Department of Defense

1 PURPOSE

1.1 The purpose of this document is to describe the policies and procedures for human subjects
research that involves any component of the Department of Defense (DOD).

2 POLICY

2.1 It is University of Washington (UW) policy to comply with all applicable regulations governing
human subjects research that involves the DOD.

2.2 Per guidance from DOD, research is considered to involve the Department of Defense when:
2.2.1 The research is funded by a component of DOD.
Example: A grant from the Office of Naval Research
2.2.2 The research involves cooperation, collaboration, or other type of agreement with a
component of DOD.
Example: An Army Medical Laboratory will conduct malaria antigen detection tests for
study
2.2.3 The research uses property, facilities, or assets of a component of DOD.
The subject population will intentionally include personnel (military and/or civilian)
from a component of DOD.

2.3 DOD policies and requirements do not apply when DOD personnel incidentally participate as
subjects in research that is not supported by DOD, and DOD personnel are not an intended
population of the research.

3 DEFINITIONS

3.1 Department of Defense: This term is used to refer to any component of the federal
Department of Defense. The Department of Defense 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
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 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

3.2 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.

4 RESPONSIBILITIES

4.1 Researchers have many additional human subjects responsibilities when conducting research
involving the DOD. See section 5.

4.2 IRB and HSD responsibilities are described in section 6.

5 PROCEDURES: Researchers

5.1 Planning. DOD related research typically requires additional compliance activities,
documentation, and subject protections. Researchers should anticipate and plan for these
requirements, which may require significant coordination of timing and activities among
offices and institutions.

5.2 Budgeting. Meeting DOD requirements may increase the costs of conducting the research.
5.2.1 DOD has provided the following guidance:
“Most costs associated with Human Research Protections are expected to be included
in an Institution’s indirect overhead rates. However, if an Institution has identified a
specific cost directly associated with performance of a particular effort and thinks the
cost should be direct [sic] charged to an award, they should approach the awarding
agency contracting Officer for further consideration. The awarding agency Contracting
Officer would normally make a determination as to whether this type of cost is
reasonable as a direct cost to their award”.
Guidance provided to the UCLA Office for the Protection of Research Subjects, as posted in the 5/31/2007
version of the document, “Guidance: Department of the Navy Human Subject Protections”.

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5.2.2 Example: for DOD projects involving greater-than-minimal-risk, a Research Monitor is

required by DOD policy. The costs associated with the monitor might qualify as direct
costs. For assistance in identifying such costs and dealing with the funding agency,
researchers should consult with the UW Office of Sponsored Programs.

5.3 DOD funding. Researchers are not allowed to expend DOD funds for human subjects research
until all of the following requirements have been met:
5.3.1 The IRB has reviewed and approved the research (or HSD has granted Exempt Status).
5.3.2 The UW Office of Sponsored Programs has furnished the Human Research Protection
Program at the DOD component that is funding the research with:
 Documentation of the IRB approval.
 If the research qualifies for exempt status: documentation of the exempt
determination, including citation of the exempt category and a rationale
statement.
5.3.3 The UW Office of Sponsored Programs has received notice from the Contracting Officer
at the DOD component that the DOD Human Research Protection Program has
reviewed the research protocol and accepted the IRB approval or exempt
determination for compliance with the DOD component policies.

5.4 DOD Supplement form. This UW IRB form is a supplement to the UW IRB application forms. It
must be completed and submitted with the appropriate IRB application form for all DOD
related research involving human subjects.

5.5 DOD approval of surveys and interviews. See Question 4.1 on the DOD Supplement form.
Research involving the administration of surveys to, or interviews of, DOD personnel (military
or civilian) may require DOD approval of the survey or interview questions. For example, see
the Navy Survey Policy entitled OPNAV Instruction 5300.8D.

5.6 Waiver of consent. See Section 3 of the DOD Supplement form.

5.6.1 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 or more of the following conditions.
5.6.1.1 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.
5.6.1.2 The Head of the DOD component involved in the research may waive the
requirement for consent 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).

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5.6.2 This prohibition does not apply to screening (sometimes called “pre” screening) of
records to identify possible subjects.

5.7 Research in which legally authorized representatives (LARs) provide consent . See Question 4.2
on the DOD Supplement form. Per military law and DOD directive, informed consent may be
provided by a legally authorized representative of subjects if: (1) the subject lacks capacity
(due to age, condition, or other reason) to make a decision regarding consent to participate in
the research; AND (2) the IRB has determined that the research is intended to be beneficial to
the individual subjects.

5.8 Monitor for greater-than-minimal risk research. An independent research monitor is required
for research involving greater-than-minimal risk to subjects. See Questions 5.1 and 5.2 on the
DOD Supplement form. The IRB is responsible for making the risk determination, using the
definition of minimal risk provided above in section 3.2
5.8.1 The monitor: a medical monitor or a non-medical monitor? DOD has advised other
institutions that if a medical monitor would not be appropriate for the research, then a
non-medical monitor may be appointed.
Advice provided to the UCLA Office for the Protection of Research Subjects, as posted in the 8/27/2007
version of the document, “Guide to Completing the Form HS-1 Navy Supplement”.
5.8.2 DOD guidance about the monitor, from Department of Defense Directive 3216.2
(section 4.4.3):
5.8.2.1 The monitor must be appointed by name.
5.8.2.2 Medical monitors may be physicians, dentists, psychologists, nurses, or other
healthcare providers capable of overseeing the research and its progress,
especially issues of individual subject/patient management and safety.
5.8.2.3 Monitors shall be independent of the investigative team and shall possess
sufficient educational and professional experience to serve as the
subject/patient advocate.
5.8.2.4 Depending on the nature of the study, the monitor may be assigned to assess
one or more of the following phases of the research: subject recruitment;
subject enrollment; data collection; or data analysis and storage.
5.8.2.5 At the discretion of the IRB, the monitor may be assigned to discuss progress
with the lead researcher; interview subjects; consult on individual cases; or
evaluate adverse events.
5.8.2.6 Monitors shall promptly report discrepancies or problems to the IRB.
5.8.2.7 Monitors shall have the authority to stop a research study; remove subjects
from a study; and take whatever steps are necessary to protect the safety and
well-being of subjects until the IRB can assess the monitor’s reports.

5.9 Protections for subjects who are military personnel. See Question 5.4.1 on the DOD
Supplement form. DOD requires certain protections for military personnel being recruited for
research that involves greater-than-minimal risk.
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5.10 Independent scientific review prior to IRB review. See Questions 7.1.2 and 8.1.2 on the DOD
Supplement form. The Navy and the Army require independent scientific review and approval
prior to IRB review of new applications and substantive modifications.
5.10.1 Who conducts the review? A scientific review conducted by a funding agency (including
DOD) or by an established internal review mechanism in the researcher’s school or
department will satisfy this requirement. In the absence of such a review, an ad hoc
scientific review may be provided by the researcher’s chair or dean.
5.10.2 What topics should the review cover? Researchers may wish to look at the National
Naval Medical Center scientific review template and at the Army’s description of
scientific review criteria in its Human Research Protections Office Policies and
Procedures. These are essentially the same as the scientific review conducted by any
federal funding agency. An internal or ad hoc review should cover the same topics
including:
5.10.2.1 Significance
5.10.2.2 Approach (conceptual framework, design, methods, analysis)
5.10.2.3 Researcher
5.10.2.4 Research environment
5.10.3 Documentation of the review. The IRB must be provided with written documentation of
the scientific review that summarizes the scientific issues raised and addressed during
the review, together with a statement that names and describes the reviewers.
Examples of appropriate documentation include: copy of a review summary from a
federal agency; or a memo from the researcher’s department chair.

5.11 Education and training requirements. The DOD education and training requirements exceed
the requirements of the UW. See section 3.2 of the DOD Supplement form, and the training
section of the HSD website. Researchers should contact the human research protection office
of the DOD component to identify any human subjects training requirements and how to fulfill
them.

5.12 International research. See question 8.1.3 on the DOD Supplement form about Navy-involved
research with human subjects who are not U.S. citizens or Department of Defense personnel.

5.13 Documentation of responsibilities. See question 3.3 on the DOD supplement form.
5.13.1 Researcher files. Researchers are required by DOD policy to maintain an extensive
number of research-related and compliance-related documents in their files.
5.13.2 DOD Documentation requirements. It is the responsibility of the researcher to provide
DOD with documents required by DOD.

5.14 Post-IRB approval responsibilities.

5.14.1 Continuing review.

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5.14.1.1 Continuing education. It is the researcher’s responsibility to provide the IRB

with documentation that any DOD-required continuing education about
human subjects has been fulfilled, with the regular Status Report.
5.14.1.2 Research results. DOD requires that the researcher provide the IRB with
copies of publications, presentations, and reports resulting from the research.
These should be provided to the IRB with the Status Report form.
5.14.2 Modifications to the research. When preparing a Modification form for IRB review, the
researcher is responsible for reviewing the DOD Supplement form that he/she has
already provided to the IRB, to ensure that it still accurately reflects the research.
5.14.2.1 If it does not, a revised Supplement (and any additional documentation)
should be provided to the IRB with the Modification form.
5.14.2.2 If a Modification involves substantive changes (e.g., new procedures, a new
subject population, a new aim), the researcher should attach documentation
of scientific review and approval of the changes to the Modification form.
5.14.2.3 If the research was not previously DOD-related but the Modification will make
it DOD-related, the researcher submits the completed DOD Supplement form
and all required attachments, with the Modification form.
5.14.3 Reporting obligations. The researcher is responsible for notifying DOD and the IRB of
any audits, investigations or inspections of DOD-related research.

6 IRB and HSD RESPONSIBILITIES

6.1 Pre-review. During the standard pre-review process, HSD staff screen IRB application materials
to identify DOD-related research. DOD research is tagged in the HSD database.
6.1.1 If the research is DOD-related but the researcher has not provided a DOD Supplement
form, HSD staff inform the researcher about the need to fulfill this requirement before
IRB review can begin.
6.1.2 HSD staff screen the DOD Supplement form for completeness, including the required
attachments, before IRB review. Missing information or clarification is obtained from
the researcher.

6.2 Initial review.

6.2.1 Regulatory checklist. The IRB and HSD staff use the CHECKLIST Master during the
review process to ensure and document compliance with DOD human subjects
regulations.
6.2.1.1 The completed checklist is placed in the IRB file. It is also considered part of
the IRB meeting minutes.
6.2.2 Mandatory IRB determinations. The CHECKLIST Master describes, and is used to
document, the DOD-related determinations the IRB is required to make, including:
6.2.2.1 Air Force Research focus area.
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6.2.2.2 Level of research risk.

6.2.2.3 Research monitor.
6.2.2.4 Benefits to individual subjects if a legally authorized representative may
provide the research consent.

6.3 Modification review.

6.3.1 Research that is already DOD-related (i.e., prior to the Modification request) and that
has already been reviewed by the UW IRB as DOD-related.
6.3.1.1 The HSD staff screen the Modification form, within the context of the existing
DOD Supplement form in the IRB file.
6.3.1.1.1 If the Supplement no longer accurately reflects the research, HSD
staff ask the researcher for a revised Supplement (and any
additional documentation).
6.3.1.1.2 If the Modification involves substantive changes, HSD staff ensure
that the researcher provides documentation of scientific review
and approval of the modifications.
6.3.1.2 The criteria for level for IRB review (i.e., expedited versus full IRB) are the
same for DOD-related research as for other types of research.
6.3.2 Research that has not been DOD-related, but that becomes DOD-related because of the
requested Modification.
6.3.2.1 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.
6.3.2.2 HSD staff ensure that the researcher has provided the DOD supplement form
and all required attachments, which should address all procedures and
populations which are DOD-related. HSD staff screen the supplement form as
described above.

6.4 Continuing review.

6.4.1 Screening. HSD staff screen the Status Report form to ensure that the following two
DOD requirements have been fulfilled. If not, the staff contact the researcher so that
the requirements can be met before the continuing review.
6.4.1.1 Continuing education about human subjects research.
6.4.1.2 Research results: copies of publications, presentations, and reports resulting
from the research.

6.5 Reporting obligations.

6.5.1 HSD and the IRB are required to report to the involved DOD component any of the
following events or situations that occur for DOD-related research:
6.5.1.1 Serious or continuing non-compliance
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6.5.1.2 Suspension or termination of research

6.5.1.3 Unanticipated problems involving risks to subjects or others
6.5.1.4 Significant communication between the UW and other federal departments
and agencies, regarding compliance and oversight.
6.5.2 This reporting obligation is fulfilled by using the standard UW federal reporting letter
template.
6.5.2.1 When a specific situation involves reporting to more than one federal agency,
then the letter is addressed to the primary federal agency (typically OHRP or
FDA), and DOD is copied.

7 REGULATORY CITATIONS

7.1 32 CFR 219, “Protection of Human Subjects”

7.2 Department of Defense (DOD) Directive 3216.2, “Protection of Human Subjects and Adherence
to Ethical Standards in DOD Supported Research”

7.3 Department of Defense Directive 5500.7-R, Joint Ethics Regulation, “Standards of Conduct”.

7.4 Department of Defense (DOD) Instruction 6200.02, “Application of Food and Drug
Administration (FDA) Rules to Department of Defense Force Health Protection Programs,
February 27, 2008.

7.5 Under Secretary of Defense Memorandum, HA Policy 05-003, March 28, 2005, “Policy for
Protection of Human Subjects in Department of Defense Sponsored Research”

7.6 Department of Defense Instruction 1100.13, November 21, 1996, “Surveys of DOD Personnel”

7.7 Section 980 of Title 10, United States Code

7.8 Section 209 of Title 18, United States Code

7.9 48 CFR 207, “Acquisition Planning” part of Defense Federal Acquisition Regulations
Supplement (DFARS). Specifically: 48 CFR 207.172

7.10 48 CFR 235, “Research and Development Contracting” part of Defense Federal Acquisition
Regulations Supplement (DFARS). Specifically: 48 CFR 235.072

7.11 48 CFR 252, “Solicitation Provisions and Contract Clauses” part of Defense Federal Acquisition
Regulations Supplement (DFARS). Specifically: 48 CFR 252.235-7004

7.12 Secretary of the Navy, SECNAV INSTRUCTION 3900.39D, “Human Research Protection
Program”.

7.13 National Naval Medical Center Scientific Review Template, revision 12-15-06.
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7.14 Naval Operations, OPNAV INSTRUCTION 5300.8B

7.15 Army Human Research Protections Office Institutional Policies and Procedures, Version 1, April
2005, Section V.A., “Scientific Peer Review of Research”

7.16 Army Regulation 70-25, January 25, 1990, “Use of Volunteers as Subjects of Research”.

7.17 Air Force Instruction 40-402, “Protection of Human Subjects in Biomedical and Behavioral
Research”, May 5, 2005.

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