM

PART l: GENERAL INFORMATION
This fillable form must be typed and submitted in pdf format, upon receipt of all
required signatures. This form must be completed by NIH staff only.

1.

Date of Request: 0411112016

2.

ls this a new request for determination or an amendment to a previously OHSRPapproved project? (Please note if fh,s ,s an amendment, we ask that you use your
previously submitted request for determination form to answer the questions on
this form.)
a. New project
b. Amendment
lf an amendment, provide the determination number of the original approved
project: OHSRP#:

X

n

3.

Project Name: Health lnformation National Trends Survey V (HINTS V) (NCl)

4.

Project Description (Please describe the research activity that will be performed in
lay terms, includíng its purpose. Explain the roles of the NIH investigator and
collaborator(s) on the project; and what each party will contribute to the research.
As you type, the box will increase to allow for additionaltext.):
The purpose of this study is to field Gycle V of the NCI Health lnformation
National Trends (HINTS) survey. HINTS collects nationally representative
data routinely about the American public's use of cancer-related
information and in its current iteration collects data using a probabilitybased address sample. The survey is sponsored by NGI staff, and
conducted by its contractor (Westat). NCI staff direct the design of the
study, including the survey questionnaire, and will conduct analysis of
aggregate study data, but have no contact with survey respondents, and
no access to individual identifiers.

5.

Proposed Start

Date:

0910112016

Proposed Completion Date (Required): 09/30/2018

6.

Requestor Details:
Name: Brad Hesse,
lnstitute/lC: NGI
(240)276
Phone Number:
6721
Email Address: hesseb@mail.nih.gov

PhD

7. Are you the Senior lnvestigator

(Sl) for this project? (i.e., the team lead. The term
"Sl" on this form does not refer to one's official NIH title. Ihe S/ must be an NIH
FTE,)
No
X

Yes fl

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OHSRP REQUEST FOR DETERMINATION FORM

7.1. lf no, what is your role?

n
n
n

a. Administrative Support
b. Other investigator
c. Other, specify:

B. lf not already included above,

provide Sl details (See instructions in Q.7.)

Senior lnvestigator Name:
lnstitute/lC:
Phone Number:
)
EmailAddress:

(

ït//t

Sl Signature (Required):

9.

2ot3

Supervisor Name: William Kl
, PhD
(Please note the supervisor cannot be a member of the research team for this
specific project.)
I (the supervisor) certify that the lC concurs that this project may proceed if it
meets regulatory and NIH policy requ
en
I

Supervisor Signature

Date:

10. ls there someone other than the Sl,

ducting this
investigator, contractor, fellow, student, etc.)?
n No

e.

IJJJJJL
BFe

a JUntor

XYes
10.1

.

rf

rovide the followi
information
NIH lnvestigator Name: Richard Moser, PhD
lnstitute/lC Name: NCI
Email Address: moserr@mail.nih.gov

11. Please provide the name(s) and email(s) of anyone else, who should receive a

of the OHSRP determination
Name: Gordon Wills

Email

Address:

Willisg@mail.nih.gov
Name
Name

Email Address
Email Address

12.What role(s) will the NIH lnvestigator(s) have on this research project? (Select all
that apply.)
a. lnteracting directly with subjects to collect specimens/data
X b. Receiving specimens/data from a collaborator to conduct research
X c. Analyzing specimens/data

n

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OHSRP REQUEST FOR DETERMINATION FORM

9-11-2015

! d. Generating genomic data (e.9. GWAS, WES/WGS; Additional NIH
requirements may apply: http:i/ods.nih.gov/O3policy2.html /
! e. Running laboratory assays for research
E f. Sending specimens/data to a collaborator to conduct research
n g. lnteracting directly or indirectly with subjects to recruit for or conduct surveys,
X
X
I

interviews/focus groups, observation of public behavior, educational research
or tests, or research on public benefit or service programs
h. Consulting/advising the collaborator(s)
i. Authoring publication(s)/manuscript(s) pertaining to this research
j. Other, specify'.

13.Will the Sl be collaborating on this research project with any other person (nof
on the NIH research team) outside or inside the NIH?

XYes nNo

13.1. lf no, will the senior investigator only be sending specimens/data to
someone not on the research team?
n
n No (lf yes, please still add úhese individuals under Q.14 below.)

Yes

14. Please include the details of each collaborator, his or her role, and when

applicable, what will be sent or received. For any more than three collaborators,
please provide the information requested below in the email request at the time of
submission. Provide the Federalwide Assurance (FWA). number for each non-NIH
collaborating institution (for more information contact OHSRP). Ask your
collaborator for the FWA number or use fhrs link to look it up:
http://ohrp.cit. n ih.qov/search/fwasearch.aspx?styp=bsc
*A Federalwide Assurance (FWA) rs issued
by the U.S. Department of Health and
(DHHS)/Office
Human Servrces
of Human Research Protections (OHRP) to
institutions whích receive Federal funds/support to conduct non-exempt human
subT'ecfs research. An FWA rs an assurance of compliance with the U.S. Federal
Policy for the Protection of Human SubT'ecfs, 45 C.F.R. 46.

a.

Collaborator Name: Terisa Davis
lnstitution/lC Name: Westat, lnc
FWA #:55551
City/State/Country: Rockville, MD
Email Address: TerisaDavis@westat.com
Receiving specimens/data:
Sending specimens/data:
Both:
Describe what will be senUreceived:Ms. Davis is the contractor study

!

X

n

manager having overall responsible for survey design, conduct, and data
file proeduction and delivery to NCl.

b. Collaborator

Name

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9-11-2015

OHSRP REQUEST FOR DETERMINATION FORM

lnstitution/lC Name:
FWA #
City/State/Country:
Email Address
Sending specimens/data:
Receiving specimens/data:
Describe what will be senUreceived

n

n

Both:

n

c.

Collaborator Name
lnstitution/lC Name:
FWA #:
City/State/Country:
Email Address:
Send ing specimens/data
Receiving specimens/data:
Describe what will be senUreceived:

n

n

Both

tr

15. For this project, will NIH be conducting a research activity with de-identified
specimens or data in support of FDA-requlated research that is currently under

IRB review at another institution?
X No

nYes

15.1 lf yes, has the collaborator confirmed that the planned research activity,
which will occur at NlH, is included in the IRB/ethics committee-approved
protocol and consent form at his/her institution?
a. Yes, the NIH activity is |RB-approved at the collaborating institution
b. No, the NIH activity has not yet been |RB-approved at the collaborating
institution (Sfop here. Do not submit this request until your collaborator
has confirmed IRB approval at his or her institution.)

n
n

16. Does this activity include any of the following? (Se/ect all that apply.)

E a. NIH research team is interacting directlv with subjects in person or has

access to identifiers to conduct survey, interview/focus group procedures,
observation of public behavior, educational tests, educational research, or
research on public benefit or service programs (lf a. only, skip to question 25.,
otherwise continue,)
X b. Research with Specimens/Data
n c. NIH BTRIS Query
n d. Case Series
I e. Program Evaluation (not meeting the definition ín the Instructions, Part ll, Q.

n
n

5b.)
f. OA/OI (not meeting the definition in the lnstructions Part ll, Q. 5c. or 5d.)
g.Other, specify:

16.1

.

lf e. or f. is selected above, does the activity involve the NIH research team
interacting directly with subjects in person or access to identifiers to
conduct survey, interview, or focus group procedures only?
Yes (Skip to question 25.)

!

