Checklist – Research Subject to Department of Defense Regulations
SECTION 1: Sections A-G of this checklist apply if any ONE of the following are true for the research project:
Note: See also section 3 for Air Force research, section 4 for Army research and section 5 for Navy research.
Criteria for Review
Yes
No
1. The study is funded by a component of the DoD


2. The study involves the cooperation, collaboration, or other type of
government agreement with a component of the DoD.
3. The study uses property, facilities or assess of a component of the DoD




4. The subject population will intentionally include personnel from a component
of the DoD, or data or specimens from DoD personnel.


 (DoD regulations apply)
 (DoD regulations do not
apply)
Determination: If at least one of the above is answered “yes”, complete the
remainder of this check list
A. Prisoners
DoD Policy:
NEIRB Policy
Research may not be conducted on NEIRB cannot review research that includes any
prisoners of war, including civilian prisoner.
internees, retained persons, or unlawful
enemy combatants.
Action:
If the research includes a prisoner population, return
to the submitter with a memo indicating NEIRB
cannot review the research.
B. Vulnerable Populations
Policy
Research involving pregnant women and children are subject to DHHS regulations subparts B and D.
Criteria for Review
For the purpose of applying subpart B, the phrase “biomedical knowledge” shall
be replaced with “generalizable knowledge”
Applicability for subpart B is limited to research involving pregnant women as
Yes (Criteria is met)
No (criteria is not met)
subjects if the research is more than minimal risk and includes interventions or
invasive procedures to the women or fetus; or if the research involves fetuses or
neonates as subjects.
Fetal research must comply with the US Code Title 42, Chapter 6A, subchapter
III, part H, 289g
(http://www.gpo.gov/fdsys/granule/USCODE-2010-title42/USCODE-2010-title42chap6A-subchapIII-partH-sec289g-2)
Research involving children cannot be exempt.
C. Waiver of Consent
Policy
Research involving a human being as an experimental subject, informed consent must be obtained in advance from the experimental subject or
the subject’s legal representative consistent with part 219 of Reference (c) if the subject cannot consent. If consent is to be obtained from the
experimental subject’s legal representative, the research must intend to benefit the individual subject. For the purpose of this policy, research
involving a human being as an experimental subject is: “an activity for research purposes, 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 (32CFR.210.102 (f) reference (c).
Examples of interventions or interactions include, but are not limited to: a physical procedure, a drug, a manipulation of the subject or subject’s
environment, the withholding of an intervention that would have been undertaken if not for the research purpose.”
Criteria for Review
Yes (Criteria is met)
No (criteria is not met)
For research in which there is an intervention or interaction with a living individual
for the primary purpose of obtaining data regarding the effect of the intervention
or interaction, consent cannot be waived.
For research in which there is an intervention or interaction with a living individual
for the primary purpose of obtaining data regarding the effect of the intervention
or interaction and consent will be obtained from subject’s legal representative, the
research is intended to benefit the subject.
If consent will be obtained from subject’s legal representative, provide protocol specific findings to support the determination that the research is
intended to benefit the subject:
Notes: Consent can be waived for screening of records for the purpose of identifying potential subjects, and does not apply to retrospective
records review.
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For research involving a human being as an experimental subject, the Assistant Secretary of Defense for Research and Engineering component
can waive consent under certain conditions.
D. Payment to Active Duty Personnel
Policy
Yes (Criteria is met)
Active duty personnel (i.e., not on leave or off-duty during participation) may not
receive payment for participation except for blood donation. Payment for blood
donation may not exceed $50 per blood draw.
Note: Non-federal subjects can be compensated in accordance with NEIRB policy.
No (criteria is not met)
E. Classified Research Involving Human Subjects
Policy: DOD-conducted non-exempt research involving human subjects that involves classified information must follow all of the requirements
listed below. Executive order 13526 describes classified information (http://www.whitehouse.gov/the-press-office/executive-order-classifiednational-security-information).
Requirement
Involvement of classified information is limited to information needed for IRB
approval and oversight of the research; information needed to inform human
subjects during the consent process; and information provided to human subjects
during the course of the research.
