1100: Department of Defense supported research
The purpose of this policy is to define the procedures as they apply to human research that is funded by the Department of Defense (DOD). Research supported by the DOD requires compliance with additional federal regulations, directives and instructions.
Research involving a human being as an experimental subject:
DOD definition of human subjects research
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 [32 CFR.219.102 (f)]. 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.
3. Specific policies
Initial and continuing research ethics education is required for all personnel who conduct, review, approve, oversee, support, or manage human research supported by the DOD or its components. 103 Training and Education requires initial and continuing education of research personnel and IRB members every 5 years. Note that individual DOD components may have stricter or more specific educational requirements. Researchers should contact their project coordinator at the DOD, or DOD component, to ensure adherence to any unique requirements. IRB coordinators assigning reviewers to protocols funded by the DOD will ensure that training requirements are current at the time of review. Regular education at IRB meetings will include DOD components when appropriate.
3.2 Research monitor
Appointment of an independent research monitor is required for research involving greater than minimal risk. The monitor must be a provider capable of overseeing the progress of the research protocol. The monitor must be independent of the investigative team and possess sufficient educational and professional experience to serve as the subject/patient advocate. The principal investigator is responsible to provide the name, contact information and responsibilities of the monitor to the IRB in the IRB application. The IRB may require a monitor for a portion of the project or for studies involving no more than minimal risk when appropriate.
The research monitor has the authority to:
- Stop a research study in progress.
- Remove individuals form the study.
- Take any steps to protect the safety and well-being of subjects until the IRB can assess.
3.3 International research
When DOD-sponsored research involves human subjects who are not U.S. citizens or DOD personnel and the research is conducted outside the United States and its territories, the investigator must obtain the permission of the host country. The laws, customs, regulations and practices of the host country and those procedures required by 411 International Research, will be followed. Evidence of permission to conduct the research in the host country by certification of local ethics review must be submitted to the IRB prior to initiation of the project.
3.4 Multi-site research
When conducting multi-site research, a formal agreement between organizations is required to specify the roles and responsibilities of each party.
3.5 Studies involving Department of Defense personnel
When research involves Department of Defense personnel, including U.S. military personnel, the following requirements to minimize undue influence will apply:
- Officers cannot influence the decisions of their subordinates
- Officers and senior non-commissioned officers need to have a separate opportunity participate in the research.
- When recruitment involves a percentage of a unit, an independent ombudsman must be present during the recruitment.
- Surveys performed on DOD personnel must be submitted, reviewed, and approved by the DOD after the research protocol is reviewed and approved by the IRB.
The following limitations on dual compensation for U.S. military personnel apply:
- An individual may not receive pay for more than one position for more than 40 hours of work in one calendar week. This limitation on dual compensation includes temporary, part-time and intermittent appointments.
- Individuals may be compensated for research if they participate in the research when not on duty.
3.6 Serious or continuing non-compliance
For any research sponsored by the DOD where there is a report of serious or continuing noncompliance, a report will be made to the Department of Defense.
3.7 Scientific review
New research and substantive amendments to approved research must undergo scientific review prior to the IRB review.
3.8 Informed consent
If the research subject of a study funded by the DOD meets the definition of “experimental subject,” then a waiver of consent by the IRB is prohibited unless a waiver is obtained from the Secretary of Defense. If the research subject does not meet the definition of “experimental subject,” the IRB may waive the consent process.
3.9 Provisions for research-related injuries
For DOD-sponsored research, DOD components may have stricter requirements than the Common Rule requirements for research-related injuries. The IRB shall apply the stricter requirements for research-related injuries as outlined by the DOD component conducting or supporting the research.
Research sponsored by the DOD may require submitting records to the DOD for archiving.
4. Applicable regulations and guidelines
DOD Instruction 3210.7 (pdf)
DOD Instruction 6200.02 (pdf)
6. Procedures employed to implement this policy & assignment of responsibility
|ORA director, chairpersons of IRBs, IRB members, IRB coordinator, and institutional official||Ensure compliance with federal regulations, policy, and procedures to guarantee the protection of human subjects participating in research.
Report to the institutional official any inappropriate attempts to influence the IRB process.