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OHSRP REQUEST FOR DETERMINATION FORM

n No (Continue.)
PART ll: RESEARCH WITH SPECIMENS AND DATA
l T.ldentify the types of specimens/data involved in this project. (Se/ecf alt that appty.)
a. Medical Records, specify:
b. Specimens, specify:
c.
X Data, specify: Answers to survey questions
d. lmaging, specify:
e. Pathological Waste/Results
f. Autopsy Materials/Specimens/Data from deceased persons (P/ease contact
your privacy officer for further guidance.)
g.Audio Recording
h. Video Recording/Conferencing
i. Fetal Tissue Additional NIH requirements apply:
https://oir.nih.qov/sourcebooldethical-conduct/research-ethics/fetal-tissueresearch
j. IPSC lines (Additional NIH requirements apply:
httos://oir.nih.qov/sourcebooldethical-conduct/research-ethics/use-human-

I
tr
n
n
!
n
n
n
n
n

nes-h u m a n -em b ryo n c-i n d u ced-p u ri pote nt-ste m-ce ls
k. hESC lines (Additional NIH requirements apply:
httos://oir nih oov/sorrrcebook/ eth ical-conduct/research-eth ics/use-h u ma n-

ste m-ce I ls/q

u id e

I

i

i

I

I

stem-cells/quidelines-human-embrvonic-induced-pluripotent-stem-cells
AND
https://oir.nih.qov/sourcebooldethical-conducUresearch-ethics/use-humanstem-cel ls/areas-proh bited-research
L WESA/VGS
m. GWAS
n. From a repository
lf an NIH Repository, specify:
o. From a publicly available source (meaning unrestricted access by anyone),
specify:
p.Other, specify:
i

n
n
n
n
n

18. Do all the specimens ldata or information already exist?

n
I
n

19.

a. Yes

b.No
c. Some exist, and other specimens/data will be collected in the future

The specimens/data in this project were (or will be) originally collected for:
a. Clinical purposes only
X b. Research purposes (even if also collected for clinical purposes)

n

20.ls there active IRB/ethics committee approval for the use of the specimens/data at
your collaborator's site?

XYes E

No

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OHSRP REQUEST FOR DETERMINATION FORM

21.Can you identify the subjects, who are the source of the specimens or data,
directly or through codes linked to individual identifiers? n Yes X No
22.Please select the response(s) that best describe(s) the specimens/data that will be
shared/used for this activity. (Please confirm this with your collaborator prior to
submitting this form.)

I

a. Specimens/data will not contain any identifiable information, and cannot be
linked to individual subjects by you or your collaborators.

!

b. Specimens/data will be coded, however that code cannot be used by
either the sender or the receiver to identify specific individuals.

E

c. Specimens/data will be coded so that the sender of the samples/data can
link them to specific individuals, but the receiver will not be able to do so.

n
!

d. Specimens/data will contain individually identifiable information
e. Specimens/data currently contain identifiable information but data will be
recorded in such a manner that subjects cannot be identified directly, or
through identifiers linked to subjects (e.9. a retrospective chart review),
or an honest broker will be utilized for de-identification.

23.|f existing identifiable specimens/ data will be de-identified (including coded) before
the research activity commences, please indicate who will conduct the deidentification:
a. Collaborator(s)
b. Senior investigator or a member of the research team at the NIH
c. Honest broker (For use only when identified specimens or data are coming
from an NIH investigator; must be someone who will not be conducting the
research) (The agreement can be found here:
https ://federation. n h.qov/ohsr/n h/formtm p. ph p ( N I H Log i n req u i red))

I
n
n

i

i

24.Wil recipient of specimens/data be returning results to the sender? (Se/ecf all that
apptv)
n a. Yes, coded results will be returned to the sender who can link them to
individual subjects
b. Yes, coded results will be returned, but neither the sender nor the recipient
will have a link to the code key
n c. Only aggregate results will be returned (e.9. summary statistics, not
individual line-item data)
d.
X No, results will not be returned

I

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OHSRP REQUEST FOR DETERMINATION FORM

241. lf a.- c. is selected above AND the sender is external to NlH, is there
IRB/ethics committee approval at his or her institution for the planned
research activity to be conducted at NIH? n Yes n No

For allreguesús, other than those involving suruey, interuiewlfocus group
procedures, observation of public behavior, educational research or fesfs, or
research on public benefit or seruice programs, stop here. Otherwise, continue
to Part lll.
Prior to submitting, review the instructions to insure that you include the correct
supportive documentation. All documentation should be submitted in .pdf format
via email fo OHSRP to ohsr nih ddir@od.nih.qov. Please write 'Request for
Review' in the subject line of the e-mail.

PART lll: RESEARCH INVOLVING EDUCATIONAL RESEARCH OR TESTING,
SURVEY OR INTERVIEW PROCEDURES, OR OBSERVATION OF PUBLIC
BEHAVIOR
2S.Specify the nature of the data to be collected by: (Se/ect allthat apply)
a. Educational Research
b. Educational Testing
c. Survey or lnterview/Focus Group Procedures
d. Observation of public behavior
e. Research on public benefit or service programs
f. Other, specify:

n
!
X
tr
n
n

allthat apply)
a. ln-person at my collaborator's institution(s) or research site(s),
specify:
b. ln-person at an NIH site
c. ln-person at another site(s), specify:
d. Online
e. Over the phone
f. Other, specify: By mail

26. How will recruitment and data collection take place? (Select

n
n
n
n
n
I

27.Who will be conducting the data collection? (Se/ecf allthat apply)
a. NIH investigator or another member of the research team
b. Non-NlH collaborator
X c. Off-site contractor, specify what company: Westat
d. Online survey tool, specify:
e. Other, specify:

n
n
n
n

28.What is the age range of subjects involved in the research?
a. Children aged < 18 years
X b. Adults aged >18 years

!

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OHSRP REQUEST FOR DETERMINATION FORM

28.1. lf a. is selected above, and the project involves observation of public
behavior, will the NIH investigato(s) participate in the activities being
observed?

!Yes E No
29. Does your project fall into any of the categories of 'clinical research' as defined by
the N I H? (See http://grants. nih.qov/qrantsiglossary. htm#ClinicalResearch for the
full NIH definition of 'clinical research'.)

n
n

X

a. Epidemiological and behavioral studies*
b. Outcomes research and health services research*
c. NONE OF THE ABOVE

*lf you a. or b. rs se/ecfed above, please be sure to include the 'Planned
Enrollment' Table described in Part II of the instructions.

Prior to submitting, revíew the instructions to insure that you include the correct
supportive documentation. All documentation should be submitted in .pdf format
via email fo OHSRP to ohsr nih ddir@od.nih.qov. Please write 'Request for
Review' in the subject line of the e-mail.

DH HS/N I H/OD/OI RYOH S RP

13

Eiserman, Julie (NIH/OD) [C]
From:
Sent:
To:
Cc:
Subject:
Attachments:

Willis, Gordon (NIH/NCI) [E]
Monday, April 25, 2016 2:47 PM
Eiserman, Julie (NIH/OD) [C]
Moser, Richard (NIH/NCI) [E]; Terisa Davis (TerisaDavis@westat.com); Hesse, Bradford
(NIH/NCI) [E]
RE: Response Request re: Request for Determination for OHSRP #13204
Appendix C - Draft Cycle 1 Instrument.pdf; Appendix H - IRB Approval.pdf; Appendix B
- Letters & FAQs.pdf

Hi Julie: 

HINTS was Approved by Westat via Expedited Approval (Appendix H – IRB Approval, attached).  

The draft questionnaire is Appendix C – Draft Cycle 1 Instrument. 

Because this is a mail survey, there isn’t a signed consent form, but I have also included the letters that are to be sent 
with the questionnaire. 

The Attachments are selected materials from the OMB package we are putting together – if you would like any other 
info, please just let me know. 

Thanks much, as always – 

Gordon 

Gordon Willis, PhD 
BRP/NCI 

From: Eiserman, Julie (NIH/OD) [C]
Sent: Monday, April 25, 2016 1:22 PM
To: Hesse, Bradford (NIH/NCI) [E]
Cc: Moser, Richard (NIH/NCI) [E]; Willis, Gordon (NIH/NCI) [E]
Subject: Response Request re: Request for Determination for OHSRP #13204
Importance: High

Hello Dr. Hesse, 

When other sites are conducting research projects for NIH (the research has been designed by NIH), my supervisor has 
asked me to collect additional information about the project as part of the approval process.  Could you find out if 
Westat has received an exemption, expedited or full committee IRB approval for the project?  Could you also please 
send me a copy of the information sheet/consent form AND the instrument that will be used with the subjects? 

Thank you. 

