IRB Letter

Matose, Takunda (NIH/OD) [C]
From:
To:
Cc:
Subject:
Attachments:

OHSR (NIH/DDIR)
Sampson, Annie (NIH/NCI) [E]
Grant, Nicole (NIH/NCI) [E]
Determination for OHSRP 12414
Request for Amendment OHSRP #____

Dear Dr. Sampson, 

Attached is the OHSRP determination of Excluded from IRB Review per 45 CFR 46 and NIH policy for your 
project NCI Advocate Database. 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 #12414 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. 

Best, 

Takunda Matose 
OHSRP ‐ National Institutes of Health 
Bldg 10, Suite 2C146 
Bethesda, MD 20892 
Office Telephone: 301‐402‐3444 
Office Fax: 301‐402‐3443 

From: OHSR (NIH/DDIR)
Sent: Friday, May 09, 2014 12:51 PM
To: Sampson, Annie (NIH/NCI) [E]
Subject: Req for Determination Rec'd_OHSRP 12414

Good afternoon Ms. Sampson, 

This email is to verify that OHSR has received your Request for Determination and it is currently being processed as 
OHSRP #12414. Please use this number in any future correspondence regarding this study.  We will contact you via 
email if any additional information is needed. Please note that due to ongoing project deadlines, determinations are 
taking longer than normal to process. 

Protocol Title: NCI Advocate Database
Thank you. 
Sincerely, 
Chris Brentin 
OHSRP ‐ National Institutes of Health 
Bldg 10, Suite 2C146                                                                                                                           
Bethesda, MD 20892 
Office Telephone: 301‐402‐3444 
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OHSRP #12414
REQUEST FORM: OHSRP DETERMINATION FORSURVEVS, INTERVIEW PROCEDURES,
PROGRAM EVALUATION, EDUCATIONAL TESTING AND RESEARCH
Date of Request: 4/29/2013
Requestor's name: Nichole Sorhaindo

e-mail: [email protected]

Role: _Administrative support X Investigator

_Other, explain: _ _ _ _ _ __

Name of NIH Senior Investigator: Annie Sampson

(The investigator must be an NIH employee)
IC: National Cancer Institute Laboratory/Branch: Office of Advocacy Relations
Building & Room No. 10A28D

Tel. No. 301-594-6831

FAX No. 301-480-7558

Is the NIH Senior Investigator an NIH employee(FTE)? X Yes

No

e 11nvestigator who will conduct research)
~, .......,____.._,

Supervisor Signature:

(Signature of official for IC, e.g., Lab/Branch Chief)
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: Kelley Landy [email protected]; Kelli Marciel

[email protected]; Annie Sampson [email protected]
1. What role will the NIH investigator(s) have in this research project? (check all that

apply)
_Conduct research activity
_Analyze samples/data only
_Consultant/advisor to collaborator(s)
_Author on publication(s)/manuscript(s) pertaining to this research

X Other, please describe: Pull information from database
2. Title: NCI Advocate Database

{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:

Central to OAR's identity is both matching qualified research advocates to engage in
research activities within NCI and engaging with a variety of advocacy organizations at
the organization level. These activities rely on a robust database to store and retrieve

Page 1 of3

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

information about the advocates, organizations and research activities. A custom OAR
application for these purposes was developed by CBIIT (accessible at
http://oar.nci.nih.gov/oar).
•
The purpose of the database, as it long has been, is to track interactions between both
individual volunteer research advocates and NCI's Office of Advocacy Relations, and
advocacy organizations and OAR. Another purpose for this database is tracking and
evaluating the process and outcomes of engaging advocates in research in support of
the NCI mission. The database is programmatic in nature.
The NCI Advocate Database stores and retrieves information about advocates,
organizations and NIH research activities in which research advocates have participated.
All information is entered into the database by OAR staff, with two exceptions; requests
for research advocate activity participation from may be submitted via online form by
an investigator and individual research advocates may edit their profiles through an
online form. The use to which this information will be put is for OAR staff to be able to
respond to internal requests from investigators to identify and match qualified research
advocates with research advocacy opportunities at NCI and across NIH.
The NCI Advocate Database is being slightly revised from its previous iteration,
architected in 2005; this revision includes updates to fields where information is
collected from participants and it also includes functionality and design changes to the
backside dashboard where OAR staff can view and search for records.
4. Proposed start date 7/1/2013

Proposed completion date: n/a

5. Specify the nature of the data: (select all that apply)
_Interview procedure
_Survey
_Educational Testing
Educational Research
_Research on public benefit or service programs
X Other, describe: Research advocate profile information for potential involvement in

NCI research activities
6. What kind of human data (e.g., private information, responses to questionnaires,
test results, recordings) will be collected in your research?

