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School of Medicine
Research sponsored or funded by the Department of Defense (the DoD) must be reviewed by the IRB under an additional set of federal regulations [32CFR219]. The Principal Investigator must meet additional DoD research requirements prior to initiation of the research. The DoD follows the DHHS and FDA regulations on human subjects research, but also applies DoD Directive (DoDD) 3216.02 “Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research.” DoD Directive 3216.02 contains additional requirements that include, but are not limited to the items below:
- Limitations on use of humans as experimental subjects
- Limitations or restrictions on some Federal employees (both uniformed and civilian) regarding payment for research participation
- Appointment of a medical monitor for all research that is greater than minimal risk to participants. The definition of minimal risk based on the phrase “ordinarily encountered in daily life or during the performance of routine physical or physiological examination 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). The definition of a medical monitor within the DoD directive differs from the industry definition and may be found in DoDD 3126.02, Section 4.4.3 “For research involving more than minimal risk (as defined in 31 CFR 219.102(i), reference (c)) to subjects, an independent medical monitor shall be appointed by name. Medical monitors shall be 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. Medical monitors shall be independent of the investigative team and shall possess sufficient educational and professional experience to serve as the subject/patient advocate.
- When the research meets the DoD definition of “Research Involving a Human Being as an Experimental Subject,” the IRB may not waive the consent process. (The definition may be found in DoDD 3216.02, Enclosure 2. Definitions. Paragraph E2.1.3: “An activity, for research purposes, where there is an intervention or interaction with a human subject for the primary purpose of obtaining the effect of the intervention of interaction (32 CFR 219.102(f)).”)
- Consent form language requirements.
- Initial and continuing research ethics education is required for all personnel who conduct, review, approve, oversee, support, or manage human participants research.
- Specific DoD educational requirements or certification is required.
- The DoD component may evaluate the education policies to ensure the personnel are qualified to perform the research, based on the complexity and risk of the research.
The OHSR consent form specialists are aware of the requirements for DoD language and are available to assist JHM researchers who may have questions about the language requirements. Any project that involves military personnel as part of the participant population includes additional privacy and confidentiality provisions to be addressed in the research application and consent form.
Survey/questionnaire research involving DoD personnel must receive IRB approval prior to final approval by DoD. ((SECNAVINST 3900.39D, para. 6e; OPNAVINST 5300.8B).
JHM researchers conducting research with DoD funding should review this guidance and consult with a member of the OHSR compliance team to discuss the DoD requirements. In the support section of the eIRB application, DoD should be listed as a funding source. The funding source will be listed on the IRB meeting agenda to alert IRB Chairs and members that DoD requirements must be addressed. The compliance team has developed a DoD checklist, which includes the specific requirements of DoD research, to facilitate IRB review of the research.
The following shall be promptly (no longer than within 30 days) reported to the DoD human research protection officer:
- When significant changes to the research protocol are approved by the IRB.
- The results of the IRB continuing review.
- Change of reviewing IRB.
- When the organization is notified by any Federal department, agency or national organization that any part of the HRPP is under investigation for cause involving DoD-supported research protocol.
Human subjects research compliance initial and continuing training is required for all research investigators (who conduct research on human participants) and their research staff, the IRB Chairs, Co-Chairs, members, management, and staff. The DoD requires documented retraining in human subjects research every three years, and the retraining requirement applies to all members of the study team of a research protocol that will receive DoD funding. To meet the DoD retraining requirement, JHM research team members may take the refresher human subjects course on the CITI website.
JHU SOM must have on file a Department of Defense Assurance Document, which is an additional requirement above the Federal Wide Assurance on file with DHHS. Contact the Assistant Dean for Human Subjects Research in OHSR regarding existing Assurance documents. In addition, when conducting DoD multi-site research, a formal agreement between the organizations is required to specify the roles and responsibilities of each party (see Organizational Policy on Cooperative Research and Multi-Center Studies, Policy No. 114.2).
The Office of Research Administration (ORA) staff will provide the required notification of IRB approval of research in accord with DoD Directive 3216.02 in conjunction with funding negotiations with DoD. Before the research may begin, ORA must be notified by the DoD funding component that it accepts the institution’s: IRB approval (or exempt determination, as applicable) and Federal Assurance documentation.
DoD policies and links to the DoD Components policies may be found at: http://www.dtic.mil/whs/directives/.