Collection and research use of human subject specimens are governed by 45 Code of Federal Regulations part 46 for studies conducted with U.S. Department of Health and Human Services (HHS) funding.
Specimens with identifiable private information may only be used for human subjects research described in a protocol and informed consent form (ICF) for the clinical study under which they were collected, unless informed consent for retention and use of specimens for future research is also obtained. Any new research use of identifiable specimens must be approved as well by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
The protocol and Clinical Trial Agreement, if negotiated, should also address the entities that will have access to the specimens. DMID has an electronic specimen tracking system, Global Trace, for authorized DMID-funded users. The Global Trace web site also contains a training video on its use.
Last Updated March 17, 2013