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pdf OHSRP #13082
9-11-2015
OHSRP REQUEST FOR DETERMINATION FORM
II. SHOULD I STOP OR GO FORWARD
WITH AN OHSRP SUBMISSION?
1. Have you already started or completed
I
your research activity
Yes (Sfop here. Please consult OHSRP.)
XNo
2.
ls the proposed activity a component of a protocol that is under NIH IRB review,
e.g. the results of this activity will be used in support of the protocol?
Yes (Sfop here. You wilt likety need to amend the NIH protocol for the proposed
activity. Please consult the IRB if you are unsure. Do not submit this request.)
I
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 specimens/data that are
either coded or anonymous to collaborators? lf the specimens/data are not
individuatty identifiabte, but the identity of the subJ'ecfs may readily be ascerfained
by the investigatororassociated with the information because of a small sample
size or other reason, please answer "Yes" below.
Yes (Sfop here. You must obtain IRB approval of an amendment to the original
protocol or tRB approval of a new protocol. Do not submit this request.)
n
XNo
4.
Does this activity involve prisoners?
Yes (Súop here. Please consult the lRB. Do not submit this request.)
I
XNo
5.
Please select the type of activity or materials involved in your project. (Select all
that apply.)
n
5a. Single Case 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
n
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. Quatity 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
DH HS/N I H/OD/OI R/OH
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OHSRP REQUEST FOR DETERMINATION FORM
9-11-2015
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.)
5g. Autopsy Materials, Specimens/Data from Deceased Persons (Please
contact your privacy officer for further guidance.)
n
5h. Specimens/data purchased from a commercial repository which will
contain no identifying information
n
5¡, Derivatives of materials (e.9. DNA, RNA, cellfragments or sub-parts,
viruses or parasites) obtained from humans which will contain no identifying
information
n
5j. Established NIH Human Embryonic Stem Cell Lines that are available
to qualified investigators and require no ethical review according to the
registry. The cell line must be listed here:
http ://q ra nts. n ih. q ov/stem cells/reoistrv/current.htm and not be identifiable to
the NIH researchers
lf 5a. - 57. rs se/ected above, and your proposed project involves ONLY these
activities: SIOP answering questions here. No submission or determination is
required from OHSRP or an lRB. However, other NIH policies or IC requirements
apply. Please retain this documentation for your files.
lf your proposed project involves anv of these activities above and other activities
not listed here or involves none of these activities above, please continue with the
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 with the request for determination form. The categories are:
DH HS/N ¡ H/OD/O
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OHSRP REQUEST FOR DETERMINATION FORM
PART I: 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: 11/18/2015
2. Is this a new request for determination or an amendment to a previously OHSRPapproved project? (Please note if this is 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
If an amendment, provide the determination number of the original approved
project: OHSRP#:
3. Project Name: Formative Research to Investigate a Web Panel and to Determine Feasibility of
Web-Based Cognitive Pretesting
4. Project Description (Please describe the research activity that will be performed in
lay terms, including 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 additional text.):
The purpose of this study is to field questions that were previously used in
the NCI Health lnformation National Trends Survey (HINTS), using
an alternative online platform for survey administration, Amazon
Mechanical Turk (mTurk; wwww.mturk.com). HINTS collects nationally
representative data routinely about the American public's use of cancerrelated
information and collects data using a probability-based sample.
This project will enable us to compare data collected from a non-probability
based sample to HINTS data collected from a nationally representative
probability-based sample to assess the quality and comparability of the
data. The proposed study will also use cognitive probes to explore how
respondents are interpreting/understanding particular questions utilizing
a novel form of probing that is self-administered, web-based, and
collected among a large sample of respondents.
Primary objectives:
1. To compare estimates collecting data using a non-probability sampling
method to responses using established probability sampling methods
2. To examine whether associations between variables are consistent
across the various sampling approaches
3. To conduct cognitive testing of select survey questions using a novel
internet-based method to assess feasibility of using this method, and to
DHHS/NIH/OD/OIR/OHSRP
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OHSRP REQUEST FOR DETERMINATION FORM
assess how respondents are interpreting those questions
5. Proposed Start Date:
/
/
Proposed Completion Date (Required):
6. Requestor Details:
Name:
Phone Number: (
Email Address:
/
/
Institute/IC:
)
-
7. Are you the Senior Investigator (SI) for this project? (i.e., the team lead. The term
“SI” on this form does not refer to one’s official NIH title. The SI must be an NIH
FTE.)
Yes
No
7.1. If no, what is your role?
a. Administrative Support
b. Other investigator
c. Other, specify:
8. If not already included above, provide SI details (See instructions in Q. 7.):
Senior Investigator Name:
Institute/IC:
Phone Number: (
)
Email Address:
SI Signature (Required): ______________________ Date: ___/___/_____
9. Supervisor Name:
(Please note the supervisor cannot be a member of the research team for this
specific project.)
I (the supervisor) certify that the IC concurs that this project may proceed if it
meets regulatory and NIH policy requirements.
Supervisor Signature (Required): _____________________ Date: ___/___/____
10. Is there someone other than the SI, conducting this research (e.g. a junior
investigator, contractor, fellow, student, etc.)?
Yes
No
10.1. If yes, provide the following information:
NIH Investigator Name:
Institute/IC Name:
Email Address:
DHHS/NIH/OD/OIR/OHSRP
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OHSRP REQUEST FOR DETERMINATION FORM
9-11-2015
3.
5.
To conduct cognitive testing of select survey questions using a novel
internet-based method to assess feasibility of using this method, and to
assess how respondents are interpreting those questions
Date:
Proposed Start
0110112016
Proposed Completion Date (Required): 1213112016
6.
Requestor Details:
Name: Richard P. Moser, PhD
Phone Number: (240)276 - 6915
Email Address: [email protected]
lnstitute/lC: NGI
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
FrE.)
