Research Supported by the Department of Defense, Justice or Energy
Department of Defense
In 1992 Congress appropriated money to create the Congressionally Directed Medical Research Programs to foster novel approaches to biomedical research in response to the expressed needs of its stakeholder: the American public, the military, and Congress.
Funding announcements and applications can be found at http://cdmrp.army.mil/funding/dmrdp
Department of Justice
There are additional requirements for protocols involving research supported by the Department of Justice, including the Bureau of Prisons. See NIH’s statement on Research Involving Vulnerable Populations. Even if your funding isn’t coming from the National Institutes of Health it is a useful website to review.
Each award from the National Institute of Justice/DOJ that involves data collection includes a special condition requiring the data to be deposited in a public archive at the conclusion of the project. Items that must be deposited include de-identified data and documentation, a data archiving plan, an IRB-approved protocol, a privacy certificate, human subject consent form(s), and journal articles emanating from the research as well as a data submission checklist. Guidelines for quantitative data, geospatial data and qualitative data as well as the checklist are available at the above website.
For research conducted with the Bureau of Prisons there is a detailed research statement that the researcher must sign, outlining the researcher’s responsibilities.
Department of Energy
The DOE has additional requirements related to maintaining confidentiality of personally identifiable information as described in DOE Order 443/1B Chg 1, Protection of Human Subjects. This includes a requirement to report to the IRB and that the IRB report within 48 hours, to DOE
- Any significant adverse events, unanticipated problems, and complaints about the research.
- Any non-compliance with human subjects’ protection procedures or other requirements.
The IRB should also immediately report any suspension or termination of IRB approval, as well as any finding of a suspected or confirmed breach involving personally identifiable information in print or electronic form.
Additional special requirements can be found at the DOE website: http://science.energy.gov/ber/human-subjects/regulations-and-requirements/doe-special-requirements/