NIH OHSRP Statement of Exemption

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

Exempt: #:

FAX:

301-480-664 1

To:

Speakman, John

4722

NCI

-

2115EJ 2115 E Jefferson St, 6009
From:

Office of Human Subjects Research (OHSR)

Nature of Research Activity:
The reporting of information through this resource is not a research activity but rather an infrastructure
development project that will be enabled by public funds expended pursuant to the American Recovery and
Reinvestment Act of 2009, P.L. 111-5. The National Cancer Institute (NCI) is developing an electronic
resource, the NCI Clinical Trials Reporting Program (CTRP) Database, which is intended to serve as a
sinale definitive snllrce nf infnrmatinn a h n ~all
~ t NCI-s~lnnrtedclinical research therehv enahlinn the NCI to

Original Request Received in OHSR on:
Responsible NIH Research Investigator(s):

John Speakman, NCI

OHSR review of vour request dated Thu, Jun 4, 2009 has determined that:
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.
-SF
NOTIFY OHSR OF ANY SIGNIFICANT CHANGES THAT MAY Al TER THE
PT STATUS OF THIS RESFARCH ACTIVITY,
NOT EX-.
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-whetherexpedited or full review is appropriate.

Confidentiality Agreement

q

Reliance
Amendment

q

Other
Office Person SPC

Note:

Admin Assist. CB

6/8/2009
ignature

Title

Date

OHSR Use Only
Human Subjects Data: Yes
Biologic Material:

No

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

REOUEST FOR REVIEW OF RESEARCH ACTIVITY INVOLVING HUMAN
SUBJECTS

INS'I'RUC'TIONS: 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: June 4, 2009
0 :

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

Ldc&k--7

From:

(Signature)
.

I

d

b--

Through: ~ V i L&3i)upb1fy D:,&p
(Signfiture o f appropriate Official for IC, e.g., LabIBranch Chief)

PC1 ( B I T

Name of NIH Principal Investigator(s): John S~eakman
IC NCI
LaboratoryA3ranch Center far Biomedical Informatics and Information
Technotoav (C61IT). Office of the Director
Building & Room No. 2115 E. Jefferson. Suite 6000 Tel. No. 301-451-8786
FAX No.
E-MAIL:john.s~eakman@nih.nov

Is the Principal investigator an NIH employee?

If no, please explain:

-

X Yes
.-

---

N

o
. .

1. What is the proposed research activity that you intend to perform at NIH (please use lay
terms): The r e ~ o r t i n n
of information throuah this resource is not a research activitv but

t wi.ll be enabled by public funds
rather an infrastructure development ~ r o i e cthat
expended pursuant to the American Recovery and Reinvestment Act of 2009, P.L. 111-5.
The National Cancer Institute (NCL) is developingan electlpnic resource, the NCI Clinical
Trials Reporting Program (CTRP) database, w 6 r c h h i g S e T e S s e N e as a single,
definitive source of information about all NCI-supported clinical research, thereby
enabling the NCI t o execute its mission t o reduce the burden of cancer and to ensure an
optimal return on the nation's investment in cancer clinical research. In addition,
deployment of this resource will allow the NCI to consolidate program and regulatory
reporting, aggregate information and reduce redundant submissions. lnformation will
be submitted by clinical research administrators as designees of clinical investigators
who conduct NCI-supported clinical research.------- -

Last revised 1 1/7/05

6

2. If applicable, list your non-NIH Collaborating Investigator(s).
3. Proposed start date of your research Julv 1.2009
Proposed completion date on~olnn

4. Will you be

these samples or data?

Collecting P W o
Receiving Y d o
Sending
YesN
5. Do the samples or data:
(a) Already exist?XYes

(b) Or are they being collected for the express purpose of this study? Y e s X N o
If "yes," please describe:
(c) Or a combination of (a) and (b)?

-Yes

No

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

-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 IRB
approved site? If so, please explain.

-X- Other (If necessary, use this space to describe your role in this research). This is

not a research activity. I serve as the acting program manager for the NCI Clinical Trials
Reporting Program and have been the project lead for the development of the CTRP
Database.