XYes n No
7.1
lf no, what is your role?
a. Administrative Support
b. Other investigator
c. Other, specify:
n
n
n
8. lf not already included above, provide
Sl details (See instructions in Q. 7.)
Senior lnvestigator Name:
lnstitute/lC:
Phone Number:
)
Email Address:
(
te: //_tJfl_"?o¿f
Sl Signature (Required):
L
Supervisor Name: William Klein, 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 requirements.
Supervisor Signatu re (Required) ,
d,n4,*-
Date:
10. ls there someone other than the Sl, conducting this research (e.9. a
tt t tl t
lJ
junior
investigator, contractor, fellow, student, etc.)?
XYes n No
10.1
.
tf
rovide the followin information
Name: Dana Wolff-Hughes
NIH lnve
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lnstitute/lC Name: NCI
Email Address: [email protected]
the name(s) and email(s) of anyone else, who should receive a
co
of the OHSRP determination:
Email
Address
Name: Dana Wolff-Hughes
[email protected]
Address
Email
Name: Gordon Willis
11. Please provide
[email protected]
EmailAddress
Name
12.What role(s) will the NIH tnvestigator(s) have on this research project? (Select all
that apply.)
a. lnteracting directly with subjects to collect specimensldata
b. Receiving specimens/data from a collaborator to conduct research
X c. Analyzing specimens/data
d. Generating genomic data (e.9. GWAS, WES/WGS; Additional NIH
req u i re me nts m a:t a p p lv: http ://sd s. n i h. gov/O3po icy2. htm I )
e. Running laboratory assays for research
f. Sending specimens/data to a collaborator to conduct research
X g lnteracting directly or indirectly with subjects to recruit for or conduct surveys,
interviews/focus groups, observation of public behavior, educational research
or tests, or research on public benefit or service programs
X h. Consulting/advising the collaborator(s)
X i. Authoring publication(s)/manuscript(s) pertaining to this research
tr j. Other, specify:
n
n
n
n
n
13.
I
Will the Sl be collaborating on this research project with any other person (nof
on the NIH research team) outside or inside the NIH?
X
---nNo
XYes
1
3.1
. lf no, will the senior investigator only be sending specimens/data to
someone not on the research team?
n No (f yes, please still add fhese individuals under Q.14 below.)
n
Yes
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-NlH
collaborating institution (for more information contact OHSRP). Ask your
collaborator for the FWA number or use this link to look it up:
http://ohrp. cit. nih.qov/search/fwasearch.aspx?styp=bsc
14. Please include
DH
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OHSRP REQUEST FOR DETERMINATION FORM
*A Federatwide Assurance (FWA) is issued by the U.S. Department of Health and
Human Seryices (DHHS)/Office of Human Research Protections (OHRP) to
institutions which receive Federalfunds/support to conduct non-exempt human
subjects research. An FWA rs an assurance of compliance with the U.S. Federal
Policy for the Protection of Human SubJ'ecfs, 45 C.F.R. 46.
a.
David Cantor
Collaborator Name: XXXXXXXXX
FWA #:55551
lnc
XXXXX
lnstitution/lC Name: Westat,
XXXXXXXX
XXXXXXXXXX
City/State/Country: Rockvi I le, MD
XXXXXXXXXXXXXXXXXXX
Email Address: david.ca
Both: n
Receiving specimens/data:
Sendingspecimens/data:
XXXXXXXXXXXXXXXXXXXXXXX
Cantor is an expert in survey
Describe what will be sent/received:Dr.
on creating the sample
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
collaborating
will
be
analysis
and
and
methods
XXXXXXXXXXXXXXXXXX
and analyzing the data
n
X
b.
Collaborator Name
FWA #:
lnstitution/lC Name:
City/State/Country:
EmailAddress:
Receiving specimens/data:
Send ing specimens/data
Describe what will be sent/received
n
I
Both:
n
n
Both:
n
c. Collaborator Name
FWA #:
lnstitution/lC Name
City/State/Country:
EmailAddress:
Receiving specimensldata
Sending specimens/data:
Describe what will be senUreceived
n
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 )
I
I
16. Does
DH
this activity include any of the following? (Se/ect allthat apply.)
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OHSRP REQUEST FOR DETERMINATION FORM
9-11-2015
n 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
n e. Program Evaluation (not meeting the definition in the lnstructions, Part Il, Q.
5b.)
n
I
f. OA/OI (not meeting the definition in the lnstructions Paft 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?
n Yes (Skip to question 25.)
n No (Continue.)
PART ll: RESEARCH WITH SPECIMENS AND DATA
17. ldentify the types of specimens/data involved in this project. (Se/ecf all that apply.)
! a. Medical Records, specify:
XXXXXXXXXXXXXXXXXXXXX
to survey questions
X b. Specimens, specify: Answers
X
I c. Data, specify: Answers to survey questions
n d. lmaging, specify:
n e. Pathological Waste/Results
I f. Autopsy Materials/Specimens/Data from deceased persons (P/ease contact
your privacy officer for furfher guidance.)
n g.Audio Recording
n h. Video Recording/Conferencing
Additional NIH requirements apply:
I i. Fetal Tissueqov/sou
rcebook/eth ica l-co n d u ct/resea rch -eth cs/feta l-tiss u e-
httos ://oi r. n i h.
