Form 1 Attachment A

Federal Interagency Traumatic Brain
Injury Research Informatics System
(FITBIR)
Data Access Request

Contents
FITBIR Informatics System Data Access Request ............................................................................................... 2
Data Use Certification for the FITBIR Research Informatics System ................................................................ 2
Introduction .................................................................................................................................................... 2
Definitions ...................................................................................................................................................... 3
Terms and Conditions ..................................................................................................................................3
FITBIR Information Security Best Practices .......................................................................................................... 6
Recipient Information and Certifications…...................................................................................................7

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FITBIR Informatics System Data Access Request
The Data Access & Quality Committee (DAQ) approves access to data and/or images from the Federal
Interagency Traumatic Brain Injury (FITBIR) Informatics System for research purposes only. The DAQ
will review the Informatics System Access Request (ISAR) and the Data Use Certification (DUC) of each
applicant requesting data and provide access based on the expectations outlined in the FITBIR policy
(see http://fitbir.nih.gov). These expectations include the protection of data privacy, confidentiality, and
security. In the event that requests raise concerns related to privacy and confidentiality, risks to
populations or groups, or other concerns, the DAQ will consult with other experts as appropriate.
Recipients seeking access to data or images from FITBIR are expected to submit their ISAR and DUC,
signed by the Principal Investigator. Completing this ISAR is a necessary step to access data or images
from FITBIR.

Steps to Request Query Access to the FITBIR Informatics System
1. Read the FITBIR Informatics System Data Use Certification (DUC) below.
2. Provide a scanned copy of the signed DUC Recipient Information and Certifications page when
requesting an account to FITBIR (with Query and Study privileges) at http://fitbir.nih.gov.
3. Access Request Review: The DAQ will review requests to access the FITBIR Informatics
System. Such reviews are generally completed within 10 business days.
4. The DAQ will notify FITBIR staff if the access request has been approved, and an account will then
be provided. Users will receive an automated notification of their account update with any modified
user name, passwords, or instructions for accessing the FITBIR Informatics System.
5. Optional: FITBIR System Training (if request approved): Contact FITBIR through FITBIR-

[email protected] to discuss specific training needs the user may have and schedule the training.

Data Use Certification (DUC) for the Federal Interagency
Traumatic Brain Injury Research (FITBIR) Informatics System
Introduction
The Department of Defense (DOD) and the National Institutes of Health (NIH) have developed an informatics
system to store the collection of data from participants in traumatic brain injury (TBI) research studies,
regardless of the source of funding. The extensive information collected by these studies, and subsequently
stored in the Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics System, provides a
rare and valuable scientific resource. Promoting optimal use on a national scale of this resource will require a
large and concerted effort, which may exceed the research capacity of currently investigators. DOD and the
NIH have responsibility to the public in general, and to the scientific community in particular, to encourage the
use of these resources to achieve rapid scientific progress. In

order to take full advantage of such resources and maximize their research value, it is important
that data be made available, on appropriate terms and conditions, to the largest possible number
of qualified investigators in a timely manner.
Data collected by the Submitters have been stripped of all individual identifiers, but the unique and
intrinsically personal nature of DNA, derivative data of which are included in FITBIR, combined with the
recent increase in the accessibility of conducting genotype and other sequence analyses (in terms of
technological capacity and cost), has altered the framework through which “identify-ability” can be
defined. To protect and assure the confidentiality and privacy of all participants, the Recipient who is
granted access to these data is expected to adhere to the specifications of this DUC. Failure to do so
could result in denial of further access to data and subject the Recipient of any other applicable
penalties and actions.

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Submitters have made a substantial long-term contribution to FITBIR by submitting data to the
Informatics System. DOD and the NIH seek to encourage appropriate data use and collaborative
relationships by outside investigators with the Submitters and to ensure that the contribution of the
Submitters is appropriately acknowledged.

Definitions
For purposes of this agreement:
“Data” refers to the information that has been collected and recorded from participants in TBI studies,
regardless of the source of funding. Data from study participants were collected through the periodic
examinations and follow-up contacts conducted pursuant to the Submitters' Cooperative Agreement
grants, other grants, contracts, and other TBI studies conducted independent of DOD or NIH.

A “Submitter” is defined as a researcher who has submitted data to the FITBIR Informatics System,
according to the policies laid out in the FITBIR Informatics System Submission Agreement. The
Submitter may have had a past or current/active grant, contract, or consulting agreement with DOD
or NIH, one of its contractors, or any other funding source.
The “Recipient” Principal Investigator is an individual who seeks access to data from FITBIR. The
Recipient and his/her Organization may be a researcher at a non-profit or for-profit organization or
corporation with an approved assurance from the Department of Health and Human Services Office
for Human Research Protections (OHRP) . The Recipient requests access to study data at his/her
sole risk and at no expense to the study, DOD, and NIH.

