Attach 9_TTC_OHSR exemption_12-01-10

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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), email to ohsr nih ddir@,od.nih.gov,or by mail (2C146). If you have any
questions, call OHSR at (301) 402-3444.
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Date:

June 10,2010

er, National Cancer Institute)
Protocol Title: Technology Transfer Center External Customer Satisfaction Survey
Name of NIH Principal Investigator(s): John D. Hewes, Ph.D.
IC: NCI
LaboratoryIBranch: Technology Transfer center
Building & Room No.: EPN 450
Tel. No. 301-4965-0477
FAX NO. 301-402-21 17
Is the Principal investigator an NIH employee?

X Yes,

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No

If no, please explain:

1. What is the proposed research activity that you intend to perform a t NIH (please
use lay terms):
The Technology Transfer Center (TTC) of the National Cancer Institute (NCI) negotiates
and manages research collaborations for the NCI Intramural Research Program and nine
other Institutes and Centers of the National Institutes of Health (NIH). (The NCI TTC
does not negotiate licenses, as this activity is relegated solely to the centralized NIH
Office of Technology Transfer.)
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The research activity is a Program Assessment of the NCI TTC funded primarily through

Last revised 8/4/09

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the NIH Evaluation Office, Evaluation Set-Aside program. The objectives of this
Assessment are to evaluate three components that are critical to the performance of the
NCI TTC:
(1) Satisfaction of TTC's external customers with its services;
(2) Preferred and expected communications channels of TTC's external
customers; and
(3) strategic direction of companies engaging in research-related partnerships
with the NIH.
The program assessment will have direct usefulness to the NCI TTC and provide
valuable information to the NIH technology transfer community. The results of the
external customer survey will be used to achieve the following goals:
(1) improvement of the TTC workflow process;
(2) more focused marketing of NIH discoveries to TTC's external customers; and
(3) better communication of industry needs to NIH scientists.
The assessment will consist of an online Customer Satisfaction Survey of external
customers, that is, those in the for-profit biotechnology and pharmaceutical sectors who
interact with the TTC. The proposed research methodology is a.brief web-based survey
conducted in two phases:
(1) a pre-test of 9 or fewer subjects; and
(2) a full-scale web-based survey.
The research participants are past, current, and potential TTC external customers (i.e.
industrial biotechnology, pharmaceutical and medical device executives). For mid-sized
to large companies, the respondents will be at the level of Manager, Director or Vice
President for Business Development. At smaller companies, the respondents will be ,
individuals at the Chief Executive Officer, Chief Medical Officer, Chief Technology
Officer, or Chief Science Officer level.
.
2. If applicable, list your non-NIH Collaborating Investigator(s).
Name
Institution
(Not Applicable)

Address Tel. # FAX #

3. Proposed start date of your research
June 2 1,2010.for pretest;
April-May 201 1 (pending OMB ciearance) for the full-scale survey
Proposed completion date
July 20 10 for pretest; July 201 1 for completion of full-scale survey data collection

Last revised 8/4/09

these samples or data?

4. Will you be

Collecting
Receiving
Sending

No
No*
No

* For the pre-test (aka "pilot survey"), we will receiving a report and revised survey design from
the contractor, but no raw data. For the full survey, which will probably require an amendment to
this application, we will have the option of receiving the anonymouslaggregated data.
5. Do the samples or data:
(a) Already exist?

Yes

X No

(b) Or are they being collected for the express purpose of this study?
X Yes
No
If "yes," please describe:

-

The results of the external customer survey will be used to achieve the following
goals: (1) improvement of the TTC workflow process; (2) more focused marketing of
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NIH discoveries to TTC's external customers; and (3) better communication of
industrv needs to NIH scientists.
(c) Or a combination of (a) and (b)?

Yes

X

No

6. What role will you have in this research project? (Check all that apply)
-Analyze sarnplesldata only.
- Consultant/advisor to

collaborator(s) listed above.

-Author

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

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

pertaining to this research.

-You or NIH hold an IND for this research.

X Decisional authority over the design or implementation of the research at the IRB
approved site? If so, please explain.

