Program Assessment and Oversight

Photo of researcher looking through a microscope

To ensure continued improvement of PNNL's Human Research Protection Program (HRPP), a variety of program assessments are performed by internal and external means, some of which are regularly scheduled and others which are conducted on a more random basis. For instance,

In 1998 the Department of Energy invited 10 nationally recognized experts to participate in an intensive 2-day program review.
The Battelle Memorial Institute Office of Research Administration has performed 4 program assessments over the last 7 years, most recently in May of 2005. The ORA conducts a yearly meeting with the three Battelle IRBs to assess overall performance and discuss plans for continued program improvement.
As part of the Legal Department, the Institutional Review Board (IRB) participates in a yearly strategic planning exercise by reviewing program performance and assessing future IRB, financial and staff resource requirements.
Informal self-assessments are conducted by the IRB Program Manager and the IRB Administrative Team to prepare for the internal and external assessments noted above and to assure that the composition and membership of the IRB meet PNNL needs for technical expertise and federal requirements for IRB membership [45 CFR 46.107].
Preparations for accreditation which are currently underway with the Association of Human Research Protection Programs, Inc. (AAHRPP) require an in-depth and comprehensive self-assessment of the overall PNNL HRPP. Efforts to achieve accreditation will require involvement of IRB members, the Institutional Official, investigators, their staff and management, subjects and in some instances, research sponsors.
IRB policies, procedures, forms and approach to community outreach are constantly scrutinized to evaluate their effectiveness, efficiency and suitability and to ensure that they reflect current regulations, guidance and institutional requirements.
While the IRB does not, as a matter of practice, conduct outreach activities in the local community, it does subscribe to the monthly HRPP Web Site Hits Report which measures the internal and external use and effectiveness of the HRPP web site as a part of its ongoing program assessement.