Terms and Conditions
I request approval to access data and/or images from the Federal Interagency Traumatic Brain
Injury Research Informatics systems (FITBIR) Informatics System for research purposes. I agree to
the following terms:
1. Research Project. These data will be used by Recipient Principal Investigator solely in connection with
the “Project Summary/Abstract” “. If the Project does involve Submitter(s), their names and the work they
will perform are also included in the Recipient Information and Certifications section.
This DUC covers only the Research Project contemplated in the Project Summary/Abstract section.
Recipient agrees that data will not be used in any research that is not disclosed and approved as
part of the Research Project. Recipient will submit a completed DUC (this document) for each research
project for which data are requested. This applies to all versions of FITBIR Informatics System data.

2. Non-transferability of Agreement. This DUC is not transferable. Recipient agrees that any substantive
change Recipient makes to the Research Project requires execution and approval of a new DUC, in
which the new Research Project is designated. If the Recipient appoints another Principal Investigator to
complete the Research Project, a new DUC in which the new Recipient is designated is necessary. If the
Recipient changes institutions and wishes to retain access to FITBIR Informatics data, a new DUC must
be executed and approved.
3. Non-Identification of Subjects. Recipient agrees that data will not be used, either alone or in
conjunction with any other information, in any effort whatsoever to establish the individual identities of
any of the subjects from whom data were obtained. Recipient agrees to notify FITBIR as soon as
possible if, upon use of FITBIR data, the Recipient discovers identifying information in those data.

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4. GUID and Access to Submitted Data. The Global Unique Identifier (GUID) is a computer-generated
alphanumeric code that is unique to each research participant. The GUID allows FITBIR to link together
all submitted information on a single participant, giving researchers access to information even if the
data were collected at different locations or through different studies. If Recipients request access to
data on individuals for whom they themselves have previously submitted data to FITBIR, they may gain
access to more data about an individual participant than they themselves collected. Consequently, these
research activities may be considered “human subjects research” and may require that they obtain
institutional IRB approval of their Research Project.
5. Data Disclaimers. Recipient agrees that DOD and NIH do not and cannot warrant the results that may
be obtained by using any data included therein. DOD and NIH disclaim all warranties as to the accuracy
of the data in FITBIR or the performance or fitness of the data for any particular purpose.
6. Notification of FITBIR of Publication. Prompt publication or other public disclosure of the results of the
Research Project is required. Recipient agrees to notify FITBIR via email [email protected] as

to when and where a publication (or other public disclosure) of a report from the Research Project will
appear. Notification of such publications can occur by sending to FITBIR an updated biographical
sketch http://grants.nih.gov/grants/funding/2590/biosketchsample.pdf or CV of the publishing author.
7. Data Access for Research. Data from active and completed studies are eligible for restricted
“Controlled Access” by qualified researchers pursuant to the terms set forth in this agreement.
Recipients of Controlled Access data acknowledge that other researchers have access to the data and
that downloading, utilization, and duplication of research are distinct possibilities.
8. No Distribution of Data. Recipient agrees to retain control over data, and further agrees not to transfer
data, with or without charge, to any other entity or any individual, except for collaborators with approved
DUCs. Recipient agrees not to sell the data in any form to any entity or individual or to distribute the data
to anyone other than his/her research staff and collaborators with an approved DUC, who will also agree
to the terms within this DUC.
9. Acknowledgments. Recipient agrees to acknowledge the contribution of the FITBIR bioinformatics
platform, the relevant FITBIR dataset identifier(s) (a serial number), and the Submitter(s) in any and all
oral and written presentations, disclosures, and publications resulting from any and all analyses of data
using the FITBIR tools, whether or not Recipient is collaborating with Submitter(s). The manuscript
should include the following acknowledgement or other similar language:
Data and/or research tools used in the preparation of this manuscript were obtained and analyzed from
the controlled access datasets distributed from the DOD- and NIH-supported Federal Interagency
Traumatic Brain Injury Research (FITBIR) Informatics Systems. FITBIR is a collaborative biomedical
informatics system created by the Department of Defense and the National Institutes of Health to
provide a national resource to support and accelerate research in TBI.

