General Dynamics Information Technology Federalwide Assurance For Human Subjects Protection.pdf

1. Institution Filing Assurance
Legal Name: General Dynamics Information Technology
City: Fairfax
State/Province: VA
Country: USA

2. Institutional Components
Name of Component or Alternate Names Used
City
State
(or Country if Outside U.S.)
General Dynamics Information Technology
Fairfax
VA
USA

3. Statement of Principles
The Belmont Report

4. Applicability
This Institution assures that all of its activities related to human subjects research, regardless of the source of support, will be guided by the following statement of principles governing the institution in the discharge of its responsibilities for protecting the rights and welfare of human subjects of research conducted at or sponsored by the institution.

(a) This Assurance applies whenever this Institution becomes engaged in human subjects research conducted or supported by any U.S. federal department or agency that has adopted the U.S. Federal Policy for the Protection of Human Subjects (also known as the Common Rule), unless the research is otherwise exempt from the requirements of the Common Rule or the department or agency conducting or supporting the research determines that the research shall be conducted under a separate assurance.

5. Assurance of Compliance with the Terms of the Federalwide Assurance
(a) This Institution assures that whenever it engages in research to which this Assurance applies, it will comply with the Terms of the Federalwide Assurance (contained in a separate document on the Office for Human Research Protections (OHRP) website).

6. Designation of Institutional Review Boards (IRBs)
This Institution elects to apply the following to all of its human subjects research regardless of the source of support, except for research that is covered by a separate assurance:

This Institution assures that it will rely upon only IRBs registered with OHRP for review of research to which this FWA applies. This institution (a) designates the following internal IRB(s) for review of research under this Assurance; or (b) does not have an internal IRB and designates the following external IRB for review of all research to which this FWA applies or, if multiple external IRBs are relied upon, the following external IRB that reviews the largest percentage of research to which this FWA applies.

7. Human Protections Administrator
First Name: John
Middle Initial:
Last Name: Alvarez
Degrees or Suffix: MS, MSHIM, MBA
Institutional Title: Principal Subject Matter Expert
Institution: General Dynamics Information Technology
Telephone: 301 815-5824
FAX: 301 815-8083
E-Mail: [email protected]
Address: 8601 Georgia Avenue, Suite 900, Silver Spring, MD, USA

8. Signatory Official
I have read and agree to the Terms of the Federalwide Assurance. I recognize that providing research investigators, IRB members and staff, and other relevant personnel with appropriate initial and continuing education and training about human subject protections will help ensure that the requirements of this Assurance are satisfied.

Acting officially in an authorized capacity on behalf of this Institution and with an understanding of the Institution’s responsibilities under this Assurance, I assure protections for human subjects as specified above. The IRB(s) that this institution relies upon will comply with the Terms of the Federalwide Assurance when reviewing research covered by this Assurance and possess appropriate knowledge of the local context in which this Institution’s research will be conducted.

All information provided with this Assurance is up-to-date and accurate. I am aware that false statements could be cause for invalidating this Assurance and may lead to other administrative or legal action.

Signature: Dan Johnson
Date: 06/17/2013

9. FWA Approval
The Federalwide Assurance for the Protection of Human Subjects for Institutions Within the United States submitted to HHS by the above Institution is hereby approved.

Assurance Number: FWA00016277
Expiration Date: 06/17/2018
Signature of HHS Approving Official: Hal Blatt
Date: 06/17/2013