OHSRP Exemption

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

OHSR (NIH/DDIR)
Dickherber, Tony (NIH/NCI) [E]
Grant, Nicole (NIH/NCI) [E]; Dahut, William (NIH/NCI) [E]
FW: Determination of OHSRP #12656
Request for Amendment OHSRP #____

Dear Dr. Dickherber, 

Thank you for your patience.  We have recently experienced a staff turnover.  Attached is the OHSRP determination of 
Excluded from IRB Review per 45 CFR 46 and NIH policy for the collection of survey data  for your quality improvement 
project, ‘Outcome evaluation of the NCI Innovative Molecular Analysis Technologies (IMAT) extramural grant program’. 
You may proceed with the project.  

Please retain this documentation as you would other research records. Amendments and or changes to the research 
must be submitted to OHSRP for review as changes may affect the determination. Please refer to OHSRP #12656 for 
future amendments to this activity. To request future amendments, please use the attached email template modified to 
meet the specific changes needed for your project. If you have any questions or need further assistance, please feel free 
to contact us. 

Sincerely, 

Julie M. Eiserman, MA, CCRP [C] 
Health Science Policy Analyst 
Office of Human Subjects Research Protections 
10 Center Drive, Bldg. 10, Suite 2C146 
Bethesda, MD  20892‐1154 
Office Phone: 301‐402‐3444 
Fax: 301‐402‐3443 
OHSRP website: https://federation.nih.gov/ohsr/nih/index.php (NIH login required) 
Public site: http://ohsr.od.nih.gov/  

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OHSRP #12656
REQUEST FORM: OHSRP DETERMINATION FORSURVEYS, INTERVIEW PROCEDURES,
PROGRAM EVALUATION, EDUCATIONAL TESTING AND RESEARCH
Date of Request :

07/29/2014

Requestor's name: Anthony Dickherber e-mail: [email protected]
Role: _Administrative support __lLinvestigator

_Other, explain : _ _ _ _ _ __

Name of NIH Senior Investigator: _ __.:.,.A.!:..n:..:.t!.!.ho::.;n:..:..yz......::.D.:..:ic:..:.:k~h.:::.e:....:rb::..::e:..:.r_ _ _ __
(The investigator must be an NIH employee)

IC

NCI

Laboratory /Branch Center for Strategic Scientific Initiatives

Building & Room No. 31/10A33 Tel. No. (301)547-9980 FAX No. (301)480-2889
Is the NIH Senior Investigator an NIH emplo

e

_ _ _ No

Supervisor Signature: - - - - - - - - :,p-----=;:.__ _ _ _ _ _ _ _ _ _ _ _ __
(Signature
Name of NIH investigator conducting research if not the NIH Senior Investigator: (i.e,
junior investigator, contractor investigator, fellow, student)

Please provide the name and e-mail of any others who should receive a copy of the
OHSRP determination: - - - - - - - - - - - - - - - - - - - - - - 1. What role will the NIH investigator(s) have in this research project? (check all that
apply)
__lL Conduct research activity
__lL Analyze samples/data only
_Consultant/advisor to collaborator(s)
_Author on publication(s)/manuscript(s) pertaining to this research
_Other, please describe: - - - - - - - - - - - - - - - - - - - - -

2. Title: Outcome evaluation of the NCIInnovative Molecular Analysis Technologies
(IMAT) extramural grant program
(Provide a short title to distinguish this activity from other projects that you may have)

3. Describe in lay terms the research activity that will be performed:
Investigator is surveying applicants and awardees ofthe NCIIMAT program as part of a
process and outcome evaluation of the program's activities and investments. The
purpose of this evaluation is to determine the appropriateness of the program structure
and goals for serving the mission of the NCI .

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REQUEST FORM: OHSRP DETERMINATION FORSURVEYS, INTERVIEW PROCEDURES,
PROGRAM EVALUATION, EDUCATIONAL TESTING AND RESEARCH
4. Proposed start date QYQ!/2015

Proposed completion date ill!/Q!/2015

5. Specify the nature of the data: (select all that apply)

_ Interview procedure
__x_ Survey
_Educational Testing
Educational Research
_Research on public benefit or service programs
_Other, describe: - - - - - - - - - - - - - - - - - - 6. What kind of human data (e.g., private information, responses to questionnaires,
test results, recordings) will be collected in your research?

