Central DOE IRB
DOE’s Central IRB has evolved to meet changing needs and emerging issues. DOE has both a Central IRB and site-specific IRBs. Considering the focus and strengths of each can help determine which one is a better fit for addressing specific protocol review.
In 2009, DOE remodeled its concept for and practice of reviewing Former Worker Studies by changing from review by individual DOE site IRBs to review by a Central Department of Energy IRB. This new concept is intended to streamline IRB review and assist DOE with more effective and consistent management of the numerous ongoing former worker projects within the DOE laboratory system. For similar reasons, the DOE Central IRB approach is being considered for application to other projects, which could potentially include determining the health impacts of exposure to nanomaterials and other evolving research topics.
Central Department of Energy (DOE) Institutional Review Board (CDOEIRB) Standard Operating Procedure This manual is to document the operating procedures (10 CFR 745.103(b) (4)) of the Central Department of Energy (DOE) Institutional Review Board (CDOEIRB), or the Board. The functions of the CDOEIRB are to assure that the risks to human participants involved in research under its purview are minimized and reasonable in relation to the anticipated benefits and to protect the rights and welfare of study participants in accordance with applicable Federal regulations, state laws, DOE directives, existing ethical principles and professional practice standards, and institutional policies. |
 |
The Central Department of Energy Institutional Review Board (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 Administrator at Becky.Hawkins@orise.orau.gov or call 865-576-1725.
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.
CDOEIRB Meetings and Events
| Protocol Submission Dates | CDOEIRB Meeting Dates |
|---|---|
| 02/13/12 | 03/13/12 |
| 03/24/12 | 04/24/12 |
| 05/14/12 | 06/14/12 |
| 07/28/12 | 08/28/12 |
| 09/23/12 | 10/23/12 |
| 11/07/12 | 12/11/12 |
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
CDOEIRB Presentations
Cancer Risks Associated with Radiation Exposure from Computed Tomography: An Overview
Isaf Al-Nabulsi, PhD, U.S. Department of Energy, Office of Health and Safety
November 30, 2011Central DOE IRB Meeting Member Orientation
Libby WhiteEvolution of DOE’s Central IRB
Libby WhiteFormer Worker Medical Screening Program
Isaf Al-Nabulsi and Mary FieldsHuman Subjects Research at DOE and Role of Central DOE IRB
Libby White
Content reviewed: May 7, 2012