After IRB approval of the research, Secretary of Defense approval is required.
Waivers of consent are not allowed
The informed consent process will included:
 Identification of the DoD as the supporting institution of the research,
unless the research involves no more than minimal. (The Secretary of
Defense may grant an exception in certain cases).
 Disclosure or use of classified information must comply with the
requirements of Executive Order 13526 for access and protection of
classified information.
Yes (Requirement is met)
No (criteria is not met)
Expedited review is not allowed; Full Board review is always required for
classified research.
At least one non-affiliated member will be a non-federal employee.
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Any IRB member who disagrees with a majority decision approving the research
may appeal the decision to the Secretary of Defense.
The IRB will determine whether potential human subjects need access to
classified information to make a valid, informed consent decision.
F. Testing of Chemical or Biological Agents
Policy
Yes (Criteria is met)
The research cannot involve the testing of chemical or biological agents.
Note: Possible exceptions can be made as described in section 4.4.5 of the DoD Directive 3216.02.
No (criteria is not met)
G. Surveys or Questionnaires Administered to DOD Personnel or Their Families
Policy
Yes (Criteria is
met)
No (criteria is not
met)
Not Applicable
DoD review and approval is required. IRB review may occur prior to DoD approval
of the materials.
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SECTION 2
Is the study greater than minimal risk under DoD definition?
Minimal Risk generally means that the probability and magnitude of physical or psychological harm anticipated in the research are not
greater in and of themselves than those ordinarily encountered in daily life, or in routine medical, dental, or psychological examinations.
However, for purposes of DoD research, “ordinarily encountered in daily life or during the performance of routine physical or physiological
examinations or tests” shall not be interpreted to include the inherent risks certain categories of human subjects face in their everyday life.
For example, the risks imposed in research involving human subjects focused on a special population should not be evaluated against the
inherent risks encountered in their work environment (e.g., emergency responder, pilot, soldier in a combat zone) or having a medical
condition (e.g., frequent medical tests or constant pain).
 No
 Yes: Complete sections H-J
H. Research Monitor
Policy:
For more than minimal risk research, an independent monitor must be appointed
by name for the research.
The required monitor should be:
 A medical research monitor
 A non-medical research monitor: (provide justification for non-medical
monitor):
Yes (Criteria is met)
No (criteria is not met)
The monitor’s duties and responsibilities are described, including the following:
- Subject recruitment and consent
- Subject enrollment
- Study procedures
- Confidentiality
- Adverse events and protocol deviations/violations
- Data and specimen collection and storage
- Data analysis
The activities that must be performed by the monitor are described, including:
- Discuss research project with the lead researcher
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-
Interview some or all subjects
Consult on individual cases
Evaluate adverse event reports
The monitor’s independence and authority are described, including whether the
monitor:
- is independent of the research team
- possesses sufficient education and professional experience to serve as
the subject advocate
- will promptly report discrepancies or problems to the IRB
- has the authority to stop the research process, remove individual subjects
from the research, and take whatever steps are necessary to protect the
safety and wellbeing of the subjects until the IRB can assess the report.
The monitor’s full name is included in the research
The monitor’s CV is included in the research
A letter from the monitor accepting the role is included in the research
I. Research Related Injury
Policy
The arrangement for emergency treatment and necessary follow-up of any
research related injury is described.
Yes (Criteria is met)
No (criteria is not met)
J. Research Involving Military Personnel
Policy: All greater than minimal risk research involving military personnel
must include the following additional protections
Yes (Criteria is
met)
No (criteria is not
met)
Not Applicable (no
military personnel
will be enrolled)
The researcher will ascertain than an individual’s decision about participation has
not been influenced by unit officers or senior noncommissioned officers (NCOs).
The research will exclude unit officers and senior NCOs from
solicitation/recruitment/consent sessions for units under their command.
The research will offer separate recruitment/consent sessions for officers and
NCOs excluded from sessions held for their units.