Julie M. Eiserman, MA, CCRP [C] 
Health Science Policy Analyst 
Office of Human Subjects Research Protections 

1

Office of Intramural Research, Office of the Director 
National Institutes of Health 
10 Center Drive, Bldg. 10, Suite 2C146 
Bethesda, MD  20892‐1154 
Direct Phone: 301‐402‐8665 
Fax: 301‐402‐3443 
Email: julie.eiserman@nih.gov 
Site for the request for determination form: https://federation.nih.gov/ohsr/nih/formtmp.php 
OHSRP website: https://federation.nih.gov/ohsr/nih/index.php (NIH login required) 
Public site: http://ohsr.od.nih.gov/  

2

Date:

March 28, 2016

To:

Marsha Dunn, Project Director

From:

Sharon Zack

Subject:

Sharon Zack, Primary Reviewer, Westat IRB I am the author of this document
Expedited Approval of HINTS, Project Number 6048.14
FWA 00005551

I reviewed the materials submitted for the following: HINTS, Project Number 6048.14. The
Westat IRB reviews all studies involving research on human subjects. This project is funded by the
National Cancer Institute.
The purpose of HINTS 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. There have been multiple previous rounds of HINTS data collection
since 2003.
Westat will conduct the data collection.
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 46.117(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 required 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 March 28, 2017.
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
Alicia Sutherland

APPENDIX B: Cover letters and FAQs

FIRST MAILING
Dear {City} Resident:
We are writing to invite you to take part in an important national survey sponsored by the U.S.
Department of Health and Human Services, the Health Information National Trends Survey (HINTS).
The goal of HINTS is to learn what health information people want to know and where they try to
find it. By completing this questionnaire, you will help us learn what health information you need and
how to make that information available to you, your family and your community.
In order to make sure we get responses from a random sample of people, we ask that the adult in
your household with the next birthday complete and return this questionnaire in the next two
weeks.
Your participation is voluntary and your responses will not be linked to your name. We have enclosed
$2 as a token of our appreciation for your participation.
You can find out more about HINTS at hints.cancer.gov. Westat, a research firm, will conduct the
survey. If you have any questions about HINTS {or if you need more questionnaires}, or if you would
like to complete this survey in a language other than English or Spanish, please call Westat toll-free at
1-888-738-6805.
Thank you in advance for your cooperation.
Sincerely,

Bradford W. Hesse, Ph.D.
HINTS Project Officer
National Institutes of Health
U.S. Dept of Health and Human Services

Si prefiere recibir la encuesta en español, por favor llame al 1-888-738-6812.
The Health Information National Trends Survey is authorized under 42 USC, Section 285A.

HINTS-FDA Methodology Report

A-1

POSTCARD TEXT
A few days ago you should have received a questionnaire packet asking for your household’s
participation in the Health Information National Trends Survey. By completing the
questionnaire, you can help the U.S. Department of Health and Human Services determine the
best ways of communicating important health information to members of your community.
We are inviting the adult in the household with the next birthday to complete the questionnaire. If that adult has already
completed the questionnaire and returned it to us, please accept my sincere thanks. If that adult has not yet completed and
returned the questionnaire, we ask that he or she please do so as soon as possible.
Your household’s participation is important to the study’s success.

Sincerely,

Bradford W. Hesse, Ph.D.
HINTS Project Officer
National Institutes of Health
U.S. Dept. of Health and Human Services

SECOND AND THIRD MAILINGS

Dear {City} Resident:
We recently invited you to participate in an important national survey sponsored by the U.S.
Department of Health and Human Services (HHS). The goal of the Health Information National Trends
Survey (HINTS) is to learn what health information people want to know and where they go to find it.
Your responses will help us keep you, your family and members of your community better informed
on the health issues that matter to you.
We have not yet received your completed questionnaire. To make sure HINTS provides accurate
information, we need all the households invited to participate in this year’s HINTS to complete the
survey. If you did send back your survey and it crossed in the mail with this letter, thank you for the
time you took to help make this study a success. In the event that your questionnaire was misplaced,
an additional copy is enclosed.
In order to make sure we get responses from a random sample of people, we ask that the adult in
your household with the next birthday complete and return this questionnaire in the next two
weeks.
Additional information about HINTS is available at: hints.cancer.gov. If you have any questions,
or would like to complete this survey in a language other than English or Spanish, please call
Westat toll free at 1-888-738-6805.
Thank you in advance for contributing to this important national study.
Sincerely,
Bradford W. Hesse, Ph.D.
HINTS Project Officer
National Institutes of Health
U.S. Dept of Health and Human Services

Si prefiere recibir la encuesta en español, por favor llame al 1-888-738-6812.
The Health Information National Trends Survey is authorized under 42 USC, Section 285A.

FIRST MAILING – SPANISH (sent upon request)

Estimado residente de {City}
Le escribimos para invitarlo a participar en una importante encuesta nacional: Encuesta Nacional de
Tendencias de Información sobre la Salud (HINTS, por sus siglas en inglés). Esta encuesta está
patrocinada por el Departamento de Salud y Servicios Humanos de Estados Unidos.
El objetivo de HINTS es averiguar qué información sobre la salud les interesa saber a las personas y
dónde tratan de buscarla. Complete este cuestionario para ayudar a averiguar la información sobre la
salud que usted necesita y cómo ponerla a disposición suya, de su familia y de su comunidad.
Para asegurarnos de obtener respuestas que contengan un muestreo aleatorio de la población, le
pedimos que el adulto en su hogar con el próximo cumpleaños, complete y devuelva este
cuestionario en las próximas dos semanas.
Su participación es voluntaria y sus respuestas no se asociarán con su nombre. Hemos incluido $2
dólares como símbolo de nuestro agradecimiento por su participación.
Usted podrá encontrar más información sobre HINTS en el sitio web hints.cancer.gov. La compañía
de estudios de investigación Westat está realizando esta encuesta. Si tiene alguna pregunta sobre
HINTS o le gustaría completar esta encuesta en otro idioma distinto al inglés o español, llame a
Westat al siguiente número de teléfono libre de cargo, 1-888-738-6812.
Gracias de antemano por su cooperación.
Atentamente,
Bradford W. Hesse, Ph. D.
Oficial del Proyecto HINTS
Institutos Nacionales de la Salud
Departamento de Salud y Servicios Humanos de
EE.UU.
La Encuesta Nacional de Tendencias de Información sobre la Salud está autorizada bajo la Sección 285A del USC 42.

HINTS-FDA Methodology Report

B-1

SECOND MAILING - Spanish

Estimado residente de {City}:
Recientemente lo invitamos a participar en una importante encuesta nacional patrocinada por el
Departamento de Salud y Servicios Humanos de Estados Unidos. El objetivo de la Encuesta Nacional
de Tendencias de Información sobre la Salud (HINTS, por sus siglas en inglés) es averiguar cuál es la
información sobre la salud que las personas quieren saber y dónde van a buscarla. Sus respuestas nos
ayudarán a mantenerlo mejor informado a usted, a sus familiares y a los miembros de la comunidad
sobre los temas de salud que les interesan.
Aún no hemos recibido su cuestionario completado. Para poder estar seguros de que HINTS provea
información acertada, necesitamos que todos los hogares invitados a participar en la encuesta este
año, la completen. Si usted ya nos envió de regreso su encuesta y se cruzó con esta carta en el
correo, le agradecemos por el tiempo que se tomó para contribuir al éxito de este estudio. En caso
que su cuestionario se haya extraviado, adjuntamos una copia adicional.
Para asegurarnos de obtener respuestas que contengan un muestreo aleatorio de la población, le
pedimos que el adulto en su hogar con el próximo cumpleaños, complete y devuelva este
cuestionario en las próximas dos semanas.
Usted podrá encontrar más información sobre HINTS en el sitio web hints.cancer.gov. Si usted
tiene preguntas o le gustaría completar esta encuesta en otro idioma distinto al inglés o
español, llame a Westat al número libre de cargo, 1-888-738-6812.
Gracias de antemano por contribuir al éxito de este importante estudio nacional.
Atentamente,
Bradford W. Hesse, Ph. D.
Oficial del Proyecto HINTS
Institutos Nacionales de la Salud
Departamento de Salud y Servicios Humanos de
EE.UU.
La Encuesta Nacional de Tendencias de Información sobre la Salud está autorizada bajo la Sección 285A del USC
42.