Dataset identifier(s): [provide]. This manuscript reflects the views of the authors and may not reflect
the opinions or views of the DOD, NIH, or of the Submitters submitting original data to FITBIR
Informatics System.
If the Research Project involves collaboration with Submitters or FITBIR staff then Recipient will
acknowledge Submitters as co-authors, if appropriate, on any publication. In addition, Recipients agree to
include a reference to FITBIR Informatics System datasets analyzed and to cite FITBIR and the federal
funding sources in abstracts as space allows.
10. Non-Endorsement; Liability. Recipient agrees not to claim, infer, or imply endorsement by the
United States Government, the Department of Defense, the Department of Health & Human Services,
or the National Institutes of Health of the Research Project, the entity, or personnel conducting the
Research Project or any resulting commercial product(s). The United States Government assumes no
liability except to the extent provided under the Federal Tort Claims Act (28 U.S.C. § 2671-2680).
11. Recipient's Compliance with Institutional Requirements. Recipient acknowledges that access, if

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provided, is for research that is approved by the Institution, which must be operating under an Office of
Human Research Protections (OHRP) -approved Assurance. Furthermore, Recipient agrees to comply
with all applicable DOD and NIH rules for the protection of human subjects, and other federal and state
laws for the use of these data. Recipient agrees to report promptly to FITBIR any proposed change in
the research project and any unanticipated problems involving risks to subjects or others. This DUC is
made in addition to, and does not supersede, any of Recipient's institutional policies or any local, State,
and/or Federal laws and regulations that provide additional protections for human subjects.
12. Recipient’s Permission to Post Information Publicly. Recipient agrees to permit DOD and the NIH to
summarize on the FITBIR Web site the Recipient’s research use of FITBIR Informatics System along
with the Recipient’s name and organizational/institutional affiliation.
13. Privacy Act Notification. In order to access the FITBIR Informatics system, the Recipient agrees to
provide the information requested below.
The Recipient agrees that information collected from the Recipient, as part of the Data Access Request,
may be made public in part or in whole for tracking and reporting purposes. This Privacy Act Notification
is provided pursuant to Public Law 93- 579, Privacy Act of 1974, 5 U.S.C. Section 552a. Authority for
the collection of the information requested below from the recipient comes from the authorities
regarding the establishment of the NIH, its general authority to conduct and fund research and to
provide training assistance, and its general authority to maintain records in connection with these and
its other functions (42 U.S.C. 203, 241, 289l-1 and 44 U.S.C. 3101), and Section 301 and 493 of the
Public Health Service Act. These records will be maintained in accordance with the Privacy Act System
of Record Notice 09-25-0156 (http://oma.od.nih.gov/ms/privacy/pa-files/0156.htm) covering “Records of
Participants in Programs and Respondents in Surveys Used to Evaluate Programs of the Public Health
Service, HHS/PHS/NIH/OD.” The primary uses of this information are to document, track, and monitor
and evaluate the use of the FITBIR Informatics datasets, as well as to notify interested recipients of
updates, corrections or other changes to the database.
The Federal Privacy Act protects the confidentiality of the Recipient’s DOD and NIH records. DOD and
the NIH and any sites that are provided access to the datasets will have access to the data collected
from the Recipient for the purposes described above. In addition, the Act allows the release of some
information in the Recipient’s records without his/her permission; for example, if it is required by
members of Congress or other authorized individuals. The information requested is voluntary, but
necessary for obtaining access to data.
14. Security. Recipient acknowledges the expectations set forth by the attached “FITBIR Information
Security Best Practices” for the use and security of data.
15. Annual Update. Recipient will provide to [email protected] an annual summary of
research accomplishments from using FITBIR informatics system and an updated biographical
sketch http://grants.nih.gov/grants/funding/2590/biosketchsample.pdf or CV. Future access to FITBIR
will be contingent upon receiving the annual update.
16. Amendments. Amendments to this DUC must be made in writing and signed by authorized
representatives of all parties.
17. Termination. Either party may terminate this DUC without cause provided 30 days written notice to
the other party. Recipients agree to immediately report violations of FITBIR Policy to the FITBIR DAQ.
Additionally, DOD and NIH may terminate this agreement with 5 days written notice if the DOD and NIH
determine, in their sole discretion, that the Recipient has committed a material breach of this DUC. DOD
and NIH may, in their sole discretion, provide Recipient with 30 days notice to remedy a breach before
termination. Upon termination of the DUC, use of the data must be discontinued. Closed accounts may
be reactivated upon submission of an updated Informatics System Access Request and DUC.

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18. One Year Term and Access Period. Accounts with active grants are valid for one year and will be
renewed annually by the FITBIR operations team. This SA will terminate 180 days following project/grant
end date. Accounts that remain inactive for 12 consecutive months may be closed at the discretion of
DOD and NIH.
19. Accurate Representations. Recipient expressly certifies that the contents of any statements made or
reflected in this document are truthful and accurate.

FITBIR Information Security Best Practices
The purpose of these Security Best Practices, which are subject to applicable law, is to provide minimum
security standards and best practices for individuals who use FITBIR to submit, access, and analyze
data. Keeping FITBIR information secure through these best practices is important. Subject to applicable
law, Recipients agree to immediately report breaches of data confidentiality to the FITBIR DAQ.