7. Will human data be? (select all that apply)
Collected
Yes_ No X
Received
Yes NoX
Sent
Yes_ No X

Page 2 of3

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

8. If receiving or sending, list the collaborating investigator(s):
lnstitution/IC
Address/e-mail
Name

FWA number*

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

Nationwide
Institution: n/a

Contact Name: n/a

Address: n/a

Phone: n/a

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?
(a) X NIH Investigator
(b)_ non-NIH Collaborator
(c)_ NIH Contractor
(d) X Other, specify: respondents input information onto online database themselves
If b or c, will an Honest Broker or data use agreement be used? Yes_ No_

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

th~

subjects

13. Per NIH guidance, are all conflicts of interest by NIH employees (sender or
receiver), if any, resolved? _ _Yes X No**

Page 3 of3

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

Bridge, Heather (NIH/OD) [E]
Friday, April 11, 2014 7:08 AM
Sampson, Annie (NIH/NCI) [E]; Matose, Takunda (NIH/OD) [C]; Brentin, Christine
(NIH/OD) [E]; Brown, Kristan (NIH/OD) [E]
FW: Office of Advocacy Relations
1833_001.pdf

Importance:

High

Follow Up Flag:
Flag Status:

Follow up
Flagged

Categories:

Red Category, Yellow Category

Hi Annie,  
I no longer process these requests but have cc’d my colleagues for you. We had some technical issues w/our inbox that 
may have caused a delay. 
Folks please make sure this determination request is processed.  
Best, 
Heather Bridge 
Office of Human Subjects Research Protections 
Office of Intramural Research 
National Institutes of Health 
10 Center Drive, 
Bldg. 10, Room 2C146 
Bethesda, MD 20892 
Direct line: 301‐402‐4504 
BB: 240‐281‐9015 
Office Main: 301‐402‐3444 
Fax: 301‐402‐3443 
E‐mail: [email protected] 
OHSRP website: https://federation.nih.gov/ohsr/nih/index.php (NIH login required) 

From: Sampson, Annie (NIH/NCI) [E]
Sent: Thursday, April 10, 2014 4:03 PM
To: Bridge, Heather (NIH/OD) [E]
Subject: Office of Advocacy Relations

Hi Heather, 

I put this request in awhile ago, you have probably reviewed it and made a recommendation, however I do not have the 
final signature page. Can you please send me your final determination? 

Thank you, 
Annie 

Annie Sampson, MSc
NIH/National Cancer Institute
Office of Advocacy Relations
1

31 Center Drive, MSC 2580
Bethesda, MD 20892
Phone: (301) 594.6831
[email protected] 

2

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

OHSR (NIH/DDIR)
Friday, June 21, 2013 10:43 AM
OHSR (NIH/DDIR); Sampson, Annie (NIH/NCI) [E]
FW: Cannot Process RE: OAR Advocate Database -- Request for Determination

Follow Up Flag:
Flag Status:

Follow up
Flagged

Categories:

Red Category, Yellow Category

Hi Annie, 
I am forwarding your question to Takunda Matose, who reviews the requests. 

Chris 

From: Sampson, Annie (NIH/NCI) [E]
Sent: Friday, June 21, 2013 10:31 AM
To: OHSR (NIH/DDIR)
Subject: RE: Cannot Process RE: OAR Advocate Database -- Request for Determination

Honestly, I’m not sure what this is. should I check with our Administrative Office? 

From: OHSR (NIH/DDIR)
Sent: Friday, June 21, 2013 10:30 AM
To: Sampson, Annie (NIH/NCI) [E]
Subject: RE: Cannot Process RE: OAR Advocate Database -- Request for Determination

Hi Annie, 
Will an Honest Broker or data use agreement be used? 

Thank you. 
Chris 

Sincerely, 
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 

From: Sampson, Annie (NIH/NCI) [E]
Sent: Thursday, June 20, 2013 9:17 AM
1

To: OHSR (NIH/DDIR)
Subject: RE: Cannot Process RE: OAR Advocate Database -- Request for Determination

I apologize, I thought I had responded. The answer is A. I will be the NIH investigator. 

Does that answer the outstanding question? 

Please let me know if you need anything else. 

