Institutional Review Boards (IRBs)

There are two central IRBs within DOE:

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 reviewed by one of the central DOE IRBs (CDOEIRB or CDOEIRB-C) or, in some cases, by a local university IRB. 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.


DOE Site

IRB Used

Contacts

Ames LaboratoryExternal link

Site

Julia Sager

Argonne National LaboratoryExternal link

CDOEIRB(s)*

Dan Schabacker
Lindsay Motz
Barbara Brown

 

Brookhaven National LaboratoryExternal link                                                           

 

CDOEIRB(s)*

 

Darcy Mallon
Lindsay Motz
Barbara Brown

East Tennessee Technology ParkExternal link

SiteExternal link

Lindsay Motz

 

Fermi National Accelerator LaboratoryExternal link

 

CDOEIRB*

 

Tom Kroc
Lindsay Motz

 

Idaho National LaboratoryExternal link

 

Site
CDOEIRB-C*

 

Dena Tomchak
Barbara Brown

Kansas City Plant / National Security CenterExternal link

CDOEIRB(s)*

Lindsay Motz
Barbara Brown

Lawrence Berkeley National LaboratoryExternal link

SiteExternal link

Dianna Bolt

Lawrence Livermore National LaboratoryExternal link

SiteExternal link
CDOEIRB-C*

Ann-Marie Dake
Barbara Brown

Los Alamos National LaboratoryExternal link

Site
CDOEIRB-C*

Judy Noles
Barbara Brown

National Renewable Energy LaboratoryExternal link

CDOEIRB*

Lindsay Motz

 

Oak Ridge Institute for Science and EducationExternal link

 

SiteExternal link

 

Lindsay Motz

Oak Ridge National LaboratoryExternal link

SiteExternal link
CDOEIRB-C*

Leigh Greeley
Barbara Brown

Pacific Northwest National LaboratoryExternal link

Site
CDOEIRB-C*

Susan Varnum
Barbara Brown

Sandia National LaboratoriesExternal link

Site
CDOEIRB-C*

Craig Nimmo
Barbara Brown

Thomas Jefferson National Accelerator FacilityExternal link

CDOEIRB*

Walter Chandler
Lindsay Motz

 

Savannah River SiteExternal link

 

CDOEIRB*

 

Karen Brown
Lindsay Motz

 

Y-12 National Security Complex

 

SiteExternal link

 

Lindsay Motz

Multiple DOE Sites+

CDOEIRB(s)*

Lindsay Motz
Barbara Brown

Projects Conducted Under the Strategic Intelligence Partnership Program

CDOEIRB-C*

Barbara Brown

Legend:
* CDOEIRB(s) = Central DOE IRB (CDOEIRB) and/or the CDOEIRB-C
+ Studies that are being performed by 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.

Following are the scheduled meeting dates for the remainder of calendar year 2018:

September 12, 2018 (Application due by August 22, 2018)
October 10, 2018 (Application due by September 22, 2018)
December 12, 2018 (Application due by November 21, 2018)

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

Mary Fields, Ex-officio; Member of DOE Management Team
mary.fields@hq.doe.gov
(301) 903-1613

Relevant Forms for Investigators Submitting Forms to the CDOEIRB:

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

Note:  Forms are available in the IRB7 Library and will also be available soon by clicking on the above links.  For more information or with questions, please contact the IRB Administrator with questions.

Relevant Forms for CDOEIRB Members:

  • DOE Human Subjects Protection Program Plan (101)
  • Standard Operating Procedures 
  • Human Research Determination (310) 
  • Engagement Determination (311) 
  • Exemption Determination (312) 
  • Expedited Review (313) 
  • Criteria for Approval (314) 
  • Waiver or Alteration of Consent Process  (410) and Written of Written Documentation of Consent (411) 
  • HIPAA Waiver of Authorization (441) 
  • Primary Reviewer Forms: Initial Review (492) | Continuing Review (493) | Modification (421)
  • Modification of the Human Environment (421) 
  • Required Training (422)

Note:  Forms are available in the IRB7 Library and will also be available soon by clicking on the above links.  For more information or with questions, please contact the IRB Administrator.
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The CDOEIRB-C
The CDOEIRB-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 third Wednesday of the month.

Following are the scheduled meeting dates for the remainder of calendar year 2018:

September 19, 2018 (Application due by August 29, 2018)
October 17, 2018 (Application due by September 26, 2018)
November 21, 2018 (Application due by October 31, 2018)
December 19, 2018 (Application due by November 28, 2018)

Contacts

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

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

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

Relevant Forms for CDOEIRB-C Investigators

  • DOE Human Subjects Protection Program Plan (101)
  • Investigator Responsibilities (103)
  • Consent Form Template  (901) 
  • Initial Application/Protocol Template (900) 
  • Continuing Review Application Form (585) 
  • Amendment/Modification Application Form (586)
  • Required Training (422) 

Note:  Forms are available in the IRB7 Library and will also be available soon here.  For more information or with questions, please contact the IRB Administrator

Relevant Information and Forms for CDOEIRB-C Members

  • Standard Operating Procedures 
  • DOE Human Subjects Protection Program Plan (101)
  • Human Research Determination (310)
  • Engagement Determination (311)
  • Criteria for Approval (314) 
  • Modification of the Human Environment (421)
  • Required Training (422)
  • Reviewer Forms: Initial Review (903)  | Continuing Review (904)  Modification (905)

Note: Forms are available in the IRB7 Library and will also be available by clicking on the above links soon.    For more information or with questions, please contact the IRB Administrator.

Last modified: 9/12/2018 11:19:33 AM