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 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 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

University of Chicago or CDOEIRB(s)*

Gail Van Gorp
Lindsay Motz
Terri Loveless

Brookhaven National LaboratoryExternal link

Stony Brook IRBExternal link

Darcy Mallon

East Tennessee Technology ParkExternal link

SiteExternal link

Lindsay Motz

Fermi National Accelerator LaboratoryExternal link

CDOEIRB *

Tom Kroc
Lindsay Motz

Idaho National LaboratoryExternal link

Site

Dena Tomchak

Kansas City Plant / National Security CenterExternal link

CDOEIRB(s) *

Lindsay Motz
Terri Loveless

Lawrence Berkeley National LaboratoryExternal link

SiteExternal link

Chris Byrne

Lawrence Livermore National LaboratoryExternal link

SiteExternal link or CDOEIRB-C

Ann-Marie Dake
Terri Loveless

Los Alamos National LaboratoryExternal link

Site or CDOEIRB-C

Judy Noles
Terri Loveless

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 linkor CDOEIRB-C**

Leigh Greeley
Terri Loveless

Pacific Northwest National LaboratoryExternal link

Site or CDOEIRB-C

Susan Varnum
Terri Loveless

Sandia National LaboratoriesExternal link

SiteExternal link

Craig Nimmo
Terri Loveless

Thomas Jefferson National Accelerator FacilityExternal link

CDOEIRB *

Walter Chandler, MD
Lindsay Motz

Savannah River SiteExternal link

CDOEIRB *

Karen Brown
Lindsay Motz

Y-12 National Security Complex

SiteExternal link

Lindsay Motz

Multiple Sites+

CDOEIRB(s) *

Terri Loveless (CDOEIRB-C)
Lindsay Motz (CDOEIRB)

Projects Conducted Under the Strategic Intelligence Partnership Program

CDOEIRB-C

Terri Loveless

Legend:
* CDOEIRB(s) = Central DOE IRB and CDOEIRB-C
** CDOEIRB-C = Central DOE IRB- Classified
+ 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 IRBs. 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.

Meeting dates

Most meetings are conducted via teleconference, the last Thursday of each month, with one face-to-face meeting in the spring or fall.

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) 586-0142

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:

  • Investigator Responsibilities (103) 
  • Consent Form Template (502) 
  • Initial Application/Protocol Template (503) 
  • Continuing Review Application Form (212) 
  • Modification Application Form (213) 

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 with questions.
Relevant Forms for CDOEIRB Members:

  • Membership List 
  • Standard Operating Procedures 
  • Human Research Determination (310) 
  • Engagement Determination (311) 
  • Exemption Determination (312) 
  • Expedited Review (313) 
  • Criteria for Approval (314) 
  • Waivers of Consent (410) and Written Documentation of Consent 
  • HIPAA Waiver of Authorization (441) 
  • Primary Reviewer Forms: Initial Review (203) | Continuing Review (204) | Modification (205)
  • Modification of the Human Environment (421) 

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.
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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.

Membership list – will be updated soon

Contacts

Terri Loveless, IRB Administrator
terri.loveless@doe.gov
(202) 586-1713

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

Stephen Nester, Vice Chair
Stephen.nester@doe.gov

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

Relevant Forms for CDOEIRB-C Investigators

  • Consent Form Templates (502 or 901) 
  • Initial Application/Protocol Template (503 or 900) 
  • Continuing Review Application Form (212) 
  • Modification Form (213) 

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 
  • Criteria for Approval (314) 
  • Primary Reviewer Forms: Initial Review (903)  | Continuing Review (904)  Modification (905)                                                                  

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

Last modified: 3/16/2017 11:59:14 AM