Institutional Review Boards (IRBs)

There are two central IRBs within DOE:

• Central DOE IRB (CDOEIRB)
• Central DOE IRB-Classified (CDOEIRB-C)

The Institutional Review Board (IRB) is a committee made up of people from differing backgrounds and perspectives charged with the responsibility of reviewing and overseeing all research proposals that involve human subjects. The board is comprised of scientists, non-scientists, and community members.

The review process is designed to protect the rights and welfare of human subjects by ensuring equitable subject selection and adequate informed consent, assessing and minimizing risks, and maintaining privacy and confidentiality. The IRB reviews all human subjects research protocols in accordance with federal regulation, state and local laws, and Department of Energy (DOE) directives.

Within the DOE complex, some DOE sites have their own IRBs and others do not. For sites without an IRB, the protocols are typically reviewed by one of the central DOE IRBs (CDOEIRB or CDOEIRB-C). The table below identifies what IRB is responsible for reviewing protocols at each DOE site that conducts human subjects research. If a DOE site does not appear in this table, but there is a concern or question about human subjects research at that site, please contact us.

Legend:
CDOEIRB(s) = Central DOE IRB and the Central DOE IRB-C
+ Studies that are being performed by or conducted at more than one DOE site

The CDOEIRB
The CDOEIRB, which was established in January 2010, 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 sponsored by DOE or involving the DOE workforce.
• Human subjects research in which multiple DOE laboratories/sites are engaged.
• A portion of the human subjects research involving manipulation of the human environment that is funded by DOE.
• The Former Worker Medical Screening Program, including the beryllium sensitization screening component.

The CDOEIRB also serves as the IRB of record for several DOE sites that do not have their own site IRB. The scope of the CDOEIRB excludes those projects that are classified, in part or in totality. These projects are overseen by a classified IRB at the DOE site or the CDOEIRB-C (when a DOE site does not have its own classified IRB or the research falls under the Strategic Intelligence Partnership Program).

Meeting dates

Most meetings are conducted via teleconference, the second Wednesday of each month, with one face-to-face meeting in the spring or fall.  Investigators should submit documents three weeks prior to the meeting that they would like to have their protocols reviewed.

Contacts:
Lindsay Motz, IRB Administrator
lindsay.motz@orau.org
(865) 574-4359

Jim Morris, PhD, IRB Chair
jemrcm@aol.com

Betsy Ellis, PhD, IRB Vice Chair
betsy.ellis@orau.org

Elizabeth White, Ex-officio; Member of DOE Management Team
elizabeth.white@science.doe.gov
(301) 903-7693

Cheri Hautala-Bateman, Ex-officio; Member of DOE Management Team
cheri.hautala-bateman@nnsa.doe.gov
(202) 586-1444 

Relevant Forms for Investigators Submitting Forms to the CDOEIRB:

• DOE Human Subjects Protection Program Plan (HRP-101)
• DOE Investigator Manual (HRP-103) 
• Consent Form Template  (HRP-502) 
• Initial Application Form/Protocol Template (HRP-503) 
• Continuing Review Application Form (HRP-585) 
• Amendment/Modification Application Form (HRP-586) 
• Required Training (HRP-422)
• Protocol Template data study (HRP-599)

Note:  Forms are available in the IRB system Library  For more information or with questions, please contact the IRB Administrator with questions.

Relevant Forms for CDOEIRB Members:

• DOE Human Subjects Protection Program Plan (HRP-101)
• Human Research Determination (HRP-310) 
• Engagement Determination (HRP-311) 
• Exemption Determination (HRP-312) 
• Expedited Review (HRP-313) 
• Criteria for Approval (HRP-314) 
• Waiver or Alteration of Consent Process  (HRP-410) and Written of Written Documentation of Consent (HRP-411) 
• HIPAA Waiver of Authorization (HRP-441) 
• Primary Reviewer Forms: Initial Review (HRP-492) | Continuing Review (HRP-493) | Modification (HRP-494)
• Modification of the Human Environment (HRP-421) 
• Required Training (HRP-422)
• Protecting Employees who want to participate in research (HRP-423)
• Reviewing Protocols that use PII (HRP-490)

Note:  Forms are available in the IRB system Library.  For more information or with questions, please contact the IRB Administrator.

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The CDOEIRB-Classified
The CDOEIRB-Classified (C), which was established in 2012, serves as DOE’s IRB of record for all human subjects research conducted at/by DOE sites through the Strategic Intelligence Partnership Program (regardless of whether this research is classified or not).  This IRB also serves as the IRB of record for other types of human subjects research that is classified (in part or totality) from sites that do not have a cleared IRB, as well as for classified protocols that involve multiple DOE sites.
In addition to the regulations under which DOE IRBs operate, including DOE Order 443.1B, Chg. 1, both the CDOEIRB-C and the classified IRBs at DOE sites operate under additional requirements specified in DOE N 443.1.

Meeting dates and deadlines

Meetings are scheduled monthly, generally on the fourth Wednesday of the month.  Investigators should submit documents three weeks prior to the meeting that they would like to have their protocols reviewed.

Contacts

Barbara Brown, IRB Administrator
barbara.brown@doe.gov
(202) 586-2858

Cheri Hautala-Bateman, Co-Chair
cheri.hautala-bateman@nnsa.doe.gov
(202) 586-1444

Elizabeth White, Co-Chair
elizabeth.white@science.doe.gov
301-903-7693

Relevant Forms for CDOEIRB-C Investigators

• DOE Human Subjects Protection Program Plan (HRP-101)
• DOE Investigator Manual (HRP-103)
• Consent Form Template  (HRP-901) 
• Initial Application/Protocol Template (HRP-900) 
• Continuing Review Application Form (HRP-917) 
• Amendment/Modification Application Form (HRP-918)
• Required Training (HRP-422) 
• Protocol Template data study (HRP-922)

Note:  Forms are available in the IRB system Library.  For more information or with questions, please contact the IRB Administrator.

Relevant Information and Forms for CDOEIRB-C Members

• DOE Human Subjects Protection Program Plan (HRP-101)
• Human Research Determination (HRP-310)
• Engagement Determination (HRP-311)
• Criteria for Approval (HRP-314) 
• Modification of the Human Environment (HRP-421)
• Required Training (HRP-422)
• Protecting Employees who want to participate in research (HRP-423)
• Reviewing Protocols that use PII (HRP-490)
• Reviewer Forms: Initial Review (HRP-903)  | Continuing Review (HRP-904)  Modification (HRP-905)

Note: Forms are available in the IRB system Library.    For more information or with questions, please contact the IRB Administrator.