Thank you, 
Annie  

From: OHSR (NIH/DDIR)
Sent: Thursday, June 20, 2013 9:14 AM
To: Sampson, Annie (NIH/NCI) [E]
Subject: Cannot Process RE: OAR Advocate Database -- Request for Determination
Importance: High

Hi Annie, 
I wanted to follow up with this request. OHSRP has not yet received your response to the email below. Please let me 
know if you would like to continue this request. 
Thanks very much. 

Sincerely, 
Chris Brentin 
OHSRP 
From: OHSR (NIH/DDIR)
Sent: Monday, May 20, 2013 2:10 PM
To: Sampson, Annie (NIH/NCI) [E]
Subject: Cannot Process RE: OAR Advocate Database -- Request for Determination
Importance: High

Hi Annie, 

I apologize that we omitted a correction that OHSRP needs in order to process your request.  The current form has a 
typo in #11.  It should read: “if A or c, will an Honest Broker or data use agreement be used?” 

11. Who will collect the data or information?
(a) X NIH Investigator
(b)_ non-NIH Collaborator
(c)_ NIH Contractor
(d) X Other, specify: respondents input information onto online database themselves
If b(A) or c, will an Honest Broker or data use agreement be used? Yes_ No_
If yes, complete and attach the Honest Broker Assurance or data-use agreement

Please answer this question in a response email. You do not have to resend the form.  I have attached an Honest Broker 
form if you do need it. Once I receive your response, I will enter it into our system for review. 
Please contact OHSRP with any questions. 
Thank you. 

Sincerely, 
Chris Brentin 
OHSRP ‐ National Institutes of Health 
2

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

From: Sampson, Annie (NIH/NCI) [E]
Sent: Thursday, May 16, 2013 9:12 AM
To: OHSR (NIH/DDIR)
Cc: Sorhaindo, Nichole (NIH/NCI) [C]; Sampson, Annie (NIH/NCI) [E]
Subject: RE: OAR Advocate Database -- Request for Determination

Good morning, 

I have attached the adjusted form here. 

Thank you, 
Annie  

From: OHSR (NIH/DDIR)
Sent: Monday, May 06, 2013 4:31 PM
To: Sampson, Annie (NIH/NCI) [E]
Cc: Sorhaindo, Nichole (NIH/NCI) [C]
Subject: RE: OAR Advocate Database -- Request for Determination

Good afternoon Dr. Sampson. 

While reviewing this request I found that question #4 – Proposed completion dates was not completed.  If you expect 
the study to continue past 5 years, enter 7/1/2018 as the proposed date.  Send an amendment request via email to 
extend the date as it gets closer to 2018.  Question #7 – Will human data be collected, received or sent (check all that 
apply) was answered no.  I assume you will be collecting?  Question #13 – Are all conflicts resolved was answered 
no.  This question has to be answered Yes before we can process your submission.  

Please let me know if you have any questions. 

Kristan Brown 
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

3

From: Sorhaindo, Nichole (NIH/NCI) [C]
Sent: Monday, May 06, 2013 11:52 AM
To: OHSR (NIH/DDIR)
Cc: Bridge, Heather (NIH/OD) [E]; Sampson, Annie (NIH/NCI) [E]; Landy, Kelley (NIH/NCI) [E]
Subject: OAR Advocate Database -- Request for Determination
Importance: High

Hello, 

I would like to submit the attached OHSRP Determination Request Form on behalf of the NCI’s Office of Advocacy 
Relations (OAR) for OAR’s Advocate Database. If you have any questions, please feel free to contact me at 
[email protected] or the PI, Annie Sampson, at [email protected]. 

Thanks, 

Nichole Sorhaindo, MPH
Contractor 
Palldian Partners, Inc. 
Office of Advocacy Relations (OAR) 
National Cancer Institute (NIH) 
Building 31, Room 10A28E 
31 Center Drive, MSC 2580, Bethesda, MD 20892‐2580 
Phone: 301‐594‐3194 
Email: [email protected] 

4

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

OHSR (NIH/DDIR)
Friday, May 09, 2014 12:51 PM
Sampson, Annie (NIH/NCI) [E]
Req for Determination Rec'd_OHSRP 12414

Good afternoon Ms. Sampson, 

This email is to verify that OHSR has received your Request for Determination and it is currently being processed as 
OHSRP #12414. Please use this number in any future correspondence regarding this study.  We will contact you via 
email if any additional information is needed. Please note that due to ongoing project deadlines, determinations are 
taking longer than normal to process. 

Protocol Title: NCI Advocate Database
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

1