The Department of Defense (DoD) has enhanced its human subjects protection requirements and has applied these requirements to researchers who are not employees of the DoD.

The University of Iowa maintains a current Addendum to its Federalwide Assurance stating it will comply with Department of Defense (DoD) regulations and policies for the protection of human research subjects when conducting, reviewing, approving, overseeing, supporting, or managing human subjects research involving the DoD.

The responsibility for upholding the additional DoD requirements for human subjects research is shared by UI researchers conducting DoD supported research, the Institutional Review Board (IRB)/Human Subjects Office (HSO), Institutional Official, and DoD.  The HSO has provided the information and links on this page to assist researchers in adhering to the DoD/DoN requirements.

Department of Defense (DoD) Researcher Guide

The Human Subjects Office has developed a DoD Researcher Guide to address specific DoD human subjects regulatory requirements.

Training Requirements

Department of Defense Requirements (DoD)

When research is funded by the DoD, human subjects research training requirements may vary depending on the sponsor (e.g., Army, Air Force).  Therefore, Principal Investigators (PIs) should contact the program officer and obtain documentation of the specific training requirements. 

Department of Navy (DoN)

When research is funded by the DoN, the UI requires that PIs complete the CITI Training Module for "DoN-Supported Extramural Performers" (link) initially and recommends "refresher" training or repeat initial training every three years. To find the correct module, users can view screen shots for existing CITI users Assurance or view screen shots for new CITI users Assurance.

PIs are responsible for ensuring that all research staff complete UI human subjects research training. 

IRB 04 Department of Defense

Full Board Meeting Schedule

All Department of Defense (DoD) new projects will require full board review. IRB-04 will meet on an ‘as needed’ basis. Please allow two to three weeks after receipt of the complete application to be placed on a meeting agenda. This time is used for preliminary review, contacting the investigator with questions, and copying and distributing the materials about a week in advance of the meeting for board members' review. The investigator is notified of the meeting date if the IRB chair request his/her presence at the meeting. Minutes are sent via HawkIRB, generally within a week of the meeting, to the Principal Investigator, delegates, and contact persons listed on the HawkIRB application.

Current IRB Members

Click here to access IRB rosters for the current year. Email the Human Subjects Office to request rosters for previous years.

IRB Chair

Andy Bertolatus, MD (Primary IRB Chair)
105A HLHS
(319)356-8225
john-bertolatus@uiowa.edu

Related Documents, Links and Topics 

Additional UI DoD Guidance

• DoD Frequently Asked Questions  

Federal Regulations and Guidance

• Title 32 Code of Federal Regulations at 32 CFR 219, Department of Defense Regulations, “Protection of Human Subjects” (DoD adoption of the “Common Rule”)
• DoD Instruction (DoDI) 3216.02, “Protection of Human Subjects and Adherence to Ethical Standards in DoD-supported Research”
• Title 10 United States Code Section 980 (10 USC 980), “Limitation on Use of Humans as Experimental Subjects”
• US Food and Drug Administration (FDA) Regulations
  • 21 CFR 50 – “Protection of Human Subjects”
  • 21 CFR 56 – “Institutional Review Boards”
  • 21 CFR 312 – “Investigational New Drug Application”
  • 21 CFR 812 – “Investigational Device Exemptions”

Additional DoD-DoN Documents

• DoD-DoN Addendum to FWA
• DoN Human Research Protection Program