Department of Defense Research
Research conducted or supported by a DoD Component requires additional information to be submitted to the IRB with the research application. Investigators should complete and attach a completed DoD Supplement Form to the Documents and Attachments page of the ERICA application.
A Department of Defense (DoD) Component is the Office of the Secretary of Defense, the Military Departments, the Chairman of the Joint Chiefs of Staff, the Combatant Commands, the Office of the Inspector General of the Department of Defense, the Defense Agencies, the DoD Field Activities and all other organizational entities in the Department of Defense.
Additionally, investigators and IRB members need to be informed of the specific requirements for research that is conducted or supported by a DoD Component (e.g. through a contract, grant cooperative agreement or other arrangement). This web page is intended for use by both the investigator and IRB members in order to comply with any required regulations.
The University of Utah IRB follows IRB SOPs, IRB guidance, and DoD regulation when reviewing human subject research supported and regulated by the DoD. The University of Utah does not review a large number of studies involving the Department of Defense and those that have been reviewed by the University of Utah IRB have involved minimal risk. The following guidance describes the DoD regulations for reviewing studies that involve greater than minimal risk or has a special consideration(s) e.g., classified research, research with vulnerable populations, etc. that does not commonly occur at the University of Utah. The information below provides a brief overview of how the University of Utah IRB would review such studies. In conducting these reviews, the University of Utah IRB will refer to and follow the applicable Department of Defense regulations.
Human Subject Research Training
University of Utah investigators and study staff who conduct human subject research must complete training before the IRB will approve a project(s). Please visit Investigator & Research Staff Training for the current University of Utah training requirements and options. Training is valid for five (5) years. If research involving a DoD component requires more frequent or other training requirements in addition to those that the University of Utah requires, the investigator will be responsible for ensuring that the training is completed for those involved in the conduct of the research. Researchers should contact the human research protection officer of the DoD component for their education requirements and obtain documentation confirming the requirements.
Additional Protections for Military Research Personnel
When research involves U.S. military personnel as participants in research, the following guidelines apply:
Recruitment and Enrollment
- Officers are not permitted to influence the decision of their subordinates.
- Officers and senior non-commissioned officers may not be present at the time of recruitment.
- Officers and senior non-commissioned officers have a separate opportunity to participate.
- When recruitment involves a percentage of a unit, an independent ombudsman is present.
- Participants may be compensated for research participation as long as the participant is involved in the research when not on duty. Enrolled individuals may not receive payment of compensation for research participation during duty hours.
- Federal employees while on duty and non-Federally employed individuals may be compensated for blood draws for research up to $50 for each blood draw.
- Non-Federally employed individuals may be compensated for research participation other than blood draws in a reasonable amount as approved by the IRB.
Waiver of Consent
In general, no Department of Defense component may conduct or use appropriated funds to support research involving a human being as an experimental subject without the prior informed consent of the subject. However, a waiver of consent may be granted for “research involving a human being as an experimental subject” if a waiver is obtained from the Assistant Secretary of Defense for Research and Engineering. If the research participant does not meet the definition of an “experimental subject”, the IRB may waive the consent process as described in IRB SOP 703: Waiver or Alteration of Consent.
Research Subject to Department of Defense requirements is prohibited from using an exception from consent in emergency medicine research unless a waiver is obtained from the Secretary of Defense.
Informed Consent Process
The following are additional requirements regarding the informed consent process for DoD conducted or supported studies.
Disclosure of Research-Related Injury
- Any requirements for disclosure of research-related injury from a DoD component must be included in the informed consent process. See SOP 701 (2.3).
Consent from a Legally Authorized Representative
- If consent is to be obtained from the legally authorized representative of an experimental subject, the research must be intended to provide direct benefit to the individual participant. The determination that the research is beneficial to the individual experimental subject must first be made by the IRB.
Combined DoD and VA Research
- A Department of Defense (DoD) consent document may be employed for active duty military personnel participating in VA research at DoD sites when VA-specific language is not necessary.
Data and Safety Monitoring
If the research involves greater than minimal risk, an independent research monitor must be appointed for the study and approved by the IRB. Additionally, a research monitor may be required for research involving minimal risk as determined by the IRB. The monitor should be appointed based on expertise relative to the risks identified in the research protocol and the skills necessary to monitor the research.
Investigators should include the following information in the IRB application on the Safety Monitoring page:
- The monitor must be named.
