DOE Human Subjects Protection Program

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Participating DOE Laboratories and Sites

Pacific Northwest National Laboratory

Pacific Northwest National Laboratory (PNNL) is operated for DOE by Battelle Memorial Institute of Columbus, Ohio. PNNL also conducts research and development for other government agencies and the private sector.

PNNLs main campus is located in Richland Washington. PNNL also has operations in Sequim, Washington; Seattle, Washington; Portland, Oregon; and Washington, D.C. The PNNL Human Research Protection Program (HRPP) applies to all PNNL operations and employees

PNNL, established in 1965, has a research business volume of 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. 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. The PNNL mission is focused in four areas:

• Strengthen U.S. Scientific Foundations for Innovation
• Increase U.S. Energy Capacity and Reduce Dependence on Imported Oil
• Prevent & Counter Terrorism and the Proliferation of Weapons of Mass Destruction
• Reduce the Environmental Effects of Human Activities and Create Sustainable Systems

Current human subjects research at PNNL includes laboratory analysis of human-derived materials at the molecular level, such as proteomics, to support health-related research in a variety of areas; development of non-invasive screening technologies for national security purposes; investigation of human perceptions and responses to environmental changes; and development of biomarkers in mammalian systems.

The PNNL IRB has the responsibility for identifying and reviewing all human research activities conducted by or involving PNNL or its employees to assure that the research is justifiable and that all human participants are protected from unnecessary harms and risks. PNNL IRB authority extends to visiting scientists and to research conducted externally by PNNL staff under collaborative agreements.

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 PNNL IRB is also fully accredited by the American Association of Human Research Protection Programs (AAHRPP).

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 ongoing reviews of standard medical screening protocols, informational materials, and consent forms for clarity and consistency.

Content reviewed: September 11, 2008