D
n
i
research
j. |PSC lines (Additional NIH requirements apply:
ou rcebook/eth ica l-co nd uct/resea rch-eth ics/use-h u ma nhttos://oir.nih
ste m -ce I ls/q
u id e
Ii
n
es-
human
-em
b ryo n i c- i n d u
ced -p
I
u ri pote
nt-ste m-ce s
I I
k. hESC lines (Additional NIH requirements apply:
d r.¡ct/resea rch-eth ics/u se-h u manhttos ://oi r. n i h. o ov/sou rcebook/eth i
ic-ind uced-oluriootent-stem-cells AN D
stem-cel ls/q u id el nes-h u m a n-em b
httos ://oi r. n h. oov/sou rce book/eth ica l-co nd ucUresea rch-eth ics/use-h u ma nstem-cel ls/a reas-proh ibited-resea rch
L WESA/VGS
m. GWAS
n. From a repository
i
i
n
n
n
DH HS/N I H/OD/O
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OHSRP REQUEST FOR DETERMINATION FORM
lf an NIH Repository, specify:
o. From a publicly available source (meaning unrestricted access by anyone),
specify'.
p.Other, specify:
n
the specimens/data or information already exist?
a. Yes
n
c. Some exist, and other specimensldata will be collected in the future
18. Do all
Xb.No
19.
The specimens/data in this project were (or will be) originally collected for:
a. Clinical purposes only
collected for clinical
b. Research purposes
I
X
20. ls there active IRB/ethics committee approval for the use of the specimens/data at
your collaborator's site?
----X No
XYes n
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
n
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.
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
I
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
I
n
DH HS/N I H/OD/O I R/OHS RP
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OHSRP REQUEST FOR DETERMINATION FORM
9-11-2015
!
c. Honest broker (For use only when identified specimens or data are coming
from an NtH investigator; must be someone who will not be conducting the
research) (The agreement can be found here:
https ://federation. n i h. qov/ohsr/n h/formtm p. p h p (N I H Log i n req u i red) )
i
24.Will recipient of specimens/data be returning results to the sender? (Se/ecf allthat
applv)
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)
X d. No, results will not be returned
I
24.1. 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? [ Yes n No
For atl reguesfs, other than those involving suruey, interuiew/focus group
procedures, obseruation of public behavior, educational research or tests, or
research on pubtic benefit or service 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{Òpd.njh,gev. 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
25. Specify the nature of the data to be collected by: (Se/ect all that apply)
n a. Educational Research
n b. Educational Testing
X c. Survey or lnterview/Focus Group Procedures
tr d. Observation of public behavior
I e. Research on public benefit or service programs
I f. Other, specify:
26. How will recruitment and data collection take place? (Select all that apply)
n
n
a. ln-person at my collaborator's institution(s) or research site(s),
specify:
b. ln-person at an NIH site
DH HS/N I H/OD/O
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lc. ln-person at another site(s), specify
xd Online phone
ne Over the
!f. Other, specify:
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
c. Off-site contractor, specify what company:
Nielsen, Survey Sampling
X d. Online survey tool, specify: Amazon mTurk, XXXXXXXXXXXXXXXXXXX
lnternational (SSl), Precision Sample
XXXXXXXXXXXXXXXXXXXXXXXXXXX
e. Other, specify:
n
tr
n
n
28.What is the age range of subjects involved in the research?
a. Children aged < 1B years
X b. Adults aged 2 18 years
n
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?
nYes n
No
29. Does your project fall into any of the categories of 'clinical research' as defined by
the N I H? (See http ://qrants. n ih.qov/qrants/qlossary, htm#Clin ical Research for the
full NIH definition of 'clinical research'.)
I
n
X
a. Epidemiological and behavioral studies*
b. Outcomes research and health services research*
c. NONE OF THE ABOVE
*lf you a. or
b.ls se/ecfed above, please be sure to include the 'Planned
Enrollment' Table described in Part II of the instructions.
Prior to submitting, review the instructions to insure that you include the correct
supportive documentation. AII documentation should be submitted in .pdf format
via email to OHSRP to ohsr-nih-ddir{Òod.nih.qov. Please write 'Request for
Review' in the subject line of the e-mail.
DH HS/N I H/O D/O
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Appendix A – Screenshots for Health Information National Trends (HINTS) online instrument
Eiserman, Julie (NIH/OD) [C]
From:
Sent:
To:
Cc:
Subject:
Moser, Richard (NIH/NCI) [E]
Monday, March 14, 2016 11:06 AM
Eiserman, Julie (NIH/OD) [C]
Willis, Gordon (NIH/NCI) [E]
RE: Survey Project
Hi Julie:
I made some minor edits to the description you sent to simplify it since we are only using Mturk and not the other
panels. See my edits below.
Also, we would like to request that the title of our submission be adjusted to be: “Formative Research to Investigate a
Web Panel and to Determine Feasibility of Web‐Based Cognitive Pretesting” to match our (eventual) OMB submission.
Thanks.
‐Rick
The purpose of this study is to field questions that were previously used in
the NGI NCI Health lnformation National Trends Survey (HINTS), using
an alternative online platforms for survey administration, including Amazon
Mechanical Turk (mTurk; wwww.mturk.com). HINTS collects nationally
representative data routinely about the American public's use of cancer-related
information and collects data using a probability-based sample.
This project will enable us to compare data collected from a non-probability
based samples to HINTS data collected from a nationally representative
probability-based sample to assess the quality and comparability of the
data. The proposed study will also use cognitive probes to explore how
respondents are interpreting/understanding particular questions utilizing
a novel form of probing that is self-administered, web-based, and
collected among a large sample of respondents.
Primary objectives:
1. To compare estimates collecting data using a non-probability sampling
methods to responses using established probability sampling methods
2. To examine whether associations between variables are consistent
across the various sampling approaches
3. To conduct cognitive testing of select survey questions using a novel
internet-based method to assess feasibility of using this method, and to
assess how respondents are interpreting those questions
1
Eiserman, Julie (NIH/OD) [C]
From:
Sent:
To:
Subject:
Attachments:
Moser, Richard (NIH/NCI) [E]
Friday, March 11, 2016 2:33 PM
Eiserman, Julie (NIH/OD) [C]
RE: Survey Project
MTurk Schematic.doc
Hi Julie:
Here are my answers to your questions:
1) Westat will not be involved in any parts of this updated study. They can be removed from the request.