- Duties, responsibilities, and authority of the research monitor should be outlined. Investigators must specifically state that the monitor has the authority to perform the following actions:
- Stop a research study in progress if the safety of participants is in question
- Remove participants from a study if the safety of the participant is in question
- Take any other appropriate steps to protect the safety and well-being of participants until the IRB can assess the study
The IRB confirms the monitor's responsibilities in the IRB approval letter. The investigator must provide a copy of the letter to the monitor.
Additional Department of Defense Investigator Responsibilities
Any surveys performed on Department of Defense personnel must be submitted, reviewed and approved by the Department of Defense after the research protocol is reviewed and approved by the IRB.
DoD supported researchers must report the following within 30 days to the DoD human research protection officer.
- When significant changes to the research protocol are approved by the IRB.
- The results of the IRB continuing review.
- Change of reviewing IRB.
- When the University of Utah is notified by any Federal department, agency or national organization that any part of its HRPP is under investigation for cause involving a DoD-supported research protocol.
Vulnerable Populations in Department of Defense Research
Research involving pregnant women, prisoners and children that is conducted or supported by the Department of Defense is subject to DHHS Subparts B, C, and D. However, the DoD has supplemental guidance for these studies. Review the table below to determine the DoD requirements and IRB guidance for each vulnerable population.
For all Department of Defense conducted or supported non-exempt human subject research involving classified information (as defined in Executive Order 13526), additional requirements must be applied. The review of research involving classified information is rare and requires Secretary of Defense approval. Additional requirements are described in the Department of Defense Instruction 3216.02 13. It should be noted that VA conducted or supported non-exempt human subject research involving classified information is not permitted.
If you are the lead investigator/site for a multi-centered study, you have additional responsibilities for overseeing the activities at the University of Utah as well as the other sites participating in the study. To meet DoD requirements (SECNAVINST 3900.39D, section 6f), you must execute an agreement or statement of work with all collaborating sites that delineates each site's responsibilities. This document should include the following elements:
- A brief description of the research
- Specific roles and responsibilities of each site, including scientific and IRB review; recruitment of participants; and informed consent procedures
- Plan for ongoing data and safety monitoring, reporting requirements, documentation retention, and compliance for the entire research project
If you are not the lead investigator for a multi-centered DoD study, ensure that you request a copy and sign the study's agreement/statement of work prior to initiating study procedures at the University of Utah.
If the DoD research is conducted in a foreign country, the investigators must submit verification of the local ethics review (i.e. approval to conduct research). The investigator must abide by the local laws, regulations and customs as applicable. For more guidance, please see the Investigator Guidance Series: International Research.
Guidelines and Policies
Note: This is not a comprehensive list of guidelines and policies for DoD research, but represents guidelines and policies commonly referenced for research reviewed at the University of Utah.
- 32 CFR 219: Department of Defense Protection of Human Subjects
- Department of Defense Directive 3216.02, Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research
(Version November 8, 2011)
- Department of Defense Directive 6200.2, Use of Investigational New Drugs for Force Health Protection (Version August 1, 2000)
- Title 10, United States Code, Section 980: Limitation on use of humans as experimental subjects
- Department of the Navy, SECNAV Instruction 3900.39D (November 6, 2006): DON Human Research Protection Program
- Department of the Navy, OPNAV Instruction 5300.8B (April 23, 1997): Coordination and Control of Personnel Surveys
How do I know if I need IRB approval for my research?
If your research will be published (even as a thesis or dissertation) or given as a presentation outside of a UT Knoxville classroom, you will need IRB approval for your research. Research done for a class presentation, unless it is to be published or presented elsewhere, does not require an IRB approval.
If I need to complete an IRB protocol for my research where do I begin?
Begin with your advisor. They can help you get started. Your department also has someone who approves IRB protocols at that level. At any time you can contact the IRB office at (865) 974-7697. Don’t be afraid to ask questions. It’s better to ask ahead of time than find out later that you left something out.
When do I need to obtain IRB approval?
IRB approval is required BEFORE starting any data collection. This is very important. If you begin your research and start collecting data without prior IRB approval you risk losing all of that data and must begin again with the collection process.
Effective September 1, 2014, all IRB applications must be submitted through iMedRIS.
What information do I need to include in my application?
The IRB has created step-by-step instructions for completion of an initial application for a new project. This document shows each screen you might encounter. The questions you see are based on your responses to previous items. Specific advice is given, with special attention given to questions that have been confusing to researchers in the past. At any time you may contact the IRB office at (865) 974-7697.
