DOE Worker Health-Related Studies and Programs
Procedures for Review of Beryllium Research Protocols
To ensure the privacy of workers included in Be research, to maintain the independence of grantee's institutions to conduct this research at DOE sites, to ensure local input in a timely fashion, and to respect the independent obligations of DOE contractors, whether by contract or law, the DOE Office of Science (SC) is establishing the following procedures concerning review of beryllium research protocols that include DOE or DOE-contractor workers in the study population.
- The CBeIRB serves as the IRB of record for purposes of satisfying the requirements of DOE and HHS for review of beryllium research protocols in which DOE or DOE-contractor workers are included as the study population. That portion of the protocol dealing with beryllium research (beryllium protocol) should be sent to the CBeIRB for approval. When the site beryllium research protocol is ready for review by the CBeIRB, a copy of the request for review and approval is sent to the CBeIRB Administrator. An e-mail alert about the submission of the research protocol to the CBeIRB should also be sent by the site IRB to Elizabeth White, DOE Office of Science. The review and approval period by the CBeIRB shall be at least two weeks, but is not to exceed six weeks from the date of receipt of the beryllium research protocol by the CBeIRB.
- As part of the site IRB review process, the site IRB will consider all comments from the CBeIRB, discuss these with the investigator, and provide responses to the CBeIRB. Comments from the CBeIRB must be received by the Chair of the site IRB within six weeks from the date of receipt by the CBeIRB. If the CBeIRB raises important issues concerning the beryllium research protocol, a CBeIRB representative should be accessible to the site IRB during its review, or re-review of the entire research protocol in order to resolve the issues.
- In the event of a disagreement between the site IRB and the CBeIRB concerning the beryllium research protocol, the CBeIRB will make the final determination regarding approval of the beryllium research protocol.
- The Chair of the CBeIRB will send copies of comments and approval to the site IRB. If there is no site IRB, the Site Occupational Medical Director will receive the comments and approval. When the research protocol is approved by the CBeIRB, Elizabeth White is informed of the approval via e-mail from the CBeIRB Administrator.
- DOE grant recipients will also have to obtain approval from the CBeIRB and the grantee's institutional IRB prior to beginning any beryllium research involving DOE workers. After the grant has been awarded, the grantee will follow the same procedure as (1) with the grantee's IRB serving the role of the site IRB. As part of the grantee's review process, the grantee's IRB will consider all comments from the Be IRB and provide responses to the Be IRB. In the event of a disagreement between the grantee's IRB and the CBeIRB, the CBeIRB will make the final determination regarding approval of the beryllium protocol.
- For studies conducted under a grant, the grant recipient will provide copies of the final beryllium research protocol, the grantee's responses to the review comments of the CBeIRB, and the approval of the institutional IRB with changes required by the CBeIRB to the CBeIRB administrator.
- For those sites that have an IRB, a cooperative amendment is executed between the site IRB and the CBeIRB stating that the CBeIRB has ultimate authority to approve or disapprove any Be research protocol based on adequacy of protection of human subjects.
- Sites that do not have a site IRB will rely on the CBeIRB for review and approval of the entire research protocol. Alternatively, the DOE Office of Science, or the program office funding the project (with the approval of the Office of Science) or will designate another site IRB to review the research protocol. All correspondence on these projects will include the site OMD, SC, and the CBeIRB.
- If any changes are made to a beryllium research protocol approved by the CBeIRB, the revised beryllium research protocol must go through the procedure outlined in (1) for review and approval by the CBeIRB.
- Once a beryllium research protocol has been approved, the CBeIRB will follow up annually with the investigator, grantee or Site Occupational Medical Director to confirm that the beryllium research protocol has not changed. The Office of Science is notified of the CBeIRB review decision by the CBeIRB.
Within the Department, the Under Secretary for Science—in consultation with the National Nuclear Security Administration (NNSA)—is responsible for making final decisions as to what constitutes DOE-related human subject research and how human research subjects protection must be implemented.
When questions or uncertainties arise regarding the applicability of human subjects protection regulations to research, the final resolution is made by Elizabeth White, the DOE Human Subjects Protection Program Manager, in consultation with the NNSA.
Return to CBeIRB page.
Content reviewed: July 9, 2007