HIC Revolving CS Survey OHSR-IRB TaubenheimA_NHLBI_4741_CY2009

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

Exempt: #:

FAX:

4741

Taubenheim, Ann

To:

NHLBl
Building 31 - Claude D Pepper Buildina, 4A10
From:

Office of Human Subjects Research (OHSR)

Nature of Research Activity:
The NHLBl seeks to collect data from NHLBl Health Information Center (HIC) customers who contact the HIC
by telephone and e-mail to assess customer perception of the quality of services provided by the HIC.
Original Request Received in OHSR on:
Responsible NIH Research Investigator(s):

Ann Taubenheim, NHLBl

OHSR review of your request dated Wed, Mav 13, 2009 has determined that:

q

Federal regulations for the protection of human subjects do not apply to above named
activity. No further action is necessary.
The activity is designated EXEMPT, and has been entered in the OHSR database.
PLEASE NOTIFY OHSR OF ANY SIGNIFI(=ANT CHANGES THAT MAY At TER THF
EMPT STATUS OF THIS RESFARCH ACTIVITY,

NOTEXEMPT.
OHSR recommends IRB review. Please forward your request to the
Chair of your IRB, who may ask you to provide additional information in order to
determine whether expedited or full review is appropriate.
Confidentiality Agreement
Reliance

q

Amendment
Other

OfFice Person SPC

Note:

Admin Assist. CB

611912009

u

Title

Date

~omestidnternational:
Domestic
OHSR Use Only
Human Subjects Data: Yes
Biologic Material:

No

0 1 B 2 0 3 0 4 0 5 0 6

REOUEST FOR REVIEW OF RESEARCH ACTIVITY INVOLVING HUMAN
SUBJECTS
INSTRUCTIONS: Please type directly on this form. You can expand the document if
you need more space. If your research involves a survey or questionnaire, please attach it
to this completed form.
Completed forms (with all required signatures) may be sent to OHSR by FAX (301-4023443) or by mail (2C146). If you have any questions, call OHSR at (301) 402-3444.
Date:
To:

May 13,2009

&a

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

From: Ann Taubenheim, Ph.D., M.S.N.
(Signature)

Through: Susan Shurin, M.D.
(Signature of appropriate Official for IC, e.g., LabIBranch Chief)
Name of NIH Principal Investigator(s):h

n Taubenheim. Ph.D., M.S.N.

IC NHLBl
Laboratory/Branch Office of Communications and LegislativeActivities
Building & Room No. Bldg31. R4A10 Tel. No. 301-496-4236 FAX No. 301-480-4907
Is the Principal investigator an N M employee? x

Yes

No

If no, please explain:
1. What is the proposed research activity that you intend to perform at NIH
(please use lay terms): The NHLBl seeks to collect data from NHLBl Health Information Center (HIC)
customers who contact the HIC by telephone and e-mail to assess customer perception of the quality of services
provided by the HIC.

2. If applicable, list your non-NIH Collaborating Investigator(s).

Name

Institution

Last revised 11/7/05

-

Address Tel. # FAX #

3. Proposed start date of your research
Proposed completion date 1212009
4. Will you be

collecting

11/2009

these samples or data?

Collecting Yes/No
Receiving Yes/No
Sending
Yes/No

5. Do the samples or data:
(a) Already e x i s t ? Y e s L N o
(b) Or are they being collected for the express purpose of this study? L Y e s N
custrmr porcoptlon01 Me qwlhy d
provided.
If "yes," please describe..We am collsctlng m p o w lo
W

~ueu

(c) Or a combination of (a) and (b)?

-Yes x

W

No

6. What role will you have in this research project? (Check all that apply)
x Analyze sampleddata only.
-

Consultant/advisor to collaborator(s) listed above.
x Author of the protocol that is being implemented by your collaborating investigator
-

(identified in question #2).

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

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

7. Where are the subjects of this research activity located?
Primarily in the United States, with some international respondents

8. If human subjects are located elsewhere (not at NIH), will you have direct
contact or intervention with them? (Examples: as subject's physician; in obtaining
samples directly from the subject; by interviewing the subject?) -Yes L N o

Last revised 1 1/7/05

o

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

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

(a) Repository Y e s

5

No

(b) Pathological waste -Yes )(

(c) Autopsy material -Yes

5

(d) Publicly available source -Yes

No

No

5

No

(el Other Electronic survey
11. Please check the box(es) that apply(ies) to the samplesldata that you will receive.
(a)

-Samples andor

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

(b)

-Samples andor

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

(c) -Samples andor data will be coded so that the provider of the samplesldata
can link them to specific individuals but the receiver will not be able to do so.
12.
Will you send results back to the provider(s) (listed in question 2 of this
form)?

X No, I will not send results back to the provider(s).
(a) (b) -Yes, I will send aggregate results to the provider(s).
(c) -Yes, I will send results to the provider(s) that are linked to identifiable
individuals.
If yes, does the provider intend to link your data to identifiable individuals?
Yes
No

Last revised 11/7/05

13. Has the research activity that vou are ~ r o ~ o sini nthis
~ form been approved by
an Institutional Review Board (IRB) elsewhere?

