For IRB Members
This section is meant to be a resource for IRB Members.
DOE Central and site IRBs value their IRB members, who perform a critical role in ensuring the protection of human research subjects.
All IRB members must complete required training which entails initial training prior to starting on the board and refresher training at least every three years. Contact your IRB Manager/Administrator for specific instructions for accessing the DOE-provided training.
- If you are a member of one of the Central DOE IRBs, the attached checklist provides additional information on DOE’s expectations with regard to training.
IRB members should also read the IRB Member Handbook (Ambdur and Bankert), which DOE provides in hardcopy to all new IRB members of its site and central IRBs. Please familiarize yourselves with the DOE requirements documents for DOE-funded/conducted HSR:
DOE makes an electronic submission system available to all its IRBs. The IRB Electronic Submission System (hereafter, IRB system) is the Huron Click Commerce-based software and is used by DOE’s Central IRBs and a number of the DOE site IRBs for processing of IRB applications. The IRB system can be accessed using the link provided to you by the IRB Administrator. Both site and DOE document libraries are available on this system. Important documents that board members from both Central DOE IRBs should be familiar with are:
- HRP-001-SOP – Definitions
- HRP-101-General – Human Subjects Protection Program
- HRP-102-General – Flowchart
- HRP-103-General – DOE Investigator Manual
- HRP-503/HRP-900-Template – Protocol with Instructions
- HRP-501/HRP-901-Template – Consent Document
- HRP-492/HRP-903-Checklist – Initial Application - Reviewer
- HRP-493/HRP-904-Checklist – Continuing Review - Reviewer
- HRP-494/HRP-905-Checklist – Modification - Reviewer
IRB Responsibilities
- Determine whether an activity is HSR, in accordance with DOE requirements, guidance, and clarifications.
- Approve, require modifications to secure approval, defer, and disapprove all HSR overseen and conducted by the Institution. All HSR must be approved by one of the IRBs designated by the DOE IO or, for research that does not fit under the purview of the Central DOE IRB(s), the IRB(s) designated by the DOE site/laboratory IO. An IO may not approve HSR that has not been IRB-approved .
- Suspend or terminate approval of HSR not being conducted in accordance with an IRB’s requirements or that has been associated with unexpected serious harm to subjects.
- Observe, or have a third party observe, the consent process and the conduct of the HSR.
- Evaluate financial interests reported by investigators and research staff and have the final authority to decide whether the financial interest and management plan, if any, allow the HSR to be approved.
- Serve as the Privacy Board, as applicable, to fulfill the requirements of the HIPAA Privacy Rule for use or disclosure of protected health information for research purposes.