Responses to a questionnaire regarding the their views of the program in question,
their research experience in developing a novel technology, and their reflections on the
current state of the technology for applicable fields of research.
7. Will human data be? (select all that apply)

Collected
Received
Sent

-Yes_X No_K_
Yes_ No X
Yes_ No_K_

8. If receiving or sending, list the collaborating investigator(s):

Name

lnstitution/IC

Address/e-mail

FWA number*

9. Where are the subjects of this research activity located? (Provide a general
description or complete the institutional information below)

Survey responders are predominantly located at institutions across the United States of
America with a small percentage of responders located at foreign institutions.
Institution :

----------

Contact Name:

----- -------

Address: - - - - - - - - - - - - - - - Phone: - - - -- -- - - 10. Will NIH investigator(s) have direct contact or intervention with the subjects of
the study? (For example, by interviewing, surveying or recording the subjects?)

Yes__x_ No_
If yes, what is the age range of subjects involved in the research?
_Children aged< 18 years
_X_ Adults aged~ 18 years
11. Who will collect the data or information?

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REQUEST FORM: OHSRP DETERMINATION FORSURVEYS, INTERVIEW PROCEDURES,
PROGRAM EVALUATION, EDUCATIONAL TESTING AND RESEARCH

(a)_ NIH Investigator
(b)_ non-NIH Collaborator
(c) _X_ NIH Contractor
(d)_ Other, specify _ _ _ _ _ _ _ _ __ _ _ _ _ _ __
If b or c, will an Honest Broker or data use agreement be used? Yes_ No__L

If yes, complete and attach the Honest Broker Assurance or data-use agreement to
this submission; e-mail ohsr nih [email protected] to request a form.
12. Select the best description that applies to the human data or information:

_Data or information will not contain any identifiable information, nor can it be
linked to individual subjects by you or your collaborators.
___x_ Data or information will be recorded in such a manner that subjects can be
identified directly or through identifiers linked to the subjects
13. Per NIH guidance, are all conflicts of interest by NIH employees (sender or
receiver), if any, resolved?

X

Yes _ _ No**

*A Federalwide Assurance (FWA) is issued by the U.S. Department of Health and Human
Services (DHHS}/ Office of Human Research Protections (OHRP) to institutions which
receive Federal funds/support to conduct human subjects research. To search for the
FWA# for domestic or international institutions go to
http://ohrp.cit.nih.gov/search/fwasearch.aspx?stvp=bsc
**If the answer is "No", note that OHSRP will be unable to make a determination and
research mav not proceed until all conflicts are resolved. For more information, see the
October 2011, A Guide to Preventing Financial and Non-Financial Conflict o(/nterest in
Human Subjects Research at NIH. For assistance review the list of Ethics Coordinators
and find the contact for your IC: http://ethics.od.nih.gov/coord.pdf

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

Dickherber, Tony (NIH/NCI) [E]
Thursday, October 16, 2014 10:41 AM
OHSR (NIH/DDIR)
Barnes, Dereck (NIH/OD) [E]; Matose, Takunda (NIH/OD) [C]
Request for OHSRP approval to survey program participants
Attachment 7_OHSRP Exemption(PLACEHOLDER).pdf

To whom it may concern: 

Please find attached a request for approval from OHSRP to issue surveys and interviews as part of an extramural 
program evaluation of the NCI Innovative Molecular Analysis Technologies (IMAT) program. This request was put 
together with guidance from Takunda Matose (cc’d) this past July, but mistakenly assumed that the submission seeking 
approval from the Office of Management and Budget for a waiver of the Paperwork Reduction Act was the appropriate 
mechanism for registering this request. It only recently became clear to me that this form should be submitted to this 
office.  

For background, this request is for permission to obtain new information from extramural researchers regarding their 
experience with technology development research supported by NIH grant programs, especially associated with the NCI 
IMAT program. Please don’t hesitate to contact me for any additional information.  

Kind regards 
Tony 

********************************* 
Tony Dickherber, PhD 
Program Director 
Innovative Molecular Analysis Technologies 
http://innovation.cancer.gov 
National Cancer Institute 
National Institutes of Health 
Tel. (301)547‐9980 
Fax.(301)480‐2889 
[email protected] 

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

OHSR (NIH/DDIR)
Monday, October 20, 2014 3:21 PM
Dickherber, Tony (NIH/NCI) [E]
Req for Determination Rec'd_OHSRP 12656

Good afternoon Dr. Dickherber, 

This email is to verify that OHSR has received your Request for Determination and it is currently being processed as 
OHSRP #12656. Please use this number in any future correspondence regarding this study.   

Protocol Title: Outcome evaluation of the NCI Innovative Molecular Analysis Technologies (IMAT) extramural grant 
program 

Thank you. 
Sincerely, 
Chris Brentin 
OHSRP ‐ National Institutes of Health 
Bldg 10, Suite 2C146                                                                                                                           
Bethesda, MD 20892 
Office Telephone: 301‐402‐3444 
Office Fax: 301‐402‐3443 

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

Please consider the environment before printing this e-mail 

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