You may also find this sample application useful. It is much like the one you will submit via iMedRIS. (You will need a UT NetID to log in and view the document.)
How do I know if my human subject research is “Exempt”?
Exempt research is based on risk to the human subjects. Research that is low risk undergoes an exempt review and is approved at your departmental level. It must be certified by the IRB office before you can begin data collection. Turn-around time is generally one week once it is received by the IRB office. Research involving children and other vulnerable populations is not eligible for Exempt review. An example of Exempt research is an anonymous survey, either online or on paper, with no identifying data.
What else is required if my research is Exempt?
Exempt research requires completion of an Information Sheet for consent. A sample of your Information Sheet should accompany your iMedRIS submission.
If my research is not Exempt what do I do?
If your research does not qualify as Exempt, it will require “Expedited” or “Full-board” review. If the research is considered to have “minimal risk” to the human subject, it may qualify as “Expedited.” Expedited review takes approximately 2-3 weeks. Research that is considered to be more than minimal risk to the subject will require Full-board approval. Typically, the most substantial risk in behavioral and social science research at UT Knoxville involves loss of confidentiality. Research involving children and other vulnerable populations may be either Expedited or may require Full-board review. Full-board review can take up to four weeks from the time of submission to receive the outcome of the IRB’s assessment. Responses to questions from the IRB will be reviewed within 1-2 weeks of resubmission. Remember that you may not begin any data collection until you have IRB approval. If you have any questions about your research protocol contact the IRB office at 865-974-7697.
All IRB applications must be submitted through iMedRIS.
What else do I need to submit with my IRB form?
A draft of all methods of data collection, such as interview questions, instruments to be completed, etc is also needed for the IRB.
If I choose to use audio or video tapes or digital recordings in my research how long must I maintain the originals?
The original recordings should be destroyed when they are transcribed. If your research requires that you keep the recording for a longer period of time you must state where they will be stored, who will have access to them while stored, and when they will be destroyed.
What about consent from the subject for Expedited or Full-board research?
Informed consent is required for all Expedited or Full-board research, unless a waiver to obtain consent is requested. “Informed consent” requires a signature from the subject before approaching a child for participation. For the child, you will also need to include an “Assent” form. Even if the child assents to research, you must obtain a signature from the parent on an “Informed Consent” form. Examples of Informed Consent and Assent are available on the Forms page.
If I want to do research at a local school, what is the procedure for consent?
You must obtain the consent of the following individuals:
- The Administrator of the school district where the research is to be performed (on letterhead).
- The Principal of the school where the research is to be performed (on letterhead).
- The Teacher(s)
- The Parent(s)/legal guardian(s) – “Informed Consent” – written at a 6th grade reading level
- The child – “Assent” – written to the child’s level of understanding
What do I need to do if my research is in a facility outside of UT?
A letter(s) from the facility/facilities, on their letterhead, must be submitted with the IRB form. Informed consent/assent forms are required of the participants before research is conducted. There may be changes in contact information for participants recruited at UT Knoxville or the Knoxville community.
What if my research includes observation in a public-access facility such as a coffee shop?
No letter is required for public-access facilities such as coffee shops.
What if I merely want to observe children in a classroom setting?
You must still get parental “Informed Consent” and each child’s “Assent.” For any child who does not obtain parental consent, that child may not be included in the research even if that child assents to participate in the research.
What if I want to have a “focus group” for my research?
Each person in the focus group must sign an informed consent form that has information that states confidentiality may not be guaranteed once the group disbands.
How long must I store my research data?
Storage of the signed consent forms for three (3) years past completion of the study is required. If you will no longer be at UT Knoxville you must work with your advisor to determine where the data will be stored and when it will be destroyed. Signed consent form must be stored at UT. Transcripts can be maintained indefinitely as long as there is no identifying information.
How long does my IRB approval last?
IRB approval is for a 12-month period from time of original approval. A renewal notice will be sent 60 days and 30 days prior to your expiration date of your study by an automated notification through iMedRIS. To renew your study, log into the electronic system, iMedRIS, and submit the continuing review form. If your continuing review is not received, reviewed, and approved prior to the expiration date, you will receive a notice of study termination.
What if I have an “adverse event” occur during my data collection?
Adverse events must be reported immediately to your advisor and the Compliance office.
What do I need to do if I need to modify my methods of data collection?
To make changes to your study, including adding procedures, research personnel, or documentation, log into iMedRIS and submit the “Change Request & Amendments” form. This form will give you an opportunity to modify your original application and submit new documentation to the IRB for review and approval.