CIRB OHSR Determination

OMB #0925-xxxx
Expiration Date: xx/xx/xxxx

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.

Date:
To:

October 14.2010
OFFICE OF

From: Mike Monte11
(Signature)
Through: Steve Friedman
(Signature of appropriate Official for IC, e.g., EabIBranch Chief)
Protocol Title: NCI Central Institution Review Board (CIRB)
Name of NIH Principal Investigator(s):Mike Montello, PharrnD, MBA
IC: N C I N I H EaboratoryIBranch CIBICTEPIDCTD
Building & Room No.: EPN, Rm 7036- Tel. No: 301-435-9206 FAX No.: 301-480-4663

Is the Principal Investigator an NIH employee? - X Y e s
If no, please explain:

No

1. What is the prbposed research activity that you intend to perform at NIH (please
use lay terms):
Though data is being collected by the CIRB. there is no intent to use this information for
research in any form. The data being collected is for the sole purpose of fulfilling the
mission of the Central Institutional Review Board (CIRB). The data available is not
intended for any use other than to conduct IRB review of studies. Therefore, data are not
being collected on human subiect participants as part of the CIRB Initiative.

The CIRB improves access to NCI-sponsored Cooperative Group cli&cal trials for
potential study participants and their physicians by enabling local IRBs to rapidly
approve clinical trials through the use of a facilitated review process. The NCI Central
Institutional Review Board (CIRB) Initiative reviews protocol, informed consent
document(s), completed CIRB application(s); and when appropriate, an investigator drug
brochure. The CIRB reduces the administrative burden on local IRB's and investigators.

Last revised 8/4/09

I

2. If applicable, list your non-NIH Collaborating Investigator(s).
Name
Institution
Address Tel. # FAX #

3. Proposed start date of your research Research is not be in^ conducted.
[The Adult CIRB began meeting Januaw 2001 ;The Pediatric CIRB began meeting
November 2004.1

Proposed completion date? There is no research being conducted.

4. Will you be

these samples or data?

Collecting Y e s m
Receiving YeslNo
Sending
YeslNN

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?
Yes X No
1Tyes," please describe:
(c) Or a combination of (a) and (b)?
-Yes
No

6. What role will you have in this research project? (Check all that apply)

i
I

-Analyze samplesldata only.
-Consultant/advisor to collaborator(s) listed above.
-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 IRJ3
approved site? If so, please explain.
Other (If necessary, use this space to describe your role in this research).

-

***We are not conducting a research proiect. The CIRB improves access to NCIsponsored Cooperative Group clinical trials for potential study partici~antsand their
phvsicians by enabling local IRBs to rapidly approve clinical trials through the use of a
facilitated review process.

Last revised 8/4/09

7. Where are the subjects of this research activity located?
Thouvh data is being collected by the CIRB. there is no intent to use this
information for research in any form. The data beinp collected is for the sole
purpose of hlfillinp the mission of the CIRB. The data available is not intended
for any use other than to conduct IRB review of studies. Therefore. data are not
being collected on human subiect ~articipantsas part of the CIRB Initiative.

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
-No
samples directly from the subject; by interviewing the subject?) -Yes

* no human subiects

,*.

.

,

..

1

.