2) We will not be involving any vendors/panels for this study.
3) MTurk participants are a group of people who have agreed to complete tasks. The NCI will create a task and
publish it through the Mturk website. Those who are interested will accept the task and will given a link to the
survey. Once they complete the task, the NCI will verify and then send them their incentive, which in this case
will be $1.50. I’ve attached a graphic that helps explain the process if that’s helpful.
4) We do not have control over who accepts and completes the task, though you have to be 18 or older to accept
tasks. We have included some demographic variables in our survey (e.g., gender) so we do have information
about them, but we are not collecting PII.
I hope this answers your questions. I’m in my office now if you would like to talk: 240‐276‐6915.
‐Rick
From: Eiserman, Julie (NIH/OD) [C]
Sent: Friday, March 11, 2016 12:15 PM
To: Moser, Richard (NIH/NCI) [E]
Subject: RE: Survey Project
I left you a vm. If you want to call or respond to my questions there via email….
I am here until 2:45 p.m. today.
Thank you.
Julie M. Eiserman, MA, CCRP [C]
Health Science Policy Analyst
Office of Human Subjects Research Protections
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: [email protected]
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/
1
From: Moser, Richard (NIH/NCI) [E]
Sent: Friday, March 11, 2016 11:35 AM
To: Eiserman, Julie (NIH/OD) [C]
Cc: Sharon Zack ; Willis, Gordon (NIH/NCI) [E] ; Wolff, Dana (NIH/NCI)
[F]
Subject: RE: Survey Project
Dear Julie:
To answer your questions:
1) The NCI will set up the task on the mTurk platform and those who want to participate will be sent a link to the
survey. Westat will not be involved in any aspects of this process for contacting respondents.
2) The NCI will collect information about the respondents but it does not include PII
3) The data will be returned directly to the NCI. Westat will not receive any data.
Hope that answers your questions. I can talk by phone as needed.
Regards,
Rick
From: Eiserman, Julie (NIH/OD) [C]
Sent: Thursday, March 10, 2016 4:36 PM
To: Moser, Richard (NIH/NCI) [E]
Cc: Sharon Zack; Willis, Gordon (NIH/NCI) [E]; Wolff, Dana (NIH/NCI) [F]
Subject: RE: Survey Project
Okay. Could you please clarify a few things so that I can amend the form prior to providing a determination?
Can you clarify how you will recruit and connect participants with the link for the survey and whether NIH or Westat will
be doing it? I’m assuming the plan would be to email the link to people and then not collect any identifiers as a part of
the actual survey itself? What will Westat’s role be in this new design? For example, will Westat obtain the data and
provide it to you or will NIH download the data directly from the website?
Thank you.
Julie M. Eiserman, MA, CCRP [C]
Health Science Policy Analyst
Office of Human Subjects Research Protections
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: [email protected]
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
From: Moser, Richard (NIH/NCI) [E]
Sent: Thursday, March 10, 2016 3:33 PM
To: Eiserman, Julie (NIH/OD) [C]
Cc: Sharon Zack ; Willis, Gordon (NIH/NCI) [E] ; Wolff, Dana (NIH/NCI)
[F]
Subject: RE: Survey Project
Dear Julie:
Thanks very much for all your time and attention to this matter. This is a new paradigm for us and appreciate you
helping us think through the unique issues here.
It may work well to do as you say and consider re‐evaluating the nature of the project. However, we certainly
understand and respect your concerns about including the survey vendors in the project without further information
from them. So, in the interest of time and hopefully getting something in the field soon (that is, after OMB review), for
our first demonstration project we are going to remove the survey vendors from the design. That is, there will be no
outside entities collecting data, and we will simply go with the Amazon.com Mechanical Turk (mTurk) platform for data
collection. Note that use of mTurk does not involve any external survey vendor, and please recall for our initial project
using the MTurk platform (with Stephanie Fowler as the PI), OHSRP had provided an approval in the form of a
determination that the project did not constitute Human Subjects Research (HSR). That said, a determination of
Exemption would also allow us to move ahead to the OMB step.
If this is acceptable to you, we will revise our plan for now, in the hope of receiving an Exemption (or possibly a
determination of no HSR?) for the revised project that eliminates the vendors. Then, for our next project, we can
attempt to work through how to include those vendors in a way that is either considered not HSR, or Exempt research.
Please let me know how to best proceed here. Thanks.
Regards,
Rick
From: Eiserman, Julie (NIH/OD) [C]
Sent: Thursday, March 10, 2016 1:49 PM
To: Moser, Richard (NIH/NCI) [E]
Cc: Sharon Zack; Willis, Gordon (NIH/NCI) [E]; Wolff, Dana (NIH/NCI) [F]
Subject: RE: Survey Project
Dear Dr. Moser,
If you would like to us to consider your project as non‐research, you could re‐submit the request for determination
explaining that you consider this project to be something other than research and the rationale for this in the project
description section. I could review the application with my supervisor to see if we believe the new project description
falls outside of the definition of research. Accordingly, we might ask you to do a consult with us to discuss the
project. In addition, if the Westat IRB agrees with Dr. Willis, that your project does not meet the definition of research
OR views the vendors as being involved in only “exempt human subjects research”, I am open to hearing their
perspective.
If you don’t believe that you are conducting research, I am not clear if you view this project as meeting the definition of
quality assessment as described on the request form. Accordingly, in preparing your request, you may want to review
the following FAQs on the OHRP website which addresses when quality improvement (assessment) activities meet (or
don’t meet) the definition of research under the human subjects regulations:
3
http://www.hhs.gov/ohrp/policy/faq/quality‐improvement‐activities/index.html
Thank you.
