The following Frequently Asked Questions (FAQs) were prepared to assist those who are involved or with or have an interest in the DOE/NNSA Human Subjects Research. For additional information, please contact Libby White or John Ordaz.
How do sites select and how often should protocols be reviewed to determine if the PIs are in compliance with the IRB conditions and in compliance with the applicable regulatory requirements?
A certain number of protocols should be selected by the IRB Chair and Manager to ensure the IRB approval conditions and the applicable regulatory requirements are being met. The Chair should appoint one or two IRB members, in partnership with the IRB Manager, to conduct the annual reviews. As a minimum and on an annual basis, review:
- one-half of the protocols that required full Board review/approval
- one-half of the protocols above minimal risk (note: in most cases the protocols in bullet one and two are the same)
- one-half of the HTM protocols (note: for the most part, HTM is managed as exempt HSR)
- two Former Worker Program (FWP) protocols (for Central DOE IRB only)
- five exempt protocols (aside from HTM and FWP protocols)
The intent of these “representative” evaluations is to determine if the researchers are following the protocol in compliance with the applicable regulatory requirements and the IRB conditions of approval. In addition, evaluate if the scope of work has changed.
In some instances, the researchers may have received additional funding from the sponsor to include additional subjects, made changes to the protocol they may have thought were minor, used co-workers because external subjects were not available, used a device that may be subject to FDA requirements, made changes to an exempt protocol, used/changed PII data not reviewed by IRB, etc.
Once protocols are selected by the IRB, meet with the Work-for-Others office (for protocols that used outside funding) to determine if there were any changes to the scope of work and/or incremental funding since the IRB review/approval. This may be the first indication that the protocol may have changed. If there were changes, review them with the PI and see if they impacted the protocol and if they exceeded the IRB conditions of approval. If so, explain to the PI the steps that should be followed and discuss with the Chair the observations and what actions should be taken by the Board.
If there are no apparent changes to the scope of work and funding, proceed with ensuring that the approved protocol is being followed, focusing on the selection of subjects (note: DOE considers, as a matter of policy, that co-workers are considered vulnerable subjects), consent process, use and protection of PII, conditions of IRB approval, applicable regulatory requirements. Verify that the scope of the protocol being implemented matches the scope of work reviewed by the IRB.