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?
The NCI uses various information collection tools to su~portClRB activities, thouah none of them
are beinq collected for research purposes. These include forms requirina completion bv a site
conductins a clinical trial eliqible for review by the CIRB, as well as forms ~0mpletedbv the ClRB
members themselves.
There are 6 qeneral areas in which forms are com~letedand data are collected. These include:
1.
mllects customer feedback pertaining to the use of the ClRB
helpdesk.
2. ClRB Institution Enrollment Forms: Enrollment documents collect information on the
institutions interested in enrolling or having already enrolled in the ClRB Initiative.
3. ClRB Membership Information: Membership documents collect information on ClRB
members. Information requested includes: name, degree, college and/or university
attended, graduation year, bio sketch, headshot, title, place of employment, address,
email address, telephone number, and picture. This is public accessible information.
4. Direct Deposit Form: This is an optional form for ClRB Members to complete should
they choose to receive honoraria via direct deposit.
5. IRE Application Forms: The application forms are required to be submitted to the
ClRB in order to complete a submission for review.
6. ClRB Reviewer Forms: Theses forms are completed by the Board Members when
they submit reviews.
The ClRB Helpdesk Survev seeks to collect information that can be used bv the CIRB in a
svstematic fashion to improve operations and enhance reviewer satisfaction with the initiative.
The remaininq forms are necessarv in order to facilitate a com~letereview of protocols bv the
ClRB with the absence of conflict of interest in place.

Last revised 8/4/09

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

No

(b) Pathological waste -Yes

(c) Autopsy material -Yes

No
No

(d) Publicly available source Y e s X No
(e) OtherCooperative Groups, Board Members, and Institutions supply a variety of information
for the conduct of the CIRB, though none of the data collected is for the intent of
research.
11. Please check the bok(es) that apply(ies) to the samplesldata that you will receive.
(a) -Samples and/or data will be anonym zedlunlinked. (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 and/or data will be coded so that the provider of the samplesldata
can linkthem 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)?
(a) -No,

I will not send resultsback 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 prouosing in this form been approved by an
Institutional Review Board (IRB) elsewhere?
There is no research being conducted. This proiect is Exempt. The reason for the exemption
would be as cited in 45 CFR 46.10 1Ib) (4): (4) Research involving the collection or study of
existing data, documents, records, patholoaical specimens, or diagnostic specimens, if these

Last revised 8/4/09

sources are publicly available or if the information is recorded bv the investigator in such a
manner that subiects cannot be identified. directly or through identifiers linked to the subiects.
Yes, the NIH research activity has been reviewed by the following IRB (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 IRB approved protocol and protocol #
Federal Wide Assurance (F WA) number* *

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

-.

(**An FWA is a contract bettveen 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.nov/searchlasearch.as~#ASUR
14. Per NIH guidance***, have conflicts of interest by NIH employees, if any, been
resolved?
x Yes
No
A

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 8/4/09

Page 1 of 1
Brentin, Christine (NIHIOD) [El
From:

Jennifer Dugan [[email protected]]

Sent:

Tuesday, October 19,2010 10:07 AM

To:

OHSR (NIHIDDIR); Pursley-Crotteau, Suzanne (NIHIOD) [El

Cc:

Montello, Mike (NIHINCI) [El; Friedman, Steve (NIHINCI) [El; Adler, Jeanne (NIHINCI) [El; Valmonte,
Claudine; Goldberg, Jacquelyn (NIHINCI) [El

Subject:

OHSR Application

Follow Up Flag: Follow up
Flag Status:

Red

Attachments:

OHSR App-101510.pdf

Dear OHSR,
Please review the attached ClRB Application.
Per instruction, signatures were obtain in advance and hopefully any remaining items can be resolved via email.

Thanks,
Jennifer
Jennifer L. Dugan, MS
Project Manager
NCI ClRB Operations Office
The EMMES Corporation
401 N. Washington Street, Suite 700
Rockville, lblD 20850
Phone: 301-251-1 161 x2827
Fax: 301-251-1355
[email protected]
www.emmes.com

Page 1 of 1

From:

OHSR (NIHIDDIR)

Sent:

Tuesday, October 19,2010 2:35 PM

To:

Montello, Mike (NIHINCI) [El

Cc:

'[email protected]'

Subject: Request for Review Rec'd-OHSRP 5469

Good afternoon Dr. Montello,
This email is to verify that OHSR has received your Request for Review of Research and it is currently being
processed as OHSRP #5469. 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: NCI Central Institution Review Board (CIRB)
Thank you.
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 kefore printing this e-mall