Julie M. Eiserman, MA, CCRP [C]
Health Science Policy Analyst
Office of Human Subjects Research Protections
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: [email protected]
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/
From: Eiserman, Julie (NIH/OD) [C]
Sent: Wednesday, March 09, 2016 5:29 PM
To: Willis, Gordon (NIH/NCI) [E]
Cc: Moser, Richard (NIH/NCI) [E] ; 'Sharon Zack'
Subject: RE: Response Requested: Request for Determination for OHSRP #13082
Hello Dr. Willis,
We have been having on‐going communications about this project for almost 3.5 months now and this is the first I have
heard that the project isn’t research. At the beginning of December, I believe I had a call with you and Dr. Moser and
discussed the need for reliance agreements with the vendors to address their engagement in human subjects research
for this project. If the research part was in question, I would have expected this topic to be discussed at this time when I
raised this point. In addition, Westat’s IRB also interpreted this project as research and human subjects research and
initially provided expedited review (not exempt or not human subjects research).
So the questions to be asked are the following and we ask them in relationship to all parties, so in this case, NIH, Westat,
and the three vendors.
1) Is this research?; 2) Is this human subjects research? and 3) Is this exempt human subjects research?
As you know the definition of research is: (d) Research means a systematic investigation, including research
development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Activities which meet this definition constitute research for purposes of this policy, whether or not they are
conducted or supported under a program which is considered research for other purposes. For example,
some demonstration and service programs may include research activities.
I was not aware that whether you project constituted research or not was ever in question. In fact, there are boxes on
the form that one could check to address this issue and they were not checked. See attached and below:
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
4
product or service and not to also conduct research to develop or
contribute to generalizable knowledge
and
16f. QA/QI (not meeting the definition in the lnstructions Part ll, Q. 5c. or 5d.)
I hope you understand my wariness at now being told that I should review the project as ‘not research’ at this point. I’m
concerned that there are many different conversations going on independently about this project and that we are not all
on the same page. Let’s set up a call with Sharon and Dr. Moser and the PI at Westat to attempt to resolve this issue.
Thank you.
Julie M. Eiserman, MA, CCRP [C]
Health Science Policy Analyst
Office of Human Subjects Research Protections
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: [email protected]
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/
From: Willis, Gordon (NIH/NCI) [E]
Sent: Wednesday, March 09, 2016 4:12 PM
To: Eiserman, Julie (NIH/OD) [C]
Subject: FW: Response Requested: Request for Determination for OHSRP #13082
Hi Julie:
I’m one of the NCI co‐Investigators on the project you’ve been discussing with Westat.
My take on this is that, based on the nature of the work we are doing, it isn’t human subjects research to begin with – so
the issues with FWA, etc. are not relevant. By definition, we are not seeking generalizable knowledge – as our objective
is to assess data quality from one or more vendors. There’s no intention to generalize the results to any other vendors,
or to a wider universe, because that would go well beyond the data we are obtaining. So we are investigating a
mechanism for data collection – as opposed to collecting survey data that are intended to inform cancer research, public
health, etc.
From that point of view, would it even be necessary to submit to OHSRP? Or, based on following the Determination
form, can we proceed directly to OMB?
Or, if the Westat IRB determines this not to be human subjects research, on this argument, would that suffice?
Thanks for your advice –
Gordon
5
Gordon Willis, PhD
NCI
From: Eiserman, Julie (NIH/OD) [C] [mailto:[email protected]]
Sent: Wednesday, March 09, 2016 3:10 PM
To: Sharon Zack
Subject: RE: Response Requested: Request for Determination for OHSRP #13082
Perhaps I could correspond directly with the PI.
I understand that Westat isn’t engaged.
I really want to understand more about the data collection process at the vendor end. I have worked on projects that
use these types of panels from these firms before and in the previous cases, the vendors were conducting hsr but it was
considered exempt. We learned that the sites have identifiers for all of the participants on their panels and the
participants are typically contacted by email. The data in their system at times may be linked to identifiers (minimally an
email address) at their site (albeit through various firewalls). I would feel better if I got saw something in writing (an
email would suffice) from each vendor explaining how data is collected and that no identifiers are ever linked to the data
even in their computer systems. Perhaps the PI or whomever is corresponding with the vendors could obtain that.
I apologize if I sound overly picky but this is an NIH research project and in this case we would typically require the other
site have an FWA and require that there be a formal exemption at the other site when there isn’t IRB review.
Julie M. Eiserman, MA, CCRP [C]
Health Science Policy Analyst
Office of Human Subjects Research Protections
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: [email protected]
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/
From: Sharon Zack [mailto:[email protected]]
Sent: Wednesday, March 09, 2016 2:59 PM
To: Eiserman, Julie (NIH/OD) [C]
Subject: RE: Response Requested: Request for Determination for OHSRP #13082
Hi Julie, my PI resubmitted her application> in so doing, explained that the vendors will not maintain any identifiers. Once a de‐
identified data set is transferred to Westat, vendors will destroy all survey data. Therefore, Westat and its vendors may not be
considered “engaged” in HSR. I wanted to run that by your office before moving forward. Thanks for your patience as we get
through this.
Best,
Sharon
Sharon Zack, MS
IRB Administrator, Westat
1600 Research Blvd.
6
Rockville, MD. 20852
www.Westat.com
301‐610‐8828 (Work)
301‐294‐3928 (Fax)
[email protected]
Sharon Zack, M.S.
