FORM: Addendum for Department of Defense Funded Research

FORM: Addendum for Department of Defense Funded Research Document No.: Edition No.: Effective Date: Page: HRP-215 002 19 Dec 2016 Page 1 of 2

Complete this form When research is funded by the Department of Defense (DoD) or any of its subparts (Army, Navy, Air Force, Marine Corp, DARPA, etc.) You must submit a typed version of this form to prevent errors and delays due to legibility problems. Blank & incomplete answers will result in delayed reviews If you have questions about the use of this form, please call 619-469-0108, toll free at 877-366-5414, or email [email protected] Research Protocol: Protocol #: Protocol Title: Sponsor Name: IRB Tracking #: (if known) Principal Investigator: Name: Additional DOD information: 1. Does the protocol prohibit superiors from influencing the decisions of Yes No NA subordinates and from being present during the recruitment sessions or the consent process? If no, explain: 2. Is the research is greater than minimal risk? Yes No If yes, complete items 2a, 2b, 2c, and 2d below. 2a. Provide the name and title of the independent research monitor by name. Name: Title: Note: This is a DoD requirement. OSD or DoD components may waive this requirement. 2b. Attach documentation for the IRB to review and approve describing the monitors’ duties, authorities, responsibilities, and CV or summary of expertise to monitor the research. 2c. Will you rely on the IRB or the HRPP Official to communicate with research IRB HRPP Official monitors to confirm their duties, authorities, and responsibilities? If the IRB, provide contact information for the research monitor: Address 1: Address 1: City: State/Province Zip/Postal Code: Country: Phone: E-mail: 2d. Will the recruitment of service member occur in a group setting? Yes No If yes, complete item 2e below.

Copyright © 2016 WIRB-Copernicus Group, Inc. All rights reserved. FORM: Addendum for Department of Defense Funded Research Document No.: Edition No.: Effective Date: Page: HRP-215 002 19 Dec 2016 Page 2 of 2

2e. Provide the name and title of the ombudsman who is not associated with the research who will monitor the voluntary involvement or recruitment of the subjects. Name: Title: 3. Is the research conducted by DoD? Yes No If yes, complete items 3a, 3b, and 3c below. 3a. Please confirm both of the following: The DoD Component has determined that the collaborating non-DoD institution has an appropriate Federal assurance. The involvement of DoD personnel in the conduct of the research is secondary to that of the non-DoD institution. 3b. Submit a written agreement defining the responsibilities and authorities of each organization in complying with the terms of the Federal assurances and the DoD Instruction. A template agreement titled “Institutional Agreement for IRB Review” is available on this military web page: http://www.health.mil/Military-Health-Topics/Research-and-Innovation/Research-Oversight/Human-Research- Protection-Program 3c. Is the research being conducted in a foreign country whose laws and regulations Yes No are applicable to that research? If yes, complete 3d. 3d. Have all applicable national laws and requirements have been met? Yes No

4. I have reviewed Department of Defense Instruction Number 3216.02: Yes http://www.dtic.mil/whs/directives/corres/pdf/321602p.pdf Attestation:

By submitting this form, I confirm that I am the Principal Investigator (PI) or the PI’s designee authorized to submit on behalf of the PI. The information within this form is accurate and complete with the PI’s full awareness of the information submitted.

Name of person completing form: Name: Title: Company: Phone: Email: