DoD Supplement
UCSD Human Research Protections Program
Date of Completion (or Revision) of this form:
PI Name:
Study Title or IRB Number:
1.
How is your project linked to the Department of Defense (DoD)? Check all that apply.
The project is funded by DoD (for example, by an Office of Naval Research grant).
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).
2.
Is this study considered “Greater Than Minimal” risk?
(a)
Yes
If yes, please address (a) & (b) below
No
If no, proceed to Question 3.
Research Monitor. Complete and check the following.
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:
Protocol section <insert name or number of protocol section>
Biomedical Research Plan Application Item 21
Privacy & Confidentiality section of the consent form(s) (if the Monitor will have
access to individually identifiable data)
(b)
Protections for Military Personnel. Check the assurance(s) applicable to your recruitment plan.
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.
Scientific Review and Approval. Check the assurance below:
I have attached documentation of scientific review and approval (including a summary of scientific
issues raised and addressed during the review).
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4.
Principal Investigator Education and Training. Check the assurance below:
I have attached documentation of completion of DoD education requirements.
5.
Does your project involve consent by a legally authorized person on behalf of a subject (e.g., parents
for children, proxy for incapacitated subjects)?
(a)
Yes
Please complete (a) below before proceeding to Question 6.
No
Proceed to Question 6.
Intention to Benefit Subjects. Please ensure the following:
Biomedical Research Plan Application item 17 specifies the benefits expected for subjects.
6.
Does your project involve collaboration with other institutions?
(a)
(b)
(c)
Yes
Please address (a) - (e) below (as applicable) before proceeding to Question 7.
No
Proceed to Question 7.
Is there an agreement on file with the other institution?
Yes
Please provide copy
No
Contact department responsible for administering funds to initiate process.
Is UCSD the lead organization for the study?
Yes
Please address (c) & (d) below
No
Please address only (e) below only
Required Documentation Related to the Performance Site(s).
Attached Documentation
IRB Approval(s) from:
<list institution(s)>
Letter(s) of Permission or
Compliance from:
<list institution(s)>
Cooperation Agreement(s)/
Contract(s) from:
<list institution(s)>
Pending Documentation
IRB Approval(s) from:
<list institution(s)>
Letter(s) of Permission or
Compliance from:
<list institution(s)>
Cooperation Agreement(s)/
Contract(s) from:
<list institution(s)>
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(d)
Protection from Medical Expenses for Research-Related Injury. Check whichever applies.
N/A- this project does not pose greater-than-minimal risk.
Biomedical Research Plan Application Item 19 and the Informed Consent Document Harm
Clause describe the injury arrangements at each of the collaborating institutions.
(e)
Required Documentation Related to the Lead Organization
Attached
Pending
Item
IRB Approval
Cooperation Agreement(s)/Contract(s)
7.
Will any portion of your project be conducted outside the United States?
(a)
Yes
Please address (a) & (b) below before proceeding to Question 8.
No
Proceed to Question 8.
Supplemental Documentation. Review the policy and check the assurances below:
I have attached the required documentation regarding the following foreign sites:
<list sites>
Documentation regarding the following foreign sites is pending:
<list sites>
(b)
Does the research involve only U.S. citizens or Department of Defense personnel?
Yes
Proceed to Question 8.
No
DOD requires the documentation listed below. Please indicate the status:
Attached
Pending
Item
Permission of the host country
Ethics review and approval by the host country or by a local
DoD or Naval IRB with host country representation
8.
Will you administer surveys or interviews of DoD personnel?
(a)
Yes
If yes, please complete (a) below
No
If no, proceed to Question 9.
Applicability of the DoD or Navy Survey Policy. 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>
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UCSD Human Research Protections Program
9.
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
Because classified research involves restriction of the dissemination of results, UCSD institutional
practice is to not accept such research. This prohibition includes the designation of “sensitive but not
classified.”
10.
DoD Documentation Requirements. DoD requires that the IRB receive and maintain the following
documentation. Please check and attach the following as applicable to your research.
Attached
Pending
N/A
Item
PI & Co-Investigator CVs
Data Collection Forms/Case Report Forms
FDA letter for IND or IDE
FDA Form 1571
FDA Form 1572
11.
Other Information. Please use the space below to provide any additional information or explanations.
Version: 11/8/10
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