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 funding.
Specimens with identifiable private information may only be used for human subjects research described in a protocol and informed consent form 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/Independent Ethics Committee.
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 website also contains a training video on its use.
- OCRR VTEU PBMC Processing SOP (OCRR SOP)
- Requirements for Use of OCRR PBMC Processing SOPs (OCRR policy)
- Selected References page for
- FDA heading - In Vitro Diagnostic Device Studies Using Leftover Human Specimens
- Human Subjects Protections heading - Office for Human Research Protections then go to sections “Biological Materials & Data” and “Checklists & Decision Trees” to determine if specimens are covered by human subjects regulations
- Training Opportunities page for Global Trace training video for authorized users