1.14 Research Subject to Department of Defense Regulatory Requirements

1.0 Purpose

The purpose of this policy and procedure is to specify the Organization’s requirements for the review, approval, conduct and oversight of human subject research funded by or involving the U.S. Department of Defense (DoD) and the U.S. Department of the Navy (DoN).


2.0 Policy


3.0 Definitions


4.0 Procedures


DOCUMENT HISTORY:

 Written: 4/13/2016 (Approved: 4/13/2016) - original author not recorded

 Revised: 3/3/2018 - revision not documented

 Revised: 6/4/2021 - Reorganized; extensive revisions based on revisions to DoDI 3216.02, 15 April 2020, SECNAVINST 3900.39E, 29 May 2018

 Revised: 8/7/2023 - added 2.3.15 and 2.3.16; revised 2.3.4 per DoDI 3216.02, April 15, 2020 Change 1, June 29, 2022 {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Revised 1/10/2024 - Revised section 2.3.2.1 to describe specific restrictions associated with 42 USC Chapter 6A, Subchapter III, Part H, 289g; revised section 2.3.3 to specify that approval by the appropriate DoD component is required prior to research starting when human subjects research is conducted in a foreign country; revised section 2.3.4 to specify that DoD component-level administrative review (CLAR) must be conducted when the research requires a waiver of informed consent pursuant to 10 USC 980, Subsection (b); revised section 2.3.13 to specify that surveys performed on DoD personnel must be submitted, reviewed, and approved by the DoD Information Management Control Officer (IMCO) after the research protocol is reviewed and approved by the IRB; revised section 4.4.2 to clarify that the IRB Analyst responsible for the protocol will assure that the PI has uploaded a copy of the DoD component approval and all applicable additional DoD approvals, and that research will not be released until the appropriate DoD approvals are on file; other minor wording changes for clarity. {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}


Revision #13
Created 21 October 2019 21:47:17 by Autumn M Eberly
Updated 21 March 2025 13:58:56 by Robert A Lewis