IRB Administrator
1600 Research Blvd. RB 4157
Rockville, MD. 20850
(W) 301‐610‐8828
(F) 301‐294‐3928
www.westat.com
From: Eiserman, Julie (NIH/OD) [C] [mailto:[email protected]]
Sent: Friday, March 04, 2016 11:31 AM
To: Sharon Zack
Subject: FW: Response Requested: Request for Determination for OHSRP #13082
Julie M. Eiserman, MA, CCRP [C]
Health Science Policy Analyst
Office of Human Subjects Research Protections
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: [email protected]
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/
From: Moser, Richard (NIH/NCI) [E]
Sent: Friday, March 04, 2016 11:07 AM
To: Eiserman, Julie (NIH/OD) [C]
Cc: Willis, Gordon (NIH/NCI) [E]
Subject: RE: Response Requested: Request for Determination for OHSRP #13082
Hi Julie:
7
I have some updated information for you regarding our study. I’ve attached an updated disposition from the Westat IRB
finding the study exempt from IRB review.
I also have contact information for the Westat IRB representative if that would be helpful:
Sharon Zack
301‐610‐8828
[email protected]
Thanks.
‐Rick
8
Eiserman, Julie (NIH/OD) [C]
From:
Sent:
To:
Subject:
Eiserman, Julie (NIH/OD) [C]
Friday, March 04, 2016 2:50 PM
Moser, Richard (NIH/NCI) [E]
RE: Response Requested: Request for Determination for OHSRP #13082
No. But I would want to see a formal memo or letter that says that the Westat IRB has made a formal determination
that ___, ____, ____ are engaged in exempt research under the regulations…..
Julie M. Eiserman, MA, CCRP [C]
Health Science Policy Analyst
Office of Human Subjects Research Protections
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: [email protected]
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/
From: Moser, Richard (NIH/NCI) [E]
Sent: Friday, March 04, 2016 2:18 PM
To: Eiserman, Julie (NIH/OD) [C]
Subject: RE: Response Requested: Request for Determination for OHSRP #13082
Hi Julie:
I appreciate you explaining all the different scenarios here. I wanted to clarify something: If Westat works with the
vendors and determines that the vendors are Exempt, does Westat still need reliance agreements with them?
Thanks.
‐Rick
From: Eiserman, Julie (NIH/OD) [C]
Sent: Thursday, March 03, 2016 4:02 PM
To: Moser, Richard (NIH/NCI) [E]
Subject: RE: Response Requested: Request for Determination for OHSRP #13082
They get to review the study and make a determination as to what type of research they think it is. Typically they would
just review their own role in the project unless a reliance agreement is in place. Then they would also review the other
sites’ roles.
The choices are:
1
Eiserman, Julie (NIH/OD) [C]
From:
Sent:
To:
Subject:
Eiserman, Julie (NIH/OD) [C]
Thursday, March 03, 2016 4:02 PM
Moser, Richard (NIH/NCI) [E]
RE: Response Requested: Request for Determination for OHSRP #13082
They get to review the study and make a determination as to what type of research they think it is. Typically they would
just review their own role in the project unless a reliance agreement is in place. Then they would also review the other
sites’ roles.
The choices are:
#1: not human subjects research because there is no interaction with human subjects or use of identified data
#2: human subjects research (interaction with human subjects or use of identified data) that is exempt from IRB review
and approval (meets certain criteria)
#3: humans subjects research that can have expedited IRB review and approval
#4: human subjects research that must have full IRB review and approval
Westat determined that this is #3 above which means they believe that they (or the other sites) need IRB review. That
means that those other sites need local IRB review or a reliance agreement with Westat.
Julie M. Eiserman, MA, CCRP [C]
Health Science Policy Analyst
Office of Human Subjects Research Protections
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: [email protected]
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/
From: Moser, Richard (NIH/NCI) [E]
Sent: Thursday, March 03, 2016 3:42 PM
To: Eiserman, Julie (NIH/OD) [C]
Subject: RE: Response Requested: Request for Determination for OHSRP #13082
Hi Julie:
I’ll get back to you regarding funding.
I can check with Westat regarding the agreements they have in place. Just to clarify, is there an issue with the Westat
memo mentioning ‘expedited authority’ as opposed to being exempt?
‐Rick
1
From: Eiserman, Julie (NIH/OD) [C]
Sent: Thursday, March 03, 2016 3:15 PM
To: Moser, Richard (NIH/NCI) [E]
Subject: RE: Response Requested: Request for Determination for OHSRP #13082
Hi Dr. Moser,
I still have some unanswered questions. Is DHHS funding be used to fund the research being done with these
companies? If so, they must have an FWA.
My original guidance I believe is that there needed to be either IRB approval at each of the sites below OR Westat would
need to do authorization agreements with these institutions to rely on Westat’s IRB. Can you send me an email from
Westat clarifying that these agreements are in place? Was this topic ever discussed with them? The situation isn’t clear
in the letter.
Sometimes survey research is exempt from IRB review but the letter suggests that Westat’s IRB didn’t think it was
exempt and instead provided expedited review of the project.
Julie M. Eiserman, MA, CCRP [C]
Health Science Policy Analyst
Office of Human Subjects Research Protections
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: [email protected]
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/
From: Moser, Richard (NIH/NCI) [E]
Sent: Thursday, March 03, 2016 3:02 PM
To: Eiserman, Julie (NIH/OD) [C]
Subject: RE: Response Requested: Request for Determination for OHSRP #13082
Hi Julie:
See below.
‐Rick
b. Collaborator Name: Precision Sampling, LLC
Institution/IC Name: private sector FWA #: none
City/State/Country: Denver, Colorado, USA
Email Address: [email protected]
Sending specimens/data: ___ Receiving specimens/data: __ Both: _XX_
Describe what will be sent/received or role:
Precision Sampling will send Westat a de‐identified dataset of survey responses from 500 members of their panel.
