DOE Human Subjects Protection Program

Participating DOE Laboratories and Sites

Regulations, Orders,
and Policies

DOE Human Subjects Resources

Other Resources

Community IRB Members

DOE Worker
Health-Related Studies and Programs

Scientific Integrity

Contract Acknowledgement

Participating DOE Laboratories and Sites

Pacific Northwest National Laboratory

Pacific Northwest National Laboratory (PNNL) is a component of the U.S. Department of Energy (DOE) national laboratory system. Battelle Memorial Institute (Battelle) of Columbus, Ohio, operates PNNL for DOE. Along with its work for DOE, PNNL conducts research and development for other government agencies and the private sector from its location in Richland, Washington. 

The main PNNL campus in Richland is augmented by associated facilities that include the Marine Research Operation in Sequim, Washington, and offices in Seattle, Washington; Portland, Oregon; and Washington, D.C.  For the purposes of this application, the DOE and Battelle efforts will be designated from here on out as the Pacific Northwest National Laboratory (PNNL) and the PNNL Human Research Protection Program (HRPP) applies to all facilities assigned to PNNL.

PNNL, established in 1965, conducts a wide range of research and development projects for government and industrial clients, amounting to more than $745 million annually. PNNL’s roots extend back to the 1940s and the early laboratories at the U.S. government’s Hanford Site. These laboratories performed vital functions as America pursued atomic capabilities in the 1940s, and continued to support the production of plutonium for the nation’s weapons needs for many years afterward. 

While PNNL ties to the Hanford Site were cut in 1965 when PNNL became a separate entity, it continued to provide research and development support to Hanford for many years, though more recently the funding in this area has decreased significantly. Today, PNNL is a diverse research organization with multiple funding sources and a strong footing in both fundamental and applied areas of science and engineering.  

PNNL recognizes that research and development cannot be successfully conducted without a talented workforce and a strong commitment to operational excellence.  The commitment to operational excellence includes an emphasis on ethical behavior; workplace safety; protection of employees, the environment, and surrounding community; security; and quality customer service.  PNNL has received national recognition for its operations practices, and continuously seeks to maintain and nurture a culture focused on protecting people and the quality of life.

The Battelle, DOE, and PNNL missions, visions, values, and strategic direction—and particularly the focus on operational excellence—clearly extend to, guide, and align with PNNL’s Human Research Protection Program. While the HRPP supports the advancement of science, its primary focus is on protecting the rights, welfare, and dignity of human research subjects. PNNL ensures that a fair and explicit process exists that allows those subjects to participate in research based on an intelligent and knowledgeable understanding of the risks and benefits that may accrue to them or to society as a result of their participation in that research.

The PNNL Institutional Review Board (IRB) was established in 1967 in response to concerns regarding prisoner studies that PNNL inherited from a previous DOE contractor, General Electric. 

Other research involving human subject activities has been conducted for over 40 years at PNNL, originally involving the effects of radiation on workers at the adjacent Hanford Site. Research conducted at PNNL has evolved considerably over the last 40 years. Today human subject activities might extend to contemporary research disciplines, such as proteomics, as well as inquiries at the molecular level where human-derived materials such as nipple aspirant fluid, for example, are used in cancer-related research. 

In response to our client’s evolving needs, PNNL recently established a second IRB to review classified human subject research. The Classified IRB (CIRB) is subject to the same policies and procedures as the regular IRB except for the security measures and protections that must be established.

The PNNL IRB is registered and is assured under the Federal-Wide Assurance (FWA) that Battelle holds with the National Institutes of Health.  To ensure compliance with the requirements of the FWA, as well as Battelle human subject policies and procedures, the PNNL IRB works closely with the Battelle Office of Research Administration (ORA) and the other IRBs included in the FWA.

The Director of PNNL, who also serves as Institutional Official (IO) for the Laboratory, is responsible for the PNNL HRPP. The IO delegates the appropriate authority to the IRB for the review and oversight of all human subject-related research activities conducted by PNNL research staff, regardless of their location or funding source.  For instance, associated facilities at Sequim, Seattle, Portland, and Washington, D.C., are subject to the same PNNL human subject policies and procedures.  IRB authority extends to visiting scientists and externally conducted collaborative research, as well.

Also of note is the Nationwide Medical Screening Program, a subset of the Former Worker Medical Surveillance Program conducted for interested former workers from the Hanford and 18 other DOE sites and sponsored by the DOE Office of Health, Safety and Security (HS-15). The PNNL IRB conducts initial and ongoing reviews of standard medical screening protocols, informational materials, and consent forms for clarity and consistency.

Content reviewed: June 25, 2007