D-2

w

Health Information National Trends Survey 4 (HINTS 4)

THIRD MAILING - Spanish

Estimado residente de {City}:
Recientemente lo invitamos a participar en una importante encuesta nacional patrocinada por el
Departamento de Salud y Servicios Humanos de Estados Unidos, la Encuesta Nacional de Tendencias de
Información sobre la Salud (HINTS, por sus siglas en inglés). El completar esta encuesta nos ayudará a
mantenerlos mejor informados en asuntos de salud que usted y su familia consideran importantes.
Si usted ya envió de regreso su encuesta y se cruzó con esta carta en el correo, le agradecemos por el
tiempo que se tomó para contribuir al éxito de este estudio.
Si aún no ha tenido la oportunidad de completar la encuesta, comprendemos que a veces es difícil
encontrar el tiempo para participar en un estudio como HINTS. Para reducir la cantidad de tiempo que va
a tomarle, hemos incluido una versión más corta de la encuesta. Esta versión corta se concentra en
asuntos que nos informan la manera como personas como usted buscan y utilizan información sobre la
salud.
Para asegurarnos de obtener respuestas que contengan un muestreo aleatorio de la población, le
pedimos que el adulto en su hogar con el próximo cumpleaños, complete y devuelva este cuestionario
en las próximas dos semanas.
Usted podrá encontrar más información sobre HINTS en el sitio web hints.cancer.gov. Si usted tiene
preguntas o le gustaría completar esta encuesta en otro idioma distinto al inglés o español, llame a
Westat al número libre de cargo, 1-888-738-6812
Gracias de antemano por contribuir con este importante estudio nacional.
Atentamente,
Bradford W. Hesse, PhD.
Oficial del Proyecto HINTS
Institutos Nacionales de la Salud
Departamento de Salud y Servicios Humanos de EE.UU.
La Encuesta de Nacional de Tendencias de Información sobre la Salud está autorizada bajo la Sección 285A del USC 42.

HINTS-FDA Methodology Report

C-1

Some Frequently Asked Questions about the
Health Information National Trends Survey
Q:

What is the study about? What kind of questions do you ask?

A:

The study concerns health and how people receive health information. For example, we will ask
how you usually get information about how to stay healthy, the sources of information you most
trust, and how you might like to get such information in the future. We will also ask about your
beliefs on what contributes to good health, how best to prevent cancer, your participation in
various health-related activities, and related topics.

Q:

How will the study results be used? What will be done with my information?

A:

Findings will help the U.S. Department of Health and Human Services promote good health and
prevent disease by determining ways of better communicating accurate health information to
Americans.

Q:

How did you get my address?

A:

Your address was randomly selected from among all of the known home addresses in the nation.
It was selected using scientific sampling methods.

Q:

Why should I take part in this study? Do I have to do this?

A:

Your participation is voluntary, and you may refuse to answer any questions or withdraw from the
study at any time. However, your answers are very important to the success of this study and will
represent thousands of others. Getting an answer from all the households chosen for the study is
the best way to make sure the study results reflect the thoughts and opinions of all Americans.

Q:

Will my answers to the survey be kept private?

A:

Yes. Your answers will be kept private under the Privacy Act. Your answers cannot be connected
to your name or any other information that could identify you or your household, to the extent
provided by law. The completed questionnaires will be stored in a separate file with restricted
access. Both the paper and electronic versions of the information will be destroyed shortly after
the research is finalized.

Q:

How long will it take to answer the questions?

A:

About 20 to 30 minutes.

Q:

Who is sponsoring the study? Is this study approved by the Federal Government?

A:

The study is sponsored by the U.S. Department of Health and Human Services. The study has
been approved by the Office of Management and Budget (OMB), the office that reviews all
federally-sponsored surveys. The OMB approval number assigned to this study is 0925-0538.

Q:

Who is Westat?

A:

Westat is a research company located in Rockville, Maryland. Westat is conducting this survey
under contract to the U.S. Department of Health and Human Services.

HINTS-FDA Methodology Report

C-2

Preguntas Frecuentes Encuesta Nacional de Tendencias
de Información sobre la Salud
P:

¿De qué se trata el estudio? ¿Qué tipo de preguntas contiene?

R:

El estudio trata sobre la salud y la manera en que las personas reciben información sobre la salud.
Por ejemplo, le preguntaremos cómo obtiene normalmente información sobre cómo mantenerse
saludable, el tipo de información en la que más confía y cómo le gustaría obtener dicha
información en el futuro. También le preguntaremos sobre lo que cree que contribuye a la buena
salud, cómo prevenir mejor el cáncer y su participación en varias actividades afines.

P:

¿Cómo se utilizarán los resultados del estudio? ¿Qué se hará con mi información?

R.

Los hallazgos ayudarán al Departamento de Salud y Servicios Humanos de EE.UU. a fomentar la
buena salud y prevenir las enfermedades mediante la determinación de formas de comunicar
mejor la información sobre la salud a los estadounidenses.

P:

¿Cómo obtuvieron mi dirección?

R:

Su dirección fue seleccionada al azar entre todas las direcciones conocidas en la nación usando
métodos científicos de muestreo.

P:

¿Por qué debo participar en este estudio? ¿Es obligatorio hacerlo?

R:

Su participación es voluntaria y usted puede rehusarse a contestar cualquiera de las preguntas o
retirarse del estudio en cualquier momento. Sin embargo, sus respuestas son muy importantes
para el éxito de este estudio y representan a miles de personas. El obtener respuesta de todos los
hogares escogidos para este estudio es la mejor manera de asegurar que éste refleje los
pensamientos y opiniones de todos los estadounidenses.

P:

¿Se mantendrá la privacidad de mis respuestas a la encuesta?

R.

Sí. Se mantendrá la privacidad de sus respuestas en virtud de la Ley de Privacidad. Sus respuestas
no pueden asociarse a su nombre ni a ninguna otra información que podría identificarlo a usted o
a su hogar en la medida de lo permisible por ley. Los cuestionarios completos se almacenarán en
un archivo separado con acceso restringido. Las versiones impresas y electrónicas de la
información se destruirán poco después de la finalización de la encuesta.

P:

¿Cuánto tiempo tomará responder las preguntas?

R:

Cerca de 20 a 30 minutos.

P:

¿Quién patrocina el estudio? ¿Está este estudio aprobado por el Gobierno Federal?

R:

El estudio es patrocinado por el Departamento de Salud y Servicios Humanos de EE.UU. El
estudio ha sido aprobado por la Oficina de Administración y Presupuesto (OMB, por sus siglas en
inglés). Esta oficina revisa todas las encuestas patrocinadas federalmente. El número de
aprobación asignado por la OMB para este estudio es 0925-0538.

P:

¿Quién es Westat?

R.

Westat es una compañía de estudios de investigación ubicada en Rockville, Maryland. Westat
realiza esta encuesta en virtud de un contrato con el Departamento de Salud y Servicios Humanos
de EE.UU.

HINTS-FDA Methodology Report

C-3

APPENDIX C: DRAFT CYCLE 1 INSTRUMENT
OMB No.: 0925-0538
Expiration Date: XX/XX/XXXX

1

START HERE:

1.

Is there more than one person age 18 or older living in this household?
Yes
No

GO TO A1 on the next page

2.

Including yourself, how many people age 18 or older live in this household?

3.

The adult with the next birthday should complete this questionnaire. This way,
across all households, HINTS will include responses from adults of all ages.

4.

Please write the first name, nickname or initials of the adult with the next birthday.
This is the person who should complete the questionnaire.

Si prefiere recibir la encuesta en español, por favor llame 1-888-738-6812

STATEMENT OF PRIVACY: Collection of this information is authorized by The Public Health Service Act, Sections 411 (42 USC 285 a) and 412 (42
USC 285a-1.a and 285a1.3). Rights of study participants are protected by The Privacy Act of 1974. Participation is voluntary, and there are no penalties
for not participating or withdrawing from the study at any time. Refusal to participate will not affect your benefits in any way. The information collected in
this study will be kept private under the Privacy Act and will only be seen by people authorized to work on this project. The report summarizing the
findings will not contain any names or identifying information. Identifying information will be destroyed when the project ends.
NOTIFICATION TO RESPONDENT OF ESTIMATED BURDEN: Public reporting burden for this collection of information is estimated to average 30
minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC
7974, Bethesda, MD 20892-7974, ATTN: PRA (0920-0538). Do not return the completed form to this address.