2
b. Collaborator Name: Survey Sampling International (SSI)
Institution/IC Name: private sector FWA #: none
City/State/Country: Shelton, Connecticut, USA
Email Address: [email protected]
Sending specimens/data: __ Receiving specimens/data: __ Both: XX__
Describe what will be sent/received or role:
SSI will send Westat a de‐identified dataset of survey responses from 500 members of their panel.
b. Collaborator Name: Nielsen Opinion Quest
Institution/IC Name: private sector FWA #: none
City/State/Country: New York, New York, USA
Email Address: [email protected]
Sending specimens/data: __ Receiving specimens/data: __ Both: _XX_
Describe what will be sent/received or role:
Nielsen will send Westat 2 de‐identified datasets of survey responses: one with 500 responses from members of their
panel and one with 500 responses from a probability sample of general population respondents.
From: Eiserman, Julie (NIH/OD) [C]
Sent: Thursday, March 03, 2016 12:36 PM
To: Moser, Richard (NIH/NCI) [E]
Subject: RE: Response Requested: Request for Determination for OHSRP #13082
Yes. Thank you. The other thing we talked about is if the data collection was being conducting by any institutions other
than Westat, they should be added to the form as collaborators as well. Can you send me the following information
about these companies?
b. Collaborator Name
Institution/IC Name: FWA #:
City/State/Country:
Email Address:
Sending specimens/data: __ Receiving specimens/data: __ Both: __
Describe what will be sent/received or role:
Julie M. Eiserman, MA, CCRP [C]
Health Science Policy Analyst
Office of Human Subjects Research Protections
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: [email protected]
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/
3
From: Moser, Richard (NIH/NCI) [E]
Sent: Wednesday, March 02, 2016 4:43 PM
To: Eiserman, Julie (NIH/OD) [C]
Cc: Willis, Gordon (NIH/NCI) [E]
Subject: RE: Response Requested: Request for Determination for OHSRP #13082
Hi Julie:
As you recall, we had a good conversation a couple of weeks back in regards to my OHSRP submission to use non‐
probability samples to compare results with an NCI‐administered survey (see attached proposal). Per our discussion,
our main contractor (Westat) was seeking approval from their IRB to administer the panels and you said to let you know
when this happened so you could give a final determination. Westat has now received approval to work with the panels
and I’ve attached the approval letter here. When we spoke, you mentioned that my study would be approved
(considered Exempt?) if you received this information and I’m hoping that is still the case, but please let me
know. Thanks.
Regards,
Rick
From: Eiserman, Julie (NIH/OD) [C]
Sent: Monday, December 14, 2015 1:53 PM
To: Moser, Richard (NIH/NCI) [E]; Wolff, Dana (NIH/NCI) [F]
Subject: RE: Response Requested: Request for Determination for OHSRP #13082
Importance: High
Hello,
I don’t believe I have heard back from you yet about your request for review. I just wanted to let you know that I will be
out on vacation from Dec. 22 – Jan. 4 with no one to cover this work while I am out. If you are not able to schedule a call
with me by Thursday, I will not be able to work on your request until after I am back from vacation.
Julie M. Eiserman, MA, CCRP [C]
Health Science Policy Analyst
Office of Human Subjects Research Protections
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: [email protected]
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/
From: Eiserman, Julie (NIH/OD) [C]
Sent: Wednesday, December 02, 2015 12:43 PM
To: Moser, Richard (NIH/NCI) [E] ; Wolff, Dana (NIH/NCI) [F]
Cc: OHSR (NIH/DDIR)
Subject: Response Requested: Request for Determination for OHSRP #13082
4
Eiserman, Julie (NIH/OD) [C]
From:
Sent:
To:
Subject:
Eiserman, Julie (NIH/OD) [C]
Wednesday, January 06, 2016 4:33 PM
Moser, Richard (NIH/NCI) [E]
RE: Response Requested: Request for Determination for OHSRP #13082
Feel free to propose a time.
Thank you.
Julie M. Eiserman, MA, CCRP [C]
Health Science Policy Analyst
Office of Human Subjects Research Protections
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: [email protected]
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/
From: Moser, Richard (NIH/NCI) [E]
Sent: Wednesday, January 06, 2016 4:33 PM
To: Eiserman, Julie (NIH/OD) [C] ; Wolff, Dana (NIH/NCI) [F]
Cc: Willis, Gordon (NIH/NCI) [E]
Subject: RE: Response Requested: Request for Determination for OHSRP #13082
Hi Julie:
Happy New Year.
I’d like to set up a time to talk about our proposal. Let me know the best way to proceed. Should I propose a time
through Outlook (I can see your availability) or would you rather send me some potential dates/times?
Thanks.
‐Rick
From: Eiserman, Julie (NIH/OD) [C]
Sent: Monday, December 14, 2015 1:53 PM
To: Moser, Richard (NIH/NCI) [E]; Wolff, Dana (NIH/NCI) [F]
Subject: RE: Response Requested: Request for Determination for OHSRP #13082
Importance: High
Hello,
1
Eiserman, Julie (NIH/OD) [C]
From:
Sent:
To:
Subject:
Eiserman, Julie (NIH/OD) [C]
Tuesday, December 15, 2015 3:34 PM
Moser, Richard (NIH/NCI) [E]
RE: Response Requested: Request for Determination for OHSRP #13082
Sounds great. Thanks for letting me know.
Julie M. Eiserman, MA, CCRP [C]
Health Science Policy Analyst
Office of Human Subjects Research Protections
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: [email protected]
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/
From: Moser, Richard (NIH/NCI) [E]
Sent: Tuesday, December 15, 2015 2:20 PM
To: Eiserman, Julie (NIH/OD) [C] ; Wolff, Dana (NIH/NCI) [F]
Subject: RE: Response Requested: Request for Determination for OHSRP #13082
Hi Julie:
As a follow‐up, we will be working with our main contractor to work with their IRB to figure out a plan that will hopefully
address any issues that you mentioned from working with the other vendors. I’ll be back in touch after the holidays.
