Ethics, Human Use, and the Department of Defense Serum Repository.
Publication Status: Published
Sponsoring Organization: Defense Health Agency (formerly TRICARE Management Activity)
Sponsoring Office: Armed Forces Health Surveillance Center
Congressionally Mandated: No
Funding Source: Defense Health Agency (formerly TRICARE Management Activity)
Release Date/Publication:
Principle Investigator Status: Government
Primary DoD Data Source: Other Clinical
Secondary DoD Data Source:
Abstract
The Department of Defense Serum Repository (DoDSR) contains a growing archive of sera from service members collected to perform medical surveillance, clinical diagnosis, and epidemiologic studies to identify, prevent, and control diseases associated with military service. The specimens are a mandatory collection under DoD and U.S. regulations and do not include informed consent for uses beyond force health protection. Any use of the specimens for research requires deidentification of the samples and must be approved by Institutional Review Boards. However, as expansion of the DoDSR is contemplated, ethical considerations of sample collection, storage, and use must be carefully reconsidered. Other similar programs for research use of specimens collected for public health purpose are also undergoing similar reviews. It is recommended that at a minimum, service members are informed of the potential storage and use of their specimens and are allowed to opt out of additional use, or a broad informed consent is provided. The DoDSR provides a tremendous resource to the DoD and global health community, and to ensure its continued existence and improvement, the DoD must stay consistent with all principles of research ethics.
Citation:
Pavlin JA, Welch RA. Ethics, Human Use, and the Department of Defense Serum Repository. Mil Med. 2015 Oct;180(10 Suppl):49-56.