| Last updated on 2010-12-29 11:20:18 |
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OUSD(P&R) Human Research Protection Program (HRPP)
Service Members & Employees Section As a member of the military, Service members and their families are more likely than members of the general public to be sought by researchers for participation in research studies and surveys because of their unique experiences. The U.S. Food and Drug Administration (FDA) is responsible for regulating studies of new drugs and devices1, but ever wonder if anyone is regulating other kinds of research or regulating all the companies and government agencies collecting personal information? There are, in fact, a host of rules and regulations that apply when the federal government is involved in research or other information collections. For example, whenever federal dollars are used for research on human subjects, whether by a university researcher with a federal grant, a research firm with a federal contract, or by the government directly, regulation requires that the research be reviewed to ensure it is ethically appropriate and in compliance with all laws. In the Department of Defense (DoD), the Human Research Protection Program (HRPP) conducts these reviews. The HRPP is composed of a network of Institutional Review Boards (IRBs), Exemption Determination Officials (EDOs), and oversight offices. The oversight office for research conducted or funded by offices under the purview of the Under Secretary of Defense (Personnel & Readiness) is a Force Health Protection and Readiness (FHP&R) program. Oversight offices for the Army, Navy and Air Force are run through the Offices of the Surgeons General. All information collections, including research surveys, interviews, and focus groups, are subject to information management control requirements. These rules help ensure quality standards for DoD information requests, seek to eliminate duplication of effort, and promote coordination of effort across the Services. Finally, the Privacy Act protects the information once it is collected. Service members who have been with the DoD for a long time may have received a Status of Forces Survey (SOFS) from Defense Manpower Data Center (DMDC) and Dr. Chu, the Under Secretary of Defense for Personnel and Readiness (USD/P&R). The SOFS begins with a privacy act notice and a consent form. The privacy act notice tells Service members that the data, once received, will be stored in a system that is controlled and protected by the Privacy Act. The consent form, which includes HRPP contact information, tells Service members that the survey procedures have been reviewed to ensure protection of their data and that the consent form itself has been reviewed to ensure full disclosure of the purpose and uses of the survey. Finally, the Report Control Symbol in the upper right hand corner tells Service members that the survey meets scientific quality standards and that it is an official DoD information collection. 1What FDA Regulates. U.S. Food and Drug Administration. http://www.fda.gov/comments/regs.html. Updated March 30, 2007. Accessed July 5, 2007.
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