Yes, the NIH research activity has been reviewed by the following IRE3 (s)
(Please provide the following information for each IRB):
Name of institution that provided the review
Address of reviewing institution
Name of PI for the IRB approved protocol
Title of IRE3 approved protocol and protocol #
Federal Wide Assurance (FWA) number*"

x

No IRB review of the research activity described in question #1 above has
taken place

(**An FWA is a contract between the U.S. Department of Health and Human Services
(DHHS) and an entity receiving DHHS funds to conduct clinical research that the latter
will follow ethical guidelines and federal regulations for the protection of human
subjects. For a list of domestic and international institutions go to
http:Nohn>.cit.nih.nov/search/asearch.asv#ASUR

14. Per N M guidance***, have conflicts of interest by N M employees, if any,
been resolved?
x
Yes
No

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

***The January 5,2005 NIH Guide to Preventing Conflict of Interest applies to all
research conducted at NIH, httv://ohsr.od.nih.nov/New/mpafwadocs.htm1

Last revised 1 1/7/05

Attachment A. Revolving Customer
Satisfaction Online and Telephone
Surveys
NHLBI Health lnformation Center (HIC)
Customer Satisfaction Survey Questions-Online Survey
OMB NO.0925-XXXX
Exp. Date xw"20xx
Public reporting burden for this collection of information is estimated to average 3 minutes or less 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 208927974, ATTN: PRA (0925-xxxx*). Do not return the completed form to this address.

Evaluation Categories
Timely response
Knowledge of NHLBI health information
Professionalism of response
Meeting the requestor's needs
Overall service

Introduction
Thank you for helping to rate the performance of the NHLBI Health lnformation Center. Please
click the appropriate button to record your rating.

Questions
Please Rate:

1. The amount of time it took the NHLBI Health lnformation Center to respond to your
request.

0 1 Poor 0 2 Fair 0 3 Good 0 4 Very Good 0 5 Excellent
2. The information specialist's knowledge of your topic.

0 1 Poor 0 2 Fair 0 3 Good 0 4 Very Good 0 5 Excellent
3. The information specialist's professionalism.

0 1 Poor 0 2 Fair 0 3 Good 0 4 Very Good 0 5 Excellent

NHLBI Supporting Statement A: HIC Revolving Customer Satisfaction Survey

A- 1

4. How well the information specialist met your information needs.

0 1 Poor 0 2 Fair 0 3 Good 0 4 Very Good 0 5 Excellent
5. The overall customer service you received.

0 1 Poor 0 2 Fair 0 3 Good 0 4 Very Good 0 5 Excellent
6. Are there other comments or suggestions you would like to make about the NHLBI
Health Information Center? If so, please type here:

NHLBI Supporting Statement A: HIC Revolving Customer Satisfaction S w e y

A-2

NHLBI Health lnformation Center (HIC)
Customer Satisfaction Survey Questions-Telephone

Survey

OMB NO.0925-XXXX
Exp. Date d d 2 0 x . x
Public reporting burden for this collection of information is estimated to average 3 minutes or less 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 208927974, ATTN: PRA (0925-xxxx*). Do not return the completed form to this address.

Evaluation Categories

Timely handling of call
Knowledge of NHLBI health information
Professionalism of call handling
Meeting the caller's needs
Overall service
Script

Thank you for agreeing to rate the service that you received today from the NHLBI Health
lnformation Center. There are six questions. After each question, please press or say the
number for your response. To repeat a question, press the pound sign.
1. Please rate the amount of time it took the NHLBI Health lnformation Center to
respond to your request. If it was poor, say or press 1. If it was fair, say or press 2. If it

was good, say or press 3. If it was very good, say or press 4. If it was excellent, say or
press 5.
2. Please rate the lnformation Specialist's knowledge of your topic. If it was poor, say
or press 1. If it was fair, say or press 2. If it was good, say or press 3. If it was very good,
say or press 4. If it was excellent, say or press 5.

3. Please rate the lnformation Specialist's professionalism. If it was poor, say or press
1. If it was fair, say or press 2. If it was good, say or press 3. If it was very good, say or
press 4. If it was excellent, say or press 5.
4. Please rate how well the lnformation Specialist met your information needs. If it
was poor, say or press 1. If it was fair, say or press 2. If it was good, say or press 3. If it

was very good, say or press 4. If it was excellent, say or press 5.
5. Please rate the overall customer service you received. If it was poor, say or press 1.
If it was fair, say or press 2. If it was good, say or press 3. If it was very good, say or
press 4. If it was excellent, say or press 5.

6. Are there other comments or suggestions you would like to make about the NHLBI
Health lnformation Center? If so, please provide them after the tone. Thanks!

NHLBI Supporting Statement A: HIC Revolving Customer Satisfaction Survey

A-3

Page 1 of 1

OHSR (NIHIDDIR)
From:

OHSR (NIHIDDIR)

Sent:

Wednesday, June 17,2009 9:53 AM

To:

Taubenheim, Ann (NIHINHLBI) [El

Cc:

McConnell, Patrick (NIHINHLBI) [C]

Subject: Request for Review Rec'd-OHSR

Good morning Dr. Taubenheim,
This email is to verify that OHSR has received your Request for Review of Research and it is currently being
processed as OHSR #4741. Please use this number in any future correspondence regarding this study. We will
contact you via email if any additional information is needed. If you have not heard from OHSR within 7 business
days, please contact us.
OHSR #4741: Study involving data from HIC
OHSR:
Ph: 301.402.3444
Fax: 301.402.3443
Thank you.
Sincerely,
Chris Brentin

Program Support Assistant
ODIOHSIUNIH
10 Center Drive, Rm. 2C- 146

Bethesda, MD 20892
30 1-402-863 1 (Direct)
30 1-402-3443 (Fax)