1

A: Looking For Health Information
A1. Have you ever looked for information about
health or medical topics from any source?
Yes
No

A5. Based on the results of your most recent
search for information about health or
medical topics, how much do you agree or
disagree with each of the following
statements?

GO TO A6 in the next column

A2. The most recent time you looked for
information about health or medical topics,
where did you go first?
MarkX only one.
Books
Brochures, pamphlets, etc.
Cancer organization
Family
Friend/Co-worker
Doctor or health care provider
Internet
Library
Magazines
Newspapers
Telephone information number
Complementary, alternative, or unconventional
practitioner

A3. The most recent time you looked for
information about health or medical topics,
who was it for?

a. It took a lot of effort to get the
information you needed ............................
b. You felt frustrated during your
search for the information.........................
c.

You were concerned about the
quality of the information ..........................

d. The information you found was
hard to understand ................................

A6. Overall, how confident are you that you
could get advice or information about
health or medical topics if you needed it?
Completely confident
Very confident
Somewhat confident
A little confident
Not confident at all

A7. In general, how much would you trust
information about health or medical topics
from each of the following?

Myself
Someone else
Both myself and someone else
a. A doctor ....................................................
b. Family or friends ................................

A4. Have you ever looked for information about
cancer from any source?
Yes
No

GO TO A6 in the next column

c.

Newspapers or magazines .......................

d. Radio ........................................................
e. Internet .....................................................
f.

Television .................................................

g. Government health agencies ...................
h. Charitable organizations ...........................
i.

Religious organizations and
leaders ......................................................

1

A8. Imagine that you had a strong need to get
information about health or medical topics.
Where would you go first?

B3.

How often do you access the Internet
through each of the following?

MarkX only one.

Books
Brochures, pamphlets, etc.
Cancer organization
Family
Friend/Co-worker
Doctor or health care provider
Internet
Library
Magazines
Newspapers
Telephone information number
Complementary, alternative, or unconventional
practitioner
Other-Specify

B: Using the Internet to Find Information
B1. Do you ever go on-line to access the
Internet or World Wide Web, or to send
and receive e-mail?
Yes
No

GO TO B4 in the next column

o
o

o

o

o

o

a. Computer at home................................
b. Computer at work ................................
c.

Computer at school ................................

d. Computer in a public place
(library, community center,
other) ........................................................
e. On a mobile device (cell
phone/smart phone/tablet) .......................
f.

On a gaming device/ “Smart
TV” ............................................................

g. Other ........................................................

B4. Please indicate if you have each of the
following.
Mark X all that apply.
Tablet computer like an iPad, Samsung Galaxy,
Motorola Xoom, or Kindle Fire
Smartphone, such as an iPhone, Android,
Blackberry, or Windows phone
Basic cell phone only

B2. When you use the Internet, do you access
it through...

I do not have any of the above

Yes No

a. A regular dial-up telephone line ...............
b. Broadband such as DSL, cable or FiOS ..
c.

A cellular network (i.e., phone, 3G/4G) ....

d. A wireless network (Wi-Fi) .......................

2

B5. On your tablet or smartphone, do you have
any software applications or “apps” related
to health?
Yes
No
GO TO B7
Don’t know
GO TO B7
Do not have a
tablet or smartphone
GO TO B7

B9.Sometimes people use the Internet to
connect with other people online through
social networks like Facebook or Twitter.
This is often called “social media”.
In the last 12 months, have you used the
Internet for any of the following reasons?
Yes No

B6. Have these apps done any of the
following?

a. Visited a social networking site, such as
Facebook or LinkedIn ...............................
Yes No

a. Helped you achieve a health-related
goal such as quitting smoking, losing
weight, or increasing physical activity ......
b. Helped you make a decision about how
to treat an illness or condition ..................
c.

B7.

Led you to ask a health care provider
new questions, or to get a second
opinion from another health care
provider ....................................................

Have you used an electronic device or
application that monitors or tracks your
health within the last year? Examples
include electronically tracking your fitness,
monitoring your blood glucose levels or
blood pressure.
Yes
No
GO TO B9
Don’t know
GO TO B9

B8.Have you shared health information from the
monitoring device with a health care
provider/professional within the last year?

b. Shared health information on social
networking sites, such as Facebook or
Twitter .......................................................
c.

Wrote in an online diary or blog (i.e.,
Web log) ...................................................

d. Participated in an online forum or
support group for people with a similar
health or medical issue ............................
e. Watched a health-related video on
YouTube ...................................................

B10. In the past 12 months, have you used the
Internet to look for information about
cancer for yourself?
Yes
No

B11. Have you sent or received a text message
from your healthcare provider within the
last year?
Yes
No
Don’t know

Yes
No
Don’t know

3

C: Your Health Care
C1. Not including psychiatrists and other
mental health professionals, is there a
particular doctor, nurse, or other health
professional that you see most often?

C5. The following questions are about your
communication with all doctors, nurses, or
other health professionals you saw during
the past 12 months.

Yes
No

C2. Do you have any kind of health care
coverage, including health insurance,
prepaid plans such as HMOs, or
government plans such as Medicare?
Yes
No

C3.

About how long has it been since you last
visited a doctor for a routine checkup? A
routine checkup is a general physical
exam, not an exam for a specific injury,
illness, or condition.
Within past year
(anytime less than 12 months ago)
Within past 2 years
(1 year but less than 2 years ago)
Within past 5 years
(2 years but less than 5 years ago)
5 or more years ago
Don't know
Never

C4. In the past 12 months, not counting times
you went to an emergency room, how
many times did you go to a doctor, nurse,
or other health professional to get care for
yourself?

How often did they do
each of the following?
a. Give you the chance to ask all
the health-related questions you
had ............................................................
b. Give the attention you needed to
your feelings and emotions ......................
c.

Involve you in decisions about
your health care as much as you
wanted ......................................................

d. Make sure you understood the
things you needed to do to take
care of your health ................................
e. Explain things in a way you
could understand ................................
f.

Spend enough time with you ....................

g. Help you deal with feelings of
uncertainty about your health or
health care ................................................

C6.

Overall, how would you rate the quality of
health care you received in the past 12
months?
Excellent
Very good
Good
Fair
Poor

None
GO TO D1 on the next page
1 time
2 times
3 times
4 times
5-9 times
10 or more times

4

C7. In the past 12 months, when getting care
for a medical problem, was there a time
when you...
Yes No

a. Had to bring an X-ray, MRI, or other type
of test result with you to the
appointment? ...........................................
b. Had to wait for test results longer than
you thought reasonable? .........................
c.

Had to redo a test or procedure because
the earlier test results were not
available? .................................................

d. Had to provide your medical history
again because your chart could not be
found? ......................................................
e. Had to tell a health care provider about
your medical history because they had
not gotten your records from another
health care provider? ...............................
f.

Have had to put together your medical
information across your health care
providers? ................................................

D: Medical Records
D1. Do any of your doctors or other health care
providers maintain your medical
information in a computerized system?
Yes
No – GO TO D5

D2. Does the doctor, nurse, or other health
professional that you see most often
maintain your medical information in a
computerized system?
Yes
No

D3. Within the last 12 months, have you
requested that your medical record be sent
electronically –that is, by computer or other
device - to another health care provider?
Electronic does not include telephone, mail
or fax.
Yes
No – GO TO D4

D4. Did the provider agree to send the medical
record electronically?
Yes
No
Do not know

D5. During the past 12 months, has a medical
laboratory given you direct access to any
test results, such as blood test results, in
either paper or electronic format?
Yes
No – GO TO D7

D6. In what format did the medical laboratory
provide the test results – paper or
electronic?
Paper
Electronic
Both paper and electronic

5

D7. Have you ever been offered online access
to your medical record by your…
Yes No

a. health care provider? ...............................
b. health insurer? .........................................

[If you answered no to D7a and D7b, go to D18.
Otherwise, go to D8]
D8. How many times did you access your
online medical record in the last 12
months?
None
1 to 2 times – GO TO D10
3 to 5 times – GO TO D10
6 to 9 times – GO TO D10
10 or more times – GO TO D10

D10. How do you view your online medical
record?
Mark all that apply
Smartphone app
Health provider or health insurer’s patient portal
or website
Software that combines medical records from all
your health providers (e.g. personal health record)
Other:_____________________________

D11. How easy or difficult was it to understand
the health information in your online
medical record?
Very easy
Somewhat easy
Somewhat difficult
Very difficult

D9. Why have you not accessed your medical
records online? Is it because…
Yes No

a. You prefer to speak to your health care
provider directly ..........................................
b. You do not have a way to access the
website ........................................................
c. You did not have a need to use your
online medical record..................................