NCI TTC created the design for the survey and questionnaire and is responsible for the
implementation of this research.
O t h e r (If necessary, use this space to describe your role in this research).
7. Where are the subjects of this research activity located?
Last revised 8/4/09

Internet respondents worldwide
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?) X Yes
No
Pre-test and Survev participants will not have personal contact by Proiect Officer.
Pre-test participants will be recruited by mailed invitation signed by TTC Director,
followed by email instructions on how to ~articipatesent bv outside contractor.
Full survey participants will be sent an invitation to participate, sinned bv TTC Director,
sent by outside contractor via two emails instructing participants that they can voluntarily
respond to survey via a secure, online questionnaire.
In both Pre-test and Survey, NCI personnel will have no direct contact with participants
and will not have an opportunity to obtain or view raw data submitted bv the respondents.
Data will be aggregated and analyzed by the outside contractor and submitted to NCI
TTC as anonymous data:

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?
Respondents will be asked to answer questions about company experiences in three areas:
(I) general respondent company information (e.cr. Is your company Public or Private?);
(2) stratepic directions (e.n. Does your company develop strategic technology
partnerships (research collaborations, licensing, etc.) with outside ornanizations?); and
(3) experience with NIH TTC services (e.a. How did you first learn about the NCI
Technolocry Transfer Center?).
No personal information will be asked. Respondents will be asked for a corporate
telephone number. (The survey instrument states "The survey administrator is a
contractor to the NIH. They may follow up by telephone with some participants to
clarify answers. If you are available for follow-up, please provide a contact number
where you can be reached.") Survey respondents will be given the opportunity at the
end of the survey to follow a link to the NCI TTC website to sign up for listserv
announcements open to the general public.

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

Yes

No

(b) Pathological waste -Yes &No

Last revised 8/4/09

I

(c) Autopsy material -Yes

No

(d) Publicly available source Y e s x
(e) Other

No

N/A

11. Please check the box(es) that apply(ies) to the samplesldata that you will receive.
(a) X Samples and/or data will be anonymized/unlinked. (The samplesldata
cannot be linked to individual subjects by you or your collaborators at other sites.)
(b) -Samples and/or data will be coded, however that code cannot be used by
either the sender or the receiver to identify specific individuals.
(c) -Samples andlor data will be coded so that the provider of the sarnples/data
can link them to specific individuals but the receiver will not be able to do so.
Will you send results back to the provider(s) (listed in question 2 of this
12.
form)?
(a) X

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

(b) -Yes, I will send aggregate results to the provider(s).
(c) -Yes, I will send results to the provider(s) that are linked to identifiable
individuals.
If yes, does the provider intend to link your data to identifiable individuals?
Yes
No
13. Has the research activity that you are proposing in this form been approved by
an Institutional Review Board (IRB) elsewhere?

Yes, the NIH research activity has been reviewed by the following IRE3 (s)
(Please provide the following inforniation for each I-):
i

Name of institution that provided the review
Address of reviewing institution
Name of PI for the IRB approved protocol,
Title of IRB approved protocol and protocol #

Last revised 8/4/09

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://ohrp.cit.nih.aov/searcl.l/asearch.as~#ASUR

14. Per NIH guidance** *, have conflicts of interest by NIH employees, if any, been
resolved?
X Yes
No

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

***The January 5,2005 NIH Guide to Preventing Conflict of Interest applies to all
research conducted at NIH, http://ohsr.od.nih.gov/New/mpafwa docs.htin1

Last revised 8/4/09

Page 1 of 1
OHSR (NIHIDDIR)
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OHSR (NIHIDDIR)

Sent:

Monday, June 28,2010 11 :42 AM

To:

Hewes, John (NIHINCI) [El

Subject: Request for Review Rec'd-OHSR 5301

Good morning Dr. Hewes,
This email is to verify that OHSR has received your Request for Review of Research and it is currently being
processed as OHSR #5301.Please use this number in any future correspondence regarding this study. We will contact
you via email if any additional information is needed. If you have not heard from OHSR within 7 business days,
please contact us.
Protocol Title: Technology Transfer Center External Customer Satisfaction Survey

Thank you.

-

Sincerely,
I

OHSR - National Institutes of Health
Bldg 10, Suite 2C146
Bethesda, MD 20892
Office Telephone: 301-402-3444
Office Fax: 301-402-3443

The NIH is committed to maintaining the highest standards for the protection of human subjects.

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