‐Rick
From: Eiserman, Julie (NIH/OD) [C]
Sent: Monday, December 14, 2015 1:53 PM
To: Moser, Richard (NIH/NCI) [E]; Wolff, Dana (NIH/NCI) [F]
Subject: RE: Response Requested: Request for Determination for OHSRP #13082
Importance: High
Hello,
I don’t believe I have heard back from you yet about your request for review. I just wanted to let you know that I will be
out on vacation from Dec. 22 – Jan. 4 with no one to cover this work while I am out. If you are not able to schedule a call
with me by Thursday, I will not be able to work on your request until after I am back from vacation.
1
Eiserman, Julie (NIH/OD) [C]
From:
Sent:
To:
Subject:
Eiserman, Julie (NIH/OD) [C]
Monday, December 14, 2015 4:14 PM
Moser, Richard (NIH/NCI) [E]
RE: Response Requested: Request for Determination for OHSRP #13082
Sounds good.
Julie M. Eiserman, MA, CCRP [C]
Health Science Policy Analyst
Office of Human Subjects Research Protections
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: [email protected]
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/
From: Moser, Richard (NIH/NCI) [E]
Sent: Monday, December 14, 2015 1:55 PM
To: Eiserman, Julie (NIH/OD) [C] ; Wolff, Dana (NIH/NCI) [F]
Subject: RE: Response Requested: Request for Determination for OHSRP #13082
Ok, thanks, Julie. We’re looking into some things on our end before talking to you. I hope to schedule something before
you take off.
‐Rick
From: Eiserman, Julie (NIH/OD) [C]
Sent: Monday, December 14, 2015 1:53 PM
To: Moser, Richard (NIH/NCI) [E]; Wolff, Dana (NIH/NCI) [F]
Subject: RE: Response Requested: Request for Determination for OHSRP #13082
Importance: High
Hello,
I don’t believe I have heard back from you yet about your request for review. I just wanted to let you know that I will be
out on vacation from Dec. 22 – Jan. 4 with no one to cover this work while I am out. If you are not able to schedule a call
with me by Thursday, I will not be able to work on your request until after I am back from vacation.
Julie M. Eiserman, MA, CCRP [C]
Health Science Policy Analyst
Office of Human Subjects Research Protections
1
Eiserman, Julie (NIH/OD) [C]
From:
Sent:
To:
Cc:
Subject:
Attachments:
Eiserman, Julie (NIH/OD) [C]
Wednesday, December 02, 2015 12:43 PM
Moser, Richard (NIH/NCI) [E]; Wolff, Dana (NIH/NCI) [F]
OHSR (NIH/DDIR)
Response Requested: Request for Determination for OHSRP #13082
MoserR_NCI_13082_CY2015.pdf
Hello Dr. Moser,
It sounds like you may be contracting with different companies in order to conduct your research. As part of your
proposed project, we need to understand all the different entities that will be involved in the project (included if they
are being subcontracted), e.g. who will be conducting recruitment, managing the data collection, maintaining
identifiers, de‐identifying data, etc. and have evidence of IRB review at these various sites. Private market research
companies don’t always have experience with obtaining IRB review so this can be complicated. The various entities
would be added as collaborators in the collaborator section of the form. Then all of the questions about the sender,
would then need to be answered with regard to each entity.
Given the complexity of the project, I think it’s best if we set up a phone call to discuss the project and the form so I can
determine what additional information is needed. Please let me know your availability to do this.
Julie M. Eiserman, MA, CCRP [C]
Health Science Policy Analyst
Office of Human Subjects Research Protections
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: [email protected]
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/
1
From:
To:
Subject:
Date:
Attachments:
Moser, Richard (NIH/NCI) [E]
OHSR (NIH/DDIR)
RE: Request for Review
Thursday, November 19, 2015 2:31:31 PM
Survey Screen Shots.doc
Hi Chris:
We are taking items from an existing probability-based survey, HINTS, and administering the items to
several groups (using different vendors) that utilize non-probability based samples and want to
compare the results. These will be done using on-line panels. I’ve attached screen shots of the online survey. Note: the OMB text on the first page is simply for demonstration purposes.
-Rick
From: OHSR (NIH/DDIR)
Sent: Thursday, November 19, 2015 2:27 PM
To: Moser, Richard (NIH/NCI) [E]
Subject: RE: Request for Review
Hi Rick,
For this project, Im unclear if you are collecting responses from past surveys, or if you are
administering a new group of survey questions to participants. Please clarify.
If you are administering a survey to groups, please submit the survey you will use.
Thank you,
Chris Brentin
OHSRP
From: Moser, Richard (NIH/NCI) [E]
Sent: Wednesday, November 18, 2015 3:08 PM
To: OHSR (NIH/DDIR)
Cc: Willis, Gordon (NIH/NCI) [E] ; Wolff, Dana (NIH/NCI) [F]
Subject: Request for Review
Dear OHSR:
I’ve attached a Request for Determination for your review.
Thanks.
Sincerely,
Rick
Richard P. Moser, Ph.D.
Acting Chief, Science of Research and Technology Branch (SRTB)
Behavioral Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
9609 Medical Center Dr., MSC 9761
Room 3E604
Bethesda, MD 20892
For Business Reply Mail, use: Bethesda, MD 20814-9692
(w): 240-276-6915
(fax): 240-276-7907
[email protected]
From:
To:
Subject:
Date:
OHSR (NIH/DDIR)
Moser, Richard (NIH/NCI) [E]
Req for Determination Rec"d_OHSRP #13082
Thursday, November 19, 2015 3:54:34 PM
Good afternoon Dr. Moser,
This email is to verify that OHSRP has received your Request for Determination and it is
currently being processed as OHSRP #13082. Please use this number in any future
correspondence regarding this study.
Protocol Title: Comparison of Survey Results and Feasibility of Cognitive Pre-Testing Using
Probability and Non-Probability Samples
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
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| File Type | application/pdf |
| File Modified | 2016-03-16 |
| File Created | 2015-11-18 |