D12. Did any health care provider, including
doctors, nurses, or office staff encourage
you to use an online medical record?
Yes
No
Do not know

d. You were concerned about privacy or
security of the website that had your
medical records ..........................................
e. Was not provided instructions on how to
access medical information online..............
f. Cost to access medical information
electronically ..............................................
g. Process to login to access my record too
complicated ...............................................
i. Language barriers (e.g. information not in
my first language) .......................................
j.

Other .........................................................

[If you have not accessed any medical records,
go to D18. Otherwise, go to D10]

6

D13. Does your online medical record include
the following types of medical information?
Yes

D15.Have you electronically sent your medical
information to any of the following?

No Don’t
Know

Yes No Don’t
Know

a. Laboratory test results ..............................

a. Another health care provider ...................

b. Current list of medications ........................

b. A family member or another person
involved with your care ............................

c.

List of health/medical problems ................

d. Allergy list .................................................
e. Summaries of your office visit ...................
f.

Clinical notes ............................................

g.

Immunization history ................................

D14. In the past 12 months, have you used your
online medical record to…
Yes No Don’t
know

a. Set or track goals related to your
health ........................................................

c.

A third party that can help manage and
store your health information, such as a
personal health record or app on mobile
device .......................................................

D16. In general, how useful are your online
medical records for monitoring your
health?
Very useful
Somewhat useful
Not very useful
Not at all useful
Not applicable

b. Made appointments with a health care
provider .....................................................
c.

Request refill of medications ....................

d. Securely message health care provider
and staff (e.g. e-mail) ................................
e. Track health care charges and costs........
f.

Filled out forms or paperwork related
to your health care ....................................

g. Look up test results...................................

D17. How confident are you that safeguards
(including the use of technology) are in
place to protect your medical records from
being seen by people who aren’t permitted
to see them?
Very confident
Somewhat confident
Not confident

h. Monitor your health ...................................
i.

j.

Download your health information to
your computer or mobile device, such
as a cell phone or tablet ...........................
Add health information to share with
your health care provider, such as
health concerns, symptoms, and sideeffects .......................................................

k.

Request correction of inaccurate
information ................................................

l.

Help you make a decision about how
to treat an illness or condition .................

D18. Have you ever kept information from your
health care provider because you were
concerned about the privacy or security of
your medical record?
Yes
No

m. Ask your health care provider new
questions, or to get a second opinion
from another health care provider ............

7

D19. If your medical information is sent
electronically – that is, by computer -- from
one health care provider to another, how
concerned are you that an unauthorized
person would see it?
Very concerned
Somewhat concerned
Not concerned

D20. Are you currently caring for or making
health care decisions for a child, a
spouse/partner, a parent, or other close
family member, friend, or non-relative with
a medical/behavioral/disability/other
condition? Please check all that apply.
Yes, a child/children
Yes, a spouse/partner
Yes, a parent/parents
Yes, a close family member, friend, or nonrelative (or multiple)
No – Go to E1

D21. Thinking of all of the kinds of help you
provide/provided for this person or
persons, about how many hours do you/did
you spend in an average week providing
care?
Hours

D22. If you selected more than one person in
F1, please think about the individual for
whom you have provided the most care.
Please check all conditions that your carerecipient has/had, for which they needed
your care.
Cancer
Alzheimer’s, confusion, dementia, forgetfulness
Orthopedic/Musculoskeletal Issues (examples:
back problems, broken bones, arthritis, mobility
problems, can’t get around, feeble, unsteady,
falling)
Aging
Mental Health/Behavioral/Substance Abuse
Issues (examples: mental illness; emotional
problems; depression; anxiety;
substance/drug/alcohol abuse)
Chronic Conditions (examples: high blood
pressure/hypertension; diabetes; heart disease;
heart attack; lung disease; emphysema;
Chronic Obstructive Pulmonary Disease
(COPD); Parkinson’s)
Neurological/Developmental Issues (examples:
brain damage or injury; developmental or
intellectual disorder; mental retardation; Down
syndrome; stroke)
Acute Conditions (examples: surgery,
wounds/injuries)
Other (specify) __________________
Not sure/ Don’t know
None of the above

D23.How many times did you access a family
member or close friend’s online medical
record in the last 12 months?
None – GO TOE1
1 to 2 times
3 to 5 times
6 to 9 times
10 or more times

D24. How did you access a family member or
close friend’s personal health information?
Yes No

a. Used family member’s login and password
b. Used a login and password assigned to
me to access their record............................

8

E: Medical Research
E1. Doctors use DNA tests to analyze
someone’s DNA for health reasons. Have
you heard or read about this type of
genetic test?

F: Your Overall Health
F1. In general, would you say your health is...
Excellent,
Very good,
Good,
Fair, or
Poor?

Yes
No - Go to F1
Don’t know – Go to F1

E2. Which of the following uses of a genetic
test have you heard of?

F2. Overall, how confident are you about your
ability to take good care of your health?
Completely confident
Very confident
Somewhat confident
A little confident
Not confident at all

Mark all that apply
Determining risk or likelihood of getting a
particular disease
Determining how a disease should be treated
after diagnosis (“precision medicine”)
Determining which drug(s) may or may not work
for an individual
Determining the likelihood of passing an
inherited disease to your children

F3. Has a doctor or other health professional
ever told you that you had any of the
following medical conditions:
Yes No

E3. Have you ever had any of the following
type(s) of genetic tests?
MarkX all that apply.

a. Diabetes or high blood sugar? .................
b. High blood pressure or hypertension? .....
c.

A heart condition such as heart attack,
angina, or congestive heart failure? .........

Paternity testing: To determine if a man is the
father of a child

d. Chronic lung disease, asthma,
emphysema, or chronic bronchitis? .........

Ancestry testing: To determine the
background or geographic/ethnic origin of an
individual’s ancestors

e. Arthritis or rheumatism? ...........................

DNA fingerprinting: To distinguish between or
match individuals using hair, blood, or other
biological material
Cystic Fibrosis (CF) carrier testing: To
determine if a person is at risk of having a child
with cystic fibrosis
BRCA 1/2 testing: To determine if a person
has more than an average chance of
developing breast cancer or ovarian cancer
Lynch syndrome testing: To determine if a
person has more than an average chance of
developing colon cancer
None of the above

f.

Depression or anxiety disorder? ..............

F4. About how tall are you without shoes?
Feet

and

Inches

F5. About how much do you weigh, in pounds,
without shoes?
Pounds

Not sure
Other-Specify

9

F6. Over the past 2 weeks, how often have you
been bothered by any of the following
problems?

G: Health and Nutrition
G1. When available, how often do you use
menu information on calories in deciding
what to order?

a. Little interest or pleasure in
doing things ..............................................

Always
Often
Sometimes
Rarely
Never

b. Feeling down, depressed, or
hopeless ...................................................
c.

Feeling nervous, anxious, or on
edge .........................................................

d. Not being able to stop or control
worrying ....................................................