Best Practices
•
•
•

•

•

Do not attempt to override technical or management controls to access data for which you have not
been expressly authorized.
Do not use your trusted position and access rights to exploit system controls or access data for any
reason other than in the performance of the proposed research.
Ensure that anyone directed to use the system has access to, and is aware of, FITBIR
Information Security Best Practices and all existing policies and procedures relevant to the use of
FITBIR, including but not limited to, the FITBIR policy at http://FITBIR.nih.gov.
Follow the FITBIR password policy which includes:
•
Choose passwords of at least seven characters including at least three of the following types of
characters: capital letters, lower case letters, numeric characters and other special characters.
• Change your passwords every six months.
• Protect your FITBIR password from access by other individuals—for example, store it
electronically in a secure location.
Notify FITBIR staff, as permitted by law, at [email protected] of security incidents, or any
incidents of suspected fraud, waste or misuse of FITBIR or when access to FITBIR is no
longer required.

Security Standards
•
•
•
•
•
•

•

Protect the data, providing access solely to authorized researchers permitted access to such data by
your institution or to others as required by law.
When you download FITBIR data, download the data to a secured computer or server with strong
password protection.
For the computers hosting FITBIR data, ensure that they have the latest security patches and are
running virus protection software.
Make sure the data are not exposed to the Internet or posted to a website that may be discovered by
Internet search engines such as Google or MSN.
If you leave your office, close out of data files or lock your computer. Consider the installation of a
timed screen saver with password protection.
Avoid storing data on a laptop or other portable medium. If storing data on such a device, encrypt
the data. Most operating systems have the ability to natively run an encrypted file system or encrypt
portions of the file system. (Windows = EFS or Pointsec and Mac OSX = File Vault)
When finished using the data, destroy the data or otherwise dispose of it properly, as permitted
by law.

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OMB control number: 0925-0677, Expiration date: 08/31/2016
Paperwork Reduction Act Statement
Public reporting burden for this collection of information is estimated to average 95 minutes per response, including the time for reviewing
instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently
valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions
for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0677).
Do not return the completed form to this address.

Recipient Information and Certifications
Date:
Type of Application:

New

Renewal

First Name:
Degree:
Institution:

Last Name:
Academic Position (or Title):
Department:

Street Address:
City:
Zip/Postal Code:
Telephone:

_

State/Province:

_

Country:
FAX:

E-mail Address:

Research Project (title):

By signing and dating this DUC as part of requesting access to data in FITBIR, I certify that I will abide by the
DUC, and the DOD and NIH principles, policies and procedures for the use of the FITBIR Informatics
System. I further acknowledge that I have shared this document and the DOD and NIH policies and
procedures with any research staff who will participate in the use of FITBIR.

Signature:

_ Date:

Recipient’s Authorized Institutional Business Official information:
Name:
Title:
Email:
Signature:__________________________________________

_
Date:

Inquiries and Requests to Submit Data to FITBIR should be sent to:
Office of FITBIR Operations
National Institutes of Health, Center for Information Technology (CIT) 12
South Dr. RM 2041
Bethesda, MD 20892
301-594-3532
Email: [email protected]

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Project Director/Principal Investigator Contact Information (if different from above)
First Name:
Degree:

Last Name:
Academic Position (or Title):

Institution:

Department:

Street Address:

_

City:

State/Province:

Zip/Postal Code:

_

Country:

Telephone:

FAX:

E-mail Address:

Other Project Information:
1. Are Human Subjects involved? Yes

No

If YES to Human Subjects
Is the Project Exempt from Federal regulations?

Yes

If yes, check appropriate exemption number. 1

2 __3 __4 __5

If no, is the IRB review pending?

Yes

No
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No

IRB Approval Date:
2. Project Summary/Abstract:
Insert here.

Senior/Key Person Profile (Collaborating Investigator)
First Name:

Degree:
Institution:

Last Name:

Academic Position (or Title):
Department:

Street Address:
City:
Zip/Postal Code:
Telephone:

State/Province:
Country:
FAX:

E-mail Address:
Project Role:

Other Project Role Category:

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Senior/Key Person Profile (Collaborating Investigator)
First Name:
Degree:

Last Name:
Academic Position (or Title):

Institution:

Department:

Street Address:
City:
Zip/Postal Code:
Telephone:

_

State/Province:

_

Country:
FAX:

E-mail Address:
Project Role:

Other Project Role Category:

_

Senior/Key Person Profile (Collaborating Investigator)
First Name:
Degree:
Institution:

Last Name:
Academic Position (or Title):
Department:

Street Address:
City:
Zip/Postal Code:
Telephone:

_

State/Province:

_

Country:
FAX:

E-mail Address:
Project Role:

Other Project Role Category:

_

Use additional sheets for additional profiles as needed.

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