The U.S. Department of Energy (DOE) is committed to the protection of human research participants in all research funded by DOE, conducted at DOE institutions, and performed by DOE employees or their contractors. Now the Association for the Accreditation of Human Research Protection Programs (AAHRPP) has conferred full accreditation to the DOE Human Subjects Protection Program, acknowledging it and DOE’s two Central Institutional Review Boards (IRB) for excellence in human subject protection.
For more than 30 years, ORISE has provided technical assistance to the DOE Human Subjects Protection Program, and most recently, played an integral role in the successful accreditation.
“With only about 300 organizations worldwide fully accredited by the AAHRPP, this a significant accomplishment for the DOE program,” said Central DOE IRB Vice Chair and ORISE employee Betsy Ellis. “It was a large group effort and we were delighted to be part of this milestone that will further extend public trust and confidence in DOE’s human subject research.”
The process began nearly two years ago with a rigorous self-assessment that evaluated DOE’s compliance with the AAHRPP accreditation standards and identified process improvements. The initial application package, which included the self-assessment, totaled more than 1,000 pages and provided policies, procedures, and practices that demonstrated DOE’s commitment to scientifically and ethically sound research. ORISE and DOE then received feedback from the accrediting body and revised any human research policies and procedures accordingly before resubmitting the updated application package.
The on-site evaluation was the next step of the accreditation process. ORISE staff led the effort to coordinate logistics and the meeting schedules for AAHRPP officials in Washington, D.C., who wanted to interview DOE IRB staff members and researchers located across the country in three different time zones. It was during the interviews that the AAHRPP evaluated DOE’s program performance against the AAHRPP accreditation standards, a process that occurred over the course of two days. AAHRPP’s Council on Accreditation reviewed the application, draft site visit report, and responses provided by ORISE, DOE and IRB staff. Then on Dec. 16, 2019, the AAHRPP approved full accreditation of DOE’s Human Subjects Protection Program.