F7. Is there anyone you can count on to
provide you with emotional support when
you need it – such as talking over problems
or helping you make difficult decisions?
Yes
No

G2. About how many cups of fruit (including
100% pure fruit juice) do you eat or drink
each day?
None
½ cup or less
½ cup to 1 cup
1 to 2 cups
2 to 3 cups
3 to 4 cups
4 or more cups

F8. Do you have friends or family members
that you talk to about your health?
Yes
No

F9. If you needed help with your daily chores,
is there someone who can help you?
Yes
No

1 cup of fruit could be:
- 1 small apple
- 1 large banana
- 1 large orange
- 8 large strawberries
- 1 medium pear
- 2 large plums
- 32 seedless grapes
- 1 cup (8 oz.) fruit juice
- ½ cup dried fruit
- 1 inch-thick wedge of
watermelon

G3. About how many cups of vegetables
(including 100% pure vegetable juice) do
you eat or drink each day?
None
½ cup or less
½ cup to 1 cup
1 to 2 cups
2 to 3 cups
3 to 4 cups
4 or more cups

1 cup of vegetables could be:
- 3 broccoli spears
- 1 cup cooked leafy greens
- 2 cups lettuce or raw greens
- 12 baby carrots
- 1 medium potato
- 1 large sweet potato
- 1 large ear of corn
- 1 large raw tomato
- 2 large celery sticks
- 1 cup of cooked beans

10

G4. How much do you agree or disagree with
this statement: “Body weight is something
basic about a person that they can’t
change very much.”
Strongly agree
Somewhat agree
Somewhat disagree
Strongly disagree

H4. How many times in the past 12 months
have you used a tanning bed or booth?
0 times
1 to 2 times
3 to 10 times
11 to 24 times
25 or more times

H: Physical Activity and Exercise
H1. In a typical week, how many days do you
do any physical activity or exercise of at
least moderate intensity, such as brisk
walking, bicycling at a regular pace, and
swimming at a regular pace?
None
GO TO H3 below
1 day per week
2 days per week
3 days per week
4 days per week
5 days per week
6 days per week
7 days per week

H5. When you are outside for more than one
hour on a warm, sunny day, how often do
you wear sunscreen?
Always
Often
Sometimes
Rarely
Never
Don’t go out on sunny days

H2. On the days that you do any physical
activity or exercise of at least moderate
intensity, how long do you typically do
these activities?
Write a number in one box below.
Minutes

Hours

H3. Over the past 30 days, in your leisure time,
how many hours per day, on average, did
you sit and watch TV or movies, surf the
web, or play computer games? Do not
include “active gaming” such as Wii.
Hours per day

11

I: Tobacco Products
I1. Have you smoked at least 100 cigarettes in
your entire life?
Yes
No

I6. How much do you agree or disagree with
this statement: “Smoking behavior is
something basic about a person that they
can’t change very much.”
Strongly agree
Somewhat agree
Somewhat disagree
Strongly disagree

GO TO I5

I2. How often do you now smoke cigarettes?
Everyday
Some days
Not at all
GO TO I5

I3. At any time in the past year, have you
stopped smoking for one day or longer
because you were trying to quit?

I7. In your opinion, do you think that some
smokeless tobacco products, such as
chewing tobacco, snus, and snuff are less
harmful to a person’s health than
cigarettes?
Yes
No
Don’t know

Yes
No

I4. Are you seriously considering quitting
smoking in the next six months?
Yes
No

I8. New types of cigarettes are now available
called electronic cigarettes (also known as
e-cigarettes or personal vaporizers). These
products deliver nicotine through a vapor.
Compared to smoking cigarettes, would
you say that electronic cigarettes are …
Much less harmful,
Less harmful,
Just as harmful,
More harmful,
Much more harmful, or
I’ve never heard of electronic cigarettes

I5.At any time in the past year, have you talked
with your doctor or other health professional
about having a test to check for lung cancer?
Yes
No
Don’t know

I9.

A hookah pipe (or shisha) is a large water
pipe. People smoke tobacco using hookah
pipes in groups at cafes or bars. Compared
to smoking cigarettes, would you say that
smoking tobacco using a hookah is…
Much less harmful,
Less harmful,
Just as harmful,
More harmful,
Much more harmful, or
I’ve never heard of Hookah.

12

J: Screening for Cancer
J1. Are you male or female?
Male
GO TO J6
Female

J6. The following questions are about
discussions doctors or other health care
professionals may have with their patients
about the PSA test that is used to look for
prostate cancer.
Have you ever had a PSA test?
Yes
No

J2. Has a doctor ever told you that you could
choose whether or not to have the Pap
test?
Yes
No

J7. Has a doctor ever discussed with you
whether or not you should have the PSA
test?
Yes
No

J3. How long ago did you have your most
recent Pap test to check for cervical
cancer?
A year ago or less
More than 1, up to 2 years ago
More than 2, up to 3 years ago
More than 3, up to 5 years ago
More than 5 years ago
I have never had a Pap test

K: HPV Awareness
K1. Have you ever heard of HPV? HPV stands
for Human Papillomavirus. It is not HIV,
HSV, or herpes.
Yes
No

J4. A mammogram is an x-ray of each breast
to look for cancer.
Has a doctor ever told you that you could
choose whether or not to have a
mammogram?
Yes
No

K2. Do you think HPV can cause…
Yes

A year ago or less
More than 1, up to 2 years ago
More than 2, up to 3 years ago
More than 3, up to 5 years ago
More than 5 years ago
I have never had a mammogram

Not
No sure

a. Cervical Cancer? ................................
b. Penile Cancer? .........................................
c.

J5. When did you have your most recent
mammogram to check for breast cancer, if
ever?

GO TO K5

Anal Cancer?............................................

d. Oral Cancer? ............................................

K3. Do you think that HPV is a sexually
transmitted disease (STD)?
Yes
No
Not sure

13

K4. Do you think HPV requires medical
treatment or will it usually go away on its
own without treatment?
Requires medical treatment
Will usually go away on its own

K5. A vaccine to prevent HPV infection is
available and is called the HPV shot,
cervical cancer vaccine, GARDASIL®, or
Cervarix®.
Before today, have you ever heard of the
cervical cancer vaccine or HPV shot?
Yes
No

K9. In the last 12 months, has a doctor or
health care professional recommended that you
or someone in your immediate family get an
HPV shot or vaccine?
Yes
No
Don’t know

L: Your Cancer History
L1. Have you ever been diagnosed as having
cancer?
Yes
No

GO TO M1

L2. What type of cancer did you have?
K6. In your opinion, how successful is the HPV
vaccine at preventing cervical cancer?
Not at all successful
A little successful
Pretty successful
Very successful
Don’t know

K7. Including yourself, is anyone in your
immediate family between the ages of 9
and 27 years old?
Yes
No

GO TO K10 on the next page

K8. In the last 12 months, has a doctor or
health care professional ever talked with
you or an immediate family member about
the HPV shot or vaccine?
Yes
No
Don’t know

MarkX all that apply.
Bladder cancer
Bone cancer
Breast cancer
Cervical cancer (cancer of the cervix)
Colon cancer
Endometrial cancer (cancer of the uterus)
Head and neck cancer
Hodgkin's lymphoma
Leukemia/Blood cancer
Liver cancer
Lung cancer
Melanoma
Non-Hodgkin lymphoma
Oral cancer
Ovarian cancer
Pancreatic cancer
Pharyngeal (throat) cancer
Prostate cancer
Rectal cancer
Renal (kidney) cancer
Skin cancer, non-melanoma
Stomach cancer
Other-Specify

L3. At what age were you first told that you had
cancer?
Age

14

L4. Did you ever receive any treatment for your
cancer?
Yes
No

Yes
No

GO TO L8 in the next column

L5. Which of the following cancer treatments
have you ever received?
Yes No

a. Chemotherapy (IV or pills) .......................
b. Radiation ..................................................
c.

L8. Were you ever denied health insurance
coverage because of your cancer?

Surgery .....................................................

L9. Looking back, since the time you were first
diagnosed with cancer, how much, if at all,
has cancer and its treatment hurt your
financial situation?
Not at all
A little
Some
A lot

d. Other ........................................................

L6. About how long ago did you receive your
last cancer treatment?
GO TO L10
Still receiving treatment
in the next
column
Less than 1 year ago
1 year ago to less than 5 years ago
5 years ago to less than 10 years ago
10 or more years ago

L7. Did you ever receive a summary document
from your doctor or other health care
professional that listed all of the treatments
you received for your cancer?
Yes
No

L10. Clinical trials are research studies that
involve people. They are designed to test
the safety and effectiveness of new
treatments and to compare new treatments
with the standard care that people currently
get. Have you ever participated in a clinical
trial for treatment of your cancer?
Yes
No
GO TO L12 on the next page
Don’t know

L11. Has a doctor or other member of your
medical team discussed clinical trials as a
treatment option for your cancer?
Yes
No

15

L12. At any time since you were first diagnosed
with cancer, did any doctor or other
healthcare provider ever discuss with you
the impact of cancer or its treatment on
your ability to work?
Discussed it with me in detail
Briefly discussed it with me
Did not discuss it at all
I don’t remember
I was not working at the time of my diagnosis.

