Central DOE IRB 

Background/Scope

DOE has both lab/site-specific IRBs and a Central DOE IRB (CDOEIRB).

The CDOEIRB was established in January 2010 by four DOE Headquarters organizations:  the Office of Science (SC), the Office of Health, Safety and Security (HSS), the National Nuclear Security Administration (NNSA), and the Office of Intelligence and Counterintelligence (IN).
This IRB evolved from DOE’s Central Beryllium IRB (CBeIRB), which was established in 2001 to bring vision, expertise and consistency to the review of all DOE-funded/conducted human subjects’ research and screening related to occupational exposure to beryllium.  In 2010, the scope of the CBeIRB was expanded and the name was changed to the CDOEIRB. This IRB serves as DOE’s IRB of record for study protocols that involve employees of DOE or its contractors and/or are explicitly funded by, or conducted by, DOE or other agencies or institutions in the following areas:

  • Beryllium exposure-related studies;
  • The Former Worker Medical Screening Program (FWP);
  • Multi-site research involving the health and/or productivity of current DOE/DOE laboratory employees;
  • A portion of DOE’s energy efficiency-related human subjects’ research and human terrain mapping projects;

Contacts

For questions about the CDOEIRB, please contact:

Central DOE IRB Manager:  Becky Hawkins

Central DOE IRB Chair:  Jim Morris

DOE Human Subjects Protection Program Manager:  Libby White

NNSA Human Subjects Protection Program Manager:  John Ordaz

CDOEIRB Standard Operating Procedure

SOP Cover

Submission of Protocols for Review

The CDOEIRB uses IRBNet for the electronic submission and management of protocols. Forms can be located at: https://www.irbnet.org/release/index.html if you are a registered user, or you can contact the IRB Manager at Becky.Hawkins@orise.orau.gov or call 865-576-1725.

CDOEIRB Meetings and Events

Tentative CDOEIRB 2014 Meetings
Protocol Submission Dates CDOEIRB Meeting Dates
  1/25/14
  3/13/14
  6/15/14
  10/23/13
  12/18/14

New submissions must be submitted in IRBNet by one of the submission dates listed above to ensure time for a thorough review before being included on the Agenda for the next meeting date. Not all new submissions require Full Board review; however, the Board is notified of all actions taken.

Applications for Continuing Review must be submitted in IRBNet at least 30 days prior to the expiration date of the current approval. IRBNet sends automated reminders to the PI (or program managers) 60 and 30 days prior to protocol expiration. If appropriate, continuing reviews may be performed by the Expedited Review Process and included on the following Agenda as a means to inform the Board of actions taken.

CDOEIRB Forms

The following forms are “read-only.”  The most recent forms can be obtained at www.irbnet.org or by sending an e-mail to Becky Hawkins.

Human Subjects Research Application

Human Subjects Research Amendment/Modification Application

Human Subjects Research Continuing Review Application

Human Subjects Research Request for Project Closure

Human Terrain Mapping or Not Human Terrain Mapping?
Questions to take in consideration when conducting Human Terrain Mapping work.

Human Terrain Mapping Data Review Process
The HTM Data Review process has been developed to help the PI and the IRBs assure that datasets received by the investigator have been de-identified to the extent practicable while still allowing the PI to complete his/her work. The IRBs will provide oversight for the management and handling of HTM datasets, and will follow-up with the PI periodically.

Report of Unanticipated Problems Involving Risks to Subject or Others (UP) Including Unanticipated Serious Adverse Events (USAE)

DOE Requirements Document

DOE O 443.1B, Protection of Human Research Subjects, dated 3-17-11
Establishes DOE procedures and responsibilities for implementing the policy and requirements set forth in Title 10 Code of Federal Regulations (CFR) Part 745, Protection of Human Subjects, and the Secretarial Policy Memorandum on Military or Intelligence-Related Human Subject Research, December 9, 2009.

Content reviewed: February 6, 2014