Frequently Asked Questions
This page provides answers to frequently asked questions regarding the DAIDS Standard Operating Procedure (SOP) for the Destruction of Clinical Trial Specimens owned by NIAID.
The SOP states that the DAIDS project officer determines which specimens can be destroyed or maintained in storage. How does the DAIDS PO obtain the information to make that determination? For HVTN specimens, HVTN Regulatory Affairs uses consent language and follow-up discussions with the sites to make that determination. I'm not aware of any involvement of the DAIDS PO in this process.
This policy applies to specimens collected by contractors that are the property of NIAID. The appropriate DAIDS program/DAIDS PO should be contacted and will decide which samples can be destroyed based on the relevant regulations, informed consent, participant wishes, and scientific value.
Does this SOP apply to HVTN specimens?
HVTN specimens are obtained under a cooperative agreement, and so this policy does not apply to them.
Shouldn't the Coordinating Center also be mentioned? In the case of the HVTN Coordinating Center, we have a significant role in this process.
As noted above, this policy does not apply to HVTN specimens.
The SOP states it is for “all” repositories, yet the scope limits it to only two labs and one of our repositories and therefore is limited to those activities that store samples at SeraCare Bioservices.
At this time the policy applies to AVEG laboratories, HIVNET laboratories, and SeraCare BioServices repository, but we expect it will apply to future contractors also.
Does the project officer (now COTR) for the contract that supported the clinical research determine which specimens can be destroyed or the project officer for the repository contract determines this?
Project officer (now COTR) for the clinical research contract determines this, not the project officer for the repository contract.
Can the DAIDS PO override the decision of the participants to have their specimens destroyed?
No. The DAIDS PO decision will be consistent with the relevant regulations, informed consent, participant decisions, IRB/EC determinations regarding the storage of the specimens.
Several repositories are listed, but there are additional HVTN repositories that are not listed, for example, the Merck repository in Seattle, and BARC in South Africa. Does this SOP apply to these repositories?
No. Since the specimens in the repositories mentioned were not obtained under contracts and are not owned by NIAID, the SOP does not apply to them.