M: Beliefs About Cancer

M3. How much do you agree or disagree with
the statement: “I’d rather not know my
chance of getting cancer.”
Strongly agree
Somewhat agree
Somewhat disagree
Strongly disagree

M4. How worried are you about getting cancer?
Not at all
Slightly
Somewhat
Moderately
Extremely

Think about cancer in general when
answering the questions in this section.
M1. How likely are you to get cancer in your
lifetime?
Very unlikely
Unlikely
Neither unlikely nor likely
Likely
Very likely

M5. Have any of your family members ever had
cancer?
Yes
No
Not sure

M2. How much do you agree or disagree with
each of the following statements?

a. It seems like everything
causes cancer ................................
b. There’s not much you can do
to lower your chances of
getting cancer ................................
c.

There are so many different
recommendations about
preventing cancer, it's hard
to know which ones to follow ...................

d. In adults, cancer is more
common than heart disease.....................
e. When I think about cancer, I
automatically think about
death .........................................................

16

N: You and Your Household

N5. What is your marital status?
Mark

N1. What is your age?
Years old

N2. What is your current occupational status?
Mark X only one.
Employed
Unemployed
Homemaker
Student
Retired
Disabled
Other-Specify

only one.

Married
Living as married
Divorced
Widowed
Separated
Single, never been married

N6. What is the highest grade or level of
schooling you completed?

N3. Have you ever served on active duty in the
U.S. Armed Forces, military Reserves or
National Guard? Active duty does not
include training in the Reserves or National
Guard, but DOES include activation, for
example, for the Persian Gulf War.
Yes, now on active duty
Yes, on active duty in the last 12 months but
not now
Yes, on active duty in the past, but not in the
last 12 months
No, training for Reserves or
National Guard only
No, never served in the military

Less than 8 years
8 through 11 years
12 years or completed high school
Post high school training other than college
(vocational or technical)
Some college
College graduate
Postgraduate

N7. Were you born in the United States?
Yes
No

GO TO N9 below

N8. In what year did you come to live in the
United States?
Year

N4. In the past 12 months, have you received
some or all of your health care from a VA
hospital or clinic?
Yes, all of my health care
Yes, some of my health care
No, no VA health care received

GO TO N5
In the next
column

N9. How well do you speak English?
Very well
Well
Not well
Not at all

17

N10. If a person speaks to you in a quiet room,
how much can you understand what the
person says?
All of what they said
Most of what they said
Some to little of what they said
Did not understand what they said

N11. Are you of Hispanic, Latino/a, or Spanish
origin? One or more categories may be
selected.
MarkX all that apply.
No, not of Hispanic, Latino/a, or Spanish origin
Yes, Mexican, Mexican American, Chicano/a
Yes, Puerto Rican
Yes, Cuban
Yes, another Hispanic, Latino/a, or Spanish
origin

N14. Including yourself, how many people live in
your household?
Number of people

N15. Starting with yourself, please mark the sex,
and write in the age and month of birth for
each adult 18 years of age or older living at
this address.
Sex

SELF

Male
Female

Adult 2

Male
Female

Adult 3

Male
Female

Adult 4

Male
Female

Adult 5

Male
Female

N12. Do you think of yourself as…
Heterosexual, or straight
Homosexual, or gay or lesbian
Bisexual
Something else – Specify
o
o

Age

Month Born
(01-12)

N16. How many children under the age of 18 live
in your household?
Number of children under 18

N13. What is your race? One or more categories
may be selected.
Mark X all that apply.
White
Black or African American
American Indian or Alaska Native
Asian Indian
Chinese
Filipino
Japanese
Korean
Vietnamese
Other Asian
Native Hawaiian
Guamanian or Chamorro
Samoan
Other Pacific Islander

N17. Do you currently rent or own your home?
Own
Rent
Occupied without paying monetary rent

N18. Does anyone in your family have a working
cell phone?
Yes
No

N19. Is there at least one telephone inside your
home that is currently working and is not a
cell phone?
Yes
No
18

N20. Thinking about members of your family
living in this household, what is your
combined annual income, meaning the
total pre-tax income from all sources
earned in the past year?

N22. At which of the following types of
addresses does your household currently
receive residential mail?
MarkX all that apply.
A street address with a house or building
number
An address with a rural route number
A U.S. post office box (P.O. Box)
A commercial mail box establishment (such as
Mailboxes R Us, and Mailboxes Etc.)

$0 to $9,999
$10,000 to $14,999
$15,000 to $19,999
$20,000 to $34,999
$35,000 to $49,999
$50,000 to $74,999
$75,000 to $99,999
$100,000 to $199,999
$200,000 or more

N21. About how long did it take you to complete
the survey?
Write a number in one box below.
Minutes

Hours

Thank you!
Please return this questionnaire in the postage-paid envelope within 2 weeks.
If you have lost the envelope, mail the completed questionnaire to:
HINTS Study, TC 1046F
Westat
1600 Research Boulevard
Rockville, MD 20850

19

Brentin, Christine (NIH/OD) [E]
From:
Sent:
To:
Cc:
Subject:
Attachments:

Hesse, Bradford (NIH/NCI) [E]
Monday, April 11, 2016 11:21 AM
OHSR (NIH/DDIR)
Willis, Gordon (NIH/NCI) [E]
OHSRP Request for Determination
Human Subjects HINTS 2016.pdf; HINTS V Intramural_planned_enrollment_report
4-11-2016.pdf

Please find attached our OHSRP Request for Determination in preparation for fielding the fifth installment of the Health 
Information National Trends Survey (HINTS).  I have also attached the HINTS V Intramural Planned Enrollment Report. 

As always, thank you for your assistance and prompt attention. 
‐Brad 

Bradford W. Hesse, Ph.D. 
Chief, Health Communication & Informatics Research Branch 
Behavioral Research Program 
Division of Cancer Control and Population Sciences 
National Cancer Institute 
9609 Medical Center Drive 
Room 3E610, MSC 9761 
Rockville, MD 20852 
Phone: (240) 276‐6721 
email: hesseb@mail.nih.gov 

1

Planned Enrollment Report
This report format should NOT be used for collecting data from study participants.
Is the NIH site responsible for conducting and coordinating the overall clinical study across multiple study sites (i.e.
coordinating site)?
■

Yes provide the numeric distribution (not percentages) for the total number of participants planned for the study.
Provide separate tables for the following: 1) NIH CC Site, 2) All Other Domestic Sites Combined, and 3) Foreign
Sites Combined. For additional guidance, see: http://nih-extramural-intranet.od.nih.gov/nih/topics/inclusionwo_main.htm
No complete the table only for the NIH CC site.
This report format should NOT be used for data collection from study participants
Select Site:

Other Domestic

Principal Investigator: Bradford Hesse, PhD
Study Title: Health Information National Trends Survey V (HINTS V) (NCI

10500

Total Enrollment: __________________________

Protocol Number: ________________________________

Ethnic Categories
Racial Categories

Not Hispanic or Latino

Hispanic or Latino

Total

Female

Male

Female

Male

48

28

32

12

120

205

174

12

7

398

22

14

18

16

70

Black or African
American

1,083

483

49

24

1639

White

3,861

2,750

800

545

7956

167

100

34

16

317

American Indian/
Alaska Native
Asian
Native Hawaiian or
Other Pacific Islander

More Than One Race

Total

5386 3549

945

620 10500

Brentin, Christine (NIH/OD) [E]
From:
Sent:
To:
Subject:

Brentin, Christine (NIH/OD) [E]
Monday, April 18, 2016 12:59 PM
Hesse, Bradford (NIH/NCI) [E]
Req for Determination Rec'd_OHSRP 13204

Good afternoon Dr. Hesse, 
This email is to verify that OHSRP has received your Request for Determination and it is currently being 
processed as OHSRP #13204. Please use this number in any future correspondence regarding this study.    
Protocol Title: Health Information National Trends Survey V (HINTS V) (NCl)
Thank you. 
Sincerely, 
Chris Brentin 
Program Specialist 
Office of Human Subjects Research Protections (OHSRP) 
National Institutes of Health 
301‐402‐3444‐Office  
301‐402‐8631‐Direct  
301‐402‐3443‐Fax 

 Please consider the environment before printing this e‐mail

1