The DoD components include, but may not be limited to:

• Navy
• Office of Naval Research
• Naval Academy
• U.S. Naval Observatory
• Army
• U.S. Army Corps of Engineers
• Military Academy (West Point)
• Air Force
• Air Force Academy
• Marines
• Coast Guard
• Coast Guard Academy
• National Guard
• Missile Defense Agency
• Defense Advanced Research Projects Agency (DARPA)
• Pentagon Force Protection Agency
• Defense Intelligence Agency
• National Geospatial-Intelligence Agency
• National Security Agency
• National War College
• Tricare Health System

A research monitor is required for research involving greater-than-minimal risk to subjects.

Definition of minimal risk: The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. The IRB is responsible for making this determination.

The monitor: A medical monitor or a non-medical monitor? The written guidance from DoD focuses on medical risks. However, DoD has advised another institution that if a medical monitor would not be appropriate for the research, then a non-medical monitor may be appointed.

DoD guidance about the monitor, from Department of Defense Directive 3216.2:

• For research involving more than minimal risk (as defined in 32 CFR 219.102(i)), an independent medical monitor shall be appointed by name. Medical monitors shall be physicians, dentists, psychologists, nurses, or other healthcare providers capable of overseeing the progress of research protocols, especially issues of individual subject/patient management and safety. Medical monitors shall be independent of the investigative team and shall possess sufficient educational and professional experience to serve as the subject/patient advocate.
• Depending on the nature of the study, the medical monitor may be assigned to assess one or more of the following phases of a research project: subject recruitment; subject enrollment; data collection; or data storage and analysis.
• At the discretion of the IRB, the medical monitor may be assigned to discuss research progress with the principal investigator, interview subjects, consult on individual cases, or evaluate adverse event reports. Medical monitors shall promptly report discrepancies or problems to the IRB. They shall have the authority to stop a research study in progress, remove individual subjects from a study, and take whatever steps are necessary to protect the safety and wellbeing of research subjects until the IRB can assess the medical monitor’s reports.

DoD-related research that involves subjects who are not U.S. citizens or Department of Defense personnel must obtain and provide:

• Permission of the host country.
• Ethics review and approval by the host country or by a local Naval IRB with host country representation.
• Additional safeguards might not be applicable to social-behavioral research involving no more than minimal risk.

DoD requires the following protections for military personnel being recruited for research that involves greater-than-minimal risk.

• 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.
• During recruitment briefings to a unit where part of the unit is being recruited, an independent ombudsman is present.
• Limitations on dual compensation prohibit an individual from receiving pay from more than one position for more than 40 hours of work in one calendar week, which includes temporary, part-time, and intermittent appointments.

The requirement to obtain consent cannot be waived for any research involving the DoD, and where there is an intervention or interaction with a human being for the primary purpose of obtaining data regarding the effect of the intervention or interaction, except under one of the following conditions:

• The research is intended to be beneficial to the subject, the subject lacks the capacity to provide consent, and a legally-authorized representative will provide consent. Examples: young minors, cognitively impaired individuals.
• The Head of the DoD component involved in the research may waive the requirement for consent with respect to a specific project, in order to advance the development of a medical product necessary to the Armed Forces, but only if the research may directly benefit the subject and the research is carried out in accord with all other applicable laws and regulations (such as 21 CFR 50.24).
• This prohibition does NOT apply to screening (sometimes called “pre” screening) of records to identify possible subjects. The IRB can grant a waiver of consent for such activities.

Researchers must comply with limitations on dual compensation for U.S. military personnel.

Research involving the administration of surveys to, or interviews of, DoD personnel (military or civilian) may require DoD approval of the surveys or interview questions.

