UC IRVINE INSTITUTIONAL REVIEW BOARD
DEPARTMENT OF DEFENSE (DoD) SUPPLEMENT FORM
Version: January 2015
Please complete this form and upload with your IRB submission for review if your study involves
conducting, reviewing, approving, overseeing, supporting or managing DoD supported research with
human subjects. For more information, refer to the DoD section of the Human Research Protections
website. For questions about completing this form, contact the HRP staff at irb@research.uci.edu.
SECTION 1: GENERAL INFORMATION
1. STUDY TITLE:
2. UCI ADMINISTRATIVE CONTACT (AC):
3. UCI LEAD RESEARCHER (LR):
4. How is your project linked to the Department of Defense (DoD)? Check all that apply.
The project is funded by DoD (e.g. research is funded by the Department of Navy, Army or Air Force).
The project involves cooperation or collaboration with DoD.
The project uses DoD property, facilities or assets.
The subject population will be DoD personnel (whether military or civilian).
SECTION 2: CHECKLIST OF DoD REQUIREMENTS
Please provide evidence of the following:
Submit the following required documentation with your IRB submission via upload
Attached N/A
Lead Researcher and Co-investigator CVs
Data Collection Forms/Case Report Forms (if not already submitted to the IRB)
FDA letter for IND or IDE
FDA Form 1571
FDA Form 1572
Education and Training: In addition to completing the UCI HRP education requirements, all
personnel who conduct, review, approve, oversee, support, or manage human participant research
must also meet DoD requirements for research ethics training. This training generally must be
completed by all personnel initially and on a continuing basis every three years. Documentation
of this completion must be uploaded with the IRB submission. For more information on DoD
research and how to complete this training requirement, refer to the DoD section of the Human
Research Protections website.
Independent Scientific Review: Secretary of the Navy Instruction 3900.39D requires that
independent scientific review and approval occur prior to IRB review. Upload evidence of this
approval with your e-IRB application (scientific review and approval by the ICTS SRC and
PRMC does suffice for this requirement but must occur prior to IRB review). In the absence
of an external review or an established internal review mechanism, you should make
arrangements with your chair or dean for an ad hoc scientific review. In planning an ad hoc
review, you may wish to consult the National Naval Medical Center scientific review template. For
more information on DoD research and how to complete this requirement, refer to the DoD section
of the Human Research Protections website.
UCI HUMAN RESEARCH PROTECTIONS
DEPARTMENT OF DEFENSE (DoD) SUPPLEMENT FORM
Version: January 2015
Page 1 of 3
SECTION 3: ADDITIONAL INSTRUCTIONS
Please review the following additional DOD requirements and check the appropriate boxes.
Completed
N/A
If your study involves parental or surrogate consent, be sure to specify the
anticipated direct or indirect benefits to subjects in Section 7C of the protocol
narrative.
If your study involves additional study sites, be sure to select, “Other Non-UCI
Sites and Locations (i.e., not UCI, UCIMC, or UCI owned/leased space)” under
Performance Sites in the e-IRB application, complete Appendix A and upload any
required document (e.g., IRB approvals from other locations, permission letters, etc.
as needed).
If any portion of your study will be conducted outside of the United States, be
sure to indicate this as International Research in the e-IRB application under
Procedures involved in the Study and complete Appendix H.
If your study involves surveys or interviews of DoD personnel, additional DOD
policies may apply. Prior to IRB submission, refer to the DoD section of the Human
Research Protections website.
Applicability of the Navy Survey Policy.
If applicable, consult with the Navy Personnel Command and indicate results below:
I have been advised that survey approval is not required.
I have attached documentation of survey approval.
I have been advised to obtain IRB approval prior to survey approval.
Other: <describe>
Completed
N/A
Prohibitions or limits related to Navy research.
Please review and check the following to acknowledge that you are aware of,
and will comply with, these limitations.
Captured or Detained Persons: SECNAVINST 3900.39D (Section 6(a)(8)) prohibits
research involving “any person captured, detained, held, or otherwise under the
control of DoD personnel (military and civilian, or contractor employee)” except DoD
personnel held for law enforcement purposes.
Payment to Active Duty Personnel: Based on 24 USC 30, the military limits
research payments for Active Duty personnel. Unless on leave status during
participation, such personnel may not receive payment for participation except for
blood donation. Payment for blood donation may not exceed $50 per blood draw.
Classified (or Sensitive but Unclassified) Research: UC institutional practice is to
not accept Classified or Sensitive but Unclassified research because such research
involves restriction of the dissemination of results.
SECTION 4: FOR GREATER THAN MINIMAL RISK RESEARCH
If this study involves greater than minimal risk, complete this sub section (subsection # 1 below).
If not, skip to the next sub section (sub section # 2) and complete the remaining sections.
1. Research Monitor: For research involving more than minimal risk (as defined in 32 CFR
219.102(i), reference (c), an independent medical monitor must be appointed by name.
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,
may be the medical monitor. The monitor must also be independent of the study team and should
possess sufficient educational and professional experience to serve as the subject/patient advocate.
UCI HUMAN RESEARCH PROTECTIONS
DEPARTMENT OF DEFENSE (DoD) SUPPLEMENT FORM
Version: January 2015
Page 2 of 3
Depending on the nature of the study, the medical monitor may be assigned to assess one or more of
the following phases of the 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 lead researcher, interview subjects, consult on individual cases, or
evaluate adverse event reports.
For more information on this requirement, refer to the DoD section of the Human Research
Protections website.
Please check and complete the following (these are required elements of protocols involving
Department of Navy).
I have designated a Monitor.
I have attached the Monitor’s curriculum vitae.
I have attached a letter from the Monitor accepting the role.
I have named the Monitor and described his/her roles in the following:
Section 2 of the Protocol Narrative
Confidentiality section of the consent form(s) (if the Monitor will have access to individually
identifiable data)
The Co-Researcher or Researcher Personnel section of the e-IRB application
2. Protections for Military Personnel: Check the assurance(s) applicable to your recruitment plan if
your study involves military personnel, unit officers and/or noncommissioned officers.
N/A- DOD personnel (military or civilian) are not a target population.
I will ascertain that an individual’s decision about participation has not been influenced by unit
officers or senior noncommissioned officers (NCOs).
I will exclude unit officers and senior NCOs from recruitment/consent sessions for units under their
command.
I will offer separate recruitment/consent sessions for officers and NCOs excluded from sessions
held for their units.
An ombudsperson not connected to the research or to the unit shall be present to monitor group
recruitment briefings.
I am implementing the following protections not specified above: <describe protection>
3. Subject Injury: Based on Department of Defense Directive 3216.02 (Section 5.3.4) and Secretary of the
Navy Instruction 3900.39D (Section 6(a)(5)), institutions must have arrangements for emergency
treatment and necessary follow-up of any research-related injury in research posing greater-thanminimal risk. This is to protect human subjects from medical expenses that are the direct result of
participation in the research. By virtue of its standard policy, the University of California system meets
this standard. If circumstances warrant, the IRB may also determine that such protection is necessary
even if the research only poses minimal risk.
Please confirm your understanding of these issues by checking the box below.
I, the Lead Researcher of this protocol, confirm my understanding of the subject injury
requirements for this study.
UCI HUMAN RESEARCH PROTECTIONS
DEPARTMENT OF DEFENSE (DoD) SUPPLEMENT FORM
Version: January 2015
Page 3 of 3