An ombudsperson not connected in any way to the research or to the unit will be
present to monitor group recruitment briefings where a percentage of the unit is
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being recruited to participate as a group, to monitor that the voluntary nature of
individual participates in adequately stressed and that the information provided
about the research is adequate and true.
Section 3: Air Force Research
Complete this section for Air Force research only.
Policy: Research involving the Air Force must comply with these
limitations:
The researcher must consult with each subject to determine whether participation
in the research would affect the subject’s ability to mobilize for readiness, to
perform duties, or to be available for duty. (Normally, if the participation could
affect these abilities, the subject should not be considered for participation in the
research.)
Apparatus, instruments and personnel will be available to deal with medical
emergencies related to the research.
Minors may be used as subjects only when the research is intended to be of
benefit to the subjects and satisfies one of the following:
 Involves no more than minimal risk to subjects; OR
Yes (Criteria is
met)
No (criteria is not
met)
Not Applicable
 Presents greater than minimal risk but presents the prospect of direct benefit
for individuals subjects and the IRB finds that:
- the risk is justified by the anticipated benefit to subject.
- the relationship of the anticipated benefit to the risk is at least favorable to
the subjects as that presented by available alternative approaches.
A mentally disabled or institutionalized mentally infirm person may not participate
as a subject, unless the study would be impossible or meaningless if such
subjects were excluded.
A mentally disabled or institutionalized mentally infirm person must give legally
effective consent, or their legal guardian must give effective consent, according to
local law.
A mentally disabled or institutionalized mentally infirm person can only be enrolled
if the research is concerned with one or more of the following:
- the diagnosis, treatment, prevention or etiology of a particular impairment
that inflicts the subjects.
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-
Any other condition, from which subjects are suffereing, provided there is
a direct benefit to the subjects and prior testing has proved the risk to be
acceptable.
- The effect of institutional life on the institutionalized mentally infirm
subjects and involves no appreciable risk to subjects.
Surveys which collect data through interaction with subjects or surveys which
contain identifiable private information are not exempt from IRB review.
For Air Force research, the IRB must specify the research focus area(s) of the study; select all options below that apply:
 Medical Readiness
Prevention
 Medium Utilization
 managed Care
 Treatment, Diagnosis or Other
Section 4: Army Research
Complete this section for Army research only.
Policy: Research involving the Army must comply with these limitations:
Yes (Criteria is
met)
No (criteria is not
met)
Not Applicable
Minors may be used as subjects only when the research is intended to be of
benefit to the subjects and satisfies one of the following:
 Involves no more than minimal risk to subjects; OR
 Presents greater than minimal risk but presents the prospect of direct benefit
for individuals subjects and the IRB finds that:
- the risk is justified by the anticipated benefit to subject.
- the relationship of the anticipated benefit to the risk is at least favorable to
the subjects as that presented by available alternative approaches.
Drugs, placebos, biologicals and vaccines not commercially available (i.e.,
investigational) will be received, stored and controlled by the pharmacy and will
not be dispensed without an approved protocol.
There is documentation of independent review and approval for scientific merit or
scholarship (including a summary of scientific issues raised and addressed during
the review). The entity that conducted the independent review must be specified
and may include agencies such as: NIH, NSF, other funding agency or a faculty
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sponsor.
Section 5: Navy Research
Complete this section for Navy research only.
Policy: Research involving the Navy must comply with these limitations:
Yes (Criteria is
met)
No (criteria is not
met)
Not Applicable
Regardless of the level of research, no superiors (supervisors, officers, NCOs),
will influence the decisions of their subordinates (e.g., junior enlisted personnel)
whether to participate as study subjects.
When conducting multi-site research, the Navy requires a formal agreement
between the organizations to specify the research, specific roles and
responsibilities of the institution responsibility for scientific and IRB review,
recruitment for subjects, and procedures for obtaining consent.
There is documentation of independent review and approval for scientific merit or
scholarship (including a summary of scientific issues raised and addressed during
the review). The entity that conducted the independent review must be specified
and may include agencies such as: NIH, NSF, other funding agency or a faculty
sponsor.
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