7. Where are the subjects of this research activity located? There are no research
subjects as the collection of information through the CTRP Database is not a research
actlvtty. Only clinical trials registration information, including information about trial
Last revised 1 1/7/05

- .-- -- - - - - - -protocols, clinical investigators and template informed consent documents, is currently
proposed for collection through this resource.

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?) N/A
9. What kind of human samples.(.e.g., .tissue,.bjoad)or data (e.g., private
information, responses to questionnaires) will be involved in your research? NONE
10. If the samples, data do not come from an lRB approved protocol, do they come
from:
(a) Repository Y

e

s -No
.

(b) Pathological waste -Yes

.*

-

No

-Yes -No
Publicly available source Y e s -No

(c) Autopsy material

(d)

(e) Other: Submissions will include the trial protocol document, the template
if available, and the
informed consent document, and IRB app~~wl-eloeurnentation,
following data elements relating to trlal registration:
Lead organization
Lead organization trial identifier
NCT number
Princlpal investigator
Protocol title
Trial type
Trial phase
Trial purpose
Sponsor
Responsible party's work email address
Responsible party's work phone number
Summary 4 funding type - - .- Summary 4 funding sponsor
NIH grant funding mechanism
NIH institute code
Serial number
NCI division/program code
Current trial status

------A-

Last revised 1 1/7/05

--- - -

-

Current trial status date
Trial start date (actual or anticipated)
Primary completion date (actual or anticipated)
IND/IDE number
IND/IDE grantor
IND/IDE holder type
Expanded access type (if applicable)

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

-Samples and/or data will be anonymized/unlinked. (The samplps/data 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 o f the samples/data
can link them to specific individuals but the receiver will not be able to do so.
Names, work telephone and work email information concerning clinical
investigators, not research subiects or patients, will be submitted.

Will you send results back to the provider(s) (listed in question 2 of this

12.

form)?
(a)

- -No, Iwill not send results back to the provider(s).

(b)

_-

(c)

-Yes, Iwill send results to the provider(s) that are linked to identifiable

Yes, Iwill send aggregate results to the provider(s).

individuals.
If yes, does the provider intend to link your data to identifiable individuals?
a
Yes
No
(d) X
Other Submitters will have full access to the CTRP Database with
respect to information they have submitted. Further, the CTRP Database
automatically generates, as a by-product of CTRP registration, trial summary files
(in XML format) that are compatible with the requirements of ClinicalTrials.gov,
After independently reviewing the trial summaries, NCI awardees can then
choose to upload the XML files directly to ClinicalTrials.gov in lieu of registering
their trials by manual entry through ClinicalTrials.gov's registration system.

13. Has the research activity that you are ~ r o ~ o s i in
n ethis form been approved by
an Institutional Review Board (IKB)elsewhere?

Last revised 1 1/7/05

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 (FWA) number**

XNo IRB review of the research activity described in question # I 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 knds 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
htt~://ohrp.cit.nih.rrov/search/asearch.asrz#ASUR

14. Per NIH guidance***, have conflicts of interest by NIH employees, if any, been
resolved?
Yes
No
N/A -This is not a research activity.

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
docs.htrnl
research conducted at NIH, http://ohsr.od.nih.gov/New/n~pafwa

Last revised 1 I17105

Page 1 of 1

OHSR (NIHIDDIR)
From:

OHSR (NIHIDDIR)

Sent:

Monday, June 08,2009 10:59 AM

To:

Speakman, John (NIHINCI) [El

Subject: Request for Review Rec'd-OHSR
Good morning Mr. Speakman,
This ernail is to verify that OHSR has received your Request for Review of Research and it is currently being
processed as OHSR #4722. 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:
Ph: 301.402.3444
Fax: 301.402.3443
Thank you.
Sincerely,
Chris Brentin

Program Support Assistant

10 Center Drive, Rm. 2C-146

Bethesda, MD 20892
30 1-402-8631 (Direct)
30 1-402-3443 (Fax)