The Naval command or activity with responsibility for the research will review all allegations of non-compliance with human subject protections and take action if appropriate. The HRPP will report the initiation of all investigations and report results regardless of the findings to the Navy SG and appropriate sponsors. [SecNavInst 3900.39D]

The Naval command or activity with responsibility for the research will review all allegations of research misconduct and take action if appropriate. The HRPP will report the initiation of all investigations and report results regardless of the findings to the Navy SG and appropriate sponsors. [SecNavInst 3900.39D]

• The IRB is prohibited from approving research involving prisoners of war.
• IRBs must be aware of the definition of “prisoner of war” for the Department of Defense component granting the addendum.

If an amendment involves substantive changes (e.g., new procedures, a new subject population, a new aim), the researcher should upload the documentation of scientific review and approval of the changes in the amendment.

• If the research was not previously DoD-related but the amendment will make the project DoD-related, the researcher must note this in the Modification Form.
• The researcher is responsible for notifying DoD and the IRB of any audits, investigations or inspections of DoD-related research.

OVPR will establish and document collaborative agreements with other institutions or non-UCSF individuals engaged in DoD-related research.

IRB staff contact the researcher or research staff if necessary, to obtain missing information or documents, clarification, or (if necessary) a revised application.

• The IRB is prohibited from approving research involving prisoners of war.
• IRBs must be aware of the definition of “prisoner of war” for the Department of Defense component granting the addendum.

Mandatory IRB determinations. In addition to checking the application for full compliance with DoD regulations, the IRB is required to make the following formal determinations for all DoD-related research. The determinations are documented in iRIS and in the IRB minutes:

Air-Force research focus areas: One or more of the following five possibilities are identified in the application as the research focus area:

• Medical Readiness
• Prevention (primary, secondary, tertiary)
• Medical Utilization
• Managed Care
• Treatment, Diagnosis, or Other

Level of research risks: Does the research involve more than minimal risk to subjects, as defined in DoD human subjects regulations? The criteria for level of IRB review (i.e. Expedited vs. Full Committee) are the same for DoD related research as for non-DoD related research.

Research monitor: For research involving more-than-minimal risk, is the research monitor appropriate with regard to: type of monitor; qualifications; and roles and responsibilities?

• Benefits: Is the research designed to be beneficial to the individual subjects when the subject lacks the capacity to make a decision regarding consent to participate and a legally-authorized representative provides the research consent?
• Disclosure: Does the disclosure include provisions for research-related injury that follow the requirements of the DoD component?

Research that is already DoD-related (i.e., prior to the modification request) and that has already been reviewed by the UCSF IRB as DoD-related.

• The IRB staff screen the Modification Form, within the context of the existing DoD Supplement in the IRB Application.

a) If the Supplement no longer accurately reflects the research, IRB staff ask the researcher to revise the Supplement (and any additional documentation).

b) If the modification involves substantive changes, IRB staff ensures that the researcher provides documentation of scientific review and approval of the modifications.

Research that has not been DoD-related, but that becomes DoD-related because of the requested modification.

• If the initial application was reviewed by the full IRB, then the modification must also be reviewed by the full IRB because a new set of regulations is involved.
• IRB staff ensures that the researcher has provided the information to address all procedures and populations that are DoD-related.

Screening: IRB staff screen the scheduled continuing review application to ensure that the following two DoD requirements have been fulfilled. If not, the staff contacts the researcher so that the requirements can be met before the IRB review.

• Continuing Education: The DoD continuing education requirement has been met.
• Research Results: DoD requires that the researcher provide the IRB with copies of publications, presentations, and reports resulting from the research. Per UCSF policy for all research (whether or not DoD-related), these should be provided to the IRB at the time of continuing review.

OVPR is required to report to DoD any of the following events or situations that occur for DoD-related research:

• Serious or continuing non-compliance
• Suspension or termination of research
• Unanticipated problems involving risks to subjects or others
• Significant communication between institutions conducting research and other federal departments and agencies, regarding compliance and oversight

*The DoD FWA number must be provided in the letter.

**When a specific situation involves reporting to more than one federal agency, the letter is addressed to the primary federal agency (typically OHRP or FDA), and a copy is sent to DoD.