1. Introduction

The information in this Guide is intended for University of Iowa (UI) investigators engaged in research involving human subjects and that is supported by, or is in collaboration with, the U.S. Department of Defense (DoD). The information presented here applies to all biomedical and social/behavior human subjects research involved with a DoD component.

Research activities which include “both a systematic investigation designed to develop or contribute to generalizable knowledge AND involve a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual or identifiable private information” will hereinafter be referred to as “research involving human subjects.”  (DoD Instruction, Glossary -  DoD-supported research involving human subjects)

Research with the DoD may involve duties and obligations in addition to those required by the UI IRB. Each component of the DoD may also have specific requirements for the application review process. The responsibility for upholding these requirements is shared among researchers, the IRB/HSO, the UI, and the DoD.

Please see Appendix I for a list of DoD components and Appendix II for a list of selected laws and regulations applicable to DoD-supported research. In this document, ‘DoD Instruction’ refers to DoD Instruction 3216.02, November 8, 2011, and specifically to Enclosure 3 thereof unless otherwise noted.

This Guide is intended only as a general reference.  It is important to check with the DoD contact for specific details or with questions about the particular study.